Professional Documents
Culture Documents
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Resource Guide
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by
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Carole Kantor
Denise L. Brown
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Published by
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Cleveland, Ohio
Functional Electrical Stimulation (FES) Resource Guide for Persons with Spinal Cord Injury or Multiple
Sclerosis
All rights reserved. No reproduction or transmission of any part of this work is permitted without the
ISBN 1-888470-03-8
Published by:
FES Information Center, 11000 Cedar Avenue, Cleveland, Ohio 44106-3052; Phone: (216)231-3257;
FAX (216)231-3258. The FES Information Center is part of the Cleveland FES Center, a consortium on
functional electrical stimulation including the Cleveland VA Medical Center, Case Western Reserve
While every effort has been made to ensure the reliability of the information presented in this publication,
the FES Information Center neither guarantees the accuracy of the data contained herein nor assumes
any responsibility for errors, omissions, or discrepancies. The FES Information Center accepts no
payment for listing; and inclusion in the publication of any organization, agency institution, publication,
service or individual does not imply endorsement by the authors or publisher. Errors brought to the
attention of the publisher and verified to the satisfaction of the publisher will be corrected in future editions.
CONTENTS
Acknowledgments .............................................................................................................................................. i
Introduction ........................................................................................................................................................ ii
How DOES FES OVERCOME PARALYSIS AND ITS RELATED PROBLEMS? ................................................................ 2
WHAT FES SYSTEMS ARE AVAILABLE? ................. ,',."., ................... ,...... ,........................................................... 7
WHAT FES APPLICATIONS CAN BENEFIT PEOPLE WITH SPINAL CORD INJURY? ............................... 11
SCI-5. FES systems for bladder and bowel control, ................................................................................ ,..... 21
WHAT FES APPLICATIONS CAN BENEFIT PEOPLE WITH MULTIPLE SCLEROSIS? ............................. .46
--
--
Argentina, Australia, Austria, Brazil, Canada, Denmark. France. Germany, Iceland. Israel. Italy.
204
iACknOWledgments
The authors wish to extend thanks: to lynn (Phillips) Bryant, Director of ABlEDATA, for her advice
and editorial assistance; to the National Spinal Cord Injury Association for their assistance with the
consumer evaluation of this publication; to our Technical Review Committee for their
knowledgeable review of the text; to our Community Advisory Committee for their guidance
throughout the project; and to the Buckeye Chapter, Paralyzed Veterans of America (PVA) and the
PVA Spinal Cord Injury Education and Training Foundation for their financial support of this project.
ii
ilntroduction
This book has been written for persons with spinal cord injury or multiple sclerosis, their families,
and the health care professionals who work with them. The book contains information on the use of
functional electrical stimulation (FES) to maximize health and function for people with these spinal
cord dysfunctions.
Although this book is specifically for people living in the United States, residents of other
countries will likely find it useful because the information was gathered from medical and
rehabilitation experts across the world. The material is current as of spring 1995. We expect to
provide supplements periodically as new developments occur. See the order form on the last page.
What is FES?
What FES applications can benefit people with spinal cord injury (SCI)?
What FES applications can benefit people with multiple sclerosis (MS)?
and
Spinal cord injury (SCI) or multiple sclerosis (MS) can produce total or partial paralysis. The person
who has one of these conditions may be unable to move parts of his or her body. Breathing, blood
circulation, bladder and bowel function may also be affected. In the last 30 years, medical scientists
and engineers have invented methods and devices to assist with these problems. One technique is
called functional electrical stimulation (FES) (pronounced "ef-ee-es".) Because FES can be
applied to many different physical problems, any person with SCI or MS may want to investigate
FES as a treatment option.
FES is a method of applying low level electrical currents to the body to restore or improve
function. A heart pacemaker is one example of an FES system. Other types of FES may restore
lost abilities such as standing or grasping. Also, FES may assist with some secondary problems of
paralysis such as poor blood circulation or slow wound healing. When used in these ways, the
treatment may simply be called electrical stimulation or ES.
It is important to understand that FES is not a cure for spinal cord injury or multiple
sclerosis. FES is an assistive device. For people with a complete spinal lesion, FES provides
benefits only when the system is operating. When the system is turned off, the benefits will
disappear. People with an incomplete spinal lesion or multiple sclerosis may be able to use FES
to recall some amount of voluntary muscle function, so that when the FES system is turned off. the
user may still receive benefits. This is a therapeutic benefit of FES. FES itself does not reverse
paralysis. Finally. people with certain types of nerve damage cannot be helped by FES. Despite
the limitations. one of the exciting things about FES is that improvements in function are possible
for people of any age and any duration, level, or completeness of injury. Many FES techniques are
still experimental. Yet. they hold real promise for helping people with paralysis. For some
individuals. FES can improve physical and emotional health in ways that cannot be achieved with
other methods available today.
-
-
Brain - __
Upper Motor Neuron
Lower Motor Neuron
Spinal Cord
Muscle
--
Electrical pulses applied to the nerve or muscle will face the same barrier faced by the normal
signals from the brain. This happens in peripheral nerve disorders or injuries, in diseases of the
nerve-muscle junction, and in muscle diseases. Recently, researchers have started to design
special stimulation equipment to activate denervated muscle directly and bypass the damaged
peripheral nerve. The biggest problem is that the muscle fatigues and gets weak very quickly.
Multiple sclerosis (MS) also produces problems in transmission of nerve signals. While
SCI is caused by a physical insult, MS is caused by degrading of the natural insulation on nerves.
Depending on where this happens, the symptoms can vary from weakness and numbness to eye
problems and dizziness.
The ideal solution to neurological problems such as these is regeneration. It involves
causing the central nervous system to grow new neurons to replace the ones that are injured or
sick. Scientists who are working on this problem are doing basic research about how cells and
nerves grow. They are studying cells and animals to learn more about nerve cell growth in humans.
Some experiments are looking at the possible benefits of electrical stimulation applied very shortly
after injury to the spinal cord. We all hope that someday FES won't be needed anymore because
regeneration will have solved the problem of paralysis. But, that day is many years in the future.
Today, we have more than a dozen applications of FES to improve health and function,
such as for improving circulation, and for moving muscles. When FES is used to move parts of the
body, it may also be called FNS or functional neuromuscular stimulation. Such FES/FNS
applications include:
cardiovascular exercise
breathing assist
grasping and reaching
transfers and standing
stepping and walking
bladder and bowel function.
Sometimes the primary purpose of FES does not involve moving muscles. Then, it may be
called simply electrical stimulation (ES), TENS (transcutaneous electrical nerve stimulation) or
electrotherapy. In such cases, the primary purpose may be to prevent or treat problems that arise
because of SCI or MS. These problems are called secondary complications and they include:
male sexual dysfunction (inability to have an erection or ejaculate)
blood clots (deep venous thrombosis)
pressure sores
spasticity (uncontrolled contraction of muscles that causes stiff awkward movement)
contractu res Ooints that cannot open fully)
loss of bone mineral (osteoporosis)
weakening and shrinking of muscles due to inactivity (atrophy)
tremor (shaking that occurs continuously or whenever a voluntary movement is made).
When FES is used for these problems, two effects can occur. One is muscle contraction and the
second is electrical current in the affected tissues, without muscle contraction. These effects are
sometimes called therapeutic electrical stimulation.
Together with heart pacemakers, electrical stimulation (ES) devices for pain control are the
most widely available ES devices. Because so much information is already available, this book
does not deal specifically with ES for pain. Neurologists, doctors who specialize in the nervous
system, often prescribe ES for pain that cannot be treated otherwise. Pain control may include
many other treatment methods such as medication, psychological therapy, and acupuncture. See
Part 3. MORE RESOURCES ON FES for information on ES for treating pain.
Inn
The picture below shows 18 different ways that FES can be used to help someone with a
spinal cord dysfunction.
1. Cardiovascular Exercise
,
,
I
2. Breathing Assistance
17. Restoring Sensation
3. Cough Assistance
4. Grasping &
Reaching
4. Preventing I Treating
~. Osteoporosis
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8. Erection &
Electroejaculation
11. Treating Pressure Sores
9. Improving Circulation
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How does FES technology work?
The main components of an FES system are the electrodes, the stimulator, and sensors or
switches. When FES is being used to move muscles, current pulses in the electrodes cause the
weakened or paralyzed muscles to contract. In other applications, currents in the electrodes may
simply produce electrical currents in the tissues without moving any muscles. The stimulator
controls the strength and timing of the low-level pulses that flow to the electrodes. The sensors or
switches control the starting and stopping of the pulses supplied by the stimulator.
Electrodes
Electrodes may be applied to the skin daily or they may be implanted in the body. Skin surface
electrodes are made of a flexible material such as rubber that conducts electricity. Tiny electrical
currents are sent through the electrode to the skin and the tissues beneath the skin. Some surface
electrodes are applied with a conductive gel. Others are self adhesive. Both types may be
reusable. Surface electrodes are widely used in therapeutic electrical stimulation for rehabilitation of
injury or weakness. It is convenient to simply apply electrodes to the skin surface. But, daily
application of the electrodes can be time consuming. Stretchable garments with electrodes already
mounted in appropriate locations have been developed by several manufacturers to simplify the
process.
Surface electrodes have some drawbacks. Because they are separated by skin and fat from
the underlying muscles and nerves, surface electrodes cannot make individual muscles active.
Instead, they stimUlate groups of muscles. Therefore the desired action may be more difficult to
achieve. Also, the muscle stimulation may vary from day to day because of differences in
placement of the electrodes. Sometimes, the skin may be irritated or burned by the electrode gel or
the electrical current itself. In people who retain feeling, there is a possibility of discomfort because
the stimUlation may accidentally activate pain nerve fibers. Researchers are developing new
stimulation equipment that avoids pain nerve activation.
Implanted electrodes are located inside the body and avoid the need for daily application.
They provide selective stimulation of particular muscles with lower current levels. But, a drawback
is the need for surgery to place the electrodes or replace them if necessary. They are also more
expensive to produce. Implanted electrodes may be fine wire coils inserted in muscles
(intramuscular electrodes), flat metal foils placed against the spinal cord or muscle surfaces
(epimysiaI electrodes), or soft cuffs of rubber and metal foil that surround nerves (nerve
electrodes).
Leads, Stimulators and Sensors
Electrodes are connected to a stimulator by insulated wires called leads. The stimulator sends
electrical pulses through the leads and to the electrodes where the electrical charge is delivered to
the nerve, muscle or other tissue. Most stimUlators are external units that can be as small as a
calculator or as large as a computer workstation. Usually, a stimulator has a computer controller
built into it. Each stimulation channel sends pulses to one or more electrodes.
Electrodes
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Leads
Instructions
OFF
Controller
Stimulator
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-ryPulse
Stimulation Unit
More advanced systems have implanted electrodes and also may have implanted
stimulators. Implanted electrodes and their leads can be completely inside the body or the leads
may pass through the skin (percutaneous leads) and connect to an external stimulator. The
surgery for implanting an FES stimulator is similar to that used in implanting a heart pacemaker.
The electrodes are connected to the stimulator inside the body. The stimulator has a built-in radio
receiver that receives command signals from an external control unit. See the pictures on pages
12, 15, 18, 27, and 41 for examples of different FES system components.
Sensors are electronic or mechanical devices that measure some feature of the
environment and send information about it back to the stimulator-controller. The controller uses the
information to adjust the stimulation. Sensors include the switches that the FES user operates to
start and stop the system. Some systems also have switches that allow the user to select from a
menu of choices. Some sensors are built into braces or shoes to detect the angle at a joint or the
pressure when weight transfers onto a foot. These are all man-made, or artificial, sensors.
Researchers are also working on using natural sensors by recording signals from the sensory
nerves in the body.
One of the important senses we use in movement and posture is proprioception. This
means knowing where the parts of our bodies are. For example, natural sensors in the area of the
knee joint tell you the position of your leg even when you cannot see it. In complete SCI, the
sensory nerve pathways are interrupted and cannot convey information about limb position to the
brain. Some FES systems use an angle sensor to get information on limb position. This electronic
device is strapped to the limb, it measures joint angle, and sends that information to the controller.
The controller then adjusts the stimulation levels according to the desired task.
To be truly practical, an FES system needs to correct for changes in the environment and
day-to-day changes in the user's body. This requires a feedback method that can adjust the
stimulation so that it accomplishes the desired movement. Examples of adjustment goals are to
give the best grasp force for a particular object or the best walking step length for a particular floor
surface. Some forms of feedback are already built into FES devices. For example, some FES
walking systems use pressure sensors in the shoes that signal the controller when a step is
completed.
Feedback information, whether it comes from artificial or natural sensors, has many
benefits. It can make the FES user aware of the FES system's status and how well it is performing.
It can help the control system to adjust to changing conditions. That adjustment may reduce muscle
fatigue. FES exercise can push muscles to their limit even sooner than would occur with normal
muscle contractions. The resulting fatigue is an ongoing problem with some types of FES. FES
systems with feedback also require less attention from the users. Developing such systems is an
important goal.
Factors that determine what an FES system can do
When a person participates in a research project, we refer to her or him as a "subject." When a person with a disability
is receiving medical or surgical care, we refer to her or him as a "patient." Sometimes we refer to the person with a
disability as a "consumer" of an FES product or service.
The development of FES systems can be divided into four progressive stages as shown in
the table on page 10: basic research, clinical feasibility studies, multicenter clinical trials, and
regulatory approval. Basic research includes testing using animals and computers. Clinical
feasibility studies are the first tests of a system, involving only a small number of human subjects.
Usually, such tests are conducted at a single location. In some studies there are no costs to the
subjects.
In the third stage of development, researchers conduct multicenter clinical trials. They
collect the same type of information at all the participating clinics and involve many more subjects.
Such stUdies are designed to gather information about the safety and effectiveness of new devices.
All testing on human subjects in the United States is governed by investigational device exemptions
(IDE) that are granted by the FDA. Naturally, other countries have their own regulations for
approval of medical devices. Often, devices are approved in other countries before they receive
FDA approval. Each facility that offers an investigational device is monitored by its own Institutional
Review Board (IRB). The IRB makes sure that subjects are fully informed about any risks or
benefits of the system that is being tested by ensuring that the subject signs an accurate informed
consent form.
When multicenter trials produce satisfactory results, the device is approved by FDA and can
then be distributed commercially. If a new device is very similar to a device already approved by
the FDA, the manufacturer may be granted approval without having to conduct multicenter trials. At
this stage, the FES application has achieved regulatory approval. It is commercially available, and
may be covered by some insurance carriers. However, it is always up to a patient's doctor to
determine if a particular device or treatment is suitable for that patient.
Some FES systems are commercially available only outside the US. The tables in this part
of the book indicate that those systems have achieved regulatory approval and shows in which
countries they are available. The FDA is usually more strict than the regulatory agencies of other
countries. As a result, the same device may be investigational in the US but approved elsewhere.
Even if an FES device is FDA-approved and commercially available, many factors affect
how widely it will be used. These include how complex it is to select the people to use the system,
how easy it is to use, its appearance and cost, how long the user must train to use it effectively,
and how well it compares to other available alternatives. There may be a shortage of doctors and
therapists who know how to select people, apply the system, and train the users. Third party payers
like Medicare or private insurance companies may be reluctant to provide reimbursement. Some
FES applications may never be widely available because of the small numbers of people who can
benefit and the complexity of the treatment.
The table on page 10 shows the development stage and availability (limited, restricted or
wide) of FES systems. The key that precedes the table provides a detailed explanation of the terms
used in the table. Each of the numbered rows names an FES application. Each column heading
names a stage of development or a degree of availability. In the box where a row and column meet,
we show the activity that exists today for the application named at the left of the row. SCI refers to
spinal cord injury. MS refers to multiple sclerosis. For example, on line 5, bladder and bowel
control, "SCI, MS" under the column headed "feasibility studies" indicates that small FDA-approved
studies are underway with people who have SCI or MS. Under the column headed "regulatory
approval, non-US", "SCI, MS" indicates that systems are approved and commercially available
outside the US for people with SCI or MS. The table also indicates that the availability of this type
of system is "restricted" for people with SCI or MS, meaning that there are only a few places in the
US providing this type of FES.
--
Applications may have activity in more than one stage, usually indicating that alternative
techniques are being investigated. See the corresponding numbered sections, beginning on page
11, for a description of each application (for example, SCI-3 for information on FES for cough
assistance). SCI applications are grouped together. MS applications follow them. See Part 2,
WHERE TO GET FES, for information about specific FES programs that provide people with
devices and training.
While FES may help many people in the future, today many FES applications are still
experimental. This becomes clear when you page through the SCI and MS applications on the
following pages. Anything that is not in the column headed regulatory approval is experimental, or
investigational. Even for most of the approved FES applications today, there is no general
agreement within the medical community that they are the preferred treatment. Education about
and training of health care providers in FES methods will help to make them more widely available
to interested consumers. Be sure to let your clinicians know that this book and other resources are
available to rehabilitation professionals who seek education and training about FES.
Development Stage
Basic Research: Usually means computer modeling or animal experimentation.
Clinical Research:
Feasibility Study: Study to prove that the treatment is effective and safe for a small
number of individuals, typically up to 20.
Multicenter trial: Identical studies conducted at multiple clinics with a sizable total
number of individuals, typically 50 -100. The goal is collection of data on safety and
effectiveness that will be adequate for regulatory approval.
Regulatory Approval: The FDA, in the US, has reviewed the data of multicenter trials
and agrees that the documentation and data support the manufacturer's claims of safety
and effectiveness. This does not mean that all clinicians agree that the treatment is safe
and effective and preferred over other alternatives. In other countries, the counterpart
agency to FDA has reviewed results of clinical studies and granted approval for marketing
of the device.
Clinical Availability (includes availability in clinical research centers as part of feasibility or
multicenter studies, mayor may not be approved by FDA)
Restricted: Available in only a few (1-6 centers in the US) specialized rehabilitation
centers or clinics serving persons with SCI or MS. Personnel require extensive training to
provide this treatment.
Limited: Available in some, but not all, rehabilitation centers or clinics serving persons
with SCI or MS. Personnel require specialized training to provide this treatment.
Wide I Extensive: Available in most rehabilitation centers serving persons with SCI or
MS. Personnel may require training but it is readily available.
A note on development stage and availability in countries other than the United States:
In each specific application section of this chapter, we have included a small table describing
the status of FES systems for that application. We have indicated specific types of systems
as being in basic research, clinical research or approved practice stages. Unless a country is
specified, we are referring to the US.
.....
1. Cardiovascular exercise
I SCI
2. Breathing assistance
Clinical
Regu'~tory
Researc;b
Approval.
Feasibility Multicenter
studies
trials
US
SCI
TSCI
SCI
SCI
3.
4. Grasping and reaching
SCI
SCI
SCI
SCI
SCI.MS
SCI.MS
SCI.MS
8.
SCI. MS
pressure sores
SCI. MS
SCI. MS
ing spasticity
SCI.MS
I SCI. MS I SCI. MS I
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SCI.MS
SCI,MS
ling tremor
I SCI. MS
SCI.MS
SCI
SCI
SCI
SCI
I SCI.MS
I SCI.MS
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sensation
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The picture on page 4 and the table on page 10 name 18 applications of FES that have been used
in people with spinal cord dysfunction. The sections that follow explain how each application works,
its purpose, status (availability) and cost, who is eligible, time needed for treatment, and expected
results or outcomes.
For each application, the status information is presented in a small table similar to the table
on page 10. The table indicates that the availability of the application may vary from a single
location where feasibility studies are underway to many clinics where an approved treatment and
device can be obtained. See Part 2. WHERE TO GET FES for specific details about where
particular FES treatments are available.
For each application there are also medical eligibility requirements. In addition, there are
factors which would disqualify a candidate. Many of these disqualifying factors apply to almost all
uses of FES. They include:
Heart rhythm or high blood pressure problems
Implanted pacing devices
Possible blood clots
Some types of tumors
Pregnancy
Unhealed wounds
Tendency for worsening of autonomic dysreflexia with FES.
People who have any of the conditions listed above should not use FES.
..
12
ergometer
Regulatory approval
Computer
controlled FES
exercise bicycle;
several styles
available
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13
People who were injured more than 5 years ago will need special assessment before starting an
exercise program. They can have a large loss of muscle mass, contractures, and brittle bones.
People over 40 years of age will need additional evaluation for possible heart problems.
People with the following conditions are disqualified:
History of leg fractures.
Severe spasticity.
Contractures.
Severe osteoporosis (thin, weakened bones).
See additional disqualifying factors on page 11.
1995.
What can I realistically expect today?
With consistent exercise, about two thirds of FES exercise system users can expect
Improved cardiovascular health.
Improved fitness.
Increased leg muscle strength.
Increased leg muscle bulk.
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About half to two-thirds of users feel better about their appearance. More than a quarter of users
experience less swelling of the legs. Some users report decreased secondary complications.
Despite all these possible benefits, it is important to remember that a person with complete SCI will
not regain voluntary control of the legs by using an FES bicycle system.
Some FES exercise users report increases in
Emp!oyment opportunities.
Participation in social activities.
Efficiency in activities of daily living.
14
FES exercise can increase pain in some people. This pain has caused people to stop FES
exercise. Newer equipment is designed to reduce pain from stimulation.
Supportive family and friends are a big help to the exercise system user in following a regular
exercise program.
See SCI-14 FES for preventing or treating osteoporosis for information about bicycle exercisers
and improving bone strength.
Ventilator.
Continuous, positive nasal air pressure device (CPAP)
Pneumobelt, a corset that inflates and deflates to assist movement of the diaphragm.
16
-
-
non-FES alternatives?
Positioning that helps gravity to drain lung secretions.
If secretions are heavy, suctioning.
"Assisted cough" (or "quad " cough) can be provided by a therapist or attendant. He or
she manually compresses the abdomen while the person controls the opening and
closing of the upper airway.
Mechanical negative pressure devices applied to the mouth and nose.
--
17
Multicenter
trials
Regulatory
approval
People may need some training to learn to coordinate their voluntary activity with the electrically
All devices are still in the clinical research stage. After testing and approval, systems may cost from
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The ability to cough on demand will allow the person with SCI to clear his or her breathing
passages at any time. This may reduce the number of lUng infections, shortness of breath, and
dependence on trained assistants.
See page 64, "What Should I Know When Choosing an FES Product or Service?"
18
19
Some systems have features that give the user feedback about how the system is operating. A
user may get confirmation of the system's settings through tones or beeps, or a screen display.
Another form of feedback to the user can be provided by a sensory electrode. It is implanted in
the skin of the upper chest or back, and it provides a tapping sensation to indicate how the system
is working. See SCI-17 FES for sensation for more information about sensory electrodes.
In addition to nerve and muscle locations, the surface of the spinal cord is a site where electrical
stimulation may be applied. Called spinal cord stimulation (SCS) or dorsal column stimulation,
this method is usually used to treat pain and spasticity. In some people, especially those with
incomplete injuries, it also improves hand and arm function. See SCI-11 for further information.
STATUS OF FES SYSTEMS FOR GRASPING AND REACHING
Basic research
Implantable
sensors for
control
Feedback to
prevent slip
Reaching
!
systems
12 channels,
surface
electrodes,
voice control
(Israel)
Regulatory
approval
20
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21
22
Another location where electrical stimulation may be delivered is the surface of the spinal cord.
Called spinal cord stimulation (SCS) or dorsal column stimulation, this method is usually used to
treat pain and spasticity. In some people, especially those with incomplete injuries, it also improves
bladder function and may be implanted for that purpose. See section SCI-12, FES for controlling
spasticity, for further information.
Most bowel problems in spinal cord injury are related to the inability to voluntarily empty the bowels.
This frequently leads to constipation. Rarely, it may happen that a person with spinal cord injury
cannot contain his or her stool, despite medical care of the problem. This is called fecal
incontinence. For this condition, an FES system has been developed to keep the rectum closed.
The system requires a surgical procedure that transfers a leg muscle (gracilis) to be a loop around
the rectum. Then, an electrode to that muscle and a stimulator are implanted in the body. During
an a-week training period, the muscle is gradually conditioned until it can remain contracted all the
time. When the person wants to defecate, he or she turns the stimulation off with a small magnet
placed against the skin over the stimulator. The method is called dynamic graciloplasty.
Pelvic floor stimulation is another method that can help correct problems with bladder or bowel
function. Stimulation is applied to the supportive muscles of the pelvis that help control urination
and defecation. Probes or catheters that contain electrodes are inserted into the rectum, vagina, or
urethra. The treatment protocols vary, but usually stimulation is applied for a certain period every
day. This method strengthens the muscles and improves sensation and contro\. Another method
to improve bladder and bowel function uses surface electrodes placed over the penile nerve (male)!
vaginal area (female), or over the anal sphincter. In addition, some clinicians have reported that
electrodes placed on the skin over the abdomen can improve bowel management for persons with
paralysis.
The wide variety of stimulation techniques that are available for improving bladder and bowel
control reflect the complexity of the problem. A proper evaluation is key to determining which
techniques, if any, are most appropriate.
STATUS OF FES SYSTEMS FOR BLADDER AND BOWEL CONTROL
Clinical research
Multicenter trials
Regulatory Approval
Basic research
SCS, 1 channel,
6 channels,
3 channel, anterior Sacral nerve
totally implanted with
sacral root
stimulator, 1
anterior sacral
battery or RF power
stimulator, totally
channel, totally
root stimulator,
(Unlabeled use except
implanted.
implanted
percutaneous
when prescribed for pain
( Considered
(Multicenter trials of
leads with
control)
i
British system
investigational in the
external
in
US,
but
available
expected
to
begin
Pelvic floor
controller
US in 1996. Available
commercially in
stimulation
Direct bladder
Europe}
commercially in
Anterior sacral root
I
stimulation
Europe, Asia, Far
Dynamic
stimulator (Europe,
East) .
Pudendal nerve
graciloplasty, 1
Asia, Far East}
PelVIC floor
stimulation
channel, totally
Sacral nerve
stimulation
implanted
stimulator (Europe)
Penile nerve!
(Considered
Dynamic
vaginal! anal
investigational in the
Graciloplasty (Europe)
stimUlation with
US, but available
commercially in
surface electrodes
Europe)
--
23
24
2 - 48 channels,
external or
implanted
electrodes, bracing
ranging from none
to HKAFOs
Regulatory approval
6 channels, surface
electrodes, often
used with AFOs
(Approved in 1994)
4 - 6 channels,
surface electrodes,
no bracing
(Slovenia)
25
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'"
""
.......
\..
""
"
"'-"
......
\",..
"
"
\"...
26
FES of the lower body has valuable health benefits. Because using FES demands so much energy,
consistent users improve their cardiovascular capability. FES may reduce spasticity of leg muscles
and increase strength in remaining voluntary muscles. Some regular users of FES standing
systems report reduced pressure sore problems and fewer urinary tract infections.
FES also has benefits for bones. In paralysis, when muscles are inactive and do not put stresses
on the bones, the bones lose mineral content. They become thinner and weaker -- this is called
osteoporosis. People who use FES standing and walking systems are putting stress on their bones.
Some studies have shown that standing with FES can stop loss of bone mineral and slow the
progress of osteoporosis.
27
The minimum system uses four channels. Activation of both thigh muscles (quadriceps) locks the
knees during standing. Stimulating the common peroneal nerve on one side and switching off
quadriceps stimulation on that side together produce bending, or flexion, of that leg. This flexion
combined with movement of the upper body and use of the arms for support allows the user to take
a step. This is called the swing phase of the gait cycle.
If the FES system has six channels, much better performance is possible. One channel on each
side is devoted to activating the hip extensors, muscles that keep the hip joint from bending.
The user voluntarily commands the FES stimulator through switches or a miniature joystick. Some
type of walking aid -- walker, crutches, or canes -- provides support and balance.
Researchers have suggested systems for restoring walking with up to 48 channels. These systems
have either percutaneous or totally implanted electrodes. Their main advantage is their ability to
selectively activate different muscle groups. This type of muscle control can produce movement
that is much more like walking than taking one step at a time.
With the command switch, the user selects from the pre-programmed patterns stored in the
stimulator. Possible functions include standing, walking, side-stepping, back-stepping, stair climbing
and stair descending. Remember that as the technology of any device becomes more complex, the
possibility of technical problems increases.
The systems that use FES together with HKAFOs are called hybrid orthoses. Electrodes (usually
surface type) activate leg and hip muscles to initiate walking. This reduces the energy demand on
the upper body.
Examples of FES systems for stepping and walking: hybrid orthosis with
surface electrodes (left) and implanted electrodes/stimulator (right)
pelVIC anatomy
skm
radio freqUf!rH; Y
tran sm IHer
coil
path of
curren
flow
28
FES systems for stepping and walking use stimulation levels that will be high enough to produce
muscle contractions even when muscles are fatigued. This is a safety measure taken to ensure
that the user's legs will not buckle when the muscles tire. If bracing is used together with FES, the
stimulation levels can be lower because the brace can provide support against buckling. Since
stimulation levels are lower, muscles do not fatigue as quickly. In addition, if the FES part of the
system should fail, the brace will prevent the user from falling.
One type of brace used in hybrid systems is the RGO, which some people feel is too bulky and
heavy. To overcome these problems, one experimental system uses a two-part brace: the leg
sections are worn all the time and the trunk section can be removed to simplify some activities. The
leg sections use feedback control to provide muscle stimulation only when needed, thus delaying
muscle fatigue. Braces offer good locations for mounting the sensors that provide the feedback
information.
Another location where electrical stimulation may be delivered is the surface of the spinal cord.
Called spinal cord stimulation (SCS) or dorsal column stimulation, this method is usually used to
treat pain and spasticity. In some people, especially those with incomplete injuries, it also improves
stepping and walking. See section SCI-12, FES for controlling spasticity, for further information.
STATUS OF FES STEPPING AND WALKING SYSTEMS
Multicenter
Regulatory approval
Basic
Clinical research
trials
research
Various
systems:
6 channels, surface
electrodes, sometimes used
2 - 48 channels;
with bracing
surface,
percutaneous, or
2 - 6 channels, surface, hybrid
exercise systems using
implanted electrodes;
I
commercial braces and muscle
bracing ranging from
Ii
stimulators (in combination
none to HKAFOs
unlabeled use)
(US, Canada)
4-channel, surface electrodes,
I
no bracing (Slovenia)
30 channels, percutaneous
electrodes (Japan)
29
The great majority of users of FES standing and walking systems will be people with thoracic (T)
spinal cord injuries, either incomplete or complete, between C-7 and T-12. There will also be some
people with incomplete cervical (C) injuries who will be able to use such systems.
30
Some of today's FES walking systems are useful for limited activities at home or at work. At the
same time, hybrid orthoses have allowed particularly athletic people with paraplegia to walk
several miles. Some systems have a great deal of external equipment. All systems require
excessive energy output. Walking with FES stresses the cardiovascular system as much as
running does in an able-bodied person. If you have paralysis on one side only (called hemiplegia)
or incomplete paralysis, you can expect improved standing and walking with FES. You will depend
less on braces or walking aids. You may be able to use FES daily at home, work or leisure
activities.
31
I
I
Regulatory approval
Electroejaculation is
available in many
European countries
Anterior sacral root
stimulator for erection
(Europe, Asia, Far East
with multicenter trials to
begin in the US in 1996)
bc
32
Erection
In several studies, about 65% of men using the implanted device described in section SCI-5
achieved full erections. A smaller group achieved partial erections. The device is usually implanted
to improve bladder function and would not likely be implanted only to restore erection.
Electroejaculation
Electroejaculation is successful in nearly all men with SCI but only 70% will have adequate
numbers of sperm to induce a pregnancy. An important issue is the potency of the sperm that is
collected. Because of changes caused by SCI, sperm tends to be much less potent than sperm
from able-bodied men. Doctors may recommend actions that can improve the quality of sperm.
When a couple is trying to conceive a child, the woman's fertility is as important as the man's.
When you undertake electroejaculation, make sure that you also have experienced fertility doctors
on your medical team. Between 30% and 50% of couples who try artificial insemination are
successful. New methods of artificial insemination may increase the success rate.
--
33
"
'
"
Regulatory approval
......
"i....
"
There is no standard and it is difficult to state a cost. Physical therapy sessions generally cost
around $80 each. Once a physical therapist instructs a patient, much of the treatment can be done
at home with a rented or purchased stimulator. Stimulator rental costs about $80 per month.
Stimulator purchase can range from $700 to $2000, depending on the technical features of the
See page 64, "What Should I Know When Choosing an FES Product or Service?"
34
....,
35
Regular use of FES to activate buttock muscles that have nerve supply from the spinal cord may
help to prevent pressure sores. People who use FES exercise, standing and walking systems
report fewer problems with pressure sores. See SCI-1, SCI-6, SCI-7, and SCI-15 for more
information.
electrical
properties of
wounded tissue
Various systems
using surface
electrodes
Physical therapy
treatment with surface
ES systems.
36
--
37
The use of implanted electrodes or stimulators also may reduce spasticity. Such electrodes may be
implanted in muscles, over nerves, or on the spinal cord. In spinal cord stimulation (SCS), low
levels of stimulation are delivered continuously. A single cable leading to a multiple electrode
provides stimulation that has a general effect on many motor nerves. Thus, an SCS device for
controlling spasticity might have beneficial effects on bladder function, arm movement, standing,
and leg movement. An individual'S level of SCI will determine exactly where on the spinal cord the
surgeon places the electrode array.
Implanted spinal cord stimulators, also called dorsal column stimulators, may be battery-powered
or controlled by radiofrequency waves passing through the skin. Similar to heart pacemakers, the
battery-powered units require replacement after several years. Both types of device are turned on
and off by the patient. Typically, users operate their stimulators most of the day. When the devices
are turned off, the benefits quickly fade.
Doctors believe that dermatomal, SCS, and sacral nerve stimulation work by a method called
neuromodulation. It seems to depend on stimulation of sensory nerves reducing the spasticity of
related motor nerves.
(SCS)
(unlabeled
use, except if
Dermatomal (skin)
implanted
to
relieve
pain)
stimulation
I
,-"
lIDs
38
--
A spinal cord stimulator, surgery to implant it, and tuning the device to provide the most benefit cost
about $18,000.
Skin surface electrodes and portable, battery-powered stimulators are used. The muscle
contraction must be strong enough to move the joint through the available ROM and "tug" a bit at
the end of the range.
--
39
Occasionally, implanted electrodes and stimulators have been used for reducing contractures as an
intermediate step to implementing a complete grasping, standing, or walking system. See sections
SCI-4, SCI-6, and SCI-7 for more information.
STA TUS OF FES TO PREVENT OR TREAT CONTRACTU RES
Basic
Clinical research
Multicenter
Regulatory approval
research
trials
Physical therapy treatment
using FES with surface
electrodes
""'
I\...
'''-
40
"""
--
Regulatory
Approval
--
41
42
The muscle response to stimulation will depend on the type of weakness or paralysis. Muscle that
is weak because of inactivity but is still under voluntary control will become stronger and bulkier
(hypertrophy). Muscle that is paralyzed due to an upper motor neuron lesion will become bulkier
but voluntary strength will not improve. However, the strength during FES will increase. Muscle that
is paralyzed due to a lower motor neuron lesion (denervated) may become bulkier, but voluntary
strength will not improve and strength during FES will probably not improve.
FES systems for cardiovascular exercise, grasping, standing and stepping (see sections SCI-1,
SCI-4, SCI-6, and SCI-7) may also make muscles stronger and larger. A crucial factor is whether or
not the stimulation regimen stresses the muscle.
STATUS OF FES FOR INCREASING STRENGTH AND BULK OF PARALYZED MUSCLES
Basic
Clinical research
Multicenter
Regulatory approval
research
trials
Special stimulators
Physical therapy treatment using
designed for
FES with surface electrodes
denervated muscle
Specialized
FES systems with
electrode garments
43
Not used in SCI. See section MS-16 for information about use of FES for controlling tremor in
multiple sclerosis.
'
Regulatory
......'....."'".1
Single skin
electrode and
electrode arrays for
substitute sensory
stimulation
Skin electrode
arrays for
substitute
sensory
stimulation
Substitute sensory
electrode in
grasping systems
44
--
45
movement may be too small to be useful. Later, it may become functional. Biofeedback, alone or
with FES, may be valuable in converting the small movement to a functional one.
Spinal cord stimulation (SCS), also called dorsal column stimulation, applies electrical pulses
directly to the spinal cord. In some people, this produces a general improvement in coordination
and strength. See section SCI-12, FES for controlling spasticity, for more information on SCS.
Basic research
Various
stimulation
systems
Clinical
research
Various
stimUlation
systems;
some with
biofeedback
Multicenter trials
Regulatory approval
!.
Various surface
stimUlation systems;
some with biofeedback
Many different FES devices may be useful in restoring voluntary function to the person with SCI.
See sections SCI-1 through SCI-17. Benefits have been reported with use of a simple two-channel
surface electrode stimulator, providing continuous pulses during sleep.
''-
'.....
46
--
47
48
--
.....,
..
LEARNING ABOUT FES
""
""
""
""
""'
'
'
""'
'
'
'
'
'
'
""
""
'
""
""
'
""
""
""""
""
""
""
""
""
""
""
""""
""
""""
""""
""
""
""'""
""
49
Pelvic floor stimulation is another method that can help correct problems with bladder or bowel
function. Stimulation is applied to the supportive muscles of the pelvis that help control urination
and defecation. Probes or catheters that contain electrodes are inserted into the rectum, vagina, or
urethra. The treatment protocols vary, but usually stimulation is applied for a certain period every
day. This method strengthens the muscles and improves sensation and control. For treating
constipation, sometimes, surface electrodes applied to the skin of the abdomen, thigh or the anus
can be used.
The wide variety of stimulation techniques that are available for improving bladder and bowel
control reflect the complexity of the problem. A proper evaluation is key to determining which
techniques, if any, are most appropriate.
STATUS OF FES SYSTEMS FOR BUADDER AND BOWEL CONTROL
Basic research
! Clinical research
Multicenter trials
Regulatory Approval
f---------f--___::--:---:----~___1r_____:=______:----___1.-_=:=_=_::__-o"-:-'-"---."--., - 3 channel, anterior - Sacral nerve
- SCS, 1 channel,
stimulator, 1
totally implanted with
. sacral root
channel, totally
battery or RF power
stimulator, totally
implanted.
(Unlabeled use except
implanted
(Multicenter trials of
British system
expected to begin in
us in 1996. Available
commercially in
Europe, Asia, Far
East)
(Considered
investigational in the
US, but available
commercially in
Europe)
Pelvic floor
stimulation
Anterior sacral root
stimulator (Europe,
Pelvic floor
stimulation with
various types of
Sacral nerve
stimulator (Europe)
electrodes
50
RESOURCE GUIDE
--
--
Braces.
Anti-spasticity drug treatment.
--
51
Various surface
electrode systems
Surface electrode
system with
feedback
Surface electrode
systems with foot
switch (US, Europe,
other regions)
Spinal cord stimUlation
(SCS) (unlabelled use
except if implanted to relieve
52
--
Masturbation.
Stimulation with a vibrator.
Use of a suction device.
Injection of drugs into the penis.
Penile prosthesis.
Electroejaculation
The doctor inserts a probe into the man's rectum and electrically stimulates the nerves that control
ejaculation. The individual may need local or general anesthesia because of the discomfort,
particularly if he retains sensation in the rectum and lower abdomen. A nurse or a second doctor
collects the sperm. In some men whose sperm goes into the bladder. the doctor or nurse will collect
it from there. A gynecologist uses the sperm to inseminate the man's partner.
STATUS OF FES FOR ElECTROEJACUlATION
Clinical
Multicenter trials
Basic
research
research
About 50 clinics in the US and
I
Canada offer electroejaculation
procedures, still considered
experimental in North America.
Regulatory approval
Electroejaculation (many
European countries)
i
--
53
"-
""-
Electroejaculation treatments should be timed with the man's partner's most fertile time each
month. A single session takes about 45 minutes plus travel time.
54
---
Regulatory
approval
--
--
"
'-'
'-'
'-'
'-'
55
It is no surprise that ES also creates electrical currents in the tissue. Normal tissue has natural
electrical currents (different from nerve s;gnals) flowing in it. These currents assist in healing of
wounds. When there is neurological disease, or degeneration (as in the elderly), these currents are
reduced or missing. Surface electrode stimulation can be used to substitute for the electrical
currents in tissue and to assist in wound healing.
Regulatory approval
trials
'
'-'
Studies
electrical
properties of
wounded
tissue
Various
systems using
surface
electrodes
...,
56
When FES is used specifically to counteract spasticity, surface electrodes are applied to the spastic
muscles or to their antagonists. Each muscle has a counterpart muscle that moves the joint in the
opposite direction -- this is called the antagonist.
Spasticity usually occurs in several muscles at once. Some studies have shown that the most
effective treatments are those where FES is applied to all the muscles of a limb. Physical therapy
treatment may also be given during the same period.
Another method for reducing spasticity is applying FES to skin areas called dermatomes. A
dermatome is an area in which all the sensory nerve receptors belong to the same spinal cord
level. Particular muscle groups also have their motor nerves at specific spinal cord levels. The
dermatome that is stimulated is chosen to have the same spinal cord level as the spastic muscle
group.
The use of implanted electrodes or stimulators also may reduce spasticity. Such electrodes may be
implanted in muscles, over nerves, or on the spinal cord. In spinal cord stimulation (SCS), also
called dorsal column stimulation, low levels of stimUlation are delivered continuously. A single cable
leading to a multiple electrode provides stimulation that has a general effect on many motor nerves.
Thus, an SCS device for controlling spasticity might have beneficial effects on bladder function,
arm movement, standing, and leg movement.
Implanted SCS stimulators may be battery-powered or controlled by radiofrequency waves passing
through the skin. Similar to heart pacemakers, the battery-powered units require replacement after
several years. 80th types of devices are turned on and off by the patient. Typically, users operate
their stimUlators most of the day. When the devices are turned off, the benefits quickly fade.
Doctors believe that dermatomal, SCS, and sacral nerve stimUlation work by a method called
neuromodulation. It seems to depend on stimulation of sensory nerves reducing the spasticity of
related motor nerves.
Grasping, standing and walking systems may help to reduce spasticity. See sections MS-4, MS-6,
and MS-7.
I
I
Regulatory approval
Physical therapy
treatment using FES with
surface electrodes
. SCS, 1 channel, totally
implanted, with battery or
RF control. (unlabeled use
except when implanted to
control pain or spasms)
---
57
People with MS who have spasticity that cannot be controlled by medical methods. For surface
electrode FES treatment, the person with MS should have
Otherwise good general health.
No allergy or excessive skin sensitivity.
See disqualifying factors on page 46.
'
'
When there was a benefit following FES treatment, in some cases it disappeared within days or
years. However, in other cases it persisted for up to 4 years. Perhaps, the natural progress of the
MS wiped out the improvement in some people. This is an area where much more basic and
clinical research is needed to know what we can expect of FES.
If spasticity is reduced over.a long period, then there will be a reduction in contractures also. See
the next section.
See page 64, "What Should I Know When Choosing an FES Product or Service?"
58
--
Basic
research
--
59
Researchers have tested a modified bicycle ergometer to increase bone density for people with
SCI. See section SCI-14, FES systems for preventing or treating osteoporosis.
I...,
'
'-...
iI....
'
'-...
'
'
'-...
Multicenter trials
Regulatory
approval
60
---
61
In a partially paralyzed muscle, the portion of the muscle that is weak because of inactivity but still
has a nerve supply will become stronger and bulkier (hypertrophy). The portion of the muscle that
is paralyzed due to neural damage will become bulkier but voluntary strength will not improve.
However. the strength during FES will increase.
FES systems for cardiovascular exercise. grasping, standing and stepping (see sections SCI-1,
MS-4, MS-6. and MS-7) may also make muscles stronger and larger. A crucial factor is whether or
not the stimulation routine stresses the muscle.
STATUS OF FES FOR PREVENTING OR
TREATING WEAK, ATROPHIED MUSCLES
Clinical research
Basic
Multicenter
research
trials
Specialized
stimulators designed
for denervated
muscle
Regulatory approval
'-'
'-'
62
Tremor is shaking that occurs continuously or whenever voluntary movement is made. Poor
muscle coordination and balance (ataxia), another symptom of MS, may also be helped by FES.
However, this is a very specialized type of treatment that requires frequent adjustment of
stimulation.
Basic
research
Clinical research
Surface electrode system fitted into a glove I
or armband, with feedback
--
63
Braces.
Drug treatment.
research
SCS, 1 channel, totally
implanted, with battery or RF
control. (unlabeled use except when
implanted to control
bs
64
--
65
66
DO find out if use of FES will require permanent or irreversible surgery. Doctors who implant FES
systems are constantly developing better surgical procedures. Ask if the surgery can be broken into
short sessions. Ask if any of it can be done on an outpatient basis. Ask about the risks of surgery.
Discuss the proposed treatment plan with health care providers whom you trust.
-
-
-
DO explore all the alternatives to FES. More traditional treatment plans may be just as effective,
You may decide to volunteer for an experimental FES project. If you do, make sure that you
completely understand your commitment to the project. Ask how the FES treatment may affect
other assistive technologies that you already use or may use in the future. Ask about the risks and
benefits of the treatment. This should be detailed in a document called an Informed Consent. The
researchers are required to write out these details and explain them to you. They will ask you to
sign the document to show that you understand it.
If you choose to partiCipate in a research project, find out in advance what expenses are
involved and who will be paying them. Ask how much time you need to be at the research clinic,
and how that will affect your daily activities. Ask what FES, if any, will be available to you when the
project is over, or when you stop being an active participant.
FES holds great potential to improve the health, well-being, and quality of life of many
people. As you would in considering any elective treatment, learn all you can about FES. If you are
satisfied that the application is safe, that it may help you, and that you can fit it into your life -- go
for it.
--
---
PART 2
General Program Information (Look for the shaded box with the envelope icon)
I
I
I
Address
r Telephone Numbers
f
Specific FES Application Information for the facility described above (Look for the clear box with the page icon)
@) 123.01
Program Application Identification Number- This number links the FES application with
the facility that offers it. If a facility offers more than one application, the last two digits
distinguish among applications. (The index refers to this number when you look up a topic)
FES Application:
Lists the FES applications that are available at this facility and that are described in the
information that follows. These are the same applications described in Part 1. Learning
about FES.
Description:
A description of the application(s) available at this facility.
History:
Describes the history of the FES application at this facility, ex. number of persons treated.
Status:
Identifies the status of this application as Clinical service or Experimental research. If
the status is research, may identify the research as a feasibility study or multicenter
clinical trial. Some treatments may include both aspects. See the Glossary for terms.
Describes, in clinical terms, the type of individual who may benefit from this application,
Candidate Description:
ex. spinal cord injury or multiple sclerosis.
Restrictions/ Contraindications:
Describes characteristics that may disqualify an individual from treatment.
Treatment course:
Describes the typical sequence of events that an individual receiving this treatment can
expect, ex. evaluation, training, check-ups, number of visits.
Explains whether it is necessary to get an evaluation from this facility vs. another facility
Requires evaluation
at this facility?
which may be closer to you.
Requires local lodging?
Explains whether it is necessary for you to live near the facility while you receive treatment.
Provides a range for the typical cost of this treatment
Typical cost:
3rd party payers typically cover:
Explains the extent to which insurers usually pay for this treatment
Type of equipment:
Describes the type of stimulation equipment used for the treatment, ex. home use
stimulator, clinic use stimulator, surface electrodes, implanted electrodes.
Availability of equipment:
Explains how the equipment is made available to the user, ex. purchase, rental.
67
USA - CALIFORNIA
ftoo
REeR8~rogtaJ'ftz1
Conta~t)Penson:
1.01
FES Application:
Neuromuscular treatments
Treating weak, atrophied muscles
Description: Topical unit - 3 leads for each extremity
History: Has been in use since 1987, more than 150
participants.
Status: Clinical service
Candidate Description:
Spinal cord injury
Cervical: Motor: C5-8 / Sensory: C5-8
Thoracic: Motor: T1-11 I Sensory: T1-11
ASIA International Impairment Scale: A B
Paraplegia
Tetraplegia/ Quadriplegia
1.02
FES Application:
Cardiovascular exercise
Bicycle ergometry
Description: Therapeutic Technologies Inc. exercise
bike - topical leads to each lower extremity
History: Has been in use since 1987, more than 150
participants.
Status: Clinical service
Candidate Description:
Spinal cord injury
Cervical: Motor: C5-8 / Sensory: C5-8
Thoracic: Motor: T1-10 / Sensory: T1-10
ASIA International Impairment Scale: A B
Paraplegia
Tetraplegia/ Quadriplegia
68
USA - CALIFORNIA
~
1 .03
FES Application:
Lower limb movement
Stepping and walking
Description: Hybrid system - Douglas RGO brace and
PEERS stimulator (6 channel system - topical) by
Henley in our office. FOR EXERCISE USE ONLY.
History: Has been in use since 1987, more than 150
participants.
Status: Clinical service
Candidate Description:
Spinal cord injury
Cervical: Motor: C5-8 / Sensory: C5-8
Thoracic: Motor: T1-11 / Sensory: T1-11
ASIA International Impairment Scale: A B
Paraplegia
Tetraplegia/ Quadriplegia
Restrictionsl Contraindications: Obesity, recent
~
1.04
FES Application:
Neuromuscular treatments
Regaining voluntary function
Description: Neuroeducator - original equipment by
Therapeutic Technologies Inc.
History: In use since 1987, more than 150
participants.
Status: Clinical service
Candidate Description:
Spinal cord injury
Cervical: Motor: C5-8/ Sensory: C5-8
Thoracic: Motor: T1-12/ Sensory: T1-12
ASIA International Impairment Scale: A B
L:::J
Paraplegia
Tetraplegia/ Quadriplegia
Restrictions/ Contraindications: Recent fractures,
lack of motivation and discipline
Treatment course:
No information provided
Requires evaluation at this facility? Yes
Requires local lodging? Yes
Typical cost: $1,000-$5,000
3rd party payers typically cover: Some costs
Type of equipment: Clinic use stimulator; FDA
approved stimulator; Transcutaneous/surface
electrode( s)
Availability of equipment: No charge
2.00
USA
Tel: 714-855-4837
TolI..free:
FAX: 714-855-9553
E-Mail:
Director: Dr. Jerrold Petrofsky
Contact Person: Dean Maccabe
Program Description: Physical therapy and research
center specializing in rebuilding paralyzed muscles for
SCI, stroke, etc. with Nobel nominee Dr. Jerrold
Petrofsky. High tech braces, gait training, computerized
muscle stimulation, bowel and bladder programs,
Information available: Printed format; Videotape
format
Hours: 8:30 AM to 5:00.PM, Monday - Friday
--
69
USA - CALIFORNIA
@l
2.01
FES Application:
'
'
'
'
'
Bladder control
Bladder emptying
Bladder incontinence
Description: Bladder control involves two stages. First
electrical stimulation is used through a transurethral
catheter for half hour treatments 4 days a week for 4
weeks. Stimulation opens up dormant receptors and
allows the restoration of feeling in the bladder wall. In
the second phase, pressure transducers inside the
bladder and the urethra help monitor pressure while
saline is infused. Pressure is monitored by computer
and neuromuscular re-education. Re-Ieaming bladder
muscle control is attempted.
History: Approximately 20 years. Approximately 5,000
individuals treated, program capacity - 10.
Status: Clinical service; Experimental research;
Feasibility study
'
Candidate Description:
'
Multiple sclerosis
@l
2.02
FES Application:
Bowel control
Bowel emptying
Bowel incontinence
Description: Bowel control uses electrical stimulation
from a multiple channel stimulator for bowel emptying.
It involves 4 sets of electrodes across the bowel to
all?w the bowel program to go more simply and easily.
Pnor to the program, electrical stimulation is used on
abdominal muscles to increase strength.
History: Approximately 20 years. Approximately 5,000
individuals treated, program capacity -10.
Status: Clinical service; Experimental research;
Feasibility study
Candidate Description:
Multiple sclerosis
Spinal cord injury
Cervical
Thoracic
Lumbar
Hemiplegia
Paraplegia
Tetraplegia! Quadriplegia
Restrictions/ Contraindications: No info. provided
Treatment course:
br
70
USA - CALIFORNIA
I@
2.03
FES Application:
Cardiovascular exercise
Circulatory/Skin treatments
Neuromuscular treatments
Feasibility study
Candidate Description:
Multiple sclerosis
I@
2.04
FES Application:
Lower limb movement
Stepping and walking
Standing / transfer assistance
Description: A small electrical stimulator, the size of a
calculator, provides up to six channels of muscle
stimulation for the lower body allowing walking with a
hybrid system, a combination of FES and braces. The
braces, or stored energy orthoses, are very light and
brace to the level of the injury. With these braces,
successful walking at normal walking speeds is
provided. Individuals with incomplete injuries can use
this technology to achieve good gait. History:
Approximately 20 years. Approximately 5,000
individuals treated, program capacity - 10.
Status: Clinical service; Experimental research;
Feasibility study
Candidate Description:
Multiple sclerosis
--
71
USA - CALIFORNIA
.p~m.lationl~rogram forSer
M~rryWia'Rehabilitatlon Hospital
.street1'Suite 416
b CA 90806
Long
USA
tek~1~~2~~1t1
F~:31'CH\9~;;a830
DJ~~~AnfJ.va~ne,. MD...~.
Co...~Per$on;AnnVa$ile.,NlE)
Pr()gramOescripton:Parsstepf:ES Ambulat!on
PrQgram;candidates i
rsons with thoracic
'
'
thir'(:ipartYp~yment
Typeoffacf~ty~'Ptivately!~upported; Inpatienffacility;
Ou~ntfaGjlity; consulta~t I Private practice;
Hospital; Rehabmtationcenter;Re~~bilitationprogram
Accreditatipn: CARF Accredited; JCAHQA~redited;
PrudentiatGenter of Excellence
.
licensiog/Certifi~tion: Board CertifiedPhysical
MediCine,snd.RehabilitatiGn
3.01
FES Application:
Lower limb movement
Stepping and walking
Description: FES Parastep system for ambulation.
Electrodes on lower extremities; hand controls on
walker; AFO (ankle foot orthosis). Ultimately
participant should be independent in use of equipment.
History: Began as an experimental grant, now FDA
approved for approximately 2 years. About 20
individuals have been treated, no limit to our capacity.
Status: Clinical service
Candidate Description:
Spinal cord injury
Thoracic
Paraplegia
Time elapsed post-injury/onset: 6 months
4.00
Mark W. Vogel. MD
8635 W. 3rd Street, #1060 W
Los Angeles CA 90048
USA
Tel: 310.652-2973
Toll-free:
FAX: 310-289-0187
E,-MaU:
Director: Mark W. VogeJ,MD
Contact Person: Mark W. Vogel, MD
Program Description: Electrical stimulation using
Seager-type device for electroejaculation.
Information available: No intormation provided
Hours: 7:30 AM 5:00 PM, Monday - Friday
Location of services: Service providers location
72
USA - CALIFORNIA
4.01
FES Application:
Sexual function
Electroejacu lation
Description: Pulsed electrical stimulation delivered via
transrectal probe to achieve ejaculation.
History: In use approximately 8 years, treated
approximately 25 persons, some repeats.
Status: Clinical service
Candidate Description:
Multiple sclerosis
Cervical
Thoracic
Lumbar
Sacral
5~OO
@J
5.01
FES Application:
Cardiovascular exercise
Bicycle ergometry
Description: This is a research program in which
subjects exercise 3 times a week for 6-9 months.
Cardiovascular, spasticity and osteoporosis
parameters are tested 3-4 times during this time period.
We use a REGYS I bicycle ergometer.
History: This program has been available for 3 years
12 subjects have completed the program. We can ha~e
4 subjects at anyone time at the West Los Angeles
location and 2-3 SUbjects at our Rancho location.
Status: Experimental research; Feasibility study
Candidate Description:
Spinal cord injury
ASIA International Impairment Scale: A
Hemiplegia
Paraplegia
Tetraplegia! Quadriplegia
Restrictionsl Contraindications: No info. provided
Treatment course:
Evaluation/ assessment - generally one time
Outpatient fitting/implementation - as many times as
necessary
Requires evaluation at this facility? Yes
Requires local lodging? No
Typical cost: Less than $1,000
3rd party payers typically cover: No costs
Type of equipment: Clinic use stimUlator; Not FDA
approved stimulator
Availability of equipment: Purchase
Paraplegia
Tetraplegia/ Quadriplegia
Time elapsed post-injury/onset: any time post injury.
Restrictions! Contraindications: No unhealed
fractures, must have spasticity, no history of
cardiovascular problems.
Treatment course:
Training - 3x1week for 6-9 months
Approximate number of visits required in total: 100
Requires evaluation at this facility? Yes
Requires local lodging? Yes
Typical cost: Less than $1,000
3rd party payers typically cover: No costs
Type of equipment: Clinic use stimulator; FDA
approved stimulator, Transcutaneous/surface
electrode( s)
Availability of eqUipment: No charge; research study
73
USA - CALIFORNIA / CONNECTICUT
6..00
Spinal Corddnjury Unit
USA
Tel: 619-552-7453
Toll-free:
i'FAX: 619,;552-7452
li;.ifVIa11~
Director: Sr. Susan SzoHa'i':.<'
CordactPerson: Or. SusarlSzollar; Dr. Kevin Gurhart;
Dr. Marc Kelly
Program Description: SCI Unit with use of FES
primarily to increase motor function.
Information available: No information provided
6.01
FES Application:
Neuromuscular treatments
Regaining voluntary function
Description: Primarily used for persons with spinal
cord injury with the goal to increase function. Can
include upper limb and/or lower limb movement.
History: Has been available since program opened 4
years ago.
Status: Clinical service
Candidate Description:
Multiple sclerosis
Spinal cord injury
Cervical
Thoracic
Lumbar
Sacral
Paraplegia
Tetraplegia/ Quadriplegia
Other spinal disorder: post-polio
Restrictions/ Contraindications: No info. provided
Treatment course:
Inpatient fitting/implementation - inpatient
hospitalization is typical.
Requires evaluation at this facility? Yes
Requires local lodging? No
Typical cost: No information provided
3rd party payers typically cover: All costs; depends
on length of treatment.
Type of equipment: Clinic use stimulator; FDA
approved stimulator
Availability of equipment: No charge; in-house use
only
CONNECTICUT
@
7.00
Yale University School of Medicine
333 Cedar Street; 121 FMB
New Haven CT 06520-7898
USA
Tel: 203-785-2705
Toll-free: 800-432-7898
FAX: 203-785-3346
E-Mail:
Director: John A Elefteriades, M.D.
Contact Person: John A Elefteriades, M.D.
Program Description: Diaphra9,mpacing for 1)
quadriplegia; 2) central hypoventilation
Information available: Printed format
Hours: 9:00 AM to 5:00 PM, weekdays
Location of services: Consumer's residence
74
USA - CONNECTICUT
7.01
FES Application:
Respiratory treatments
Breathing assistance
Description: Pacemakers are implanted on the
phrenic nerve in the chest via mini thoracotomies and
the diaphragms are trained to accept electrical '
stimulation. Independence from the ventilator and
normal speech are achieved.
History: 25 years
Status: Clinical service
Candidate Description:
Spinal cord injury
Cervical: Motor: C3-4 / Sensory: C3-4
Tetraplegia! Quadriplegia
Restrictionsl Contraindications: Intact mental status.
. 8.00
Treatment course:
Evaluation/ assessment - 3 days
Pre-implementation therapy/treatment - 0 -14 days
Inpatient surgical procedure(s) - 2 days
Training - 2 weeks - 3 months
Post-implementation therapy/treatment - 2 weeks - 3
months
Maintenance / check-ups - every 2 years
Requires evaluation at this facility? Yes
Requires local lodging? No
Typical cost: More than $20,000
3rd party payers typically cover: Some costs
Type of equipment: Clinic use stimulator Home use
stimUlator; FDA approved stimulator; Not FDA
approved stimulator
Availability of equipment: Purchase
8.01
FES Application:
Cardiovascular exercise
Bicycle ergometry
Description: Includes integrated EMG Biofeedback
History: Active since 1985. One of the first programs
in the country.
Status: No information provided
Candidate Description:
Spinal cord injury
Paraplegia
Tetraplegia! Quadriplegia
Time elapsed post-injury/onset: 3 weeks
Restrictionsl Contraindications: Requires good
range of motion in lower extremities
Treatment course:
Evaluation/ assessment
Pre-implementation therapy/treatment
Training
Maintenance / check-ups
Requires evaluation at this facility? Yes
Requires local lodging? Yes
Typical cost: $1,000-$5,000
3rd party payers typically cover: Some costs; For
initial training and evaluation
Type of equipment: Clinic use stimulator; Home use
stimulator; FDA approved stimulator
Availability of equipment: Purchase; must purchase
Stimwear
75
USA - DISTRICT OF COLUMBIA
9.0~;
Male'Fe
National R
102 Irving
Wasbington
U~~4V,:.... ......../ ..
2949
c.,~Ui':.02~77'"~~5
,Fmc:202..a17...a592
I:)irector: Or.S;W.J.8eaQer;Or."L.S.
. COfJtactPersOrfz;f)r.S.~iJ. Seager
HaIsf~t:f
.
P~r;am
.~c.z:F'J'fE!"fertility Programcat the
NatIonal
.. fiHos~1 in Northwest
Washington, D.C., isdfferedtb men with neUrological
impairmentsW!1o wish to father children or todetermine
whether they l"I1ightbe able.tofatl1er children in',the
future.
9.01
FES Application:
Sexual function
Electroejaculation
Description: Fertility evaluation begins with an
educational overview of the procedure, and a
comprehensive assessment including a medical and
physical exam, psychosocial evaluation, and laboratory
tests. On subsequent visits, the electroejaculation
procedure is performed to assess and improve fertility
potential. Generally, between four and six 30-minute
visits are needed. Electroejaculation is a simple
procedure that involves inserting a specially designed
probe into the rectum adjacent to the prostrate gland.
Using a low-level current, electrical stimulation is
applied to the tissues and nerves adjacent to the
prostrate and seminal vesicles, often resulting in
ejaculation.
History: The fertility program at NRH has been
ongoing for the past 9 years. The number of males that
have been treated in this and other programs is 600+.
Status: Experimental research; Feasibility study
Candidate Description:
Multiple sclerosis
Spinal cord injury
~'info!fixedt;tates
Payrnent.. m~d$:Wil1blltlhsurance
Type offadlly~PrivatelysuPported; For profit;
Hospital; Rehabilitation cent.er
AecreditatignlCARF Accredited; JCAHO Accredited
Licensing/6ertification: Not appliCable
Cervical
Thoracic
Lumbar
Sacral
ASIA International Impairment Scale: ABC D
Other spinal disorder: Spina Bifida
Paraplegia
Tetraplegial Quadriplegia
Time elapsed post-injury/onset: 6 months
Restrictionsi Contraindications: Fertile age range
needed. Restrictions: persons with cardiac pace
makers.
Treatment course:
Evaluationl assessment - 1 hour
Outpatient surgical procedure(s) 1 hour
Approximate number of visits required in total: 1 - 10
post visits
Requires evaluation at this facility? Yes
Requires local lodging? No
Typical cost: Less than $1,000
3rd party payers typically cover: Some costs
Type of equipment: Clinic use stimulator; Research
prototype stimulator
Availability of equipment: No charge; in-house use
only
76
USA - FLORIDA
~. 10.00
thefrllJ~ibi' Pro~1tOCuteParalysis
Uni\l~~ity~ofMia
1600~N;W/1oth A
ool/,ofMm;tiCine
MiamLFL" 33136
USA
.
Tel: 305:"f4~001't0l1~fiee! 800-7&2~a87
FAX: 305"2~3-6017.e~Mall:
Director:R:ichard Bunge, Ph:D.; Barth Green,MD
Contact Person: Maria':Amador, RN
Program Des~ription: The Miami Project, a research
center.forspinal cordfinjury,is investigating the effect of
FES applications on spinal.corcl injured individuals.
Current'studies are. evaluating electroejaculation
equipment and amassisted,walking system: Future
studies will focus,on the application of FEStar upper
extremity; Clinical services proposed for Parastep1
10.01
FES Application:
Lower limb movement
Stepping and walking
Description: Utilizing Parastep I from Sigmedics Inc.
we are evaluating the physiologic effects of ambulating
with FES. This is a research program only. The length
of the study participation is 5 months.
History: We have been involved with the application of
FES for upper extremity and lower extremity activity for
over 8 years. Our involvement with the Parastep I
began in 1991.
Status: Experimental research; Feasibility study; Multi
center clinical trial
Candidate Description:
Spinal cord injury
Thoracic: Motor: T4-11/ Sensory: T4-11
10.02
FES Application:
Upper limb movement
Grasping
Description: Device designed to assist persons with
quadriplegia in achieving powerful hand opening and
closure function. The device is activated through
tenodesis action.
History: Initial study Jan, 1995, we have evaluated 4
people, limited to 5 participants at a time.
Status: Experimental research; Feasibility study; Multi
center clinical trial
Candidate Description:
Spinal cord injury
Cervical: Motor: C4-6 / Sensory: C4-6
Tetraplegial Quadriplegia
Restrictionsl Contraindications: Spasticity in
forearm, contractu res of the hand.
InformatiolJavailable: Printm;t:wrmat
trarisriJrt
Paraplegia
Time elapsed post-injury/onset: greater than 6 months
Restrictionsl Contraindications: All candidates must
be: without fractures, contractu res or dislocations of the
lower extremities, medically stable, and without obesity.
Treatment course:
Evaluation/ assessment.: 1 week
Training - 5 months
Requires evaluation at this facility? Yes
Requires local lodging? Yes
Typical cost: Less than $1,000
3rd party payers typically cover: No costs; research
Type of equipment: Clinic use stimUlator; FDA
approved stimUlator; Transcutaneous/surface
electrode(s)
Availability of equipment: Purchase; upon
completion of the study, from Sigmedics
Treatment course:
Evaluationl assessment - 1 day
Outpatient fitting/implementation - 1 day
Training - 6 months
Maintenance / check-ups - as needed
Approximate number of visits required in total: as
needed
Requires evaluation at this facility? Yes
Requires local lodging? No information provided
Typical cost: Less than $1,000
3rd party payers typically cover: No costs; research
Type of eqUipment: Home use stimulator; Research
prototype stimulator; Transcutaneous/surface
electrode(s)
Availability of equipment: No charge; !\lot available
for purchase.
77
'
'
.......
"""
\...
10.03
FES Application:
Sexual function
Electroejaculation
Description: We use electroejaculation to obtain
semen from men with SCI for use in research and to
help them father children. History: Available since Feb.
1991. Studied 145 individuals. Waiting list
approximately 6 weeks at this time (Spring 1995).
Status: Experimental research; Feasibility study; Multi
center clinical trial
Candidate Description:
Spinal cord injury
Paraplegia
Tetraplegia/ Quadriplegia
Restrictions/ Contraindications: 1. heart problems;
2. younger than 18; 3. lesions in bowel; 4. unable to
understand procedure.
Treatment course:
Evaluation/ assessment - 1 hour orientation
Inpatient fitting/implementation - some inpatients
undergo electroejaculation once a month until they are
out of the hospital
Outpatient fitting/implementation - Mostly (95%) are
done as outpatients, once - twice/month for 2-6 months
Approximate number of visits required in total: 2-30.
depending on which protocol participant is in.
Requires evaluation at this facility? Yes
Requires local lodging? No; Can travel to the center
on days of treatment
Typical cost: Less than $1,0.0.0.
3rd party payers typically cover: No costs; research
Type of eqUipment: Clinic use stimulator; Not FDA
approved stimulator
Availability of equipment: No charge; Not available
for purchase
\...
'
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GEORGIA
W .t1.00 ...
11 .01
FES Application:
Neuromuscular treatments
Regaining voluntary function
Description: FES is integrated into surface EMG
stimulation where FES is "triggered" based upon
VOluntary muscle activation of the same muscle or a
synergist. History: No information provided
Status: Clinical service
Candidate Description:
Spinal cord injury
Hemiplegia
Tetraplegia/ Quadriplegia
Restrictionsl Contraindications: In-tact sensation,
and paretic rather than plegic.
Treatment course:
Evaluationl assessment - weeki
78
USA - GEORGIA
"",' 12.00
Shepherd Center'
2020 Peachtree RoaQ:;;NW.
Atlanta GA 30309
USA
Tel: 404;.350-7487
Toll-free: 800.:54845651
FAX: 404--350-7356
E-Mail:
DirectoflDOnald P. Leslie, MD
ContactiPerstm: .
B. Abice, PT
Program Descri
i'l~:Parastep FESiSa:fe'E! for
ate two Physical.:tbertiPists
service progJ"am.
trained in system:use. Wecsn see about 210 4;st a
tirne. P:el'Sons ml;!stmakegood progress.mcol'ltinue.
there 1$a commitment for 32 sessions, 2,.. 5 x I Wk.
Il1fol'rt'l8tron available:' Printed format
Hours~9:00 AM to 4tOO PM, Monda - Frida
~
12.01
FES Application:
Lower limb movement
Stepping and walking
Standing I transfer assistance
Description: The Parastep System is manufactured
fur stepping and standing. Electrodes are applied in a
surface manner. Electrode cables connect the
electrodes to a microprocessor which is battery
powered. The system is connected to a walker.
Standing and step taking is achieved through finger
switch controls on the walker handle.
History: Served as a clinical trial site fur Parastep pre
FDA approval. We continue to see clients post FDA
approval. We have trained 20 clients. We can see 2 to
4 clients at one time.
Status: Clinical service
Candidate Description:
Spinal cord injury
Cervical: Motor: C8 I Sensory: C7
Thoracic: Motor: T1-11/ Sensory: T1-11
ASIA Internationallmpairrnent Scale: A B
Other spinal disorder: Transverse myelitis
Paraplegia
---
Tetraplegia! Quadriplegia
Time elapsed post-injury/onset: 6 months - 10 years
Restrictions! Contraindications: Must have enough
hand function to trigger switches. Contra indications:
recent fractures; osteoporosis; severe spasticity; hip,
knee and ankle contractu res; extreme de-conditioning;
obesity.
Treatment course:
Evaluation/ assessment - 3 hours, in one day
Outpatient fitting/implementation - 1 day
Training - 32 sessions, 2 - 5 times a week
Maintenance I check-ups - quarterly
Approximate number of visits required in total: 33 - 35
Requires evaluation at this facility? Yes
Requires local lodging? No; If the partiCipant can
travel back and furth at their own cost, they are free to
travel to and from the Hospital without restraint.
Typical cost: $10,000-$20,000
3rd party payers typically cover: Some costs; about
a 60% success rate with private insurance companies
Type of equipment: Clinic use stimulator; Home use
stimulator; FDA approved stimUlator;
Transcutaneous/surface electrode(s)
Availability of equipment: Purchase
13.00
..
--
79
USA - GEORGIA !ILLINOIS
~ 13,01
FES Application:
Cardiovascular exercise
Circulatory/Skin treatments
Lower limb movement
Neuromuscular treatments
Description: No information provided
History: No information provided
Status: Clinical service
Candidate Description:
Multiple sclerosis
Spinal cord injury
ILLINOIS
JiJ 14~!OO
~~Pl'itzk~f!.stitQt&,o;MediCan:ng!l1eering
;~l:i6cat1on
"b,.
. 'ti"
,
: .... ... .'ofservices'N
. . . . ' 0 .'Inlvf;[r1a
on pro
10West32nd Sffeet,.E1-125
Chicago Il 60616~S793 .
.
Areasse.ved::No informatiol1provided.
USA'
..
.
14.01
FES Application:
Respiratory treatments
Breathing assistance
Cough assistance
Description: We stimulate abdominal muscles either
open-loop or closed-loop in synchrony with normal
breathing. This is a research study only - no treatment
is involved.
History: This research has been going on since 1992.
Over 50 persons have been studied.
Status: Experimental research; Feasibility study
Candidate Description:
.
Spinal cord injury
Cervical: Motor: C4-8
Thoracic: Motor: T1-6
Paraplegia
Tetraplegial Quadriplegia
80
USA -ILLINOIS
15.00... . . .. . . . . . . . . ...............
F'ESfor A~no~icll)ysfunction
15.01
FES Application:
Respiratory treatments
Breathing assistance
~escription: Small percutaneous wires are implanted
In chest muscles and stimulation is conducted to
determine if ventilation is assisted. Studies conducted
only in the clinic, electrodes are then removed.
History: This is a new project, just starting.
Status: Experimental research; Feasibility study
Candidate Description:
Spinal cord injury
Cervical: Motor: C1,2 or above
Tetraplegial Quadriplegia
15.02
FES Application:
Bladder control
Bladder emptying
Description: Percutaneous wire electrodes evaluated
fo! direct bladder stimulation. The extremely small
wires are placed low in the abdomen and stimulation is
conducted during a one hour session. The goal is to
determine implant candidates.
.
History: This application has been available for 5
years; 30 have been treated; capacity of 30 new
individuals.
Status: Experimental research; Feasibility study
Candidate Description:
Spinal cord injury
Paraplegia
Tetraplegia! Quadriplegia
fhformationavailible:Prif1ted tormat
~on ofs
:Consumer's;residence;$ervice
providers la
ACC~Sibility:Vvneefahairaccessible, irlek~hrooms"
transport
Pipulationssel
Areasserv
lnlinrt!teo.
Referral requ
1"No ;
P!?ment met~od~~JIlOinforrnatlonprovided
Rehabilitation center
.
Accreditation: Nojntormation.provided
81
USA -ILLINOIS / MAINE
15.03
FES Application:
Bladder control
Bladder incontinence
Description: Small pocket stimulator with surface
electrodes placed over dorsal penile nerve (male) /
vaginal area (female) or over anal sphincter.
Stimulation is applied during periods when urinary
incontinence may be a problem. For home use.
History: This application has been available for 3
years; 5 have been treated; capacity of 5 new
individuals.
Status: Experimental research; Feasibility study
Candidate Description:
Multiple sclerosis
Spinal cord injury
Paraplegia
Tetraplegia! Quadriplegia
Restrictionsl Contraindications: Restrictions - must
have documented urinary incontinence
lJ
Treatment course:
Evaluation/ assessment - urodynamics with a urologist
Pre-implementation therapy - record incontinence
episodes
Outpatient implementation - shown how to use portable
stimulator
Training - as outpatient
Maintenance / check-ups - followed by phone and mail
Approximate number of visits required in total: 1 or 2
Requires evaluation at this facility? Yes; Other
institutions getting IRB approval could use the device.
Requires local lodging? No
Typical cost: Less than $1,000
3rd party payers typically cover: No costs; research
Type of equipment: Home use stimUlator; Not FDA
approved stimulator; Transcutaneous/surface
electrode(s)
Availability of equipment: No charge
15.04
FES Application:
Bowel control
Bowel emptying
Bowel incontinence
Description: Surface electrodes are placed around the
anal opening. Stimulation is applied to induce bowel
emptying. Longer daily stimUlation used for
incontinence of stool.
History: This is a new project.
Status: Experimental research; Feasibility study
Candidate Description:
Spinal cord injury
Thoracic: Motor: T1
Paraplegia
Restrictions! Contraindications: Restrictions - must
be in good health, no ulcers around anal area.
Treatment course:
Evaluationl assessment - 1 week
Inpatient fitting/implementation - 10 weeks
Training - 1 day
Maintenance / check-ups - 1 week
Requires evaluation at this facility? No; Defecation
is the end point
Requires local lodging? No
Typical cost: Less than $1,000
3rd party payers typically cover: No costs; research
Type of equipment: Home use stimulator; Not FDA
approved stimulator; Transcutaneous/surface
electrode(s)
Availability of equipment: No charge
MAINE
16.00
transport
Populations served: Aged (age 65 or older); Adult
(age 16 to 65); Child (up to age 16)
Areas served: Anywhere inthe U.S.A
Referral required? No
Billing info: Varies with ability to pay; Require
documentation of financial need
Payment methods: No information provided
Type of facility: Privately supported; PubKcly
supported; Non-profit; In~tient facility; Outpatient
facility; Research.& development center
Accreditation! JGAHO Accredited - for Kennebec
Valley Medical Center
licensing/Certification: Not applicable
82
16.01
FES Application:
Lower limb movement
Standing / transfer assistance
Description: Paraplegic subject, implanted in 1991
with a modified cochlear FES-22 stimulator for lower
extremity restoration of function. Our subject is
standing regularly.
History: See application description.
Status: Clinical service; Experimental research;
Feasibility study
Candidate Description:
Spinal cord injury
MARYLAND
~
17,.00
Physical Medicine and Rehabilitation Service
Baltimore Veterans Affairs Medical Center
10 N. Greene Street, Mail Stop 117
Baltimore MD 21201
USA
Tel: 410-605-7171
Toll-free:
FAX: 410-605..7932
E.;Mail:
Director: Dr. Peter Gorman
Contact Person: Linda Marshall, M.S., OTR
Program Descriptiom No information provided
Information available! Pril1tedformat; Videotape
format
Hours: 8:30 AM to 5:00 PM; Monday - Friday
Location of services: Consumer's residence; Service
providers location
Accessibility: Wheelchair accessible, incl. bathrooms;
17.01
FES Application:
Upper limb movement
Grasping
Description: Research program testing
NeuroControl's Freehand system, Neuroprosthetic
Hand Grasp System, to produce functional grasp and
release in persons with C-5/6 quadriplegia. Produces
lateral and palmar grasp patterns.
History: Has been available for three years, have
implanted 3 persons, able to accept at least 7 more at
this time (as of 4/95), have had successful outcomes of
all 3 participants.
Status: Experimental research; Feasibility study; Multi
center clinical trial
Candidate Description:
Spinal cord injury
Cervical: Motor: C5-6 / Sensory: C5-6
Tetraplegia! Quadriplegia
Restrictions/ Contraindications: Contraindications:
severe upper extremity contractu res, incomplete injury,
--
83
USA - MARYLAND
,~h!:~rs~~ltI\a.'SClf'fnalOng;term>se,ttiDg~
fnfoMati'
, Printeaformat'"
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Injured
,Metlicalllln
nseling Center
2 Wisconsi
,Suite 530
CheVy Chase MD 208,14
USA
'
Thursday.F~",
Tel: 301-654-3638
Toll-free:
E*Mail:
J)iJ1ftor: CharteEJneRFrazier, RN
S!!"ct Person:Charleene Frazier, RN; Kathy"
I?Ssha, RN
Program D~riptlon:inisGOmputerizedFES
(CFES) Pr~fSm;',s Offetedina multidisciplinary'~linic
that stre~holisticn~lalthandwhere clients ar~
enco~~ged'and guided to ,become active h~lthSelf"
careslvers:Jhe comprehensive rehab.
is
'
managed~y' nurses withadvanceddegr
"
extensive professional"eXperience. In addition to the
CFES,tt:fesenursE!s,Q~~wide~range of services
FAX.:~3U1-652':90M
to
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18.01
FES Application:
Cardiovascular exercise
Bicycle ergometry
Description: The REGYS-ERGYS Program of
computerized functional electrical stimulation is cycle
ergometry utilizing the lower extremities through
synchronized sequential electrical stimulation delivered
by a computer through surface electrodes placed on
quad,rice~s, hamstring and gluteal muscles. Multiple
phYSiological benefits are achieved and sense of well
being is improved.
History: Began REGYS in 1986; began ERGYS in
1989; began full time offering in 1992 through May
1995. Over time about 20 participants have been in the
in-patient program, of those, 7 currently own and use
an ERGYS consistently 2-3 times per week, There are
currently 5 persons in the clinic program and 2 to be
evaluated to start,
Status: Clinical service
Candidate Description:
Spinal cord injury
Cervical: Motor: C4-7 I Sensory: C4-7
Thoracic: Motor: T 1-11 / Sensory: T 1-11
ASIA International Impairment Scale: A B, with no pain
sensation Paraplegia
Tetraplegia! Quadriplegia
Time elapsed post-injury/onset varies
area
?YesFrorn~ Howev.e'r,:rnust'have
Referrall'ef4"
been seen
'previous};~ear fora~e:ornplete
physical e
hysiatrist familiarwitfilSCI.
BIlling Infl.
las::; .
..,
84
USA-MARYLAND/MASSACHUSETTS
19.00
19.01
FES Application:
Sexual function
Electroejaculation
Description: Rectal probe electroejaculation - A probe
is placed in the rectum and voltage is discharged to
stimulate contraction and emptying of ejaculatory
apparatus. Once semen quality is acceptable, artificial
insemination or in-vitro fertilization is pursued.
Hi~t0':Y.: Has been available for 4 years; approximately
15 individuals have been treated; 5 pregnancies to
date, 3 live births, 2 miscarriages, 1 expecting (as of
5/95).
Status: Experimental research; Feasibility study; Multi
center clinical trial
Candidate Description:
Multiple sclerosis
MASSACHUSETTS
20.00
Department of Urology
Boston University School of Medicine
DOB Suite 606
720 Harrison Avenue
Boston MA 02118
USA
Tel: 617-638-8485
Toll-free:
FAX: 617-638-8487
E-Mail:
Director: Dr. Robert D. Oates
Contact Person: Dr. Robert D. Oates
Program Description: All types of management of
infertility including rectal probe electroejaculation.
Information available: Printed format
Hours: 9:00 AM to 5:00 PM, Monday - Friday
Location of services: Service providers location
.....
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85
USA-MASSACHUSETTS
~ 20.01
FES Application:
Sexual function
Electroejaculation
Description: Rectal probe electroejaculation for
treatment of infertility.
History: This has been available for seven years, we
have treated 50 individuals.
Status: Experimental research; Feasibility study; Multi
center clinical trial
Candidate Description:
Multiple sclerosis
Spinal cord injury
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21.00
tetraplegics.
Information available: Printed format
Hours: 8:00 AM to 4:30 PM, Monday - Friday
Location of services: Service providers location
Accessibility: Wheelchair accessible, incl. bathrooms;
Handicapped parking available; Near accessible public
transport
Populations served: U.S. Veteran Only; Aged {age 65
or older); Adult (age 16 to 65)
Areas served: New England States
Referral required?Yes From: Physician
Billing info: No charge; Fixed rates
Payment methods~ No information provided.
Type of facility: Publicly supp?~ed; VA ~gency;
Inpatient facility; Outpatient faCIlity; Hospital;
Rehabilitation center; Rehabilitation program
Accreditation: JCAHO Accredited
Licensing!Certification: Not applicable
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21.01
FES Application:
Lower limb movement
Stepping and walking
Description: Development of a hybrid orthosis for.
limited paraplegic gait. Uses FES and leg braces With
magnetic particle brakes at knees.
History: 5 subjects active over 5 years
.
Status: Experimental research; Feasibility study; Multi
center clinical trial
Candidate Description:
Spinal cord injury
Thoracic: Motor: T4 or below
Paraplegia
Restrictions! Contraindications: Need to be in good
health; no autonomic dysreflexia; no denervation of
quadriceps muscles, hamstrings, or glutii.
Treatment course:
Evaluation/ assessment - 2 hours
Pre-implementation therapy/treatment - FES exercise
for 1-3 months
Outpatient fitting/implementation - 2 or 3 times a week
bicycle ergometry
Training and evaluation of gait - 1 time/wk for 6-12 wks
Requires evaluation at this facility? Yes
Requires local lodging? Yes
Typical cost: Less than $1,000
3rd party payers typically cover: No costs; research
Type of equipment: Home use stimulator; Not FDA
approved stimulator; Transcutaneous/surface
electrode(s)
Availability of equipment: No charge
86
21.02
FES Application:
Upper limb movement
Grasping
Description: We are a satellite center for
implementation of the NeuroControl Freehand system
for improving hand function of persons with C5/C6
tetraplegia.
HiStory: 1 implantation as of 3195.
Status: Experimental research; Feasibility study; Multi
center clinical trial
Candidate Description:
Spinal cord injury
Cervical: Motor: C5
Tetraplegia! Quadriplegia
Restrictionsl Contraindications: Candidates should
be in good health, no upper limb contractu res,
controlled spasticity, no hand function beyond weak
. wrist extension, no previous tendon transfers to their
~
21.03
FES Application:
Neuromuscular treatments
Treating weak, atrophied muscles
Description: To assist in muscle strengthening and
maintenance of function after neurological damage
including stroke, nerve palsy, etc.
History: No information provided
Status: Clinical service
Candidate Description:
Spinal cord injury
Cervical
Other spinal disorder: stroke, nerve palsy, etc.
Hemiplegia
Tetraplegia! Quadriplegia
Restrictionsl Contraindications: Healthy, able to
---
MICHIGAN
~
22.00
87
USA - MICHIGAN
22.01
FES Application:
Cardiovascular exercise
Bicycle ergometry
Description: An ERGYS I home rehabilitation system
is used to develop and maintain cardiovascular fitness
in persons with tetraplegia. Participants ride 1-3 xl wk
for 30 min. with 1 on 1 assistance at all times.
History: FES-LCE has been available here for 5 years.
Five people have participated regularly during the past
5 years. The program has a total capacity of 10.
Status: Clinical service
Candidate Description:
Spinal cord injury
Cervical: Motor: C5-7
Tetraplegia! Quadriplegia
Time elapsed post-injury/onset: 1 year
Restrictionsl Contraindications: Lower motor neuron
lesions; mod-max lower extrem. spasticity; inadequate
lower extrem. range of motion; poor general physical
~.
23.00
I@
23.01
FES Application:
Sexual function
Electroejaculation
Description: Electrical stimulation is applied via rectal
electroejaculation probe to stimulate ejaculation.
Progressively increasing voltage is delivered in a wave
like pattern until ejaculation is achieved. Blood
pressure is monitored throughout the procedure.
History: The program began in 1985 and has been a
pioneer program in male infertility associated with
spinal cord injury and disease. We have treated over
200 couples and welcome all injuries.
Status: Experimental research
Candidate Description:
Multiple sclerosis
Spinal cord injury
Cervical
Thoracic
Lumbar
Sacral
Hemiplegia
Paraplegia
Tetraplegia/ Quadriplegia
Restrictionsl Contraindications: Not suitable for
persons with surgical removal of rectum or chronic
ano-rectal inflammatory problems.
Treatment course:
Evaluation/ assessment - 1 time a month until ready to
begin partner insemination
Pre-implementation therapy- intake via phone by nurse
Outpatient surgical procedure(s) - done with
anesthesia for persons with incomplete lesions
Approximate number of visits required in total: 4 - 5
Requires eva!. at this facility? Yes
Requires local lodging? No
Typical cost: $1,000-$5,000
3rd party payers typically cover: No info. provided
Type of equipment: Clinic use stimulator; Not FDA
approved stimulator; Availability of equipment: No
charge; Not available for home use
88
USA - MICHIGAN
24~OO
~hab!Utitibn Institute'ofNlichigan
Detroit: Medical Center
261 Mack Boulevard . . .
Detroit /MI. 48201
USA
Tel: 313-74So9801 i ',+
FAX! 313-745-1019t>
Director. Patti Detiear
Totl.free:
e:'MaH:.
Contact Petson:'tineenPuei
Program.OBscriplon: FESis:used in our new
Parastepsystem: This atlowsparsenstoambulate with
sti~ula~ntothed~Em!~it'ie$r4a~anassistive
device. We also USe FEa~fbstrengtnen muscles and
treat.~eakened or 8trophiedmusclesr0Ccasionally
FES Isused,toc()ntrolspastim~:
~ 24.01
FES Application:
Lower limb movement
Stepping and walking
Description: The neuromuscular stim. generates
sequences of electrical impulses that are targeted at
the quadriceps and peroneal nerves. This causes knee
extension which allows the person to stand. The
peroneal nerve causes hip flexion and allows the knee
to bend. The Parastep system is a comprehensive
a~proach to enable standing & short distance walking.
History: Currently Parastep is just getting underway
here, there have been no persons evaluated with this
system as of mid March '95, one evaluation is
scheduled for late March '95.
Status: Clinical service
Candidate Description:
Paraplegia
Restrictionsl Contraindications: Cardiac demand
pacemakers; cancer in electrode placement area;
severe scoliosis; severe osteoporosis; skin disease at
@] 24.02
FES Application:
Neuromuscular treatments
Treating weak, atrophied muscles
Description: FES for treating muscle weakness is
done by placing electrodes over the affected muscle(s)
and by setting up contract/relax patterns that
correspond with active or assistive exercises.
History: Regularly available
Status: Clinical service
Candidate Description:
Spinal cord injury
Restrictionsl Contraindications: Pacemakers
implanted defibrillators, implanted pain control d~vices,
cardiac instability. Restricted to complete SCI.
payment
Treatment course:
Evaluation/ assessment
Training
Post-implementation therapy/treatment
Maintenance / check-ups
Approximate number of visits required in total: 32
Requires evaluation at this faCility? Yes; Participant
must be evaluated by a therapist trained with Parastep
and a PhysiCian.
Requires local lodging? Yes; Because the treatment
is ongoing and the participant must be in the area to
attend sessions.
Typical cost: More than $20,000
3rd party payers typically cover: Some costs;
Medicare/Medicaid payment being researched
Type of equipment: Clinic use stimulator; Home use
stimulator; FDA approved stimulator;
Transcutaneous/surface electrode(s)
Availability of equipment: Purchase
Treatment course:
Evaluation/ assessment - 2-3 days
Pre-implementation therapy/treatment - 2 days
Outpatient fitting/implementation; Training
Maintenance / check-ups - as needed
Approximate number of visits required in total: variable
Requires evaluation at this faCility? Yes
Requires local lodging? Yes
Typical cost: No information provided
3rd party payers typically cover: No infor. provided
Type of equipment: Clinic use stimulator; Home use
stimulator; FDA approved stimulator;
Transcutaneous/surface electrode(s)
Availability of equipment: Purchase; Rental
89
USA - MICHIGAN / MINNESOTA
T
R
515 Mia
,Suite200
usA
Tel:616-4584:~
,FAX.: 616-4
Di8~tor:Xi~
MUl;,
lFoll~free:
E-Mail:
.'
ulatiOn.."
" ,
7:
Informati.n'a\f.ila~I"~l Printed"andMdeG~tima~
' m
I@
25.01
FES Application:
Neuromuscular treatments
Treating weak, atrophied muscles
Description: Therapeutic Electrical Stimulation (TES)
can be used as treatment for many conditions (Bladder
Control, controlling incontinence; Lower Limb Mobility stepping and walking, standing I transfer assistance;
Upper Limb Movement - grasping, reaching;
Neuromuscular Treatments - controlling spasticity). It is
a low intensity night-time stimulation used to facilitate
muscle, nerve and even bone growth in children.
History: Program began January, 1994; 50 active
participants.
Status: Clinical service
Candidate Description:
Spinal cord injury
Cervical
Thoracic
Lumbar
Sacral
Hemiplegia
,'ee
11
:profit
Paraplegia
Tetraplegia/ Quadriplegia
Time elapsed post-injury/onset: acute to 6 years
Restrictionsl Contraindications: Must be at least 2
years of age or at least have a body build to allow 2
inches in between electrodes. Contraindications
cancer, obesity, pregnancy, pacemaker.
Treatment course:
Evaluationl assessment - 1 hour
Training -1-2 hours
Maintenance I check-ups - at 6 weeks, 3 months, 9
months, 1 year, then every 6 months.
Approximate number of visits required in total: 5 times
for the first year.
Requires evaluation at this facility? Yes
Requires local lodging? No
Typical cost: $1,000-$5,000
3rd party payers typically cover: All costs
Type of equipment: Home use stimulator; FDA
approved stimulator; Transcutan/surface electrode(s)
Availability of equipment: Purchase; must be
purchased from Mayatek, Toronto, Canada
MINNESOTA
26- ~oo
Electrically Stimulated,SkeletalMtlscle
Neosphincter
~.
90
USA - MINNESOTA
[@
26.01
FES Application:
Bowel control
Bowel incontinence
Description: A gracilis muscle neosphincter is
surgically created and maintained in a tonically
contracted state by use of an implantable pulse
generator.
History: Has been available for 2 years; 10
participants have been treated to date.
Status: Experimental research; Feasibility study; Multi
center clinical trial
Candidate Description:
Spinal cord injury
Sacral
Paraplegia
@
27.00
University of Minnesota I Minnesota VA
Medical Center
111 Church Street, SE
Minneapolis MN 55455
USA
Tel: 612-625-0099
TolIfree:
FAX: 612-624-1398
EMail:
wkdurfee@maroon.tc.umn.edu
Director: William K. Durfee, Ph.D.
Contact Person: William K. Durfee, Ph. D.
Program Description: A feasibility study on FES
aided standing and gait which combines electrical
stimulation with orthotics.
Information available: No information provided
[@
27.01
FES Application:
Lower limb movement
Stepping and walking
Description: A feasibility study on FES-aided standing
and gait which combines electrical stimulation with
orthotics.
History: Three year project, three to four users at any
onetime.
Status: Experimental research; Feasibility study; Multi
center clinical trial
Candidate Description:
Spinal cord injury
Restrictions/ Contraindications: Must meet these
requirements: (1) full motion range of leg joints; (2)
good stability of leg joints; (3) can stand using a
standing frame; (4) good upper body strength and trunk
stability; (5) no lower motor neuron damage; (6) at least
3 months post-injury; (7) realistic expectations about
the technology. Contraindications: (1) no response to
---
91
USA - MISSOURI
lnfonna~~vailabl~'Rrlhtfiiformat; \fj~tape,
Uni
Pro'
Ul'livets. of
5IONorth,
fqr~at;AQ~f?rmat~ . . . .
,..
... HQ~~:a:OO~A~;to:i5:00~onday. ~Friday
LOCition'9fY$etytces:;~.IGe . providerslooation
Accessibmty:Wh~I~~accessible; lOcI. bathrooms".
transport
, .'
.. "
methods: Cash;
I'~Y,fJlentPlan
Cha~~dit Card;
nenlti.j~l.n('JiWElVa~lableat
ent
Accted~J1:JC,Al",'j;l)i,)4~~ited;>
28.01
FES Application:
Sexual function
Electroejaculation
Description: A probe is placed into the rectum
electrical stimulation applied causes ejaculation. The
semen is collected, processed and intrauterine
insemination of the partner is performed. Used for
persons with SCI and any other persons with
ejaculatory failure.
History: In operation since 1990; no capacity limitation;
successful pregnancy rate about 30% (national
average).
Status: Experimental research; Multi-center clinical
trial
Candidate Description:
Multiple sclerosis
Spinal cord injury
Cervical
Thoracic
Lumbar
Sacral
Other spinal disorder
Hemiplegia
Paraplegia
Tetraplegia! Quadriplegia
Restrictions/ Contraindications: Contraindication:
HIV+
Treatment course:
Evaluationl assessment - 1 visit
Outpatient surgical procedure(s) - 6 visits usually 1
month apart
Approximate number of visits required in total: 7
Requires evaluation at this facility? Yes
Requires local lodging? No; All outpatient, usually
candidates live some distance away
Typical cost: $1,000-$5,000
3rd party payers typically cover: Some costs
Type of equipment: Clinic use stimulator; Not FDA
approved stimulator
Availability of equipment: No information provided
92
USA - MISSOURI
.OO.0{~
ra,G,s .. REGY'S.
A'cCcps.ibility:.~eelchair.aooessible, . inel...battlptnSi'
;~tnstitute
fi~l1dQjp:pedpa,Tklng;~aiISbIe; Neara~lepublic
t~f'l~poilr
KansssCi
USA
Tel:
Toll-free:
FA
..E,.Mail:
Director: PatH~'dart, CRRN
Contact ~tI1lQn~ linda Jessen, PT; Ra~o,Leightoh;
PT
Program
REGysteR.
decumtus.ul
Informati'
popUiationss
A ...asserved:
restriQtio~
ed
.Ref."l s l7rom:Physidjan;ln.smance .
~mplny, .
'Iv~ti:~nyonecan.referiibutneeda
.. ~of"sonjerto.f:j .......
~ j~fO!
mentm
billlnsUll'artet
p~paYment
of facni!:pl.lJjl~ty supported;JNon-pr~' .
tlent facilitVr.Qutpatlentfacility;Rehabjii1:a~on
cenfer..
..
A~Cfeditatioft:(;~~7~ited. ....
Licen'Sih
29.01
FES Application:
Cardiovascular exercise
Bicycle ergometry
Description: REGYS and ERGYS bikes - training
phase on REGYS bike to advance to independence on
ERGYS bike.
History: Available for 8 years. Approximately 10-15
have started in the program, with about 7-8 with
insurance approval to continue. Capacity of 3-4 in
training at one time.
Status: Clinical service
Candidate Description:
Spinal cord injury
Cervical: Motor: C6 / Sensory: C6
Thoracic: Motor: T1-10 / Sensory: T1-10
ASIA International Impairment Scale: A
Sacral: Motor: / Sensory:
Tetraplegia! Quadriplegia
Time elapsed post-injury/onset: 6 months
Restrictionsl Contraindications: Bone fractures in
~
...,
29.02
FES Application:
Lower limb movement
Stepping and walking
Description: Parastep system: synthesized gait
restoration for spinal cord injured individuals.
History: Has been available since Jan. 1995.
Status: Clinical service
Candidate Description:
Spinal cord injury
Cervical: Incomplete
Thoracic: Motor: T3-9
Paraplegia
Tetraplegia! Quadriplegia
Time elapsed post-injury/onset: 6 months
Restrictions/ Contraindications: Bone fractures in
the last 3 years; cardiovascular deficits; decreased
bone density; poor upper extrem. function; lower motor
neuron injury
Treatment course:
Evaluation/ assessment - MD and PT evaluation
Pre-implementation therapy/treatment -leg training if
appropriate, time varies
Outpatient fitting/implementation
Training - 30 sessions, 2-3 times a week
Maintenance / check-ups
Approximate number of visits required in total: 30-40
Requires evaluation at this facility? Yes
Requires local lodging? Yes
Typical cost: $10,000-$20,000
3rd party payers typically cover: Some costs
Type of equipment: FDA approved stimulator;
Transcutaneous/surface electrode(s)
Availability of equipment: Purchase
93
USA - MISSOURI
29.03
FES Application:
Treatment course:
Circulatory/Skin treatments
Treating pressure sores
Description: E-Stim (electrical stimulation) at
approximately 100 Volts 60pps to decubitus ulcer for
healing.
History: Has been available for approximately 3 years,
about 10 persons treated.
Status: Clinical service
Candidate Description:
Spinal cord injury
~ 29.04
FES Application:
Candidate Description:
Spinal cord injury
Cervical: selected cases that are incomplete
Thoracic: Motor: T4-12
Paraplegia
Tetraplegia! Quadriplegia
Time elapsed post-injury/onset: 1 year
Restrictionsl Contraindications: See stepping and
walking programme
30.00
~E'S;Ut:J~r,EXtremityHandGrasp,SJ$tef1l
Carncal'Study
eenter for Physical
Reftabilitati(>Iil'2i3~Mfan1i'Stteet
St.Louis MO 63118
USA
~,314-577-5706
,IolI",free:
...,............. 3t4-172~19'92l .... ~..,.iil~
lli~,.'.S~~anMciLa~gnlin '
.g.~~~ac,t~~n:.Susal1.MpLaughlin
p~~J .p~t1pti?~:FoJI~ing!f'OAlfRB~pproval
thIS
. >.~f1f~llnicalrS$earclil~lte fotan
sho
Treatment course:
LUttterancMedicab~enter,
Evaluation/ assessment
:~~egtipi8ndr~elaseitfirougtisman
ermovement8;
Informalion.avaflaijJe:.Printed'fOrmat
traosport:
."
POf)~latfo~ise"e;d: Adijlt;(ag~.16to 65),
Areasservijd~ I3nlimited
Referral~~it8d? No
BIQinginfGiFixe<i:ra~;, ....... . . .
p~ym!ntrpetftodsrlNOi'in~/prO~i~.
TYp&'offa~lity~Feoeral;11lgen .,. .
()l;ItPati~l1tTa~ifity;Hom~cheal .......
Rehabllitation~nter;Reh8bifitation?
....."
. ;'tf;taoili~
.)tal;;;~., '
. "rRes~J:Ch
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Accredftation:;C}\R~ ACor~jtedpJC~Ff9bAeOreditti.
l.IcensingtCeJtifieation~N~hpplicable,; ..;.
94
USA - MISSOURI
~
30.01
FES Application:
Upper limb movement
Grasping
Description: Implanted device for active grasp and
release through the use of small shoulder movements.
History: This is an anticipated research site pending
FDA approval. The device has been available at other
sites for several years, more than 20 persons have
received the device.
Status: Experimental research; Feasibility study; Multi
center clinical trial
Candidate Description:
Spinal cord injury
Cervical: Motor: C5-6 complete / Sensory: C5-6
complete
Tetraplegia! Quadriplegia
Time elapsed post-injury/onset: 1 year
Restrictions/ Contraindications: No info. provided
Treatment course:
Evaluation/ assessment
Pre-implementation therapy!treatment - 1-2 mos
Inpatient surgical procedure(s) - 7-9 hrs, 3-5 day stay
Outpatient fitting - 5-15 times over 3-6 mos
Training - 3-6 months with 5-15 therapy sessions
Post-implementation therapy - 5-15 times over 3-6 mos
Maintenance I check-ups - every 6 mos. for at least 1
year, once annually thereafter
Approximate number of visits required in total: 20-25
Requires evaluation at this facility? Yes
Requires local lodging? No
Typical cost: More than $20,000
3rd party payers typically cover: Some costs
Type of equipment: Research prototype stimulator;
Implanted electrode(s)
Availability of equipment: No charge; research
device
Building 52
USA
Tel: 314.;894"-6671
Toll-free:
E..,...U:
FAX: 314-8455039
Director: .. ..
Isey; MD
Contact Pe
Jai Park
Prog-:am DescfiPtiom The FES program is prifnarily
designeCl for. adult veterans with a variety Of diagnoses
(primarily SCI). The goals program includelncteasing:
muscle strength; muscle bulk; bone density in the lower
extrem.; and cardiopulmonary conditioning.
Information available: Printed format
Hours: 7:30 AM to 4:30 PM, Monda - Frida
I~
Handicapped:parKingavailable; N
8$; pub1ic
transport ...
...
. . . . . . . . ........ .
Populations served: U.S. VeteranOnty~Adtllt (age.16<
~~
31.01
FES Application:
Cardiovascular exercise
Bicycle ergometry
Description: The ERGYS bike is used on individuals
with spinal cord injury. Benefits include: reversal of
muscular atrophy, increased bone density in the lower
extrem., and increased cardiopulmonary conditioning.
History: Have had the ERGYS unit for about 4 years,
approximately 8 participants have been treated,
capacity is 2 clients / day, max. of 4 at a time.
Status: Clinical service
Candidate Description:
Spinal cord injury
Cervical: Motor: C5-8 / Sensory: C5-8
Thoracic: Motor: T1-12 / Sensory: T1-12
Lumbar: Motor: L 1 / Sensory: L 1
Paraplegia
Tetraplegia! Quadriplegia
Time elapsed post-injury/onset: when cleared by a IVID
Restrictionsl Contraindications: No: pacemaker; hip
disarticulation; hypertension; denervated muscles;
--
95
USA - MISSOURI 1 NEBRASKA
31 .02
FES Application:
Neuromuscular treatments
Treating weak, atrophied muscles
Description: Designed to treat atrophic musculature,
weakened from disuse or partial innervation.
History: Available more than to years, with 100+
treated throughout the program. Capacity - 5 - 101 day.
Status: Clinical service
Candidate Description:
Multiple sclerosis
Spinal cord injury
Cervical: Motor: <1= C5 1 Sensory: </= C5
Thoracic: Motor: T1-12/ Sensory: T1-12
Lumbar: Motor: L 1-5 / Sensory: L 1-5
Hemiplegia
Paraplegia
Tetraplegia/ Quadriplegia
Time elapsed post-injury/onset: as close to original
injury as possible to 5-10 years post injury
l)
NEBRASKA
'-
32.
Physical Th~ra~BepartJnent
Immanuel R.eli$pilitafionCenter
6901 N. 7200 Street
Om:aha NE6S'f22
UsA
Tel: 402-572;'4;)27
ToU-free:
FAX: 402-572 .
E-Mail:
Director. K
ones, PT
Contact Persol1:KatherineJones, PT
program Description: We evaluate and train persons
with paraplegia the use of theParastepFES system
for standing and taking steps. Also used as a training
tool in re-Iearning.gpit for personswithincomplete SCI.
Info. available: Printed format; Vtdeotapeformat
HourS: 8:00 AMto 5:00 PM,Monda .:. Frida b
in
Il
32.01
FES Application:
Lower limb movement
Stepping and walking
Description: Surface electrodes placed on quadriceps
and gluteals to provide kneelhip extension in stance.
Surface electrodes are placed over the peroneal nerve.
A walker with remote finger switches activates the
stand and step fu nctions.
History: Available since Dec. 1991, experimental from
Dec. 1991 till April 1994. Ten have been treated since
Dec. 1991. Capacity of 2-3 .
Status: Clinical service
Candidate Description:
Spinal cord injury
Thoracic: Motor: T3 & below 1 Sensory: T3 & below
Lumbar: Motor: L 1 1 Sensory: L 1
ASIA International Impairment Scale: ABC
Paraplegia
Time elapsed post-injury/onset: usually 6 months
appointment)
location of services: Service providers location
AccessibJlity: Wheelchair;aecessib,le,incl. bathrooms;
Handicapped
i l1g avail~ble;Neafaccessiblepublic
transport;Ho
House'
populatiorisserved:Ncrtestrictions
Areas served: Iowa; Nebraska
Referral'required?;Yes From: Physician
Billing info: NoinformatfonRfOvided
Payment methods:ArrangedthroughSigmedics
Type of facility: Privately supported; Non~profit;
Rehabilitation center
Accreditati.on: CARFAccredited; JCAHO Accredited
licenSing/certification: Not applicable
96
USA-NEBRASKA/NEVADA
~ 32.02
FES Application:
Lower limb movement
Stepping and walking
Description: Surface electrodes are placed on
quadriceps and gluteals (if needed) to provide knee/hip
extension in stance. Surface electrodes are placed
over the peroneal nerve. A walker with remote finger
switches is used to activate the stand and step
functions through the above surface electrodes.
History: Available since Dec. 1991. Ten individuals
have been treated since Dec. 1991. Capacity: 2-3 at a
time. FES has been used to facilitate gait retraining for
2 persons with incomplete SCI. Begin ambulating with
FES and continue conventional PT, when ambulating
distance with FES equals distance without, FES is
discontinued.
Status: Clinical service
Candidate Description:
Spinal cord injury
Lumbar: Motor: L3-5 ASIA Intemationallmpairment
Scale: B C
---
Paraplegia
Tetraplegia! Quadriplegia
Time elapsed post-injury/onset: 4 - 6 months
Restrictions! Contraindications: Must have:
functional range of motion in trunk and lower extrem.;
good finger dexterity; decreased or absent lower
extrem. sensation. No: joint instability; contractu res in
the lower extrem.; history of long bone fractures.
Treatment course:
Evaluation/ assessment - 1 treatment
Outpatient fitting/implementation - 1 treatment
Training - 2-3 times a week for 2 - 4 weeks
ApprOXimate number of visits required in total: variable
Requires evaluation at this facility? Yes
Requires local lodging? No
Typical cost: No information provided
3rd party payers typically cover: All costs; billed as
gait training
Type of equipment: Clinic use stimulator; Home use
stimulator; FDA approved stimulator;
Transcutaneous/surface electrode(s)
Availability of eqUipment: Rental; exercise unit only
NEVADA
[;j 33.0'0
"Help Them Walk Again" .Foundation, Inc.
5300 W. CharlestooBoulevard
Las Vegas NV 89102
USA
Tel: 702-878--8360
Toll-free:
FAX: 702878.;.9508
E-Mail:
Director: JoAnne Toadvine, Ph.D.
Contact Person: JoAnne Toadvine, Ph.D.
Program Description: No information provided
Information available: Printed format
Hours: 9:30 AM to 4:00 PM, Monday - Friday
Location of services: Service providers location
Accessibility: Wheelchair accessible, inc!. bathrooms;
~ 33.01
FES Application:
Circulatory/Skin treatments
Improving circulation in limbs
Description: FES leg trainer - one lower extrem. is
connected to the stimulator and electrodes are' placed
over the quads. A weight is usually placed around the
ankle. Movement produces an increase in circulation
for about 30 minutes. The other leg is then stimulated.
History: No information provided
Status: Clinical service
Candidate Description:
Spinal cord injury
Paraplegia
Tetraplegial Quadriplegia
--
97
USA-NEVADA/NEW JERSEY
'
'
'
'
1,
'
'
'
'
33.02
FES Application:
Neuromuscular treatments
Regaining voluntary function
Description: PCI 4000 is used with hemiplegic.
paraplegics. tetraplegics and quadriplegics (incomplete
lesions). Individual muscles or reciprocal muscles are
stimulated using weights as a form of resistance while
stimulation is applied for 10 to 30 minutes per muscle.
History: No information provided
Status: Clinical service
Candidate Description:
Spinal cord injury
Hemiplegia
Paraplegia - incomplete
33.03
FES Application:
Cardiovascular exercise
Bicycle ergometry
Description: ELA 2500 ergometer is used for
cardiovascular exercise with persons with paraplegia,
tetraplegia/quadriplegia. The participant pedals for 30
minutes and resistance is varied. There is sequential
stimulation of the gluteals. quadriceps and hamstrings.
History: No information provided
Status: Clinical service
Candidate Description:
Hemiplegia
Spinal cord injury
Paraplegia - incomplete
Tetraplegia! Quadriplegia - incomplete
Restrictions/ Contraindications: Contraindications:
pacemaker. Restrictions: No +HIV, we do not have the
NEW JERSEY
34.00
98
Tetraplegia! Quadriplegia
Neuromuscular treatments
Treating weak, atrophied muscles
Description: Muscle re-education and strengthening
of: upper and lower extrem., back extensors.
History: History of 5 years, used with other therapies.
Status: Clinical service
Candidate Description:
Multiple sclerosis
Spinal cord injury
Spinal levels: depends on completeness of the injury
Cervical
Thoracic
Lumbar
Sacral
Hemiplegia
ParapleQia
ll
34 .02
FES Application:
Neuromuscular treatments
Treating weak, atrophied muscles
Description: REGYS Electrical Stim bike - for use in
stimulating quadriceps to increase strength, improve
circulation. REGYS bike used before starting ERGYS
electrical stim bike.
History: Used for approximately 5 years on many
clients. Used in conjunction with other therapies.
Status: Clinical service
Candidate Description:
Cardiovascular exercise
Bicycle ergometry
Description: The ERGYS bike provides electrical stim
to muscle groups for "cycle-type" 1)10vement. Benefits
are: cardiovascular: increased: muscle girth and
circulation; decreased osteoporosis.
HiStory: About 5 years. Used with other therapies.
Status: Clinical service
Candidate Description:
---
metastatic disease
Treatment course:
Tetraplegia! Quadriplegia
Time elapsed post-injury/onset varies
Restrictionsl Contra indications: Standard FES
contraindications: Pacemaker, metastatic disease
Treatment course:
99
USA - NEW JERSEY
l
34.04
FES Application:
Neuromuscular treatments
Treating weak, atrophied muscles
Description: Stim. of upper and lower extrem, and
back musculature, strengthening / re-training muscles.
History: Used for approximately 5 years. Used in
conjunction with other therapies.
Status: Clinical service
Candidate Description:
Multiple sclerosis
Spinal cord injury
Cervical
Thoracic
Lumbar
Sacral
Hemiplegia
Paraplegia
~
35.00
Kessler Institute for Rehabilitation, Inc.
Tetraplegia! Quadriplegia
Restrictionsl Contraindications: Standard FES
contraindications: Pacemaker, metastatic disease.
Treatment course:
Evaluation/ assessment - one time
Sessions 2-3 times a week
Approximate number of visits required in total: varies
Requires evaluation at this facility? Yes; Needs
evaluation by a physical therapist
Requires local lodging? No; Can train for home use
Typical cost: No information provided
3rd party payers typically cover: Some costs,;
depends on the insurance policy
Type of equipment: Clinic use stimulator; Home use
stimulator; FDA approved stimUlator;
Transcutaneous/surface electrode(s)
Availability of equipment: Purchase; Rental
l
35.01
FES Application:
Cardiovascular exercise
Bicycle ergometry
Description: REGYS / ERGYS computerized bicycle
program available for cardiovascular exercise.
Involves application of surface electrodes on gluteals,
hamstrings and quadriceps, through computer
sequencing individual cycles for about 30 minutes.
History: Available for 11 years" have seen over 100
individuals, no limit on number can accommodate
Status: Clinical service
Candidate Description:
Spinal cord injury
C4 to T11-12
Cervical
Thoracic
ASIA International Impairment Scale: A B
Paraplegia
Tetraplegia! Quadriplegia
Time elapsed post-injury/onset: any time post injury
Restrictionsl Contraindications: cardiac/phrenic
pacemakers; severe cardiac or respiratory disease;
100
Paraplegia
Tetraplegia! Quadriplegia
Time elapsed post-injury/onset: any time post injury
Restrictions! Contraindications: pacemaker;
pregnancy; intolerance to stimulation / sensation.
Treatment course:
Evaluation/ assessment - 1 session
Pre-implementation therapy/treatment - 1 hr
Approx. number of visits required in total: as needed
Requires evaluation at this facility? Yes
Requires local lodging? Yes; Done as an inpatient
Typical cost: $1,000-$5,000
3rd party payers typically cover: Some costs;
depends on length of treatment
Type of equipment: Clinic use stimulator; FDA
approved stimulator; Transcutaneous/surface
electrode(s)
Availability of equip.: No charge; in-house use only
~
35.03
FES Application:
Lower limb movement
Stepping and walking
Description: Parastep computerized ambulation
system allows for standing and walking through the use
of surface electrodes stimulating the quadricep muscle
and peroneal nerve.
History: Approximately 2 years (during investigational
period prior to FDA approval) 12 individuals have
received this treatment, no accommodation limit.
Status: Clinical service
Candidate Description:
Spinal cord injury
Thoracic: Motor level: T4-12
ASIA International Impairment Scale: A 8
Paraplegia
Time elapsed post-injury/onset: any time post injury
Restrictions! Contraindications: cardiac/phrenic
~
35.04
FES Application:
Neuromuscular treatments
Treating weak, atrophied muscles
Regaining voluntary function
Description: Neuromuscular reeducation and
strengthening for any diagnosis requiring this
treatment. Typically use portable stimulators, apply
surface electrodes to muscle requiring retraining.
History: Available for 15+ years, no accommodation
limit
Status: Clinical service
Candidate Description:
Multiple sclerosis
Spinal cord injury
Cervical
Thoracic
Lumbar
ASIA International Impairment Scale: ABC
Hemiplegia
Paraplegia
Tetraplegia/ Quadriplegia
Time elapsed post-injury/onset: typically after 8 weeks
Restrictions! Contraindications: cardiac and/or
phrenic nerve pacemakers; pregnancy; no placement
over cancerous lesions
Treatment course:
Evaluation/ assessment - 1 session
Treatment - for 2 - 3 x/ wk till the goal is achieved
Approximate number of visits required in total: varies
dependent upon the response
Requires evaluation at this facility? Yes
Requires local lodging? Yes, but could perform this
treatment at home with training and periodic check-up
Typical cost: $1,000-$5,000
3rd party payers typically cover: Some costs
Type of equipment: Clinic use stimulator; Home use
stimulator; FDA approved stimulator;
Transcutaneous/surface electrode( s)
--
--
--
101
USA - NEW ~IERSEY / NEW YORK
Il
35.05
FES Application:
Sexual function
Electroejaculation
Description: Men undergo electroejaculation for the
purpose of obtaining semen in order to father children.
History: No information provided
Status: Experimental research; Feasibility study; Multi
center clinical trial
Candidate Description:
Multiple sclerosis
Spinal cord injury
Cervical
Thoracic
Lumbar
Sacral
Paraplegia
Tetraplegia! Quadriplegia
NEW YORK
l.:.I .36JOO
FESlriduced.LowerExtremity;;Emometry
102
.' aff,ero
Malei,,.ipro
~
Q~~nhati()OlipirOVtrJed
The Mount
5 East 98th.Street.;J.~'
Box.1272
Ne\iV:Vork NY 1d9
USA .
............ ..
Tel:212.,241~~?11
.ilable;;.~(~araoce$Siti[~i:public.
To.l-free:
Oonta.'gerson;.. Nafjll~BarChamaf!Ml)
P
Male ReproducWe
m;. Off~nMfe~~l.Inseling,
elec~jacu(~tfon, vibratoiy~dlfug~~lOn,mal~
reprodtfctivelechnologies.
Hours: No information.provided
37.01
FES Application:
Sexual function
Electroejaculation
Description: Electroejaculation for sperm retrieval and
use with other assisted reproductive technologies.
History: No information provided
Status: Experimental research; Feasibility study; Multi
center clinical trial
Candidate Description:
Multiple sclerosis
Spinal cord injury
Restrictionsl Contraindications: Diabetes,
psychogenic problems, idiopathic problems,
. ...s sel'V~Male.qt:lly,
A.reas~ed:
38.00
ElectroejacUlation
The New York Hospital I ComeliMedical Center
525 East 68th Street, Box 29
New York NY 10021
USA
Tel: 212-746-5473
Tollfree:
FAX: 212-746-0468
E-Mail:
Direct():t: J.FrancoisEid, MD
Contact Persom.J;. Francois Eid, MD
Program Desenption: Electro.:ejaculation(EEJ)is the
application of rectal electrostimulation inanejaculatory
men .t~ producesemen.Althoughthe EEJ.procedure
was Initially developed in men in order to produce'
sernen in spinal cord injured (SCI) males, the technique
finds application in all cases ofaneJaeulation. Other
groups oimen who are candidates for this procedure
are men with myelodysplasia, mUltiple sclerosis, men
.....
4nt~'t!~SA
Refe~lIqui
TypeOffaci;I~Q~~Ij(;IYSU~ported; VA ag~~;
--
103
USA - NEW YORK
38.01
FES Application:
Sexual function
Electroejaculation
Description: Electro-ejaculation is an outpatient
procedure for inducing ejaculation in men who are
unable to ejaculate on their own. Proctoscopy before
and after the electro-ejaculation procedure will be
performed. A probe is then inserted into the rectum
adjacent to the prostrate gland. Using a low level
current, electrical stimulation is applied to the tissues
which often results in ejaculation. The strength and
duration of the electrical stimulation will be limited so as
to minimize the possibility of rectal injury. Semen will
be collected, examined and when appropriate, used for
artificial insemination. If ejaculation occurs retrograde
the sperm can be retrieved by flushing out the bladder.
History: Electro-ejaculations were first performed at
the New York Hospital I Comell Medical Center in
1990. To date we have 45 participants with 16
pregnancies and 12 births.
Status: Experimental research; Feasibility study; Multi
center clinical trial
39.00
Strong Mernotial Hospital
39.01
FES Application:
Upper limb movement
Grasping
Description: Biofeedback used to improve hand
function in consumers with quadriplegia injury.
History: 5 plus years
Status: Clinical service
Candidate Description:
Spinal cord injury
Cervical
Tetraplegial Quadriplegia
Restrictions/ Contraindications: Not applicable
Candidate Description:
Multiple sclerosis
Spinal cord injury
Restrictions/ Contraindications: No info. provided
Treatment course:
Evaluationl assessment - one visit is needed for
evaluation
Pre-implementation therapyltreatment - preop visit 2
weeks before the procedure
Outpatient surgical procedure(s) - procedure is
outpatient, discharge the same day
~pproxim~te number of visits required in total: 2 every
time the chent has the procedure. Requires preop appt.
Requires evaluation at this facility? Yes
Requires local lodging? No; Electro-ejaculation is
done as an outpatient procedure, we have clients who
live out-of-state.
Typical cost: $1,000-$5,000
3rd party payers typically cover: Some costs
Type of eqUipment: Clinic use stimulator; Not FDA
approved stimulator
Availability of equipment: No charge; for outpatient
Treatment course:
Evaluationl assessment - 1 time per week
Pre-implementation therapy/treatment - 2 times per
week for at least 6 weeks
Approximate number of visits required in total: 12 +
Requires evaluation at this facility? Yes
Requires local lodging? No; Outpatient treatment
Typical cost: Less than $1,000
3rd party payers typically cover: Some costs
Type of eqUipment: Clinic use stimulator; FDA
approved stimulator
Availability of equipment: No information provided
104
~ 39.02
FES Application:
Sexual function
Erection / electroejaculation
Description: Electroejaculation technique available to
spinal cord injured males for fertility evaluation for
purpose of procreation.
History: New program, less than 1 year.
Status: Experimental research; Feasibility study; Multi
center clinical trial
Candidate Description:
Spinal cord injury
Hemiplegia
Paraplegia
40.00
Parastep
Burke Rehabilitation Center
785 Mamaroneck Avenue
White Plains NY 10605
USA
Tel: 914-948"()050
Toll-free:
FAX: 914-684-0358
E-Mail:
Director: Vicki Clark
Contact Person: Vicki Clark
Program Description: The Parastep program is
designed to provide a means for standing and
ambulation for persons with spinal cord injuries. The
use is similar to long leg braces, in that it serves as an
adjunct to wheelchair mobility, but is not a replacement.
The use of FES makes the standing and ambulation
~ 40.01
FES Application:
Lower limb movement
Stepping and walking
Description: Use of Parastep System requires surface
electrodes applied to the quadriceps muscles and
lower legs. In conjunction with a computerized FES
delivery system and a modified walker, the user of the
syst~m can stand and walk. The use of the system
requires several Physical Therapy sessions and
.
purchase of the equipment.
History: New program as of 1/95; no one has yet
participated; capacity to be determined.
Status: Clinical service
Candidate Description:
Spinal cord injury
Cervical: Motor: C5-8 / Sensory: incomplete
Thoracic: Motor: T1-8 / Sensory: incomplete
Thoracic: Motor: T4-11 / Sensory: complete
Paraplegia
---
Tetraplegia/ Quadriplegia
Time ~Ia?sed post-injury/onset: any time post injury
Restrictions/ Contraindications: No info. provided
Treatment course:
Evaluation/ assessment - 1 time per month
Approximate number of visits required in total: 4 - 6
Requires evaluation at this facility? Yes
Requires local lodging? No; 30 minute procedure
performed monthly
Typical cost: $1,000-$5,000
3rd party payers typically cover: Some costs
Type of equipment: Clinic use stimUlator; Research
prototype stimulator
Availability of equipment: No information provided
Tetraplegia/ Quadriplegia
Time elapsed post-injury/onset: 6 months
Restrictions/ Contraindications: Contraindications
are not judged individually but as a whole; will be
screened at initial evaluation.
Treatment course:
Evaluation/ assessment - one time
Pre-implementation treatment - 2x1wk for 16 wks
Training - coincides with treatment
Approximate number of visits required in total: 32
Requires evaluation at this facility? Yes; To
determine appropriateness of candidate
Requires local lodging? No; As long as the
participant can commute 2 times a week.
Typical cost: No information provided
3rd party payers typically cover: All costs; if
approved
Type of equipment: Home use stimulator; FDA
approved stimulator; Transcutaneous/surface
electrode(s)
Availability of eqUipment: Purchase
105
USA-OHIO
ue
zG~tlcIMati.ii6H#f45220~2489
USA
Tel: 5ta-8;t2~2481iTo'l4'ree:
FAX: 51i3a12~31~3
Di~tor: ~~rY~~, MO
E4IIratf:
Coi'itact Be~llFNanCYl'f~k~, PT
.programilescnptionri:rheParastep (R)SYstern.isan
FESsystem thatenablesunbracedstanding and short
dJstance,walking by persons with. upper-motor neuron
parapJegia.iand . some~ersonswithiii~complet9
41 .01
FES Application:
Lower limb movement
Stepping and walking
Description: The Parastep(R) System consists of a
microcomputer controlled neuromuscular stimulator a
battery pack with a recharger, surface applied
'
electrodes, a control and stability walker with control
switches and physical therapy trainer. The system
operates based on the use of electrical stimulation to
actively control selected muscle groups in the legs.
History: Prior to FDA approval Good Samaritan
Hospital was involved in experimental research
clinical trials of the Parastep system for about 2 years,
followed by another year after FDA approval. Two
participants have been through the program.
Status: Clinical service
Candidate Description:
Spinal cord injury
Cervical: Sensory: T12 or above
Thoracic: Motor: T6-12/ Sensory: T12 or above
Paraplegia
Tetraplegia! Quadriplegia
~estrictionsJ Contraindicatio~s: (1) joint instability,
hiP, knee or ankle; (2) skin intolerance to electrical
stimulation; (3) poor trunk controllbalance; (4) intact
sensation for lower extremities; (5) no muscle response
106
.159.
E-Mail:
.&tidrg
Dlrector:.. RiCharcbR~i~M$I2}.
---
transport,
Payment
Payment;
rv,edicaio; Win . .
payment
C!0ntaCtPersomDElniel ~lyi;.f!.:l.
with parapl
result of multiple sclerosis.
center
42.01
FES Application:
Neuromuscular treatments
Controlling spasticity
Description: Use of FES to decrease spasticity with
home Focus unit.
History: 10 years available, hundreds treated
Status: Clinical service
Candidate Description:
Multiple sclerosis
Restrictionsl Contraindications: No info. provided
Treatment course:
Evaluation/ assessment - physical therapy evaluation
Training - same day as evaluation
42.02
FES Application:
Lower limb movement
Stepping and walking
Description: This is a pilot study with clients with
multiple sclerosis who can transfer independently but
are unable to walk 25 feet in less than 1 minute. The
Parastep system is used which uses skin surface
electrodes with controls on a walker.
History: Available for 1 year, 3 participants completed,
10 total capacity
Status: Experimental research; Feasibility study; Multi
center clinical trial
Candidate Description:
Multiple sclerosis
Restrictionsl Contraindications: Candidates must be
able to independently transfer; may be able to take a
few steps but unable to walk 25 feet in less than one
minute; must have stable multiple sclerosis with no
change in Kurtzke EDSS in 6 months; absence of
cognitive defiCits, ataxia, orthopedic conditions,
--
---
107
USA-OHIO
I@
42.03
FES Application:
Neuromuscular treatments
Treating weak, atrophied muscles
Description: Treatment of weak atrophied muscles
due to recent injury, disuse because of pain, disuse
because of recent episode of inactivity I bed rest, or
immobilization.
History: Common physical therapy treatment
Status: Clinical service
Candidate Description:
Multiple sclerosis
Restrictionsl Contraindications: No info. provided
Treatment course:
42.04
FES Application:
Neuromuscular treatments
Controlling pain
Description: Use of transneuromuscular electrical
stimulation for intractable pain in multiple sclerosis.
History: Common physical therapy treatment
Status: Clinical service
Candidate Description:
Multiple sclerosis
Restrictionsl Contraindications: No info. provided
Treatment course:
Evaluation/ assessment - 1
@
43.00
Cleveland FES Center
Cleveland VA Medical Center
Motion Study Laboratory 151 W
10701 East Boulevard
Cleveland OH 44106
USA
Tel: 216-791-3800 ext. 3099
Toll.;.free!
FAX: 216-231.;.a886
E-Mail:
cleve_fes@po.cwru.edu
Director: E.B. Marsolais. MD, Ph.D.
Contact Person: Jane Marek,RN, ext. 5109; Carol
Bieri, MS,PT, ext. 3834
Program Description: The ClevelandFESCenter is a
consortium in FES technology'including the Cleveland
VA Medical Center, CaseWestem Reserve University,
MetroHealthMedical Center,andEdison
BioTechnology Center. The Motion Study/Laboratory
conducts. research and development of FES
applications for the lower extremity. EmphaSis is
Evaluation/ assessment
Outpatient fitting/implementation
Training - 3 -10 sessions
Approximate number of visits required in total: 3 - 10
Requires evaluation at this facility? No; Common
treatment in physical therapy
Requires local lodging? No information provided
Typical cost: Less than $1,000
3rd party payers typically cover: Some costs
Type of equipment: Clinic use stimulator; Home use
stimulator; FDA approved stimulator;
Transcutaneous/surface electrode(s)
Availability of equipment: Purchase; Rental
Training
Maintenance / check-ups
Approximate number of visits required in total: 1 - 2
Requires evaluation at this facility? No
Requires local lodging? No
Typical cost: Less than $1,000
3rd party payers typically cover: Some costs
Type of equipment: Home use stimulator; FDA
approved stimulator; Transcutaneous/surface
electrode(s)
Availability of equipment: Purchase; Rental
108
USA-OHIO
43.01
FES Application:
Lower limb movement
Standing / transfer assistance
Description: FES-assisted standing and pivot
transfers for incomplete SCI. 8 channels of stimulation
to hip, trunk and knee extensors for exercise and
functional standingltransfers. A short trial of
percutaneous stimulation is followed by implantation of
an 8-channel receiver/stimulator. All procedures done
on an outpatient basis. One year follow-up required
post-implant.
History: 15 years history of FES for standing and
walking in persons with SCI, head trauma and stroke.
Over 30 volunteers. Currently 4 - 8 active standing
pivot transfer participants.
Status: Experimental research; Feasibility study
Candidate Description:
Spinal cord injury
Cervical: Motor: </= C5
Thoracic: Motor: >/= T 4
ASIA Intemationallmpairment Scale: ABC
Paraplegia
Tetraplegia! Quadriplegia
Time elapsed post-injury/onset: 6 months or
neurologically stable
Restrictionsl Contraindications: Must be able to
travel to Cleveland. No: history of other
orthopedic/medical problems; history of drug
43.02
FES Application:
Lower limb movement
Stepping and walking
Description: 16-Channel walking mobility. Short phase
of percutaneous stimulation via intramuscular
electrodes followed by implantation of 2 8-channel
receivers/stimulators. At least 1 year follow-up post
implant.
History: 15 year history of FES for standing and
walking in persons with SCI, head trauma and stroke.
Over 30 volunteers.
Status: Experimental research; Feasibility study; Multi
center clinical trial
Candidate Description:
Spinal cord injury
Thoracic
ASIA International Impairment Scale: A
Paraplegia
Time elapsed post-injury/onset: 6 months or
neurologically stable
Restrictions/ Contraindications: No: cardiovascular,
skin, bone/joint problems (range of motion +/- 5
degrees of normal); history of drug dependency. Intact
--
109
USA-OHIO
43.03
FES Application:
Lower limb movement
Stepping and walking
Description: The FES and leg bracing mobility
system, in addition to supplying the stimulation to move
the lower extremities, operates the locking and
unlocking brace joint mechanisms. Locking and
unlocking is synchronized with stimulation to give
stability and eliminate continuous stimulation. The
brace is designed for extended wear. Proposed
functional activities include crutch walking, stair ascent
/ descent, rising from the floor or low chair, ingress and
egress of motor vehicles, maneuvering in tight spaces,
and extended hands-free standing.
His~ory: Initial year of a 3 year study. Currently 3
subjects are participating with 3 more to be added.
Status: Experimental research; Feasibility study
Candidate Description:
Spinal cord injury
Thoracic: Motor: T4-12
Thoracic: Motor: will evaluate T1-4 on a case by case
basis
,44.00
nd:,~a.ter
MEiiElalCenfet
Paraplegia
Time elapsed post-injury/onset: evaluated on a case by
case basis, no set time Restrictionsl
Contraindications: Candidate must have unimpaired
upper extremities and good balance (balance not
impaired by head il1.iury).
Treatment course:
Evaluationl assessment - over approximately 3 one
hour visits
Training - more than required for use, due to research
Maintenance / check-ups - 1 hour a week
Experimental Protocol - requires 2 yrs of 2-3 visits/wk
Approximate number of visits required in total: 200
Requires evaluation at this facility? Yes
Requires local lodging? Yes; Must be able to visit the
laboratory several times a week for 2 years minimum
Typical cost: More than $20,000
3rd party payers typically cover: No costs; research
Type of equipment: Home use stimUlator; Not FDA
approved stimulator; Implanted electrode(s}
Availability of equipment: No charge; research study
Iriformati~fl;avaiiable:Printed aildVide9tli~format.
Hours:a:09~M to5:~~Pf!A' w~d~YS)<
Location.'()fi~,rvice&:~O:Stlmers~residence; S~ce
Providers location
2500 Metr()blealth!!>rive
Atcessibilnr:~eelchairaqces~i~l~i' incl~,~room~;
usA
transport "
cl~velandeH44109
Tel:i\216q"8~3480
Handicap~~pmingavaifable;. Neara~ssiblepUbUo
Toll;'free~
FA)t:216-778-4259E-Mall:
cleve::..fes@po.cwru.edu
Director! P;Hul'lterPeckham, Ph.D.
ContaClilJerson: I<evin Kilgore,. Ph.D.
Program Des1,iption: The Clevelaf]d' FES Center is a
co".sortium in functionalelecfficall$tirnulation .inclUding
the Cleveland VA~edical Center,.~:Westem
R~servel:Jniversity, MetroHealthM~iealCenterand
EdisonBioTechnoldgy.Center. ThisprOgrain2incI1l4es;a
vari~ of(jinicalandre~'FESap:~lica~$, .
primarily.fdrpers~ns:lNith..sPinaloordinjuries;~ut.l!IISO
.. ..
Populationsserved: No restrictioQs
Area.sserved:Untimited
.
Refem.1 fequired~~O
!!l'
110
USA OHIO
44 .01
FES Application:
Upper limb movement
Grasping
Reaching
Description: Electrical stimulation of the triceps is
used to provide elbow extension. Control is provided by
a gravity sensor or MES derived from the posterior
deltoid muscle. A neuroprosthesis provides hand
opening and closing.
History: 4 partiCipants have been treated
Status: Experimental research; Feasibility study
Candidate DeSCription:
Spinal cord injury
Cervical: Motor: C5-6
Tetraplegial Quadriplegia
Restrictions/ Contraindications: No info. provided
Treatment course:
Evaluation/ assessment - 4 days
Pre-implementation therapy/treatment - 4 - 16 wks as
an outpatient
~ 45.00
Hand Grasp,BladderSttfnuJation and
--'-"
---
--
111
USA-OHIO
II
45.01
FES Application:
Respiratory treatments
Breathing assistance
Description: Combined intercostal and unilateral
diaphragm and respiratory muscle pacing for artificial
ventilation.
History: Used in 2 persons.
Status: Experimental research; Feasibility study
Candidate Description:
Tetraplegia! Quadriplegia
Time elapsed post-injury/onset: 3 - 6 months
Restrictionsl Contraindications: Traumatic
quadriplegia, ventilator dependent, unilateral phrenic
function
@]
45 .02
FES Application:
Upper limb movement
Grasping
Description: Voluntary movement of shoulder or wrist
position is used to control the degree of grasp opening
/ closing. An 8-channel implanted stimulator is used.
History: FES has been researched for approximately
25 years. Approximately 50 have received
percutaneous systems, 11 have received implants and
14 have been implanted outside of Cleveland.
Status: Experimental research; Feasibility study; Multi
center clinical trial
Candidate Description:
Spinal cord injury
Cervical: Motor: C5-6
Tetraplegia! Quadriplegia
Restrictionsl Contraindications: Must have the
appropriate stimulatable muscles.
Treatment course:
Evaluationl assessment - 4 days
Pre-implementation treatment - 4-16 wks as outpatient
l
Treatment course:
Evaluation/ assessment - 2 - 3 days
Pre-implementation therapy/treatment - 2 weeks
Inpatient surgical procedure(s) - 10 day admission
Training - 6 weeks
Approximate number of visits required in total: variable
Requires evaluation at this facility? Yes
Requires local lodging? Yes
Typical cost: More than $20,000
3rd party payers typically cover: No info. provided
Type of equipment: Not FDA approved stimUlator;
Implanted electrode(s)
Availability of equipment: Purchase
45 .03
FES Application:
Bladder control
Bladder emptying
Description: For people with spinal cord injury, an
electrical stimulator implanted surgically in the body
produces emptying of the bladder reducing infection,
medication and catheter usage.
History: Available for 3 years in Cleveland and for 17
years in Europe. Seven participants have been treated
in Cleveland, over 1,000 worldwide.
Status: Experimental research; Feasibility study; Multi
center clinical trial
Candidate Description:
Spinal cord injury
Cervical
Thoracic: Motor: T121 Sensory: T12
ASIA International Impairment Scale: A
Paraplegia
Tetraplegia! Quadriplegia
Time elapsed post-injury/onset: 1 year
112
USA-OHIO
@
48.00
The!OhloiState'tI:~v~.rSity
2154DQcfdHail
480 W.9tffAvenue
Columbus OH 43210.
USA
Tel: 614-293\..561a
Toll-free:
FAX:
E-Mail:
Director: James e.iBaldi,PIID
ContactPer&on:James c.'Bald~PhB
Program Description: FES9yclej:Srgometty'and
TENS unitstimulationare.proviaed.topersons within
the Qrst two months after spina1cordj;jnjury:
Mainten~nce of musclemass andbbne minerS~density
are monitored over a1 year trainingperio(j.
Information available: No information .provided
46.01
FES Application:
Cardiovascular exercise
Bicycle ergometry
Description: No information provided
History: This has been underway approximately 3
years, about 40 persons have been involved.
Status: Experimental research; Feasibility study
Candidate Description:
Spinal cord injury
Restrictionsl Contraindications: Candidates include
individuals who have been injured less than three
months. No chronic injury studies are presently being
conducted.
LOcation2~,!,rvlces~s
'providerslocation
Haftdieal;)p'edparkingavailable;.Near acce$SibIePUbli~
transport
'
populati0mJ'served:Nc);in~rrnati0f1"provided
Areas'seJ"l:~d,;iQhio, FrE:lnkfin>and.Neighboring
Counties
,.
Treatment course:
Training - 3 times a week for 15 months
Requires evaluation at this facility? Yes
Requires local lodging? Yes; Must be within driving
distance
Typical cost: More than $20,000
3rd party payers typically cover: All costs; research;
government funding
Type of equipment: Clinic use stimulator; FDA
approved stimulator; Transcutaneous/surface
electrode( s)
Availability of equipment: No charge; to research
partiCipants
~ 47.00
Wright State University Institute for
Rehabilitation Research and Medicine
Referral required? No
Direct()r: ROger M. Glaser, Ph.D.
..
...
113
USA-OHIO
47.01
FES Application:
Cardiovascular exercise
Bicycle ergometry
Description: Hybrid exercise, FES leg cycling
performed simultaneously with arm cranking, is able to
promote higher levels of hemodynamic, metabolic and
cardiopulmonary responses than either mode
performed separately. We consider this exercise to be
the state-of-the-art for upper-body and lower-body
conditioning and for the development of aerobic
(cardiopulmonary) fitness.
History: We have been performing research on hybrid
exercise since 1987. It may be used in conjunction with
other FES training modalities.
Status: Experimental research; Feasibility study
Candidate Description:
Spinal cord injury
Paraplegia
l
47.02
FES Application:
Cardiovascular exercise
Bicycle ergometry
Description: FES-induced leg cycle ergometry
promotes peripheral and central hemodynamic
responses, and elicits magnitudes of metabolic and
cardiopulmonary responses for aerobic training. Also
effective in reducing the secondary medical
complications caused by a sedentary lifestyle. We are
performing research on the efficacy of this induced
exercise, and on how to advance this technology.
History: We were involved in the development of the
original FES leg cycle ergometer and its
commercialization. The original prototype was
constructed in 1982. Over 100 have been involved in
our FES cycling research.
Status: Experimental research; Feasibility study
Candidate Description:
Spinal cord injury
Paraplegia
l
Tetraplegia! Quadriplegia
Time elapsed post-injury/onset: 6 months
Restrictionsl Contraindications: No significant lower
motor neuron damage. If subject has sensate skin,
need to tolerate the FES without undue discomfort.
Treatment course:
Evaluation/ assessment - 2-3 days
Training -12 week period
Post-training Evaluation - 2-3 days
Approx. # of visits required in total: 40 / training period
Requires evaluation at this faCility? Yes
Requires local lodging? Yes
Typical cost: No information provided
3rd party payers typically cover: No costs; research
Type of eqUipment: Clinic use stimulator; Home use
stimulator; FDA approved stimulator;
T ranscutaneous/su rface electrode( s)
Availability of equipment: Purchase
Tetraplegia! Quadriplegia
Time elapsed post-injury/onset: 6 months
Restrictionsl Contraindications: No significant lower
motor neuron damage. If research subject has sensate
skin, need to be able to tolerate the FES sensation
without undue discomfort.
Treatment course:
Evaluation! assessment - 2-3 days
Training - 12 week period
Post training evaluation - 2-3 days
Approximate number of visits required in total: 40 per
training period
Requires evaluation at this facility? Yes
Requires local lodging? Yes
Typical cost: No information provided
3rd party payers typically cover: No costs; research
Type of equipment: Clinic use stimulator; Home use
stimulator; FDA approved stimulator;
TranscutaneouS/surface electrode(s)
Availability of equipment: Purchase
47.03
FES Application:
Orthopaedic treatments
Circulatory/Skin treatments
Preventing/treating osteoporosiS
Description: Use of strong, rhythmiC. pulsed isometric
(static) contractions of the paralyzed calf and thigh
muscles following spinal cord injury may provide
beneficial effects to the muscles, bones and Circulatory
system. May also be useful for preventing deep venous
thrombosis since it enhances blood flow in the legs.
History: Used since 1988.
Status: Experimental research; Feasibility study
Candidate Description:
Spinal cord injury
Paraplegia
Tetraplegia! Quadriplegia
Time elapsed post-injury/onset: immediately post-injury
114
USA-OHIO
ll
47.04
FES Application:
Neuromuscular treatments
Treating weak, atrophied muscles
Description: FES knee extension resistance (weight
training) exercise used to increase strength and
endurance of paralyzed leg muscles for maintaining the
integrity of the lower-limb and improving muscle
function for other FES applications. Beneficial effects in
the activated muscles and possibly the bones of the
paralyzed limbs. Cardiovascular benefits - minimal.
History: Used since 1982. Many have been
successfully trained.
Status: Experimental research; Feasibility study
Candidate Description:
Spinal cord injury
Paraplegia
Tetraplegia! Quadriplegia
Time elapsed post-injury/onset 6 months
48.00
Ptlysic;I;.iThefapyDepartment
48 .01
FES Application:
Neuromuscular treatments
Treating weak, atrophied muscles
Description: Use electrical stimulation to assist with
sensory feedback to increase control of muscles and
strength, used with bio-feedback.
History: Used for 20 years. Have treated
approximately 15-20 / day with electrical stimulation.
Status: Clinical service
Candidate Description:
Multiple sclerosis
Spinal cord injury
Cervical: Motor: all levels / Sensory: all levels
Thoracic: Motor: all levels / Sensory: all levels
Lumbar: Motor: all levels/ Sensory: all levels
Sacral: Motor: all levels/ Sensory: all levels
ASIA International Impairment Scale
Hemiplegia
Paraplegia
Tetraplegia/ Quadriplegia
Other spinal disorder: stenosis, compression
Time elapsed post-injury/onset: any time post injury
Restrictions! Contraindications: Pacemaker, open
skin lesions
Treatment course:
Evaluationl assessment - 1 time
Training - daily 3-4 weeks
Approximate number of visits required in total: 20
Requires evaluation at this facility? Yes
Requires local lodging? No; Could be continued in
home area by referral.
Typical cost: Less than $1,000
3rd party payers typically cover: All costs
Type of eqUipment: Clinic use stimulator; Home use
stimulator; FDA approved stimUlator;
Transcutaneous/surface electrode(s)
Availability of equipment: Purchase; Rental
--
115
USA-OHIO
ll
48.02
FES Application:
Cardiovascular exercise
Bicycle ergometry
Description: REGYS I Bicycle Ergometry System
used particularly with persons with SCI to increase
fitness and facilitate function in persons with
incomplete SCI.
History: Available since 1982 - used with persons with
SCI (high levels).
Status: Clinical service
Candidate Description:
Spinal cord injury
Cervical: Motor: C2-7 / Sensory: C2-7
Thoracic: Motor: T1-10 / Sensory: T1-10
Hemiplegia
Paraplegia
Tetraplegia! Quadriplegia
Time elapsed post-injury/onset: any time post injury
ll
49.01
FES Application:
Lower limb movement
Stepping and walking
Standing I transfer assistance
Description: FES is used on a "case by case basis"
after physical therapy evaluation and client's response
and motivation. Prescription for ongoing use often
includes home usage and remote heel switch for
assisted ambulation.
History: FES has been used with the outpatient
population for 2+ years.
Status: Clinical service
Candidate Description:
Multiple sclerosis
Spinal cord injury
Other spinal disorder: incomplete spinal lesions,
neuropathy Hemiplegia
Paraplegia
Tetraplegia! Quadriplegia
Restrictions! Contraindications: Participant reQuires
116
USA-OHIO
49.02
FES Application:
Neuromuscular treatments
Treating weak, atrophied muscles
ContrOlling tremor
Regaining voluntary function
Enhancing neural regeneration
Description: FES is used on a "case by case basis"
when seen potentially beneficial via physical therapy
evaluation and client's response and/or motivation.
Prescription for ongoing use often includes home
usage. It is provided in the context of a physical
therapy program.
History: FES has been used with the outpatient
population for 2+ years.
Status: Clinical service
Candidate Description:
Multiple sclerosis
Spinal cord injury
Other spinal disorder: incomplete spinal lesions,
neuropathy Hemiplegia
Paraplegia
Tetraplegia! Quadriplegia
Restrictionsl Contraindications: Participant requires
a prescription for a medical doctor; needs to be able to
49.03
FES Application:
Neuromuscular treatments
Regaining voluntary function
Description: FES is used when seen potentially
beneficial on the basis of a physical therapy evaluation
and client's response. FES is used along with or in
conj~nction with other PT treatments. Voluntary
functions could include upper limb movement,
grasping, reaching and weight bearing on upper
extremities.
History: FES has been used with the outpatient
population for about 2.5 years.
Status: Clinical service
Candidate Description:
Multiple sclerosis
Spinal cord injury
Other spinal disorder: incomplete spinal lesions,
neuropathy Hemiplegia
Paraplegia
Tetraplegia! Quadriplegia
Time elapsed post-injury/onset: varies
Restrictions/ Contraindications: Prescription
-'
117
:z~~fe~1 required;?tYes/F"fom:'GQVemment~gency;
~xslclan
..
Pl1iymellt. .
50.01
FES Application:
Upper limb movement
Grasping
Description: Participating in FDA multicenter study for
FES grasp device in persons with quadriplegia.
History: Beginning the program, evaluating first
participant. (as of 5/95)
Status: Experimental research; Feasibility study; Multi
center clinical trial
Candidate Description:
Spinal cord injury
Cervical: Motor: C4-51 Sensory: C4-5
[~ 51.00
FES. Research'Progratn
Sh~ners
USA
TeJt215-332-4500
. FAX~215-332:Jj766
Toll-free: 800-"281'-4050
E"lllall:
mUlcahey@astro;ocis~temple;edu
Djt(!Cfor:RandalR. .Be12:,'Mo
GOfitact P..-son: M.J. MtitdShey, M.B:,.OTRIL
p.,aram Description: The ResearehF"rGgram at the
PhdadelphiaWnit ofShriner's'HoSpftalS"forerippJed
Children is dedicated toenhancing'th~iridependence
of children with spinal cord injury or cere6tal palsy
through the use of Functional Electrical'Slfmulation for
walking, ,stepping and hand andarm function.
'.... '
.'
...."
Tetraplegial Quadriplegia
Restrictions/ Contraindications: No info. provided
Treatment course:
No information provided
Requires evaluation at this facility? Yes
Requires local lodging? Yes
Typical cost: More than $20,000
3rd party payers typically cover: No costs
Type of equipment: Clinic use stimUlator; Home use
stimulator; Not FDA approved stimulator; Implanted
electrode(s)
Availability of equipment: Purchase
118
USA- PENNSYLVANIA
51.01
FES Application:
Upper limb movement
Grasping
Description: The FES system is designed to provide
two grasps: a "key pinch" to hold objects such as a
pencil or fork and "palmar grasp" to hold large objects
like a soda can. FES grasps are controlled with
motions of the opposite shoulder. Stimulation is
delivered to hand muscles with percutaneous
intramuscular electrodes.
H~story: Sinc~ the program began in 1989, 14 persons
With SCI ranging from 8-18 years have participated in
the FES program. Five persons with C5 SCI will be
added to the program over the next two years.
Status: Experimental research; Feasibility study
Candidate Description:
Spinal cord injury
Cervical: Motor: C5-6/ Sensory: C5-6
Tetraplegia! Quadriplegia
Restri~tionsl Contraindications: 6-13 years of age.
No: eVidence of active medical complications;
limitations in upper extremity joint range that interferes
with system use; lower motor neuron damage of target
51 .02
FES Application:
Upper limb movement
Grasping
Description: This system is designed to provide
stimulated grasp and arm movements to be employed
for everyday tasks such as eating, drinking and
grooming. Percutaneous intramuscular electrodes are
implanted in hand and arm muscles. The user controls
stimulated movements with motions of the opposite
shoulder.
History: Since the program began in 1989, 14 persons
with SCI ranging from 8-18 years of age have
participated in the FES program. Two persons with C4
SCI will be added to the program over the next two
years.
Status: Experimental research; Feasibility study
Candidate Description:
Spinal cord injury
Cervical: Motor: C4 / Sensory: C4
Tetraplegia! Quadriplegia
Restrictionsl Contraindications: 6-18 years of age.
No limitations in upper extremity jOint range that
,.,.
,.,.
--
,.,.
--
--
119
USA- PENNSYLVANIA
~ 51 .03
FES Application:
Upper limb movement
Grasping
~escription: This system is designed to provide key
pinch and palmar grasp. Key pinch provides the ability
to hold a pencil or fork and palmar grasp to hold larger
objects like a soda can. FES grasps are controlled with
movement of the opposite shoulder. Stimulation is
delivered via completely implanted electrodes and
stimulator.
History: Since 1993, 5 participants with C5 SCI have
had the FES hand grasp system implemented. Fifteen
more individuals will be added, pending approval of
funding.
Status: Experimental research; Feasibility study; Multi
center clinical trial
Candidate Description:
Spinal cord injury
Cervical: Motor: C5-6 / Sensory: C5-6
ASIA International Impairment Scale: A B
Tetraplegia! Quadriplegia
Restrictions/ Contraindications: Skeletally mature
(approximately 16 to 18 years of age). No lower motor
51 .04
FES Application:
Lower limb movement
Stepping and walking
Description: The FES system is used to provide
standing up from the wheelchair to allow reaching and
one-handed activities, and limited mobility away from
the wheelchair, including transfers into cars or other
seats, hopping or stepping (using a walker or
crutches), maneuvering into inaccessible places, and
ascending or descending stairs.
History: Since the research program began in 1986
we have worked with over 30 individuals. Fourteen
participated in standing or mobility training; the
remainder contributed to the study of exercise effects.
In a typical three-year grant cycle we accept at least
five participants into the program.
Status: Experimental research; Feasibility study
Candidate Description:
Spinal cord injury
.
Thoracic: Motor: T1-12/ Sensory: T1-12
Paraplegia
Time elapsed post-injury/onset: 1 year
Restrictions/ Contraindications: Children between
the ages of 13-18. Previous training in knee-ankle-foot
orthosis and functional independence in self-care and
wheelchair mobility skills desired. Contraindications:
Lower motor neuron damage to quadriceps and/or
120
USA- TEXAS
52.00'
Parast,p
DatiasiR.
.."
ilitation Institute.~ltlealtbSbuth
91q.s Harry!JfinesBoulevard
DallasTX 76220
USA
Tel: 214-351-2014
FAX~
P()pulatf~"s
214-35j-4012
~tions'
P~m~riptioq:Th
system is a
neu~useuIEaffunctional~mulation progr~m for
Area
..... ihtheU;$,f..
Referrafreq
Frotn:~lCian
Billing infG:
.....
. . ..
Pa
methods: Cflarge/CredilCalii.f: Will hill
4yp~Of.facilifJ!t:fQPatient
... . .... .
<
.' .'. .
.,
Director: Geti)rgeWharton,MD
Con~Cf~P~: Patricia, .
be,
ari'd~vefSing
muscularatrop~y,iina-~asing.ldcatbl()od.flmt~1"I
..
iouq,afientfaeility;
.' . ..... deveIOptl1el1t~ntelr
ReHabilitation ~nter; .
Accreditation: CARF Accredited;JQAHOAccredlfE!cl'
Licensing/CerlfflcatiOn,.Not appficabfe~
--
52.01
FES Application:
Lower limb movement
Stepping and walking
Description: The user of the Parastep system controls
it by initiating commands to the microcomputer
controlled stimulator which in turn activates electrical
impulses to the lower extremities to enable standing
and walking. Once standing has been achieved, users
progress to walking with a walker adapted with control
switches. The walker assists in balance.
History: This program was started in March, 1994.
Four have entered into the program so far.
Status: Clinical service
Candidate Description:
Spinal cord injury
Thoracic: Motor: T1-12/ Sensory: T1-12
ASIA International Impairment Scale: A
Paraplegia
Time elapsed post-injury/onset: any time post injury
53.00
121
USA- TEXAS
53.01
FES Application:
Sexual function
Electroejaculation
Description: Our group specializes in assisted
reproductive procedures. We perform
electroejaculation for men with ejaculatory failure. The
~peci~en. is collected, processed and usually used for
insemInation. Other assisted reproductive technologies
are available.
History: Electroejaculation has been available at our
facility for 10 years. We have treated over 250 persons
during this time.
Status: Experimental research; Feasibility study; Multi
center clinical trial
Candidate Description:
Multiple sclerosis
Spinal cord injury
Cervical: Motor: all levels! Sensory: all levels
Thoracic: Motor: all levels I Sensory: all levels
Lumbar: Motor: all levels! Sensory: all levels
Sacral: Motor: all levels! Sensory: all levels
t\w
54
1;S5ut
1717
lft,Yf~enter'.. ..
Road.~ Suite;1 0.3'
'Hurst T
USA'
Tel:81Toll~lree:
FAX: 81
344
E"1I!Iail:
Contact'PetSon:SaranGoadrich
. Prog@mDescription:>Electroejaculation Programfor
insemination, in vitrofertilitation and microinjection.
Initial EEJrecommended for semen analysis.or
cryopreservation.
Information: available~Printed format
54.01
FES Application:
Sexual function
Electroejaculation
Description: For men with infertility only. Rectal
stimulation to produce semen for insemination or in
vitro fertilization.
History: Performing EEJ since 1991 for infertility
services.
Status: Clinical service
Candidate Description:
Spinal cord injury
Ho
L
Ae
2)'.,
'.
alf:
Handi~;~ngavallable ....
Popul~SerVed. MaleoOnty:
Areas dJjed:tJnlifnited .
......
Refet'rafrJiqulred? .Yes Ftom;}PhySieian
,Silling Info:FlXeorates
PaymenUnethods:Cash; Char~/Gtedi~,eatdPlviltblll
Insurance
.
Type of facility: Privately. supported~ For pn1Ifiij'" .
OutpatienHacillly
...
..
Accreditation:;6ARFAccredited ...
Ucensing/Celtifleatio"; Doctor FACOG
122
5.5.10:';
pfovide~/Iocation
t[.iy,efSity!~
U~ersity of'Ulah
SON. MeqiCatDrivex;~:
Salt Lake;Clty UT 84:'fj~
USA
...
Tel: 801'-5814705
x4705
FAX: 801~a1-6127e~MllJr
Director~ Stewart T. Landau,. MD
ContactPerison: StewartT: LandauMD
program:D~ription:
-
-
transp'Qif'
55.01
FES Application:
Sexual function
Electroejaculation
Description: This program involves vibratory
stimulation and electroejaculation.
55.02
FES Application:
Lower limb movement
Stepping and walking
Description: Stimulate sacral or superficial peroneal
(sensory) nerve at constant low level to elicit flexion
reflex which aids in walking.
History: Limited use, no one else uses the system
described.
Status: Experimental research; Feasibility study; Multi
center clinical trial
Candidate Description:
Multiple sclerosis
Spinal cord injury
Other spinal disorder: myelopathy with spastic
paraparesis or monoparesis.
Tetraplegia! Quadriplegia
Time elapsed post-injury/onset: 6 months
Restrictionsl Contraindications: Should not have
evidence of active infection.
Treatment course:
Evaluationl assessment - one time
Post-implementation therapy/treatment - oncel month
Approximate number of visits required in total: 5-6
Requires evaluation at this facility? No; Can be
done at other facility office
Requires local lodging? No; Treatment is intermittent
and participant can return home between visits
Typical cost: $1,000-$5,000
3rd party payers typically cover: No costs; insurance
only sometimes covers costs
Type of equipment: Home use stimulator; Not FDA
approved stimulator
Availability of equipment: No charge
..."
--
123
USA - VIRGINIA
56.01
FES Application:
Lower limb movement
Stepping and walking
Description: We are training appropriate candidates
for use of the Parastep(R} System by Sigmedics
surface electrodes are applied to lower extremities and
commands to stand and walk are delivered by the user
via a specially wired walker and microprocessor.
History: We have had our program since 1992
(summer). We have enrolled 5 people into the "active"
phase of the program. We can treat up to 3 at a time.
Status: Clinical service
Candidate Description:
Spinal cord injury
Thoracic: Motor. T2-12/ Sensory: T2-12
ASIA International Impairment Scale: A
Paraplegia
[i:J
57.00
Informationavailab1e:pnnteftcformat
Billing info!;Requj~.;documentationofcflnancialneeck
LicensingleertificattDn~No;imformati9tprovided
L
124
USA - VIRGINIA
I
57.01
FES Application:
Respiratory treatments
Breathing assistance
Description: Diaphragmatic pacemaker to both right
and left diaphragms, Pacer by Avery Labs.
History: Not a program as such. Eligibility made on a
case by case basis by attending physician or request.
Status: Clinical service
Candidate Description:
Spinal cord injury
Cervical: Motor: C3 / Sensory: C3
Tetraplegia! Quadriplegia
Time elapsed post-injury/onset: 2 years
Restrictionsl Contraindications: No info. provided
Treatment course:
Evaluation! assessment - 9 months
Inpatient surgical procedure(s) - 1 day
Training - 6 months
Maintenance! check-ups - on going
Requires evaluation at this facility? Yes
Requires local lodging? No; Can be an outpatient
Typical cost: More than $20,000
3rd party payers typically cover: No costs; VA pays
for pacemaker, surgeon, and hospital stay;
manufacturer provides some support
Type of equipment: FDA approved stimUlator;
Implanted electrode(s)
Availability of equipment: No information provided
I
57.02
FES Application:
Lower limb movement
Stepping and walking
Description: The system allows persons to walk
without the use of traditional long leg braces. Mounted
electrodes are placed on the thighs and legs to
stimulate the muscles and nerves to produce
movement. A battery powered stimulator is worn
around the waist and connected to an adapted walker
with hand controls.
History: Available as of 2/95, 4 persons screened with
one deemed a candidate. Candidate to begin 10/95.
No more than 2 persons at the same point in time.
Status: Clinical service
Candidate Description:
Spinal cord injury
Intact motor unit L1 and below
ASIA International Impairment Scale: A, B
Tetraplegia! Quadriplegia
Time elapsed post-injury/onset: 6 months
Restrictions/ Contraindications: Cardiovascular
disease, pulmonary insufficiency, epilepsy, severe
--..
--'
..,
58;00
---
125
USA - VIRGINIA! WISCONSIN
58.01
FES Application:
Lower limb movement
Stepping and walking
Standing! transfer assistance
Description: Parastep - FES in persons with
paraplegia, for enhancing ability to stand and ambulate.
History: Has been available for 1 year.
Status: Clinical service
Candidate Description:
Multiple sclerosis
Spinal cord injury
Thoracic
Lumbar
Paraplegia
Restrictionsl Contraindications: No info. provided
Treatment course:
No information provided
Requires evaluation at this facility? Yes
Requires local lodging? Yes
Typical cost: $10,000-$20,000
3rd party payers typically cover: All costs
Type of equipment: Home use stimulator; FDA
approved stimulator; Transcutaneous/surface
electrode(s)
Availability of equipment: Purchase
WISCONSIN
'l;;.5g,,~OO
'-26540~~1 ~
E~
D
.. Stenberg. PT; Arthur Rodfiquez. MD
Contact:fJerson:Setl1 Stellberg;:PT
Program Descrlpli_'Motor reli'iilinmgclinicWith .
emphasis on isolated motorrecrt.litment1acilitated'by
feedback mechanisms. Deveiophomep~yt;l!Ims:
Information available: Printed format; .Videotape
format; Phone contaet .
Hours.: 8:00 AM to 5:00 PM, weekdays
Location of services: Service providers location;
Home ro rams
\Jred~~l'lIo
Billing ill
for service
Payment methoCfS: Cash; Charge/Credit Card;
PaYl1lent Plan Optio~;Will oilllnsllrance; Will,lili"
Medicaid; WIll bill Medicare; Will bill Othertkl~rty
pl!iyment
TYpe of facility: Publicly supported; State agency;
Non-profit; Outpatient facility;Fedetal agency;
Rehabilitation .program
Accreditation: -.lCAHO Accredited
Liceri.in ICertification: Not a licable
59.01
FES Application:
Neuromuscular treatments
Treating weak, atrophied muscles
Description: Feedback used to help learn motor
control; increase movement ! muscle proprioception;
strengthen muscles; increase endurance; and reduce
shoulder subluxation. It is used as part of an
individualized home program. It may be used in
exercise and!or a functional activity.
History: FES has been used since 1983. 10-15% of
client load is SCI. About 250 persons seen per year.
Status: Clinical service
Candidate Description:
Spinal cord injury
Cervical
Thoracic
Lumbar
Sacral
Hemiplegia
Paraplegia
Tetraplegia/ Quadriplegia
Incomplete
126
USA - WISCONSIN
59.02
FES Application:
59.03
FES Application:
Neuromuscular treatments
Regaining voluntary function
Description: FES is one of a variety of types of
feed~ack used to assist a person in regaining voluntary
function (often in conjunction with biofeedback
sessions; neuromuscular retraining). We most often
use single joint movement applications like triceps
activity in upper extremity weightbearing, or reaching;
ankle dorsiflexion during gait.
History: FES used since 1983. 10-15% of client load is
SCI. A total of approximately 250 persons (all
diagnoses) are seen per year.
Status: Clinical service
Candidate Description:
Multiple sclerosis
Spinal cord injury
Cervical
Thoracic
Lumbar
Sacral
Paraplegia
Tetraplegia/ Quadriplegia
Time elapsed post-injury/onset: 6 months - 1 year or
when other therapies have been discontinued.
Treatment course:
127
ARGENTINA
.[~]
6Q:iUo
F"~IEleCtncal;
"MarGeld~. FiteiReh~buitatr
Av: Spnta!Fe5380~1'4"E:"
Aires 1425
rit
, ,:Tlt:J~
Tel: 54-1,"7:7~
F~f~l~E";Mail:
,. Di~:~ft'eeha
Contact,Perifoo:
pro9~tftDesctipti
'~~,.quired? No
60.01
FES Application:
Lower limb movement
Stepping and walking
Description: Surface stimulation of quadriceps and
peroneal nerve for standing and walking; sometimes an
ankle foot orthosis (AFO) is used in combination with
FES.
History: This program is 6 years old. Eighty persons
have been treated. The capacity of the program is 6-10
persons a day.
Status: Clinical service
Candidate Description:
Spinal cord injury
Thoracic: Motor: T4-10 / Sensory: T4-10
ASIA International Impairment Scale: A. B, C
Hemiplegia
Paraplegia
60.02
FES Application:
Lower limb movement
Stepping and walking
Description: Stimulation of the knee extensor and/or
peroneal nerve for assisted walking.
History: No information provided
Status: Clinical service
Candidate Description:
Multiple sclerosis
Restrictionsl Contraindications: Articular limitation'
strong spasticity; cardiovascular diseases.
'
Rehabilitation center
Treatment course:
Evaluationl assessment - 2 hours
Pre-implementation therapy/treatment - 3 - 5 times a
week for 2 weeks
Training - 3 - 5 times a week for 4 weeks
Maintenance I check-ups - every 2 months
Approximate number of visits required in total: 30 - 40
Requires evaluation at this facility? Yes
Requires local lodging? Yes
Typical cost: $1,000-$5,000
3rd party payers typically cover: No costs
Type of equipment: Clinic use stimUlator; Home use
stimUlator; Not FDA approved stimUlator;
T ranscutaneous/su rface electrode( s)
Availability of equipment: Purchase
128
ARGENTINA
60.03
FES Application:
Neuromuscular treatments
Treating weak, atrophied muscles
Description: Used for persons with atrophied muscle
because of long term rest, to prevent / improve
contractures, or for partially denervated muscles to
improve muscle power.
History: This is a new treatment implemented in 1993.
There are a few persons in the program and the
preliminary results are good.
Status: Clinical service
Candidate Description:
Spinal cord injury
Cervical: Motor: C4-8
Thoracic: Motor: T1-12
ASIA Intemationallmpairment Scale: A, B, C
Paraplegia
60.04
FES Application:
Neuromuscular treatments
Controlling spasticity
Description: Surface stimulation to the lower limbs for
persons with upper neuron lesions. Thirty minutes of
daily exercise to the quadriceps and gastrocnemius
muscle for 5 seconds on and 6 seconds off.
History: Since 1990 we've treated many persons with
a severe degree of spasticity because of SCI or MS
Status: Clinical service
Candidate Description:
Multiple sclerosis
Spinal cord injury
ASIA International Impairment Scale: A, B, C
Time elapsed post-injury/onset: any time post injury
60.05
FES Application:
Upper limb movement
Other - shoulder and forearm
Description: Stimulation to the shoulder and forearm
muscle to reduce spasticity, edema and increase range
of motion. Sometimes used in coml:!ination with
biofeedback.
History: No information provided
Status: Clinical service
Candidate Description:
Spinal cord injury
Cervical: Motor: C4-8 / Sensory: C6-8
ASIA International Impairment Scale: A, B
Tetraplegia! Quadriplegia
..-
Tetraplegia! Quadriplegia
Time elapsed post-injury/onset: any time post injury
Restrictionsl Contraindications: Cardiovascular
diseases
Treatment course:
Evaluation! assessment - 1 hour
Training - about 5 times a week for 5 weeks
Approximate number of visits required in total: 25
Requires evaluation at this facility? Yes
Requires local lodging? No; It is possible to have the
treatment at home
Typical cost: $1,000-$5,000
3rd party payers typically cover: No information
provided
Type of equipment: Not FDA approved stimulator;
Transcutaneouslsurface electrode(s)
Availability of equipment: Purchase
--
---
129
AUSTRALIA
Tet:'08
)FA'K= 61 . . .
14
EilII/Iiil:
Contact~,rson:Hello/
Ith, Physiotherapist
ProgramJ;tescription:C>i / ... ns with SCI or
disease",I!ES gaitlistanaitfgrf'J!itagramme; FESdriVen
hybrid exerci~e device "Power Trainer"; eXJYerimental
study of. FES fitness/aerobic training; and assessment
of FES for (assure areas/decubiti revention; . .
l]
61 .01
FES Application:
Circulatory/Skin treatments
Improving circulation in limbs
Preventing/treating pressure sores
Upper limb movement
Neuromuscular treatments
Treating weak, atrophied muscles
Controlling spasticity
Description: FES may be implemented via surface
electrodes on an individual basis.
History: Used clinically as physiotherapy tool for >6
years; specific use for gait/standing/stepping for 4 yrs.
Status: Clinical service
Candidate Description:
Spinal cord injury
Cervical: Motor: C4->
information provided
Type .PriVately.supported; Publicly
supported; Non"'profit; Outpatient facility; Home health
agency; Rehabifitation center
Accreditation: No information provided
LicensinglGertification: Not applicable
61 .02
FES Application:
Cardiovascular exercise
Bicycle ergometry
Description: Surface electrodes and lower limb FES
using Power Trainer to obtain hybrid exercise workout,
following a period of home-based muscle conditioning.
History: Available for about 2 years. Six treated so far.
Power Trainer (Sinties, USA model) plans to expand
programme to provide alternative venue for fully trained
persons in the community, dependent upon funds.
Status: Experimental research
Candidate Description:
Spinal cord injury
Thoracic: Motor: T4-12
Paraplegia
Time elapsed post-injury/onset: 1 year
Restrictionsl Contraindications: Restrictions: age 18
to 55. No: active medical problems; substance abuse;
autonomic dysrefJexia; active heterotrophic ossification;
peripheral vascular insufficiency. Contraindications:
osteoporosis> 30% loss via bone density studies;
br
130
AUSTRALIA
61 .03
FES Application:
Lower limb movement
Stepping and walking
Description: 2 dual channel stimulator system using
external electrodes and commercial stimulators.
Stepping and gait and exercise / muscle conditioning
only. Regular clinic attendance required to upgrade
parameters. Used in acute spinal rehab unit.
History: Available for 4 yrs, individuals treated: 4 (3
higher than T6) of these 1 has continued to manage
steppage gait plus rollator walking frame at home.
Status: Clinical service
Candidate Description:
Spinal cord injury
. Thoracic: Motor: T6-12
Paraplegia
Timeela sed
Fli
A
St
H
ictoria 3081
'AUSTRAL~IA
Tel: Qa-4~91
41easse.ve : Atistraria
FAX:~96;t3626.
. ..." mire
info. ...
Ditijtol';'Or
C
.
y-fo
t'l
No";~,> <
..,.' .',. ,
. .
..
or it
--
Paytneth
elCredltfG'ilttji
Payment Plan O}'
Type of facility: Privatelysupported:"PubltaJy'
supported; Non;;;profit; Inpatient facility; Outpatient
facility; Hospital;R.ehabtlitation center
A@reditation: No informati.on provided
Licensjn . . Ce~on: Nota licable
---
131
AUSTRALIA
asrehabllita:60n for adtiftsandchildroo'Withphysical
dl~abilities, a:ndprovisi?n ofresec;trch~chol~rShipsfor
pr&doctol'~;aJ1d post-idocto~1 trainee$.at the
oe .
~,
slatlQn,tb .langUSiges:,o
:f6f1ml!;.Sp~ifio
ancErigtisn upon
request
HOUrsl2~:POAM to 8;OOPM. Monday - Saturday
Toll.o:free :
Loc~,9fsel"{i~.s::Gonsumer's residence; Service
E"Maib
v i.get'S'!ocation
Qro
.8lJ
Accessibility: Whe~fch
essible incL bathrooms'
nQBvisj.. FACSM
HandiCapped pal'kir'lg<:Jv ilable; Near accessible public
'!llr,.Glenn Davis,[A9SM
transport
crrptk)n:Th~. Sha~e-B-I~ .
f'opUla~ionsserved:AduJqage15 to 55)
I$; . " .'
exercise\~~oi1y~~~dfunCtio
A.reas served: New$outh Wales; Austratia; New
. inQepenclenceofp~rsofl~;With~l~~rl:lfml:)
..Zeala
South PacIfiCRim Countries
J~seactjVi(I~~in~i~de: . (i)~~~E~ndtJGe9up4p~r Refe ..... ui~d1NojnfmmSltion provided
an '. Jw~rJimtY'musGl.llar~ntracti?nsfor augnjenting""
Billing info:No charge;Varies with ability to pay
exereiseoapacity;{ii)AeSiiijnduceaioWer..ritnb
Payment met~d~:WiIl biJIl.flSOrance'WiIl bill
mtJsc~Ia:~ co~ . . .....
. .. . . '. . s; ant;f!(ilii)
Medicare; Wnrbinbther third;;;,panypa?ment ....
rese~~and d~vel
:'of "fcdlf~nt~nr'(lfJ~
Type of facility~Privatelysuppbrt~d;PublfcJy
AU$trala$i~ Paci(IC..
) inexpensiveNMESand
suppo~~; Federa.,agency;~II~e' Univel'Sity
FESElppljanoes. sl.Ippertit'l{ithe priortocL TheShake..a
pr?gramiResearch & devel?pmentcenter
Leg I?roject.alS()'supports researchanddevel.opment of
Accreditation: NointormatiM provided
IOwer':'lirTltl~~Os~, education of health care
Licensin:g{6'eFtiffca:tion: Not applicable
professionals.conceming exercise therapy
""',
@l
63.01
FES Application:
Cardiovascular exercise
Bicycle ergometry
Description: Use of concentric and isokinetic lower
I~mb cyclin~, by itself, or in concert with voluntary upper
11mb exercise (usually arm cranking or wheelchair
propulsion) for the improvement of cardiovascular
fitness and general health. As experimental research
we follow WHO guidelines with WHO monitoring via
institutional ethics committee.
History: Availability since 1989; 68 total individuals;
capacity of 6 participants per week.
Status: Experimental research
Candidate Description:
Spinal cord injury
Cervical: Motor: C7 (incomplete.) / Sensory: T1
Thoracic: Motor: T4/ Sensory: T1
Lumbar: Motor: all levels / Sensory: varies
Paraplegia
Tetraplegia/ Quadriplegia
Time elapsed post-injury/onset: 1 year
-- -'-
','
132
AUSTRALIA
63.02
FES Application:
Neuromuscular treatments
Treating weak, atrophied muscles
Controlling spasticity
Description: Use of concentric and isokinetic lower
I~mb cyclin~, by itself, or in concert with voluntary upper
11mb exercise (usually arm cranking or wheelchair
propulsion) for the improvement of cardiovascular
fitness and general health. As experimental research
we follow WHO guidelines with WHO monitoring via
institutional ethics committee.
History: Availability since 1989; 16 total individuals;
capacity of 3 participants per week.
Status: Experimental research
Candidate Description:
Spinal cord injury
Cervical: Motor: C7 (incomplete) I Sensory: T1
Thoracic: Motor: T4/ Sensory: T1
Lumbar: Motor: all levels / Sensory: varies
Paraplegia
Tetraplegia! Quadriplegia
63.03
FES Application:
Lower limb movement
Stepping and walking
Standing / transfer assistance
Description: Use of concentric and isokinetic lower
I~mb cyclin~, by itself, or in concert with voluntary upper
11mb exercise (usually arm cranking or wheelchair
propulsion) for the improvement of cardiovascular
fitness and general health. Offered as an in-patient and
out-patient clinical service. As experimental research
we follow WHO guidelines with WHO monitoring via
institutional ethics committee.
History: Availability since 1994; 5 total individuals;
capacity of 5 partiCipants per week.
Status: Clinical service; Experimental research
Candidate Description:
Spinal cord injury
Cervical: Motor: C7 (incomplete) / Sensory: T1
Thoracic: Motor: T10 / Sensory: T8.
Lumbar: Motor: L2 I Sensory: varies
Paraplegia
--
-----
Tetraplegia/ Quadriplegia
Time elapsed post-injury/onset: 1 year
Restrictionsl Contraindications: Restricted by age
(see above); restricted by neuromuscular efficacy
response to NMES/FES. Contraindicated by
osteoporosiS and recent or poorly-healed fractures
(determined by planar x-rays); contraindicated for
some other conditions.
Treatment course:
Evaluation/ assessment - usually 2 weeks of
assessment
Pre-implementation therapy/treatment - 12 weeks
Training - minimum 14 weeks
Post-implementation therapy/treatment - 14 weeks
Maintenance / check-ups - as needed
Approximate number of visits required in total: = 60
Requires evaluation at this facility? No
Requires local lodging? Yes
Typical cost: $5,000-$10,000
3rd party payers typically cover: No costs
Type of equipment: Research prototype stimulator;
Transcutaneous/surface electrode(s)
Availability of equipment: No charge
---
133
AUSTRALIA I AUSTRIA
Sj~oo
R~fortitidnOf,,;
transport
Sydney ~SW2(je2
Populationsserv~NO' restrictions
.AUS1;"'All~> . .~.
Areuservetl:Ausualia
Tel:02~92~7226
Referral required? No
FAX:02:.906..1685e"MitU:
lJillinginfo:.NO charge
trsb@cortex~physiol.su.oz.ati
Payment methods:NQihformatlonprovided
Director:l3r,~TI'imScott; Dr. James Middleton
Type Of facilitY: privately supported; Inpatient facility;
ContacfPerson:Or. TirnScott; Dr. James Middleton
Outpatient faciliJM; College I University. program;
Program OeScription;.~esearch investigatiOnsofthe
Hospital; Rehabilitation center
applications offunCtional electricalstimulationt9the
Accreditation: No information provided
upper eXtremity.
Licensing/C~rtification; Not applicable
FE~
................... /. . . . . .........
. ' .. .
~ 64.01
FES Application:
Upper limb movement
Grasping
Description: Investigations are being made into new
configurations of hand grasp and release and the uses
of control of these.
History: This is a new research program.
Status: Experimental research; Feasibility study
Candidate Description:
Spinal cord injury
Cervical: C5 I weak C6
Tetraplegia/ Quadriplegia
Time elapsed post-injury/onset: 1 year
AUSTRIA
~ 65.00
Electrostimulation/Electromodulationjnthe
Re-education of Bladder-dysfunction
University Hospitals
Neuro-Urology Unit, Department of Urology
35 AnichstrtaBe
Innsbruck A-6020
AUSTRIA
TolI::free:
Tel! 0..512-'504",,2010
FAx:.loCO~512-504-2017
E:.Mail:
Dlrector.;Prot: Dr. H. Madersbacher, Urological
Surgeon
Contact:Person: Prof. Dr. H..Madersbacher,
UtologicalSurgeon
Program Description: This unilprovides for persons
with lowe('tractdysfunction (1) intravesical
elec;trostifnuiation,(2) transcu.taneous electrical
stimUlatiOn oUheN/pudendtls\\ (3) electrostijnulationof
the pelvic floor, (4)anteriorsacral root stimulation by
134
AUSTRIA
65.01
FES Application:
Bladder control
Bowel control
Sexual function
Description: 1.) Intravesical electrostimulation of
bladder; 2.) transcutaneous electrostimulation of the
perineal nerve combined with biofeedback; 3.)
transrectal electroejaculation; 4.) transvaginal pelvic
floor re-education; 5.) anterior sacral root bladder
stimulation (Brindley); 6.) sacral root stimulation
(Schmi?t). Applications can include bladder emptying,
controlling bladder incontinence, bowel emptying,
contrOlling bowel incontinence, and erection /
electroejaculation.
History: Intravesicular electrostimulation since 1978
peri~her~1 nerve stimulation since 1985; Brindley ,
deVice since 1985; transrectal since 1974.
Status: Clinical service
Candidate Description:
Multiple sclerosis
Spinal cord injury
ViennaWo
University of
Department of BtornedicalEilgineerfng:andRhysies
AKHEbene 4/L
Waehringerguertel18-20
Vienna A;.1 097
AUSTRIA
Te~: 0043-1-40400'-1984 (secretary)
Toll-"fte&:.
FAX: 0043440400-3988
EMall:
m:9ijak@bmtp.akh-wien.ac.at
Director: Univ. Prof. Herwig Yhoma,.Ph.D.
ContactPerson: H. Thoma;A!1.Bljak
Ptograr:n Description:The~$rmaWorking6r.o!'Jp
FES ~dlrectors H. ThomaandJ.Holle -isYactivein
phrenic nerve pacing since 1973. Carrousel
stimulation (aSPS 330.342/75) viitepil'!~ural
electrodes has.been clinicafly,ijsedinipijrenfcnEaf!'\ie
stimulation via{externallycontmned~hanf:\elttr!~nts
aSiwen:~sfor stimulation of 1~;~re~1<jn
persons with paraplegia (since 1982),. The~enna
Working GrOup FESis leading inmul~annel FES
implants: (1) externally controlled 8-cnanneLsystemin
the European market since 1983 (2) externally
controlled>2O-Channelsystem tested in animal studies
--
.....
WHERE TO GET FES
135
AUSTRIA! BELGIUM
66.01
FES Application:
Lower limb movement
Stepping and walking
Description: Two 8-channel implants (+16 channels)
are used for extension of knee and hip joints (4
electrodes for each nerve). The implants are externally
controlled and RF powered. The participant adjusts the
stimulation mode (standing up - walking - sitting down)
and gait by switches which are integrated in one of the
two forearm crutches.
History: Since 19821834 participants - have been
implanted
Status: Experimental research
Candidate Description:
Spinal cord injury
Thoracic: Motor: T3-12 / Sensory: open
Paraplegia
l1
66.02
FES Application:
Respiratory treatments
Phrenic Pacemaker
Description: Externally controlled 8-channel implant
with epineural electrodes, implantation of electrodes
either inside the chest or in the neck area. Normal or
hyper ventilation of both lungs for 24 hours a day is
possible. Closure of trachesotoma. Clinical service
according to TUEV (Europe).
History: 1 operation 1981, commercialized 1983, 30
participants, operation service free in Europe,
rehabilitation strategy essential for good results
Status: Clinical service
Candidate Description:
Spinal cord injury
Cervical: Motor: CO-3! Sensory: open
Tetraplegia! Quadriplegia
Time elapsed post-injury/onset: any time post inju~
BELGIUM
L.::J
67.00
u.z. Pellenberg
Weligerveld1
LubbeekB"'-3212
BELGIUM
Tel: 32":16-338700
TolIfree:
FAX: 32-16-338703
EMail:
Director: Dr. CarlotteKiekens, MD
ContactPerson~Dr. Carlotte Kiekens,MD
Program Descrlption: Phrenic nerve pacemaker
(Atrotectl(R; Gli~ical trial with superficial FES
(Handmaster,NESS) in . persons with stroke and SCI;
Rectal probe' electrostimulation ~Seager).
...... ---
---------------------136
BELGIUM
~ 67.01
FES Application:
Upper limb movement
Grasping
Description: Handmaster superficial FES device
NESS (R), Israel. Clinical trial for Dr. Weingarden
History: 1 person with tetraplegia; 2 persons with
hemiplegia; in use for about 6 months.
Status: Experimental research; Multi-center clinical
trial
Candidate Description:
Spinal cord injury
Cervical: Motor: C5-6
ASIA Intemationallmpairment Scale: A, B
Hemiplegia
Tetraplegia/ Quadriplegia
Restrictions/ Contra indications: No info. provided
Treatment course:
Evaluation! assessment - 1 time
Inpatient fitting/implementation - outpatient possible
Training - 3 - 5 times a week for 3 months
Requires evaluation at this facility? Yes
Requires local lodging? Yes
Typical cost: No information provided
3rd party payers typically cover: No information
provided
Type of equipment: Home use stimulator; Not FDA
approved stimulator
Availability of eqUipment: No charge
67 .02
FES Application:
Respiratory treatments
Breathing assistance
Description: Diaphragm pacemaker through bilateral
phrenic nerve stimulation.
History: Available since 1994, one individual
successfully treated (24 hour stimulation) using
Atrotech (R) stimulator.
Status: Clinical service
Candidate Description:
Spinal cord injury
Cervical: Motor: C2
Tetraplegia/ Quadriplegia
Time elapsed post-injury/onset: 6 months
~ 67.03
FES Application:
Sensory aids
Electroejaculation
Description: Rectal probe electrostimulation with
Seager device for electro-ejaculation.
History: Available for three years. About 15 individuals
treated.
Status: Clinical service
Candidate Description:
Spinal cord injury
Paraplegia
T etraplegial Quadriplegia
Time elapsed post-injury/onset: any time post injury
--
!]
68.01
FES Application:
Lower limb movement
Stepping and walking
Description: Portable, microcontrolled "N" channel
(4,8 or 16 channels) surface stimulation towards
restoring gait. Artificial neural networks and sensor
based strategies (strain gauge, FSRs, EMG, etc.).
History: Available as an experimental as well as
clinical set-up since January 1989.
Status: Experimental research
Candidate Description:
Spinal cord injury
Cervical: Sensory: C3-8
Thoracic: Sensory: T1-11
Hemiplegia
Paraplegia
Tetraplegia! Quadriplegia
Time elapsed post-injury/onset: 1 year
!]
68.02
FES Application:
Neuromuscular treatments
Treating weak, atrophied muscles
Description: Experimental trials on triggering spinal
cord capability of controlling movement: repetition of
gait characteristics through neuromuscular electrical
stimulation training.
History: Research and development for 7 years, about
300 persons treated.
Status: Experimental research
Candidate Description:
Spinal cord injury
Cervical: Sensory: C3-8
Thoracic: Sensory: T1-11
Hemiplegia
Paraplegia
Tetraplegia! Quadriplegia
Time elapsed post-injury/onset: 1 year
137
138
BRAZIL
68.03
FES Application:
Sensory aids
Sensation / feedback
Description: Artificial proprioception: Eletrotactile
stimulation -electrode matrices and phi phenomena.
History: This has been available for 2 years; 5
individuals have participated.
Status: Experimental research
Candidate Description:
Spinal cord injury
Cervical: Sensory: C5
Thoracic
Lumbar
Sacral
Hemiplegia
Paraplegia
Tetraplegia! Quadriplegia
Time elapsed post-injury/onset: 1 year
68.04
FES Application:
Upper limb movement
Grasping
Description: Microcomputer controlled stimulation (5-6
channels) for C4 - C6 tetraplegics. Control via open
loop, finger sensors and neural networks for voice
activation system; instrumented glove for tetraplegics.
History: Available for 7 years; 20 participants.
Status: Experimental research
Candidate Description:
Spinal cord injury
Cervical: Sensory: C4
Tetraplegia! Quadriplegia
Restrictions! Contraindications: All general to
~Iectrical stimulation. No de nervation of upper limbs.
@
69.00
FES for Spinal Cord Injured Patients
HospitalDas Clinicas DaFaculdade de Medicina
Rua diderot, 43
Sao Paulo 04116-030
BRAZIL
Tel: 55;;-011-549"!.0111
Toll-free:
FAX.55-011..s49..0556 e"lIall:
Director: LinamaraRizzo Battistella.MD:; Ph.D.
Contact Person: Silvia Mazzali Souza; Luis Henrique
Cuzziol; Claudete Lourenco
Program Description: FESprograms started in 1989.
Our program is based on the l:jubljana tecfJl1ology yet
now has been improved with mixed methods.
Infotmattonavailable: Printed format; Languages
other than English - Portuguese
-
--
Treatment course:
Evaluation/ assessment - 1 week
Pre-implementation therapy/treatment - 1 week
Outpatient fitting/implementation - 2 times/wk for 2 wks
Training - 2 times a week for 2 months
Approximate number of visits required in total: at least
one year (100)
Requires evaluation at this facility? Yes
Requires local lodging? No
Typical cost: $5.000-$10,000
3rd party payers typically cover: No costs
Type of equipment: Clinic use stimUlator; Research
prototype stimulator; Transcutaneous/surface
electrode(s)
Availability of equipment: No charge; research
device
--
---
139
BRAZIL
69.01
Hemiplegia
Paraplegia
Tetraplegia! Quadriplegia
Restrictions/ Contraindications: No info. provided
Treatment course:
No information provided
Requires evaluation at this facility? Yes; By
physiatrist
Requires local lodging? No; Outpatient treatment 2
3 times per week
Typical cost: No information provided
3rd party payers typically cover: No information
provided
Type of equipment: Clinic use stimUlator; Home use
stimulator; FDA approved stimulator;
Transcutaneous/surface electrode(s)
Availability of equipment: No information provided
FES Application:
Circulatory/Skin treatments
Upper limb movement
Neuromuscular treatments
Orthopaedic treatments
Sensory aids
Description: Use of FES in clinical treatment as
support of the Rehabilitation Program. (These can
inclu?~ grasping, reaching, controlling spasticity,
regaining voluntary function, enhancing neural
regeneration, preventing/treating pressure sores,
preventing/treating contractu res, sensation and
feedback.)
History: No information provided
Status: Clinical service
Candidate Description:
Multiple sclerosis
Spinal cord injury
tt~Y" 70;iOO.
\~~~;f()tf$Ri,oJI'Cord/lftjJjl!ed;'Patienm+".,
"
"
'~Bi6medtlinengrtieeririg:LabOr~tpry .. Polyt~chnical
/l~ool~;,ySP\?ivisao!D95ReaBlttamao. Hospfttal D~f
70.01
FES Application:
Lower limb movement
Stepping and walking
Description: Provides stepping and walking
assistance.
History: Available for 5 years; 30 individuals treated;
capacity of 10 persons per year.
Status: Experimental research
Candidate Description:
Spinal cord injury
Cervical: Motor: C7 / Sensory: indifferent
Thoracic: Motor: T1-10 / Sensory: indifferent
Paraplegia
Tetraplegia! Quadriplegia
Time elapsed post-injury/onset: varies
140
BRAZIL / CANADA
~
70.02
FES Application:
Lower limb movement
Standing / transfer assistance
Description: Provides standing / transfer assistance.
History: Available for 5 years; 30 individuals treated;
capacity of 10 persons per year.
Status: Experimental research
Candidate Description:
Spinal cord injury
Cervical: Motor: C7 I Sensory: indifferent
Thoracic: Motor: T1-10 I Sensory: indifferent
Paraplegia
Tetraplegia/ Quadriplegia
Time elapsed post-injury/onset: varies
CANADA
~71
.00
Division of Neuroscience
University of Alberta
513 Heritage Medical Research Centre
University of Alberta
Edmonton Alberta T6G 252
CANABA
Totl..free:
Tel:403'-4~2-5t4S
FAX:4Q3-492-1617
S.MaU:
Olre.ctor: RiChard Stein
ContacfPer.son: Marguerite Wieler
Program De.cription: W'e;'liavebeen. doing research
with FESih Edmol1tonfor 9 years. Weare currently
running amulti'-Centl'eclinicaltrial using simple 1-4
channel surface stimulators to assessFES ahd the
changes in walking in persons with Incomplete 'Spinal
cord injury. [Division of NeUroscience, Edmonton; G:F.
Strong, Vancouver; Lyndhurst Spinal Cord Centre,
Toronto; University of MCGill, Montreal.] Edmonton is
also investi atin other s stems, includin anei ht
~
'H"
channelstimulatoranct:aself-contaitied,si~gJe channel
stimulator.andmoresoHhi~ticated:pontr61.strategies
than srmpleswi~hesandisenso'P"
Inforrnationaviilable:'.i?rint
Houl'f.t 8:30Af\I1 to 6:00
MRnda~7,Ffiday
Locationof~tvjc.,!'~~eiVice;BrC!ll"idersi~fi()n
P:IYI{ . . .
Accessjbility;Vheelcnair~ccessitJle,incl.bathroomsi ;.
ca
Handi l?pedparkingllvsilable;Near:accessible;:public
transport
PopulationS.'s.~J'Ve<J:;No restr:ictiorns
Areas s~ed:.xtanColJver; Torohto;Montfeal.
R..ferralreq..-irelt?;No
Billing'ffnfo:No cMrge
Paymentme~h(Jds:.No informatfonprovided
Type of faci.lity.Publ~1y supported; Canadian MRC
and AHFMR; Research & development center
Accreditation. No. information.provlded
LicensihgfCertification: Not applicable
71.01
FES Application:
Upper limb movement
Grasping
Description: Bionic Glove: Self-adhesive surface
electrodes are placed on two to four positions on
forearm and hand. A
self-contained garment (the Bionic Glove) makes
automatic contact with the electrodes and delivers
hand-opening and pinch grip stimulation based on wrist
movement.
History: 5 years development, 35 users by April 1995
Status: Experimental research; Feasibility study; Multi
center clinical trial
Candidate Description:
Spinal cord injury
Cervical: Motor: C4-7
Hemiplegia
Tetraplegial Quadriplegia
Time elapsed post-injury/onset: 3 months
141
CANADA
71 .02
FES Application:
Neuromuscular treatments
Controlling tremor
Description: Tremor attenuation system: we have
designed and evaluated both an analog and a digital
FES controller which attenuates tremor by stimulating
muscles in a syncopated manner. Slow voluntary
movements are unaffected. The device is being
implemented in a version of the Bionic Glove.
History: In progress since 1992
Status: Experimental research; Feasibility study; Multi
center clinical trial
Candidate Description:
Multiple sclerosis
Other spinal disorder: essential tremor, Parkinson's
disease
]
71 .03
FES Application:
Lower limb movement
Stepping and walking
Description: FES systems have been built in
Edmonton and are CSA approved. They have 1-4
channels of stim. and can be controlled by hand / foot
switches, sensors or by computer. Most use surface
electrodes, a few use percutaneous wire electrodes.
History: We have been using FES for 9 years to
address gait problems. Our main focus is with those
with incomplete SCI. The multi-centre trial has allowed
Canadians to access simple surface systems.
Status: Experimental research; Feasibility study
Candidate Description:
Spinal cord injury
Cervical
Thoracic
ASIA International Impairment Scale: D
Paraplegia
Tetraplegia/ Quadriplegia
Hemiplegia
Restrictionsl Contraindications: Inclusion criteria
no lower motor neuron lesion, able to go from sit to
~
72.00
.
Therapeutic Electrical Stimulation
Consumer's residence
Accessibility: Wheelchair accessible, incl. bathrooms;
Handicapped parking available; Near accessible public
transport; Accessible hotel nearby
Populations served: Aged (age 65 or older); Adu!t,
(age 16 to 65); Child (up to age 16); Preschool, at feast
2 years old; School age; Adolescent
Areas served: Unlimited
Referral required? Yes From: Physician
Billing info: Fixed rates
Payment methods: Cash; Charge/Credit Card
Type of facility: Privately supported; Fofprofit;
Outpatient facility; Consultant / Private practice;
Research & development center
Accreditation: No information provided
LicenSing/Certification: Not applicable
....
142
CANADA
ll
72.01
FES Application:
Neuromuscular treatments
Treating weak, atrophied muscles
Description: Therapeutic Electrical Stimulation (TES)
involves the use of night-time, low-level stimulation to
treat disuse atrophy of muscle. Following evaluation
and determination of functional goals, the client is
instructed in the use of the neuromuscular stimulator
and appropriate placement of the electrodes for on
going home-based TES therapy.
History: Available since 1989. It is also available in
Grand Rapids, MI (Dr. Chester Hoyt 616-458-1088).
Status: Clinical service
Candidate Description:
Spinal cord injury
Cervical
Thoracic
Lumbar
Sacral
Hemiplegia
Paraplegia
TetrapleQia! Quadriplegia
. 73.00
Urology Division
The Toronto Hospital- Western Division
399 BathurstStreet, M.P. 8-320
Toronto Ontario M5T 2S8
CANADA
Tel: 416-603-5018
Toll-free:
FAX: 4164303-1961
E-Mail:
Director: Magaly M. Hassouna,M:,[);, Ph.D.
ContadPerson: M. Hassouna, M:tl, Ph.D.
Program Description: Sacral Neurostim for voiding in
persons with voiding dysfunction -neurogenic and
functional. Electroejaculation for infertile men (SCI.)
Information available: Printed format; Languages
other than English-French
Hours:No information rovided
--
73.01
FES Application:
Bladder control
Bladder emptying
Bladder incontinence
Description: FES of sacral roots for bladder control.
Neuromodulation of the pelvic floor musculature can
ensure voiding and/or continence in those with severe
frequency, urgency and in urinary retention (non
mechanical obstruction).
History: Since 1985, capacity of 5 per day 5 dys/wk
Status: Clinical service
Candidate Description:
Multiple sclerosis
Spinal cord injury
Paraplegia
Tetraplegia! Quadriplegia
Time elapsed post-injury/onset: > 6 months
Restrictionsl Contraindications: MS in flare ups
---
--
143
CANADA
73.02
FES Application:
Bladder control
Bladder emptying
Bladder incontinence
Description: FES of sacral roots helps bladder control.
By neuromodulation of the pelvic floor musculature, it is
possible to ensure voiding and/or continence in
persons with severe frequency, urgency and in urinary
retention (non-mechanical obstruction).
History: Since 1985, capacity of 5 patients a day 5
days a week
Status: Experimental research; Feasibility study; Multi
center clinical trial
Candidate Description:
Multiple sclerosis
Spinal cord injury
Paraplegia
Tetraplegia/ Quadriplegia
Time elapsed post-injury/onset: > 6 months
[
[
73.03
FES Application:
Sexual function
Electroejaculation
Description: For achieving fertility in persons with
paraplegia/quadriplegia. Transrectal electroejaculation
to retrieve sperm followed by artificial insemination.
History: Available for 6 years - 38 persons have
participated with 3 successful pregnancies.
Status: Clinical service
Candidate Description:
Multiple sclerosis
Spinal cord injury
Cervical
Thoracic
Lumbar
Paraplegia
Tetraplegia/ Quadriplegia
Restrictionsl Contraindications: Rectal anomalies
Treatment course:
Evaluation/ assessment - 1x every 4 wks, for 3-4 times
Approximate number of visits required in total: 5
Requires evaluation at this facility? Yes
Requires local lodging? No
Typical cost: Less than $1,000
3rd party payers typically cover: Some costs;
internal funds from the hospital budget
Type of equipment: Clinic use stimulator; FDA
approved stimulator
Availability of equipment: No information provided
74.00
G.F. Strong~f;~E;,,&::studv
Universi1ofAtberta
Brltish:~fumbia Rehabilitation Society
G. F. Strong Centre
425:5 laurelStreet
VanCouver British ColumbiaN5Z-2G9
CANADA
Tel: 604~737-6237'
Tollfree:
FAX::aO~737-6359
E"Nlail:
DlreetOt;Maura WhtttakerfB.Sc.R.; Dr. Richard Stein
ContactPerson: Maura:Wh:tttaker, B.Sc.R,
I'I'OgramDescriptfon:T
opulatiOfi:" inoomplete
SCI, 1 yearpostinjuryor . of disease, medicalry
stable. Canstand<aoo,pemaps take.a few steps>oslng
aid buHack hiplknee/dorsfflexiontotake a step" ie.
onelegdrags behind. Walklng~ir>eed about or less
than 3 meters a second: Extensor spasticity may
interfere with hi l;<nee flexion: Ind.ividual
144
--
CANADA
74.01
FES Application:
Lower limb movement
Stepping and walking
Description: Stimulation to the flexor withdrawal
response through surface electrodes on the common
peroneal nerve to illicit a stepping action in one or both
legs. Typically subject can stand with a walker or
crutches but walking is extremely slow (less than 3
meters/second). Subject cannot advance legs to take a
step. Incomplete SCI only; 1 - 4 channel stimulators.
History: Feb. 1992 G.F. Strong Physical Therapy
Department expressed interest in being part of a
~anadian multi-centre trial on FES. Oct. '92 accepted
Into the study, received funding. Jan. '93 1st subject.
12 (approximately) subjects - 6 appropriate. Program
capacity - uncertain but seeking participants.
Status: Experimental research; Multi-center clinical
trial
Candidate Description:
Spinal cord injury
Cervical: Motor: C6 / Sensory: Incomplete
Thoracic: Motor: T2-7/ Sensory: Incomplete
Paraplegia
Tetraplegia/ Quadriplegia
ASIA International Impairment Scale: C D
T2 epidural hematoma; transverse myelitis
74.02
FES Application:
Neuromuscular treatments
Treating weak, atrophied muscles
Description: Therapeutic use in SCI as adjunct to
strengthening program. Commonly applied to muscles
such as wrist extensors, deltoids, biceps, triceps or in
lower extremities - quadriceps. With shortened duration
over weeks, depends on the participant and therapist.
History: No information provided
Status: Clinical service
Candidate Description: No info. provided
75.00
---
-'
--
l
WHERE TO GET FES
145
CANADA/DENMARK
75.01
FES Application:
Neuromuscular treatments
Treating weak, atrophied muscles
Regaining voluntary function
Description: Used for partially innervated muscles
(greater than grade 3) for strengthening and re
education to optimise functional movement.
History: Units have been available for 8+ years.
Separate data is not kept for persons who have been
treated with FES.
Status: Clinical service
Candidate Description:
Spinal cord injury
Paraplegia
Tetraplegia! QUadriplegia
Time elapsed post-injury/onset: acute and early rehab,
0-3 months
Restrictionsl Contraindications: No info. provided
Treatment course:
No information provided
Requires evaluation at this facility? Yes
Requires local lodging? No
Typical cost: No information provided
3rd party payers typically cover: All costs
Type of equipment: Clinic use stimUlator; FDA
approved stimUlator; Transcutaneous/surface
electrode(s)
Availability of eqUipment: No information provided
DENMARK
r::ot" ,> 16'
..
2,~.I.C
forS~hsory-Moto.r~.lnteraction
. activate theparaly:Zedmtl~~. Nerve cUff/electrodes.
Department of Medical Informatics and:lmage AnalysB .. ~te implantedt)n sensory nerves; these;neural
Aalbor:g:"University
recordings.ar;e. proceSsed and: then usedto control
Fteank Bajers Vej 70
stimUlation ofparatyzed mussles.
. . Aalborg9000
Information avail86te:Noinfonnation .provitfea
DENMARK
Hours: No information provided
Tef:45",98158522
Toll-free:
Location ofse~jces: No information provided
,E;:.Mail: ts@miba.auc.dk
Accessibility:N'tfinformation provided.
FAX: 45-98154008
Ditecto~'ThomasSinkjaertPh.D.
Po~ulationsserved~Ad~lfl(age 16 to 65}
to develop'individual. functional,andriliabledevices
Billing info: No information provided
....
76.01
FES Application:
Lower limb movement
Stepping and walking
Description: To date three subjects have had nerve
cuff electrodes chronically implanted. Two of these
persons have drop-foot (one has CP the other has
MS). The processed neural signal (obtained from either
the sural or tibial nerve) is used to indicate foot-floor
contact. Indication of foot contact triggers a stimulator
which stimulates the peroneal nerve using surface
electrodes, providing foot dorsiflexion. This system is
portable.
History: This application has been available for 5
years, it was started in 1990. Three persons have
participated, there is a very limited capacity and it is
only experimental research at this time.
Status: Experimental research
Candidate Description:
Spinal cord injury
Multiple sclerosis
Hemiplegia
Tetraplegia! Quadriplegia
Restrictionsl Contraindications: Sensory peripheral
nerves that are used to provide a feedback signal have
to be healthy in a neurophysiological term.
Treatment course: Varies as research is done on a
very limited number of persons.
Requires evaluation at this facility? No; At the
hospital
Requires locallodging1 No
Typical cost: No information provided
3rd party payers typically cover: No info. provided
Type of equipment: Research prototype stimulator;
Implanted electrode(s); Transcutaneous/surface
electrode(s)
Availability of equipment: No information provided
hrnr
146
DENMARK
rthanEnglish ~ Danish
--
Payme
. . . :Nainfo
center
~
77.01
FES Application:
Lower limb movement
Upper limb movement
Muscle strengthening
Description: A training branch with adjustable
resistance is developed. For stirn. a modified
commercially marketed stimulator (TENS) is used. The
goal is to test how FES should be used to be efficient
on M. quadriceps and M. extensor carpi radilias.
History: Recruiting 24 persons with paraplegia for m.
quadriceps stirn and 12 with tetraplegia for wrist
extensor stirn.
Status: Experimental research
Candidate Description:
Spinal cord injury
Cervical
Thoracic
Lumbar
Paraplegia
Tetraplegia! Quadriplegia
Time elapsed post-injury/onset: more than 3-6 months
Restrictionsl Contraindications: No info. provided
Treatment course:
Evaluation/ assessment - 3 times a week, pre-training
Inpatient fitting/implementation - 1 time
Training - 6 times a week for 12 weeks (at home)
Maintenance/check-ups -1x1wk every 2 wks for 12 wks
Evaluation/ assessment - 3 times a week, post-training
Approximate number of visits required in total: 6-8
Requires evaluation at this facility? Yes
Requires local lodging? Yes
Typical cost: $1,000-$5,000
3rd party payers typically cover: All costs;
government or private funds
Type of equipment: Home use stimulator; Research
prototype stimulator; Transcutan.lsurface electrode(s)
Availability of equipment: No charge
77 .02
FES Application:
Upper limb movement
Grasping
Description: FES of a paretic muscle controlled by the
remaining voluntary myoelectrical signal from the same
muscle. Development of a device using said technique
on the forearm muscle(s) for restoration of grasp.
History: No information provided
Status: Experimental research
Candidate Description:
Spinal cord injury
Cervical: Motor: C5-6
Tetraplegia! Quadriplegia
Restrictionsl Contraindications: Must have some
---
147
DENMARK
"
"
"
\,...
\...
\...
"
I\.
"
"
"
"
\.
"
\.
~ 77 .03
FES Application:
Upper limb movement
Grasping
Description: The system uses EMG signal form
partially paralyzed wrist extensor muscles to control the
stimulation of the same muscle. By stimulating the
wrist extensor muscles and by using the tenodesis
effect, it is possible to restore a useful grip.
Hi~tory: A newly developed prototype is currently
being tested on selected subjects.
Status: Experimental research
Candidate Description:
Spinal cord injury
Cervical: Motor: C5-6
Tetraplegia/ Quadriplegia
Restrictionsl Contraindications: No info. provided
Treatment course:
No information provided
Requires evaluation at this facility? No information
provided
Requires local lodging? No information provided
Typical cost: No information provided
3rd party payers typically cover: Some costs; Costs
can't be determined
Type of equipment: Clinic use stimUlator; Research
prototype stimulator; Transcutaneous/surface
electrode(s)
Availability of equipment: No information provided
77 .04
FES Application:
Sexual function
Electroejaculation
Description: Seager NRH model 12 and 12E,
electrostimulation power unit and temperature
monitoring probes with accessories. The system is
used in men with spinal cord injury and ejaculatory
dysfunction. An electrical probe is inserted in the
rectum and the procedure is performed with and
without anesthesia, depending on the completeness of
the cord lesion.
History: Has been available for 3 years; 30 individuals
have been treated, with a capacity of 40 per year.
Status: Clinical service
Candidate Description:
Spinal cord injury
~ 77 .05
FES Application:
Cardiovascular exercise
Bicycle ergometry
Description: The REGYS I bike: crank position
controlled stimulation of hamstrings, quadriceps,
gluteals.
History: Has been available since 1991; can treat 10
persons with SCI in one year
Status: Experimental research; Feasibility study
Candidate Description:
Spinal cord injury
Cervical: Motor: C5-7/ Sensory: C5-7
Thoracic: Motor: T4-7 I Sensory: T4-7
Paraplegia
Tetraplegia! Quadriplegia
Time elapsed post-injury/onset: minutes to 2 years
(max. 24)
Restrictions! Contraindications: Not yet determined
Treatment course:
Training - 1 year
Approximate number of visits required in total: 150
Requires evaluation at this facility? Yes
Requires local lodging? No
Typical cost: More than $20,000
3rd party payers typically cover: No costs; research
Type of equipment: Home use stimulator; FDA
approved stimulator; Transcutaneous/surface
electrode(s)
Availability of equipment: Purchase
148
tiO",l1S= No;l~afio~:pmVided
lJ.ocatio
046704
F:MC: 33;6i'0467ffO
b
C
h! Dr. E
Program Description:
p~raplegia(c1osed,JEJi!Jp,.l};:CALlES(GQ~ter
AldedL?co'oo.tion ... ' . .
Electrical StirntilStion):
prod"~QJ1of,~plantr:{44c.naml~ls) .fdr gajt1"~storation.
Information'8YzailatilelNOinfQrmation pr~
78.01
FES Application:
Bladder control
Lower limb movement
Neuromuscular treatments
Description: Bladder stimulation using the Brindley
system. Development of a full implantable system for
gait restoration. Standing up and standing. Use of
Parastep system. Other applications could include
bladder emptying. controlling incontinence, stepping
and walking, standing / transfer assistance, treating
weak. atrophied muscles, controlling spasticity, and
erection / electroejaculation.
History: 5 years, 15 participants for verticalization; 13
for bladder stimulation
Status: Clinical service; Experimental research
Candidate DeSCription:
Spinal cord injury
Thoracic: Motor: T6/ Sensory: T6
Paraplegia
T etraplegia/ Quadriplegia
ormation provided
.,.. .
... ssible, incl. bathrooms'
H~ndicapped>~ng available
~oPu..tio~.served: No restrictions
A.r_8e~Jt;.;EQfO~
l~edf1Yes,Prom;,Physician
e:::c ,
. . paYm,pt'
ds: N~informatio~provjded
",peof fa. .. Non-profit: 'Inpatient facility;
Outpatient facility; Rehabilitation center; Rehabilitation
program
Aooredltation.:No,informatton'provided
Ltcensing/Gertific8tlon: Notappfitable
GERMANY
@
79.00
FESfor Paraplegic Patients
Klinik Berlin
Department ofNeurologic Rehabilitation
Free UniversitjBeriin
Berlim140a9
GERMANY
Tel:49130136503..102 ToU'"free;
FAX: 49130136503-222 E~Mail:
Director:. Stefan Hesse; K.H. Mausitz
Contactl'Person:StefanHesse
PfogramiDescription: No informationpro'lided
Infonnation available: Printed format; Videotape
format
--
149
GERMANY
79.01
FES Application:
Lawer limb mavement
Stepping and walking
Description: Standing is provided byextemal
stimulatian 'Of bath quadriceps muscles, first trained in
a standing bar and later in a walker. Far stepping
f1exian is elicited by shart stimulatian 'Of the peroneal
nerve, cantralled by the participant, 4-8 weeks 'Out
patient pragramme recammended. Later participant
s~auld handle himself. Nate: FES is nat mability but a
vlgaraus physical training programme for persans with
paraplegia.
History: Started in 1993, presently 10 persans have
been treated, capacity 'Of 10 new participants per year.
Status: Experimental research
80.00
Restoration of Stance andsGait'fbV FES
NeOrologieal Clinics
Klinikum Grosshadeum ofUniversity
Marchioninistrasse 15
Munich 0-81377
GERMANY
Tolf~free:
Tel: 49..;89-70906.118
FAX: 49-89-70906101
E-Mail:
u73Iar@sunmail,lrz.munchen.de
Director: Dr. JochenQuintem
COntact Person: Dr. Joehen Quintem
Program Description: 1.)Training: Re'-strengthening
of muscles, stance andgaitwith FES in persans with
paraple~ia (commerciallY/available stimulatars); 2.)
Evaluatian of FESin rehabilitatianofpersons wha have
had a stroke; 3.) DevelopmentafclOsed-laop FES
systems for stance, gait, stair climbing.
Info available: Lang. other than English - German
80.01
FES Application:
Lawer limb mavement
Stepping and walking
Description: Restrengthening of muscles, stance and
gait with FES in persons with paraplegia.
History: Third year of research, 10 persans treated to
date, capacity of 50 participants.
Status: Clinical service
Candidate Description:
Spinal cord injury
Tharacic: Motar: T1-12
Paraplegia
. Time elapsed past-injury/anset: 3 manths - 20 years
Restrictions/ Contraindications: Drug abuse,
Candidate Description:
Spinal cord injury
Paraplegia
Restrictions/ Contraindications: Clinically camplete
persans with paraplegia below C7.
Treatment course:
Past-implementation therapy/treatment - 3-5 timeslwk
Requires evaluation at this facility? Na
Requires locallo~ging? Na
Typical cost: $1,000-$5,000
3rd party payers typically cover: Na casts
Type of equipment: Hame use stimulatar; Not FDA
approved stimulatar; Transcutaneous/surface
electrode(s)
Availability of equipment: Purchase; Na charge
L
150
GERMANY
80.02
FES Application:
Stair Climbing
Candidate Description:
Paraplegia
~81
.00'
Neurolog
eni
t
Heu~t1waBe'!4Q
Wuppertal422S3
GERM.AfiII
Tel~,0202;;gga..2263
TolI..free:
F~()202.:.s96-2139
E"Mail:
[)r~tGt'::J.W. Thurdoff,MD; Markus Hoheilfellner,MD
Contact,PenotH
ProgtamDejcrlptiol1: Saeralneuromodulation .and
sacral deaffefentation, Ventral sacral rootstimulation
for treatment of neurogenic bladder dysfunction.
Information avaitable: No information provided
Hours: No information'provided
81.01
FES Application:
Bladder control
Bladder incontinence
Description: No information provided
History: Sacral neuromodulation has been used since
1989, 110 test stimulators have been used and 30
implants have been performed. Sacral deafferentation
has been used since 1995, - 4 procedures completed.
Status: Clinical service; Experimental research; Multi
center clinical trial
Candidate Description:
Spinal cord injury
Cervical: Motor: C5
Thoracic
Lumbar
Sacral
Paraplegia
Tetraplegia! Quadriplegia
Time elapsed post-injury/onset: depends on the type of
cardiac pacemaker.
Treatment course:
Evaluation/ assessment - 2 x I month during the project
Pre-implementation therapy/treatment - 4-6 weeks
Inp~t~ent fitting/implementation - about every 2 months
Training - at home for one hour daily
Maintenance / check-ups - at each evaluation
Approximate number of visits required in total: 20 - 50
Requires evaluation at this facility? Yes
Requires local lodging? No
Typical cost: $5,000-$10,000
3rd party payers typically cover: Some costs; only
for the training stimulators
Type of equipment: Clinic use stimulator; Research
prototype stimUlator; Transcutan./surface electrode(s)
Availability of eqpmnt: No charge; research device
...,>:eationofse~ices:No information~Ovided
~cessibility:'Wheelchair accessible,lncl. bathrooms;
Ha!ldicappectj:l5irking available
POpJJJationsserved: Aged (age 65'6r older); Adult
(age'l6 to 65)
Areas.:Served:.LJnlimited
Ref,rral requli'ei.lt? No
BUIiI't!,.!nfo:Fixedrates
PaYnlentmethods: Ca5h;.Gharg~rectjtGard:. Wm~biil
Insurance
Type offacility!P~blicIY.supported;Fed~ralaQency;
No~-profit; Inpatientfacility" Outpatient.~; College!
Umv;prc>gram; Hosptl; Research>& dvlpliultcenter
Atcreditation:No informationprovided
Licensing/C,rtification:Not~ppncable .
151
',
ICELAND /ISRAEL
10
1'~!r~3'54~560-1595" .;;!~n-free:
DeThrdurHe1g:a~G!rr
..Pers(l)..~~~ordur Helgason .
,p ..... mDescriPlron:~~information pl1)}lided
1nformation avaiiable~:I.:.:anguagesot/1er;:~an EnglishIcelandic
.
Hours: 8:00 AM to 12:00 nbOn, MondlilY;' Friday
,"0
[@
82.01
FES Application:
Neuromuscular treatments
Controlling spasticity
Regaining voluntary function
DeSCription: We are treating a person with MS with
m.ultichannel electrical stimulation to reduce spasticity.
History: 5 years, 9 individuals serviced, capacity of 12
per year.
Status: Experimental research
Candidate Description:
Multiple sclerosis
Hemiplegia
Restrictionsl Contraindications: Has to be able to
walk with or without aid.
Area$served:lceland
Referraht;equired? No
Billing1limo:Noch~rge
Pay~e~t m~ods,N,o infol'n1ation provided
Type~';faCillty: Publit:lysupparted; Non-profit'
Treatment course:
Evaluation/ assessment - 1-2 times a week
Post-implementation therapy/treatment - 11-12 times a
week
Approximate number of visits required in total: 60
Requires evaluation at this facility? No
Requires local lodging? Yes; Treated each day at the
hospital
Typical cost: $10,000-$20,000
~rd part:Y payers typically cover: cost is per year; No
information provided
Type of eqUipment: Clinic use stimulator; Not FDA
approved stimulator; Research prototype stimulator;
Transcutaneous/surface electrode(s)
Availability of equipment: Purchase
ISRAEL
@
83.00
FESTIM
LoYienstein Rehabilitation Center
Department of Biomechanics
Lowenstein Rehabilitation Center
P.O. Box 3
Raanana 43100
ISRAEL
Tel: 972-9-909090
TolI"-free:
FAX: 972-9-446666
E-Mail: jm@biomecUechnion.ac.i1
Director: Dr. Eisakov (medical);Prot J., MiZrahi
(scientific)
Contact Person: Dr. E. Isakov
Program Description: The program deals with the
mobilization of paraplegicsby.;FES. Transcutaneous
stimulation is used by means ofa self desig'riedlmade
stimulator. The participant undergoes an extensive
evaluation program, before and during treatrhetit,f6r
152
ISRAEL /ITALY
~
--
83.01
FES Application:
Lower limb movement
Stepping and walking
Description: Secondary benefits include lower limb
movements of standing / transference assistance, and
neuromuscular benefits of treating weak I atrophied
muscles and contrOlling spasticity. The system
combines a 6-channel electrical stimulator and an
instrumented walker. The stimulator is computer
controlled (microprocessor) and can be on-line
operated by a personal computer or in a remote mode,
with its own microprocessor.
History: 13 years of research; over 45 persons with
SCI have been treated; capacity is 3 to 4 participants.
Status: Experimental research
Candidate Description:
Spinal cord injury
Thoracic: Motor: TS-12/ Sensory: TS-12
Paraplegia
Restrictionsl Contraindications: Age above 50 yrs;
severe spasticity; or contractures; chronic disease
Treatment course:
Evaluation! assessment - 2 times a week for 2 weeks
Pre-implementation treatment - 2 timeslwk for 2 weeks
Outpatient fitting/implementation - 2 times/wk for 1 wk
Training - 3 times a week for 12 weeks
Post-implementation therapyltreatment - 1 x! month
Maintenance / check-ups - 1 time every 6 months
Approximate number of visits required in total: 50
Requires evaluation at this facility? Yes
Requires local lodging? Yes
Typical cost: $10,000-$20,000
3rd party payers typically cover: All costs
Type of equipment: Home use stimulator; Research
prototype stimulator; Transcutan/surface electrode(s)
Availability of equipment: Purchase
ITALY
7:.84i.:~OQ
N.ESsi!G5.~e61FEsS.ystemi>Multi..centR$tud"
NES 'Unite' Spinelec
..
AZle
alieraCart!Q!i-C.T.O,l.,Jnlta' 51081$
Largo>palagi 1
.
Firenze 50100
ITALY
TeJ:()03g.;,55-.4278417 Ton..fr$e:
FAX:"i6039.l:55-4278417 "!":Mail:'
Director: Dr. HaroldWetngarden
Contact.Person:0r. Aito Sergio - Unita'Spinalel: ~.
Firenze
Progi1llftDescnptibn: We ara studying a single
channel, portable FES device to obtain the
rehabilitation of lost functions in persons witheS
84.01
FES Application:
Upper limb movement
Grasping
Description: The device is portable and can be used
by the participant. After a 3 week training period, the
participant continues the exercises at home. We have
obtained some satisfactory results.
History: Available for 1 year; 14 persons treated; 40
persons can be treated.
Status: Exprmntl research; Multi-center clinical trial
Candidate Description:
Spinal cord injury
Cervical: Motor: CS-6 / Sensory: CS-6
ASIA International Impairment Scale: A
Tetraplecgiai Quadriplecgia
Restrictionsl Contraindications: Only CS or C6 level
injuries, aged 18 to 65. Contraindications: pace
--
...
WHERE TO GET FES
153
ITALY
85.00
Public!ftospital
Ospedc:lIedi l.onato-O~~o
Oivisione;'(Ii;;NeuroriabilitSzione
Lonato($tesda) 25017
ITALY
Tel: 3Q..991;:e933
F~3Q..99~1:39 3a
Di~/f)r:~'VittoriO }\lfieii~~~D~.
85.01
FES Application:
Lower limb movement
Stepping and walking
Description: Use FES and Reciprocating Gait
Orthosis (RGO). Sometimes persons prefer to use
RGO without FES. In any case electrical stimulation is
always applied for preparation to standing and walking
with RGO in order to reduce spasticity and tremors.
History: Dr. Alferi started using TES in 1973 at
S.Gerardo Hospital in Monza for persons with
hemiplegia. In 1989 started using TES and FES for
persons with SCI again in Monza and from 1993 in the
Rehab. Center in Lonato-Brescia in collaboration with
Dr. Ruggero Prati and Dr. Stefano Visconti. A total of
18 persons treated.
Status: Experimental research
Candidate Description:
Spinal cord injury
Cervical: Motor: C5-7
Thoracic: Motor: T1-12
ASIA International Impairment Scale: A B
Paraplegia
Infonnation~~i.lQbleiNo~information provided
Hours: 8:0O::AMto5:0{)
' a week
Location of servicet~;Co
ence; Service
proviClet"$~tioP',
'
ACC~iJJI1rllY:wfleelchairafceSSi6!\J~incl..bathrooms;
Han
p~ng
.'
available ....
AreasS,fl'V:ed:Jtaly, Norlt'iem0:~,
R e f e . " 1 YesFrom:~e':hmentAgency;
Physl
8iltin
..
. . . . . . ..... .. arge
Outpatientfaejlity; Hospitat:
Accreditation: No informatibnp1pVlded
Licensing/Certification: Not applicable
Tetraplegia! Quadriplegia
Time elapsed post-injury/onset: from 4 weeks - 12
months
Restrictionsl Contraindications: Compromised
general conditions, pace-maker (cardiac and
respiratory), some types of uncontrollable spasticity.
Treatment course:
Evaluation/ assessment - once a week for 6 weeks
Training - twice a day, 5 days a week for 6 weeks
Post-implementation therapyltreatment - once a day, 5
days a week for 6 weeks
Maintenance / check-ups - bimonthly for 6-12 months
Approximate number of visits required in total: 10 - 14
Requires evaluation at this facility? Yes
Requires local lodging? Yes; Only in the first 2-3
months
Typical cost: More than $20,000
3rd party payers typically cover: All costs; except for
the stimulator when discharged
Type of equipment: Home use stimulator; FDA
approved stimulator; Implanted electrode(s)
Availability of equipment: Purchase
154
'
ITALY
85.02
FES Application:
Neuromuscular treatments
Treating weak, atrophied muscles
Controlling spasticity
Controlling tremor
Description: The primary purposes (indivisible) of
therapeutic electrical stimulation (TES) are
Neuromuscular and Circulatory. We use 4 channel
electrical stimulators on each muscle group of the trunk
and limbs in physiological sequences.
History: Dr. Alferi started using TES in 1973 at
S.Gerardo Hospital in Monza for persons with
hemiplegia. In 1989 started using TES and FES for
persons with SCI again in Monza and from 1993 in the
Rehab. Center in Lonato-Brescia in collaboration with
Dr. Ruggero Prati and Dr. Stefano Visconti. There have
been a total of 18 persons treated.
Status: Experimental research
Candidate Description:
Spinal cord injury
Cervical: Motor: C5-7
Thoracic: Motor: T1-12
ASIA Intemationallmpairment Scale: A B
85.03
FES Application:
Circulatory/Skin treatments
Improving circulation in limbs
Description: The primary purposes (indivisible) of
therapeutic electrical stimulation (TES) are
Neuromuscular and Circulatory. We use 4 channel
electrical stimulators on each muscle group of the trunk
and limbs in physiological sequences.
History: Dr. Alferi started using TES in 1973 at
S.Gerardo Hospital in Monza for persons with
hemiplegia. In 1989 started using TES and FES for
persons with SCI again in Monza and from 1993 in the
Rehab. Center in Lonato-Brescia in collaboration with
Dr. Ruggero Prati and Dr. Stefano Visconti. There have
been a total of 18 persons treated.
Status: Experimental research
Candidate Description:
Spinal cord injury
Cervical: Motor: C5-7
Thoracic: Motor: T1-12
ASIA Intemationallmpairment Scale: A B
Paraplegia
Paraplegia
Tetraplegia! Quadriplegia
Time elapsed post-injury/onset: from 4 weeks -12
months
Restrictions/ Contraindications: Compromised
general conditions, pace-maker (cardiac and
respiratory), some types of uncontrollable spasticity.
Treatment course:
Evaluation! assessment - once a week for 6 weeks
Training - twice a day, 5 days a week for 6 weeks
Post-implementation therapy/treatment - once a day, 5
days a week for 2-6 weeks
Maintenance / check-ups - check-ups bimonthly for
6-12 months
Approximate number of visits required in total: 10 - 14
Requires evaluation at this faCility? Yes
Requires local lodging? Yes; Only in the first 2 - 3
months
Typical cost: More than $20,000
3rd party payers typically cover: All costs; except for
the stimulator when discharged
Type of equipment: Home use stimulator FDA
approved stimulator; Implanted electrode(~)
Availability of equipment: Purchase
--
Tetraplegia/ Quadriplegia
Time elapsed post-injury/onset: from 4 weeks -12
months
Restrictions/ Contraindications: Compromised
general conditions, pace-maker (cardiac and
respiratory), some types of uncontrollable spasticity.
Treatment course:
Evaluationl assessment - once a week for 6 weeks
Training - twice a day, 5 days a week for 6 weeks
Post-implementation therapyltreatment - once a day, 5
days a week for 2-6 weeks
Maintenance I check-ups - check-ups bimonthly for
6-12 months
Approximate number of visits required in total: 10- 14
Requires evaluation at this facility? Yes
Requires local lodging? Yes; Only in the first 2-3
months
Typical cost: More than $20,000
3rd party payers typically cover: All costs; except for
the stimulator when discharged
Type of equipment: Home use stimulator; FDA
approved stimulator; Implanted electrode(s)
Availability of equipment: Purchase
155
ITALY / JAPAN
Roul'IJ:",pjI)J()rm~tionp
',:~,
loc~~~~~~~s: ,"',.,
,.
atio~~providei~h"
available..... .
. , . .,
No restrictioAls:;.
86.01
FES Application:
Upper limb movement
Grasping
Description: We aim at controlling force, and slip of
the object from the hand. Sensors of force and slip are
located on the hand and/or on the object.
History: Has been in use at this facility for 1 year. We
are in the phase of FES system (electronics and
computer control)
implementation. Preliminary trials on healthy subjects
and 1 person with tetraplegia are in development.
Status: Experimental research
Candidate Description:
Spinal cord injury
Cervical
Tetraplegia! Quadriplegia
Restrictions/ Contraindications: No info. provided
Treatment course:
No information provided
Requires evaluation at this faCility? No information
provided
Requires local lodging? No information provided
Typical cost: No information provided
3rd party payers typically cover: No costs
Type of equipment: Research prototype stimulator;
Transcutaneous/surface electrode( s)
Availability of equipment: No information provided
JAPAN
87.00
Director: JiroKawamura
Contact Pel'Son:Jiro~aWamura
Prog~mDe$Criptfo.n.:li6IihicalappUcation of
augmenting cough by FES.
Information available: No information provided
Accessibility: Whe~tcliaip'acCessjb;le.incl.bf.itflrooms; .
Lice"sing/~ertification:N~tappUcable
156
JAPAN
87.01
FES Application:
Respiratory treatments
Cough assistance
Description: No information provided
History: No information provided
Status: Experimental research
Candidate Description:
Spinal cord injury
Cervical: Motor: C5 I Sensory: C5
Tetraplegia! Quadriplegia
@ .... ~_~G(J
~.nailf&S Project
TOhokul,l:Jniversily
2-1 Selry&machi,Aoba-ku
Sendai980,,77
JAPAN
Tel~~g1,;,()~!;';273-9014
TolI;,;free:
FAX: 81;1.022-274-0608E;;'Mail:
Direetor:yasuflpbu. Handa; N6z0muHoshimiya
Contact Pert
Yoshiora Kiyoshfge
Programl! . . . <on;We.havethe limited population
programth~as'JlPparteabtl&teMlnlsVy of welfare
at Tohoku t..Jnivef'Sly. Thererore, we opened the
speciaIFES:elj~iGdor convenience (Hokuryo FE9t:linic
since 1991).
Information available: languages otherthanngflsh
88.01
FES Application:
Bladder control
lower limb movement
Upper limb movement
Neuromuscular treatments
Orthopaedic treatments
Respiratory treatments
Sensory aids
Description: The first step is electrode implantation.
Neuromuscular treatments are then carried out at
home to strengthen and decrease spasticity. After this
FES programmed movement will start. Specific
~ppli~tions include: bladder emptying, controlling
Incon~mence, preventing I treating pressure sores,
steppmg and walking, standing / transfer assistance,
grasping, reaching, treating weak, atrophied muscles,
controlli.ng spasticity, regaining voluntary function,
enhanCing neural regeneration, preventing / treating
osteoporoSiS, preventing / treating contractu res
breathing assistance, and sensation I feedback:
History: We started clinical FES applications 12 years
ago. In 1991 the present FES equipment (30 ch
portable stimulator and implanted electrodes) were
--
Japanese
Houl'S~/9:00 AMfo12:00,.2daysaiweek; 9:00 AM to
4:00. PM; weekdays
locati()n ofl$erviC8$~Serviceprovfders locatior1\l
Acc8S$ibility~Wheel~hairaccessiblei j~I~batfjro()ms;
Bandleapped parkiog:availabte;:Neat~ccessiblepublic
transport
Populations ser\lSd:~No restrictions
Areas served: Japan; Korea
Referral:requi~~?Yes From: Physician
Billing info: Fixed rates
Payment tnethCJds! Cash
TypeOffacility:Pederal{agenC.~:e()flege rUniversity .
program; Hospital
Accreditation: NoinfOlmation pr.ovided
Licensing/Certification:Not appl~ble
Lumbar
Hemiplegia
Paraplegia
Tetraplegia! Quadriplegia
Treatment course:
No information provided
Implanted electrode(s)
I~
157
NETHERLANDS
1'
'-"
:.~~~of,*rvic
~~~i. .
......
"''-"
<Popt.tli(tfons ..,
.. .
;:~rea:si$erved?ntethenands
RQ,"erra
"-
"'"
\.,..
Yes Frbm:Physician
Dotch law
bilUnsurance
u~~rted; F~eralcy;
'
.... . . . . . .
. . . acility;Gbllege J Unl
tion,{~ro.vl(f~di
..
. .ehabilitationprogram; Research &
()ffilijl};)tl'liatl anglish"A"~' ..elopm~f}tcenter
AccreditatiQI1~X~ information provided
Licensing/certff(Cation: Not applicable
89.01
FES Application:
Sexual function
Electroejacu lation
Description: The fertility program is offered to men
with a spinal cord dysfunction, and ejaculation
impairment, with a partner who carries the child. When
vibration fails, the man is treated with electrostimulation
in collaboration with in-vitro fertilization labs.
History: Has been available for 5 years.
Status: Clinical service
Candidate Description:
Spinal cord injury
@
90.00
Electrical Bladder Stimulation inSpillal.Cotd
Injury
University Hospital St. Radboud
Departmentof Urology
P.O. Box 9101
Nijmegen NL,.s500 HB
NETHERLANDS
Tel: 32-80-613920
Toll-free:
FAX: 31-80-541032
E-Mail:
Director: Philip EV. Kerrebroeck, M.D., Ph.D.
ContactPerson: Philip e.v. Kerrebroeck, M:D~, Ph.D.
Program Description: No informatiofl:provided
Information available: PrintedforrY"\StjVideOtape
format; Languages otherlhan English - Dutch
158
NETHERLANDS/POLAND
90.01
FES Application:
Bladder control
Bladder emptying
Bladder incontinence
Description: Intra- or extra-dural sacral rhizotomies
and implantation of a Finetech-Brindley bladder
controller. EEC approved clinical service.
History: Available since Jan., 1989,52 persons have
been treated, capacity for 10 - 15 implants per year.
Status: Clinical service
Candidate Description:
Spinal cord injury
Cervical: Motor: complete I Sensory: complete
Thoracic: Motor: complete / Sensory: complete
Lumbar: Motor: complete / Sensory: complete
ASIA International Impairment Scale: ABC D
Paraplegia
Tetraplegia! Quadriplegia
POLAND
@91:~OO
EIeett!CaI:Stimulation in Tretatmtl'tpfSJlinal
Cord~lhjuriesMetropolitarfiRenatiilitiftid'rt
center
Wiet2ajewskiego 12
Konstancin05.;.511
POLAND
Tel: 48-22~56-40.;.G1
TOII..ftee:
FAX: 48..22.;.58-46-80
E-Mail:
Director:.Prof.Jerry Kiwerski, M.D., Sc.D.
ContactPerson: Ass. Prof. Roman Pasniczek, Eng.D.
Program Description: The control of paralyzed hand
function by electrical stimulation of peripheral nerves
(no radialis and n. medianus). Electrostimulation ofthe
damaged spinal cord (after trauma).
91.01
FES Application:
Upper limb movement
Grasping
Description: Control of paralyzed .hand function
through stimulation via implanted electrodes of median
and radial nerves.
History: FES of peripheral nerves and spinal cord
stimulation - about 20 years
Status: No information provided
Candidate Description:
Spinal cord injury
Cervical: Motor: C6, C71 Sensory: C6
Tetraplegial Quadriplegia
. Time elapsed post-injury/onset: 2 - 3 months
Restrictions! Contraindications: No info. provided
Irlfonnation availabl@=Nofnrormationprovided
Hours:1:00tb2:00, .5faays.awee~
Locationmservicest:Noinfotmation prnvided
j%ceessibility: Wtieelchairaccessible, inCl. bathrooms;
Randicappedparking available; Neaf accessible public
transport
Populationsserved:.No restrictions
Areas served: Poland, .central region
Referral required? Y~s From: Physician
Billing info: Varies wltttability)topay
Payment methods: Cash; Will bill Insurance
Type offacllity: Non"profit
Accreditation! No information provided
licensing/Certification: Notapplicable
Treatment course:
Evaluation! assessment
Pre-implementation therapy/treatment
Inpatient surgical procedure(s)
Inpatient fitting/implementation
Training
Post-implementation therapy/treatment
Approximate number of visits required in total: one
hospital stay for about 3 months
Requires evaluation at this facility? Yes
Requires local lodging? Yes
Typical cost: $10,000..$20,000
3rd party payers typically cover: No info. provided
Type of equipment: Clinic use stimulator; Home use
stimulator; Research prototype stimUlator; Implanted
electrode(s)
Availability of equipment: No information provided
-'
--
....",
159
POLAND
91.02
FES Application:
Neuromuscular treatments
Enhancing neural regeneration
Description: Spinal cord directly stimulated with
implantation of stimulating electrodes in contact with
th~ spinal cord. Operation on the first day after trauma.
History: FES of peripheral nerves and spinal cord
stimulation - about 20 years
Status: No information provided
Candidate Description:
Spinal cord injury
Time elapsed post-injury/onset: to 20 hours
Restrictions/ Contraindications: No info. provided
fRl92.00
'tJ,nlf~itet of;
28ci~1
Poznarrc61-545\" '
POLANo.
Tel: O.;a1-310;;217
16"',,'6%:\
FAX:
E-Mail:
. Program,~~crlpti
andbladdar~ntrol;l8r
Treatment course:
Evaluation/ assessment
Pre-implementation therapy/treatment
Inpatient surgical procedure(s)
Inpatient fitting/implementation
Training
Post-implementation therapy/treatment
Requires evaluation at this facility? Yes
Requires local lodging? Yes
Typlcalcost: $10,000-$20,000
3rd party payers typically cover: No info provided
Type of equipment: Clinic use stimulator; Home use
stimulator; Research prototype stimulator; Implanted
electrode(s)
Availability of equipment: No information provided
tion Ofs
ersloCa
Atcessibility:
i'Handicapped pa
t~nsport
,'.....
Populations~ed!;NS~stJietions
Area$1Served: Poland
Refe~,.requia:8d7:~,eS.'F'rom~:#hY~iclan
B.illin~Nmo: t"lpl:!l1'arge'
Paymel'1t,methodS: No information
eo
. j~~
q~nopedi~atmening With~1e after
Outpati~nt facility; Hospital; Rehabilitat!Ghcenter;
spi.nalcord.i9itJries, hes(Hrauma; MS, and~
RehabilitatiofffPragram
.
o~hopediediSeases...
InformafiOttavaUablaf-FNoinformation provided
Hours:~tOOAMto12:00'PM
92.01
FES Application:
Bladder control
Bladder emptying
Description: Three electrodes with different impulses
used. Sometimes we modulate impulses if it is
necessary.
History: Treatment in use for 20 years. This program
is available to all who need it. Instructions were made
by Polish Academy of Sciences.
Status: Clinical service
Candidate Description:
Multiple sclerosis
Spinal cord injury
Cervical: Motor. C4-7 / Sensory: C4-7
Thoracic: Motor / Sensory
Lumbar: Motor: L4-5 / Sensory: L4-5
Sacral: Motor: S1-2/ Sensory: S1-2
Hemiplegia
Paraplegia
Tetraplegia! Quadriplegia
Accredlta,oo~tPolishAcademyofcScience
UcensinglCertification: NotappOcable
160
POLAND / PORTUGAL
~
92.02
FES Application:
Neuromuscular treatments
Treating weak, atrophied muscles
Description: We are using what is typically used in our
country, Stymat 120, Stymat 200, Interdyn.These use
low frequency and low intensity currents and
transcutaneous electrodes.
History: We have used this treatment for 20 years.
This program is available for all who need it.
Instructions were made by Polish Academy of
Sciences.
Status: Clinical service
Candidate Description:
Spinal cord injury
Cervical: Motor: C5-7
Lumbar: Motor: L1-5
Hemiplegia
Paraplegia
Tetraplegia! Quadriplegia
Time elapsed post-injury/onset: 1 month
Restrictions/ Contraindications: Neoplasma, cardiac
disease, angiopathia III and IV grades, psychiatric
disorders, metal implants.
Treatment course:
Evaluationl assessment - 2 times per week
Training - each day during hospitalization, 5 series of 4
times per week
Approximate number of visits required in total: 15
Requires evaluation at this facility1 Yes
Requires locallodging1 No
Typical cost: No information provided
3rd party payers typically cover: No costs;
government funding
Type of equipment: Clinic use stimUlator; FDA
approved stimUlator; Transcutan/surface electrode(s)
Availability of equpmt.: No charge; in-house use only
PORTUGAL
~
,93.00
F.E;;S~
floqitaIGe,,~11StAntonio
Servico.DelFisima
Pdrt04000
PORTUGAL
Tel: 351-2-5483191
Toll-free:
FAX:351-2-3203'1SE;'Mail:
IMormatlon availabl.Siilnfcirmation:igivenv~rbally.
Handi~Rped
g available
...d:. NorestrlQtions
Populati6ns
Areaaserved:vPotitttsii' .
,.
Refefritlfequi.11:'~Nc) .
Billip9'info: Fi~;;r;itM<
PaY'mentmetI101fS='No'inm~Qrrprovided
FeGferafcsgerreyt
nt facility; Hospital
Typeof:facil
Non;;;proflf, In
Accreditation:
Lieensin Certificatibn:'Notil':i
93.01
FES Application:
Lower limb movement
Stepping and walking
Standing I transfer assistance
Description: The device we use has 2 channels and
works with surface electrodes, channels are operated
sequentially by manual control. The first allows knee
joint locking by quadriceps stimulation, the second
stimulates the peroneal nerve leads into a withdrawal
reflex resulting in flexion in all 3 pOints of the lower limb.
History: The FES program was inifiated in Jan. 1993
with inpatients for muscle strengthening, standing and
walking. Since August 1993 it has been used in
outpatients too. Capacity to treat 7 persons, 8 have
achieved standing and walking.
Status: Clinical service
Candidate Description:
Multiple sclerosis
Spinal cord injury
Cervical
Thoracic
Lumbar: Motor: L2
161
PORTUGAL / SLOVENIA
93.02
FES Application:
Neuromuscular treatments
Treating weak, atrophied muscles
Description: The FES device we use allows a muscle
to work during 4 seconds with a 4 second pause. Using
two surface electrodes in each channel it is possible to
choose the muscles to be worked. Technical data:
frequency 20 Hz, pulse range 0.25 ms; amplitude
0-180 rnA (alkaline battery).
History: We have treated 42 persons for muscle
strengthening so far.
Status: Clinical service
Candidate Description:
Multiple sclerosis
Spinal cord injury
Cervical
Thoracic
Lumbar
ASIA International Impairment Scale: C D
Paraplegia
Tetraplegia/ Quadriplegia
Other spinal disorder: strumfel disease
I
SLOVENIA
W
94.00
Centre for tmplantableTechnology and
Sensors
ITIS d.o~o. Ljubijana'
U~pipot 11
Ljubljana 61000
SLOVENIA
Tel: 386..a1-1251-161
TO!l"ft'ee:
F~X:,386..a1,;2t3S..s06
E~1Utait:'
Qi,.ctor: Dr.Janez~;Rozman
Person. Dr. Janez Rozman
Program Description: Gentepfor implantable
teehnology and sensors'is dealing with 'the modeling,
design and fabrication of systems for surface and
implantable stimUlation of neuro-muscular'systems as
well as electrode: systems for recording of muscle and
nerve activity. We: organize an evaluation of different
Comet
implantable: systemsandanimal'experimerits..
.
Information available: Printed and Videotape.formal ,
Hours: No information provided
.. '.
location of services: No information provkfed
Accessibility: No information provided
Populations served: No restrictions
Areas served: Unlimited
Referral required? Yes From: Physician
Billing info: Fixedrates;Varte~ with ability to pay
Payment metllods~Casll;(,)l1arg~/CreditCard; Will bill
Insurance; WiIl~l:jllll\1ledicaid;WiIi bill. Medioare;.WlII bill
Other third-party payment
Type oUacility: Privately supported; Federal agencw
For profit; Non-profit; Research & development center
Accreditation: No information provided
Licensing/Certification: Not applicable
94.01
FES Application:
Lower limb movement
Stepping and walking
Description: FNS is applied during the swing phase of
the affected leg, dorsiflexing the foot and correcting its
equinovarus position. As the leg rises, the person
releases the heel switch that turns on the external unit,
thus transmitting information and energy to the
implanted assembly via the antenna.
HiStory: Available for 2 years; have treated 3
individuals; with a capacity to treat 10 per year.
Status: Experimental research
Candidate Description:
Hemiplegia
Restrictions/ Contraindications: Spasms of the
affected foot
Treatment course:
Slovenia citizens
162
95.01
FES Application:
Lower limb movement
Stepping and walking
Description: 2 channel FES system for walking; 4
channel FES system for walking (in our Institute rarely
are more channels used); surface stimulation. Has
been approved by domestic authorities.
History: For persons with SCI, our Institute has used
FES for more than 15 years.
Status: Clinical service
Candidate Description:
Spinal cord injury
Cervical: Motor: C8
Thoracic: Motor: T1-12
Hemiplegia
Paraplegia
95.02
FES Application:
Circulatory/Skin treatments
Treating pressure sores
Description: Usually one channel transcutaneous
electrical stimulation with electrodes on intact skin
around the wound (approximately 2 hours of
stimulation a day). Has been approved by domestic
authorities.
History: This has been used for more than 10 years
for research purposes, about 5 years in routine use.
Status: Clinical service
Candidate Description:
Multiple sclerosis
Spinal cord injury
Hemiplegia
Paraplegia
Tetraplegia! Quadriplegia
--
Tetraplegia! Quadriplegia
Time elapsed post-injury/onset: after approx. 1 month
Restrictionsl Contraindications: General
contraindications for low frequency electrical stim.
Treatment course:
Evaluation/ assessment - approximately 1 wk.
Inpatient fitting/implementation - approx. 1-2 mos.
Outpatient fitting/implementation - approx. 1 - 2 mos.
Training - approximately 1 - 2 months
Requires evaluation at this facility? Yes
Requires local lodging? Yes; Mostly
Typical cost: $1,000-$5,000;$5,000-$10,000
3rd party payers typically cover: No info. provided
Type of equipment: Home use stimulator; FDA
approved stimulator; Transcutan.lsurface electrode(s)
Availability of equipment: Purchase; Rental
--
163
SLOVENIA
~
95.03
FES Application:
Bladder control
Bladder incontinence
Description: Rectal and vaginal applications. Has
been approved by domestic authorities.
History: This has been used for more than 15 years.
Status: Clinical service
Candidate Description:
Multiple sclerosis
Spinal cord injury
Hemiplegia
Paraplegia
Tetraplegia! Quadriplegia
Time elapsed post-injury/onset: - after about 1 month
~
95.04
FES Application:
Respiratory treatments
Cough assistance
Description: This FES application is still in a research
phase.
History: This has been used for about 2 years.
Status: Experimental research
Candidate Description:
Spinal cord injury
Cervical
TetraRlegia/ Quadriplegia
~
95.05
FES Application:
Sexual function
Electroejaculation
Description: This FES application is still in a research
phase.
History: Positive effects have been observed for at
least about 10 years.
Status: Experimental research
Candidate Description:
Spinal cord injury
Thoracic
~
96.00
FESfor Lower Extremities after SCI
164
SLOVENIA / SPAIN
96.01
FES Application:
Lower limb movement
Stepping and walking
Description: Four-channel (two two-channel units)
FES is delivered to knee extensors and peroneal
nerve. Walking is voluntarily controlled by the
participant through two push buttons built into the
handles of the walker or crutches.
History: The FES gait restoration is available for 15
years, over 100 individuals have been treated.
Status: Experimental research
Candidate Description:
Spinal cord injury
Thoracic
Paraplegia
Tetraplegia! Quadriplegia
The~~cf(efi.I'9Y
23,f'ratr,4a
..... .
'. '.
FAX:'~~12-0543i!;:
DlteQt8rt;ttarry;,l;.a"l1om;
G~tiP ..
O.T..
...................
LawhomiO~~~:~
Fttoj"m.
.
n:Smali
- 4 TTl
ERG~S.'bycle efgometers, TIF!fi~ter-1I for
8io~back; AlT - n- walking system ror"ersons with
paraplegia;'Micro FES - portable stimulator tot persons
with-hemiplegia.
Information'8Y8I1able: Printed format; .languages
97.01
FES Application:
Lower limb movement
Stepping and walking
Description: Portable 4 channel stimulator (ALT - 2)
from Ljubljana. Bilateral stimulation of quadriceps and
peroneal nerve for persons with par:aplegia for standing
and walking.
History: Has been available for 2 years, maximum
capacity of 6 persons per day.
Status: Clinical service
Candidate Description:
Spinal cord injury
Thoracic: Motor: T6-12
Paraplegia
Time elapsed post-injury/onset: 3 months
Restrictions/ Contraindications: No: cardiac
pacemaker, severe autonomic dysreflexia, severe
'. . 1 . batttroomS;
. Handicap~
transport
iI$l)~;~~~a,ccessible public
,. ...................... " . .
.P"Ulationsse~~~~~s
:-~1'eas'Served: Untimibii ......' .....
Referralrequired?'Y$~. From:pny,$iofan
i3i1ling info: FixedrateB; Va!iesw~.ability to pt!lY
Payment methods: Gash; Charge/CreditCard
Type of!facility: Privately supported; . Outpafientfacility
Accreditation: Not.a~r5ljcat)le"
Licensing/Certification: No information provided
165
SPAIN
97.02
FES Application:
Cardiovascular exercise
Bicycle ergometry
Description: TTl ERGYS cycle ergometry - computer
controlled stim. of quadriceps, hamstrings, and gluteal
muscles via 18 surface electrodes, for persons with
paraplegia & tetraplegia, 30 min. of exercise 3 x / week.
History: Available for 2 years, capacity of 6 per day.
Status: Clinical service
Candidate Description:
Spinal cord injury
Cervical: Motor: C3-8
Thoracic: Motor: T1-12
Lumbar: Motor. L1
Paraplegia
Tetraplegia! Quadriplegia
Time elapsed post-injury/onset: 3 months
97.03
FES Application:
Neuromuscular treatments
Treating weak, atrophied muscles
Description: TTl SpectraStim 2000 p 2 channel
computer controlled stimulator. Used to strengthen
atrophied muscles, usually in preparation for cycle
ergometry or walking.
History: Has been available for 2 years, maximum
capacity of 6 persons per day.
Status: Clinical service
Candidate Description:
Spinal cord injury
Cervical: Motor: C3-8
Thoracic: Motor: T1-12
Lumbar: Motor: L 1
Hemiplegia
Paraplegia
Tetraplegia! Quadriplegia
97.04
FES Application:
Neuromuscular treatments
Regaining voluntary function
Description: TTl NeuroEducator II 4 channel
biofeedback computer controlled system for regaining
voluntary function of impaired muscles.
History: Available for 2 yrs, capacity of 6/ day.
Status: Clinical service
Candidate Description:
Spinal cord injury
Cervical: Motor: C3-8
Thoracic: Motor: T1-12
Lumbar: Motor: L1-5
Sacral: Motor: S1-3
Hemiplegia
Paraplegia
Tetraplegia/ Quadriplegia
Time elapsed post-injury/onset: 1 month
Restrictions/ Contraindications: No unhealed bone
fractures.
Treatment course:
Evaluationl assessment -1-2 hours (initial evaluation)
Pre-implementation therapyltreatment - 3 times a week
Requires evaluation at this facility? Yes
Requires local lodging? Yes
Typical cost: Less than $1,000
3rd party payers typically cover: No costs
Type of equipment: Clinic use stimulator; FDA
approved stimulator; Transcutan/surface electrode(s)
Availability of equipment: No information provided
166
languages
98.01
FES Application:
Bladder control
Bladder emptying
Bladder incontinence
Candidate Description:
Paraplegia
Tetraplegia! Quadriplegia
98.02
FES Application:
Bowel control
Bowel emptying
Bowel incontinence
Description: SARS (Sacral Anterior Root Stimulator)
for bladder control, Brindley system.
History: 20 cases in five years.
Status: Clinical service
Candidate Description:
Spinal cord injury
Cervical: Motor: C7-8 / Sensory: C7-8
Thoracic: Motor: All levels / Sensory: All levels
Lumbar: Motor: L 1 / Sensory: L1
ASIA International Impairment Scale: A, B
Paraplegia
Tetraplegia! Quadriplegia
Time elapsed post-injury/onset: 1 year
--
--
167
SPAIN
98.03
FES Application:
Sexual function
Erection / electroejaculation
Description: SARS (Sacral Anterior Root Stimulator)
for erection control, Brindley system.
History: 20 cases in five years.
Status: Clinical service
Candidate Description:
Spinal cord injury
Cervical: Motor: C7-8/ Sensory: C7-8
Thoracic: Motor: All levels I Sensory: All levels
Lumbar: Motor: L1 / Sensory: L1
ASIA International Impairment Scale: A. B
Paraplegia
Tetraplegia! Quadriplegia
Time elapsed post-injury/onset: 1 year
98.04
FES Application:
Lower limb movement
Stepping and walking
Standing / transfer assistance
Description: Joseph Stefan Institute - ALT-2 is a dual
channel stimulator for cyclical training of muscles for
standing and gait for persons with spinal cord injuries.
Each participant needs two devices.
History: We started in 1991; 33 have been treated.
Status: Experimental research
Candidate Description:
Spinal cord injury
Thoracic: Motor: T4-11 / Sensory: T4-11
ASIA International Impairment Scale: A, B
Paraplegia
'99.00
168
99.01
FES Application:
Lower limb movement
Stepping and walking
Description: We use the Parastep (R) System to
restore independence and function of selected Spinal
Cord Injured individuals in order to improve
independently and take steps.
History: Available for 2 years, more than 12 persons
have been treated, we have 30 beds for spinal cord
injured and we use inpatient and outpatient resources.
Status: Clinical service
Candidate Description:
Spinal cord injury
ASIA International Impairment Scale: A
Paraplegia
--
UNITED KINGDOM
~ 100.00
UniYersityofBristol
Bristol Royal Infirmary
Clinic 8 level 5
Bristol Royallnfirinary
MarlbOrough'Street .
Bristof.BS281TW
UNITEDKINGDOM
Tel: 44.117-928-3022. Toll-free:
FAX: 44-117-928-2470. E-Mail:
Director: Dr. Rosie Jones
Contact Person: Dr. Rosie Jones
Program Description: Exercise stimulation and
footdrop FES for persons with multiple sclerosis and
peripheral nerve injury. Stimulation of facial
musculature for function restoration, myoplastic
stimulation for incontinence.
100.01
FES Application:
Lower limb movement
Stepping and walking
Description: Exercise stimulation for improvement of
footdrop. Use of heel switched footdrop devices for
selected users.
History: Available for 5 years, evaluation of
neuromuscular performance and outcomes of
stimulation strategies.
Status: No information provided
Candidate Description:
Multiple sclerosis
Restrictionsl Contraindications: Not ataxic
Treatment course:
Evaluation/ assessment - on admission
Pre-implementation treatment - exercise programme
Outpatient implementation - 1 mo. after exercise started
Post-implementation therapy/treatment - review of
whole programme is 12 weeks
Maintenance / check-ups - monthly for 12 weeks, then
every 6 months
Requires evaluation at this facility? Yes
Requires local lodging? No; Live all over the United
Kingdom
Typical cost: No information provided
3rd party payers typically cover: No costs
Type of equipment: FDA approved stimulator
Availability of equipment: No charge
hra
169
UNITED KINGDOM
100.02
FES Application:
Bowel control
Bowel incontinence
Description: Feedback and stimulation in persons with
fecal incontinence from neurologic damage and
ideopathic nerve degeneration. Myoplastic stimulation
for anal repair.
History: New project.
Status: No information provided
Candidate Description:
Other spinal disorder: Peripheral nerve injury
Lumbar
Sacral
Restrictions/ Contraindications: Ideopathic nerve
Dr.
injury.
Treatment course:
Evaluation/ assessment - on admission
Pre-implementation therapy - exercise programme
Inpatient surgical procedure(s) - varies if repair required
Outpatient implementation - 1 mo after exercise started
Training - 1 session
Post-implementation therapy/treatment - monthly
Requires evaluation at this facility? Yes
Requires local lodging? No; Live all over the U.K.
Typical cost: No information provided
3rd party payers typically cover: No costs
Type of equipment: FDA approved stimulator
Availability of equipment: No charge
Nick Donaldson
101.01
FES Application:
Lower limb movement
Standing / transfer assistance
Description: 12-channellumbar anterior root
stimulator, using intradural tripolar electrodes and RF
linked multiplexor implant stimulator. External
equipment software controlled.
History: Current programme 1992-1997.
Investigational use of up to 8 devices. One device so
far has been implanted under this programme (as of
3/95).
Status: Experimental research
Candidate Description:
Spinal cord injury
Thoracic: Motor: T 4-12 / Sensory: T6-12
Paraplegia
Restrictions/ Contraindications: Excess spasticity,
lower motor neuron paraplegia. hip or knee
contractu res. heterotropic ossification, significant
concurrent medical illness. autonomic dysreflexia, no
170
UNITED KINGDOM
~
101.02
FES Application:
Lower limb movement
Stepping and walking
Description: Train and stand using the external closed
loop control standing system, the implant is intended to
enable standing and basic stepping.
History: Started 2 years ago, first implant 3 months
ago (as of 2/95). Development work still to come.
Status: Experimental research
Candidate Description:
Spinal cord injury
Thoracic: Motor: T3-12
Paraplegia
Time elapsed post-injury/onset: 1 year
~
102.00
Evaluation'of a Hybrid Walking Orthosis
Combini~g Functional Electrical Stimulation
with theJiReciprocating Gait Orthosis
---
102.01
FES Application:
Lower limb movement
Stepping and walking
Description: FES is applied using surface electrodes
to stirn. quadriceps with the contralateral hamstrings.
Knee lock produces reciprocal flexion/extension at the
hip. An initial conditioning programme strengthens the
muscles and improves fatigue resistance. Afterwards
stimulated walking with the RGO is introduced. The
participant is taught to coordinate muscle stirn. of the
legs with the appropriate phase of the gait cycle. In this
way propulsion during ambulation can be assisted.
History: The programme runs from Feb, 1993 to Feb.
1996 and allows for 10 participants, 7 are currently
involved or being assessed (as of March '95).
Status: Experimental research
Candidate Description:
Spinal cord injury
Paraplegia
Tetraplegia/ Quadriplegia - incomplete
Other spinal disorder: spina bifida
Restrictionsl Contraindications: Participant must be:
adult; suitable candidates for an RGO or already an
RGO user; no lower motor neuron lesion of nerves
supplying quadriceps or hamstrings; non progressive
171
UNITED KINGDOM
Dlil_Clfa;' TQnyTi'orrmh$
COliilaJctFten~on: ToilY,tJ".romaI1S"
tion!l'heBrindl~:(};itl~techJ
blt;ldder sti
.......<implanted for imProVement of.
blatJder function ~O(terection.
103.01
FES Application:
Bladder control
Bladder emptying
Description: Brindley (Finetech) bladder implant.
History: Available for 3 years in Salisbury.
Status: Clinical service
Candidate Description:
Spinal cord injury
Cervical
Thoracic
Paraplegia
Tetraplegia! Quadriplegia
...
Restrictions/ Contraindications: No significant spinal
sensation. Must have adequate hand control.
@
104.00
Dukeof'CotnwallSpinal TreatmenH::entre.
Depa
ntof Medical'.Physics:anttr;;
Bio
alEngineering
i.icensing/Cettlftcation: Ndt'applicable
Treatment course:
Evaluation/ assessment - video-urodynamics and anal
stimulation
Inpatient fitting/implementation - 1-2 wks hospitalization
Maintenance I check-ups - 6 monthly follow-up
Requires evaluation at this facility? No; One of
several centers
Requires local lodging? No
Typical cost: $10,000-$20,000
3rd party payers typically cover: No info. provided
Type of equipment: Not FDA approved stimulator;
Implanted electrode(s)
Availability of equipment: No information provided
Handicappedparking~'ilable
PopulationsserV!d:Adult(age 16 t06S)
SalisburyWiltshire'SP28BJ
Referral required? Yes From: Physician
UNITED KINGDOM
Billing, info: No charge
FAX: 1722-325904
E~MaiU
Type of fac,lity: DepartmentofH~lthiNon-ptofft;
.Director: Ian SWian for standing and gait; John Hobby ... Outpatient facility; Hospita~ Rehabmtation center;
for hand grasp
RehabiUtatiooprogram; Researchoi&development
ConuctPerson:.Paul Taylor .. ~1
center
Program Description:.:No.inform'atlorl:provided
AccreditatiomNoinformation provided
InforrnationavailabkcPrinted format ..
licenSing/Certification: Not applicable
Hours: 1:00 PM t05:30.PM,Tues., Wed. and Thurs.
'00
172
UNITED KINGDOM
l
104 :01
FES Application:
Lower limb movement
Standing / transfer assistance
Description: Quads and glutes stimulated for knee
and hip extension. Knee angle monitored and
feedback to control quad stimulation, surface
stimulation. Participants stand for typically 15 minutes,
1 hour maximum, system used for standing anywhere.
History: Developed over the last ten years, here,
University of 8ath, and at Rnom Stanmore. Used by
about 30 persons, capacity of 10 a year.
Status: No information provided
Candidate Description:
Spinal cord injury
Paraplegia
Thoracic: Motor: T3-12 / Sensory: T3-12
Restrictionsl Contraindications: Joint contractu res,
poor health, bad spasticity
Treatment course:
Evaluation/ assessment - one session
104.02
FES Application:
Lower limb movement
Stepping and walking
Description: A single channel dropped foot stimulator
and a two channel stimulator that can be adapted for
several different functions are available. The devices
are controlled using foot switches or hand switches.
History: Developed over 6 years in Salisbury, over 120
partiCipants but this includes 70 or so persons with
stroke.
Status: No info provided; Experimental research
Candidate Description:
Multiple sclerosis
Hemiplegia
Cervical
Thoracic
Sacral
Time elapsed post-injury/onset: 1 year
Restrictions/ Contraindications: Good health, no
joint contractures, no severe spasticity.
Treatment course:
Evaluation/ assessment - varies case to case
Requires evaluation at this facility? No; Here or at
Marie Theties House, St Michaels Hospital Hayle,
Cornwall
Requires local lodging? No
Typical cost: Less than $1,000
3rd party payers typically cover: All costs
Type of equipment: Clinic use stirn.; Home use stirn.;
Not FDA approved stimltr.; FDA approved stirn.;
Transcutaneous/surface electrode(s)
Availability of equiDment: Purchase; No charge
l
104 .03
FES Application:
Upper limb movement
Grasping
Description: The Cleveland implant is a totally
implanted 8 channel stimUlator designed to provide key
and palmar grip. It is controlled by movements of the
contralateral shoulder.
History: PartiCipant selection started last year. First
implant planned for April, 1995.
Status: Experimental research; Feasibility study; Multi
center clinical trial
Candidate Description:
Spinal cord injury
Cervical: Motor: C5-6/ Sensory: C5-6
Tetraplegia/ Quadriplegia
Time elapsed post-injury/onset: 2 years
Restrictionsl Contraindications: Must be in good
health, no contractu res, no severe spasms
Treatment course:
Evaluation/ assessment - 3 sessions
Pre-implementation therapyltreatment - 5 wks as
outpatient
Inpatient surgical procedure(s) - 1 week as an inpatient
Inpatient fitting/implementation - daily 3 weeks training,
one month after implant
Training - continues
Maintenance / check-ups - continues
Approximate number of visits required in total: 8 - 10
Requires evaluation at this facility? Yes
Requires local lodging? No
Typical cost: More than $20,000
3rd party payers typically cover: All costs; Funded
by charity and the Department of Health
Type of equipment: Home use stimulator; Not FDA
approved stimUlator; Implanted electrode(s)
Availability of equipment: No charge
--
WHERETO
FES
173
UNITED KINGDOM
.. 'ers location
incl. bathrooms;
pssible public
S:$lemed~
''rolL:.fre.Zt;.
114'i~11~~i403 ~,:;"
b.heller@sheffi~ld:ac.uk
Director: DrJBen Heller
of FESproquCed standingj\A.'~lkingandconti~
105.01
FES Application:
Lower limb movement
Stepping and walking
Description: Investigating the detection of anticipatory
movements to improve balance control in FES
standing.
History: Available for 1 year, is a research
programme.
Status: Experimental research
Candidate Description:
Spinal cord injury
Thoracic: Motor: T6 / Sensory: T6
Paraplegia
Time elapsed post-injury/onset: 2 years
105.02
FES Application:
Bladder control
Bladder emptying
Description: We support the Sheffield Spinal Injuries
Unit in the set-up and follow-up of the Finetech
Brindley Sacral Anterior Root Stimulator.
History: Available for 10 years, approximately 50
people have partiCipated.
Status: Clinical service
Candidate Description:
Spinal cord injury
Thoracic: Motor: T1
Lumbar: Motor: L1
Paraplegia
Restrictionsl Contraindications: No info. provided
No restricti~~, . ..........
Kingdom, N~m
Yes From: Physician
charge
No infol'iTlBonprovided
Publicly suppolted; BtitishNational
Non-profit; ReS~~& development
O';>",UII.1:I\.1
Treatment course:
Evaluation! assessment
Inpatient surgical procedure(s)
Inpatient fitting/implementation
Training
Maintenance / check-ups
Approximate number of visits required in total: 6
Requires evaluation at this facility? Yes; Need
urodynamic equipment
Requires local lodging? No
Typical cost: $5,000-$10,000
3rd party payers typically cover: All costs; NHS
Type of equipment: Home use stimulator; Not FDA
approved stimulator; Implanted electrode(s)
Availability of equipment: No charge; provided by NHS
174
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PART 3. MORE RESOURCES ON FES
This part has been compiled to assist readers who like to do as much research as they
can before making a big decision. You may want more information than this book alone
can provide. The resources in this part can assist you in gathering the additional FES
information you need. Because there are many general resources available on spinal
cord injury or multiple sclerosis, there is no attempt to duplicate that material here. If you
need more information on non-electrical stimulation topics, such as details on traditional
treatments, contact the entries in this section marked with an asterisk (*) for assistance.
The following additional resources are contained in this part:
Professional Organizations
An alphabetical listing of professional organizations that sponsor special interest
activities in functional electrical stimulation
175
.om
I. Popular Literature
For someone who does not have a technical background in functional electrical stimulation, finding
good reference materials is difficult. Most of the articles that appear in the popular press tell one person's
story, and do not review all of the options, FES or otherwise. Some of the materials listed below are reviews,
others are not, but each was selected because they do describe current FES techniques. A layperson should
be able to understand the information in these materials with minimal technical assistance. Most of these
references should be available from a public library. Ask your librarian if you need help locating them, or
contact the FES I nformation Center.
GENERAL
FES Information Center. Introduction to Functional Electrical Stimulation. FES Information Center:
Cleveland OH, 1992.
FES Information Center. Layperson's Glossary on Functional Electrical Stimulation. FES Information
Center: Cleveland OH, 1992.
Functional Electrical Stimulation. In: Spinal Network, Spinal Network: Boulder CO, 1993, P 147.
Himrich BL and Thornley S. ElectrifYing Medicine. How Electricity Sparked a Medical RevolLition. Lerner
Publications: Minneapolis, 1995.
Kantor, C. Implantable Motor Prostheses. Medical Device Research Repott. Vol 2, No 2, pp. 8-10, 1995.
Maddox S. The promise of electricity: function, nerve growth, cure? In: Spinal Network. 1st Edition, Spinal
Network: Boulder CO, 1987, pp 95-98.
CARDIOVASCULAR EXERCISE
FES Bikes. In: Spinal Network. Spinal Network: Boulder CO, 1993, pp 158-160.
RX for Fitness Part 3: Start Doin' It! Paraplegia News, June, 1995, pp 42-49.
BREATHING ASSISTANCE
Underhill W. Assisted Breathing. In: Spinal Network, Spinal Network: Boulder CO, 1993, pp 107-112.
COUGH ASSISTANCE
Coughing device patented. SCI Life, Spring, 1995, p 10.
Medical News: Hit the cough button. New Mobility, Fall, 1992, p 21.
176
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Kilgore KL and Bryden A. Heart in Hand - Regaining Hand Function. Team Rehab Report, July, 1995, pp.
26-29/40.
New device may restore use of hand. SCI Life, Spring, 1995, p 10.
BLADDER CONTROL
King T. Taking control- Proper diagnosis and treatment are the keys to controlling, not just managing,
Perkash I. The paralyzed bladder: Currenttreatments. Paraplegia News, Vol 45, No 9, pp 20-21, 1991.
Kobetic R. Advancing step by step. IEEE SPECTRUM, Vol 31, No 10, pp. 27-31,1994.
Olofson C. Computer-aided walking: Restoring natural gait to paraplegics. Technology Review, Vol 96, No
1, pp 11-12, 1993.
ELECTROEJACULATION
Fertility for men. In: Spinal Network, Spinal Network: Boulder CO, 1993, pp 332-338.
PAIN MANAGEMENT
Kahn, J. Pain management using electrotherapeutic modalities. Rehab Management, Feb/Mar 1994,
p.133.
PREVENTINGITREATING OSTEOPOROSIS
Gerhart KA. Osteoporosis: a fact of life. Paraplegia News. August, 1995, pp 32-36.
Mysiw WJ. The role of weight bearing and functional electrical stimulation -induced exercises on bone loss
after an acute spinal cord injury. Paraplegia News, December, 1990, pp 38-39.
177
complications. Archives of Physical Medicine and Rehabilitation, Vol 73, pp 195-199, 1992.
CARDIOVASCULAR EXERCISE
Glaser RM. Functional neuromuscular stimulation. Exercise conditioning of spinal cord injured patients.
Intemational Joumal Of Sports Medicine Vol 15, No 3, pp 142-148, 1994.
Sipski ML, Alexander CJ, Harris M. Long-term use of computerized bicycle ergometry for spinal cord injured
subjects. Archives Of Physical Medicine And Rehabilitation Vol 74, pp 238-241, 1993.
Ragnarsson K. Lower limb endurance exercise after spinal cord injury: Implications for health and
,~.---------------------------------------------------------------------------I
178
BREATHING ASSISTANCE
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Elefteriades JA. Pacing of the diaphragm. In: Schields JW, Ed. Surgery of the Chest. Lea & Febiger:
Philadelphia, 1994.
Peterson DK et al. Electrical activation of respiratory muscles by methods other than phrenic nerve cuff
electrodes. Pace, Pacing And Clinical Electrophysiology, Vol 12, pp 854-860, 1989.
COUGH ASSISTANCE
Jaeger RJ et al. Cough in spinal cord injured patients: Comparison of three methods to produce cough.
Archives Of Physical Medicine And Rehabilitation, Vol 74, pp. 1358-1361, 1993.
Wieler M et al. Electronic glove augments tenodesis-grip and hand-opening in people with quadriplegia.
Physiotherapy Canada Vol 46, No 2, Suppl, p 94, 1994.
Tanagho EA, Schmidt RA, Orvis BR. Neural stimulation for control of voiding dysfunction: a preliminary
report in 22 patients with serious neuropathic voiding disorders. Journal of Urology, Vol 2 Pt 1, pp 340
345,1989.
Yarkony Get al. Functional neuromuscular stimulation for standing after spinal cord injury. Archives of
spinal cord injury - observed benefits during gait studies. Paraplegia, Vol 31, No 4, pp 207-215,1993.
Graupe D and Kohn KH. Functional Electrical Stimulation for Ambulation by Paraplegics: Twelve Years of
Clinical Observations and System Studies. Kreiger Publishing Company: Malabar, FL, 1994.
Kantor C et al. Report on a conference on motor prostheses for workplace mobility of paraplegic patients in
North America. Paraplegia, Vol 31, pp 439-456,1993.
Pedotti A and Ferrarin M. Restoration of Walking for Paraplegics. Recent Advancements and Trends. lOS
Press: Burke, VA, 1992.
----
179
Phillips CA. Functional electrical rehabilitation technological restoration after spinal cord injury. Springer
Verlag: New York, 1991.
Stein RB, Belanger M, Wheeler G. Electrical systems for improving locomotion after incomplete spinal
cord injury: an assessment. Archives Of Physical Medicine and Rehabilitation, Vol 74, pp 954-959, 1993.
ELECTROEJACULA TION
Bennett CJ et al. Sexual dysfunction and electroejaculation in men with spinal cord injury: review. Journal
Of Urology, Vol 139, pp453-457, 1988.
Ohl D. Electroejaculation. Urologic Clinics of North America, Vol 20, No 1, pp. 181-188, 1993.
CONTROLLING TREMORS
Javidan M, Elek J, Prochazka A. Attenuation of pathological tremors by functional electrical stimulation. II:
Clinical evaluation. Annals of Biomedical Engineering, Vol 20, No 2, pp 225-236, 1992.
MULTIPLE SCLEROSIS
Davis R. Is spinal cord stimulation for incomplete spinal cord injury and multiple sclerosis a useful
rehabilitation prosthesis? Proc. of 12th World Congress, International Federation of Physical Medicine and
Rehabilitation. Sydney, AUSTRALIA. March 1995.
Jones RJS et al. The influence of neuromuscular stimulation on physiological activity and functional ability
in multiple sclerosis. Clinical Rehabilitation, Vol 6, Suppl., p 36,1992.
Livesley E. Effects of electrical neuromuscular stimulation on functional performance in patients with
multiple sclerosis. Physiotherapy, Vol 78, pp 914-917, 1992.
...
180
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ABLEOATA
8455 Colesville Road, Suite 935
Silver Spring, MD 20910-3319
(301 )588-9284 or (800)227-0216
E-Mail: naric@cap.gwu.edu
ABLE INFORM BBS: (301)589-3563
ABLEDATA, funded by the National Institute on Disability and Rehabilitation Research, provides information
and referral assistance on a wide range of assistive technology products. The center maintains a database of
information about products for people with disabilities that includes some FES products. The database is
available via the Internet or on CD-ROM. Services are available for a nominal fee.
ECRI
5200 Butler Pike
Plymouth Meeting PA 19462
(215)825-6000
ECRI is widely recognized as the world's leading independent organization committed to the improvement of
health care technology. The organization produces the annual Health Devices Sourcebook, based on the
world's largest medical product database, which lists electrical stimUlation products. Services such as
publications, information systems, consulting, and laboratory services are provided for a fee.
181
182
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NARIC, funded by the National Institute on Disability and Rehabilitation Research, provides information and
referral assistance on all topics related to disability and rehabilitation. The center maintains a copy of FES
Information Center databases and can provide information on FES topics. Other services include publications
such as bibliographies, directories, and a newsletter. Services are provided for a nominal fee. Some services
can be accessed via the Internet.
National Spinal Cord Injury Association (NSCIAf
545 Concord Avenue, Suite 29
Cambridge MA 02138
(617)441-8500 or (800)962-9629
E-Mail: NSCIA1@eworld.com
NSCIA is the largest civilian-based organization serving the needs of the US spinal injury community. It was
started by the Paralyzed Veterans of America after World War II. The mission of the association and its
chapters is to improve the quality of life for persons with spinal cord injury and diseases and their families.
The NSCIA supports a resource center/information clearinghouse on SCI, and publishes a quarterly
magazine, SCI Life. They offer a Fact Sheet on Functional Electrical Stimulation.
Paralyzed Veterans of America (PVA)"
801 Eighteenth Street, NW
Washington DC 20006
(202)872-1300 or (800)424-8200
The PVA was founded following World War II to assist paralyzed veterans who had recently returned from the
war in re-entering mainstream society. There are member chapters around the country. The Spinal Cord
Research Foundation (SCRF) is one of the nation's largest private funding sources for spinal cord research,
supporting grants ranging from basic neuroscience to applied clinical research. The Spinal Cord Injury
Education and Training Foundation (ETF) supports innovative educational and training programs designed to
improve the knowledge and abilities of health care professionals, people with spinal cord injury or disease and
their families. Each foundation has supported electrical stimulation projects. This book was sponsored in part
by ETF. PVA also provides resources on services for disabled veterans, SCI and MS demographics, the
economic consequences of spinal cord disease, wheelchair standards, ADA accommodations, and many
other topics.
Spinal Cord Injury Hotline'
2201 Argonne Drive
Baltimore MD 21218
(800)526-3456
This hotline, run by and for persons with spinal cord injury, is available 24 hours a day and can provide much
information about spinal cord injury and treatment options, including electrical stimulation. The service is
recently affiliated with the Paralyzed Veterans of America.
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.These organizations can provide general resource information on spinal cord injury or multiple sclerosis.
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183
184
The purpose of this new society, formalized in 1995, is to promote the understanding of the application of
electrical stimulation in the field of medicine through meetings, tutorials and publications. The society
communicates primarily through an electronic mail LlSTSERVat the University of Alberta. IFESS plans to
sponsor an annual technical meeting. English is the official language of the society.
...,
Bethesda MD 20892
(301)496-5746
This program supports investigators studying the rehabilitation of individuals with spinal cord injury and
other types of paralysis. Research focus areas are neuroprosthesis development, detection and
processing of nervous system signals, and selective activation of the nervous system for restoration of
function. The program provides quarterly progress reports and sponsors an annual technical workshop.
2) National Center for Medical Rehabilitation Research
National Institute on Child Health and Human Development
Bethesda MD 20892
(301 )402-2242
Established in 1990, the mission of the center is to improve medical rehabilitation efforts to restore or
improve function in persons with disability through research on: mobility, behavioral adaptation to
functional loss, whole body response to lost function, assistive devices, outcome measures, epidemiology,
demography, and treatment intervention effectiveness. The center has funded FES projects for bowel and
bladder control, coughing, and restoration of sensation.
National Science Foundation
Biomedical Engineering and Research to Aid Persons with Disabilities
4201 Wilson Boulevard
Arlington VA 22230
(703)306-1319
The National Science Foundation is a federal government agency whose aim is to promote and advance
scientific and engineering progress in the US. The objective of the Biomedical Engineering programs is to
foster the development of biomedical engineering through the support of research and training. The program
funds various research related to FES, as well as special design projects that allow engineering students to
construct custom prototypes for persons with disabilities.
...,
183
APTA is a professional organization for physical therapists. It provides many services, including publications,
educational programs, and conferences. APTA sponsors special interest groups in electrotherapy, neurology
and spinal cord injury. They also maintain a roster of therapists around the country who are certified in clinical
specialty areas, including electrotherapy.
American Spinal Injury Association (ASIA)
250 E. Superior St., Room 619
Chicago IL 60611
(312)908-3425
ASIA is an interdisciplinary professional association for health care professionals working in the field of spinal
cord injury. The annual scientific meetings regularly address advances in treatment and rehabilitation for
persons with spinal injury. On occasion, their annual meeting and educational publications cover electrical
stimulation topics.
Association for the Advancement of Medical Instrumentation (AAMI)
3330 Washington Boulevard, Suite 400
Arlington VA 22201-4598
(703)525-4890
AAMI is a unique alliance of the health care professions, providing information on the development and use of
medical technology. The association plays a major role in developing standards for medical equipment,
including electrical stimulation equipment. AAMl's services include conferences and publications.
Biomedical Engineering Society (BES)
PO Box 2399
Culver City CA 90231
(310)618-9322
The society encourages the development, dissemination, integration, and utilization of knowledge in
biomedical engineering. The society publishes a quarterly bulletin. Their annual conference usually covers
electrical stimulation topics.
IEEE Engineering in Medicine and Biology Society (EMBS)
345 East 47th Street
New York, NY 10017
(212)705-7900
The IEEE-EMBS is a society of the Institute of Electrical and Electronic Engineers dedicated to engineering
applications in medicine and biology. Their publications and conferences regularly cover topics in electrical
stimulation. They provide a fee-based document delivery service.
International FES Society (IFESS)
c/o Paul Meadows, Secretary
5030 N. Hill Street
La Canada, CA 91011 USA
184
The purpose of this new society, formalized in 1995, is to promote the understanding of the application of
electrical stimulation in the field of medicine through meetings, tutorials and publications. The society
communicates primarily through an electronic mail LlSTSERV at the University of Alberta. IFESS plans to
sponsor an annual technical meeting. English is the official language of the society.
..
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185
Baltimore MD 21202-4051
(410)962-1800
The mission of the RR&D Service is to improve the quality of life of impaired and disabled veterans through
support of an intramural research and development program. The program is designed for rapid transfer of
RR&D technology and dissemination of information into the VA medical care system. The Service publishes a
quarterly journal and annual progress reports that are available free of charge. In addition to merit review
research projects on functional electrical stimulation at individual VA Medical Centers, RR&D also supports a
Center of Excellence in FES.
Arlington VA 22209-1903
(703)524-6686
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RESNA is an interdisciplinary association for the advancement of rehabilitation and assistive technology. It
sponsors an annual conference and publishes a newsletter and a journal, Assistive Technology. The society
supports a special interest group on Electrical Stimulation (SIG-10) that meets annually and coordinates FES
activities at the annual conference. The association has a special mission to include consumers with
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cooperation, and education in the study and clinical applications of the effects of electricity and magnetism in
growth, repair, and regeneration of human cells and tissues. Electrical stimulation applications such as
pressure ulcer treatment, promoting bone growth, and regeneration of neural tissues are of particular interest
Whitaker Foundation
901 15th Street, NW, Suite 1000
Washington, DC 20005
(202) 408-1505
The Whitaker Foundation is the major private source of funding for biomedical engineering in the US. It has
provided funding for various FES projects in recent years. The foundation recently announced its plans to
liquidate its assets by the year 2006 in order to concentrate its efforts and funds over a brief time span to best
serve the biomedical engineering community.
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186
3M Health Care
3M Center Building, 275-4E-01
st. Paul, MN 55144-1000
800- 228-3957
Products- Electrode: Transcutaneous/surface
Treatment Applications
Cardiovascular Exercise
Lower Limb Movement
Neuromuscular Treatments
Treatment Applications
Upper Limb Movement
Atrotech Co.
Treatment Applications
P.O. Box 28
Respiratory Treatments
FIN - 33721
Tampere, FINLAND
Products- StimUlator
Description- Atrostim , JUKKA - Phrenic nerve stimulator. See also Medlink Technical Corporation.
pacers; Micturition Stimulator - activation of bladder contractions by direct spinal cord stimulation;
Percutaneous Electrical Nerve Stimulator, Implantable Peripheral Nerve Stimulator - for severe,
intractable pain.
Treatment Applications
Cardiovascular Exercise
Lower Limb Movement
Upper Limb Movement
Neuromuscular Treatments
Respiratory Treatments
Treatment Applications
Bioflex, Inc.
736 Kenwick Road
Bowel Control
Cardiovascular Exercise
Columbus, OH 43209
614-236-8079; 800-552-3539
Neuromuscular Treatments
Products- Electrode: Transcutaneous/surface
Description- Custom garments incorporating electrodes. Bioflex's services are for a wide variety of
persons with central nervous system disabilities, and include neuromuscular stimulation systems for
the lower extremities, upper extremities and trunk. Garments are compatible with any commercial
FDA stimulator and are designed for home use.
Biomech Designs Ltd.
Treatment Applications
7955 - 98 Avenue
Lower Limb Movement
Edmonton, Alberta T6A OB5
CANADA
403-469-3484
Products- Stimulator
Description- Quadstim (4 channel), Unistim (1 channel) - Multi-use stimulator for therapeutic or
rehabilitation purposes.
187
Treatment Applications
Neuromuscular Treatments
Products- Stimulator
Treatment Applications
DynaWave Corporation
2520 Kaneville Court
Neuromuscular Treatments
Circulatory / Skin Treatments
Geneva, IL 60134
708-232-4945
Products- Stimulator
Description- DynaStim 50, Dynawave Model 12 Unit - Stimulators for TENS, EMS, and NMES.
Treatment Applications
Neuromuscular Treatments
EMPI, Inc.
1275 Grey Fox Road
S1. Paul, MN 55112
612-636-6600; 800-328-2536
Treatment Applications
Cardiovascular Exercise
Lower Limb Movement
Upper Limb Movement
Neuromuscular Treatments
Products- Stimulator
Description- Focus, Respond II - Dual channel stimulator for NMS; Respond Select - NMS stimulator
allowing preset or programmable protocols.
188
Finetech Limited
Treatment Applications
13 Tewin Court, Welwyn Garden City
Bladder Control
Hertfordshire AL7 1AU, England
Bowel Control
Tel: 0707 330942
Products- Stimulator; Electrode: Implanted
Description- Sacral anterior root stimulator for enhancing bladder, bowel, and sexual function
Treatment Applications
Respiratory Treatments
Treatment Applications
Lower Limb Movement
Life-Tech, Inc.
Treatment Applications
10515 Harwin
Bladder Control
P.O. Box 36221
Houston, TX 77036
718-988-6060
Products- Stimulator; Electrode: Implanted
Treatment Applications
Bladder Control
Bowel Control
Cardiovascular Exercise
Lower Limb Movement
Neuromuscular Treatments
Circulatory / Skin Treatments
Products- Stimulator
Description- Challenge 4010 Stimulator - Use of stimulator can increase muscle bulk and circulation
in individuals with lower motor neuron injury or peripheral nerve injury.
MEDimplant, Inc.
Treatment Applications
Respiratory Treatments
Laudongasse 10
A-1080 Vienna AUSTRIA
Tel: 4311-408-68-48
Products- Stimulator
Description- Respiratory Pacemaker - Functional electrostimulation of phrenic nerves in central or
peripheral disorders of respiration. Battery-powered control device supplies the implanted 8 channel
pacemaker via an external transmission aerial with stimUlation pulses and power.
Treatment Applications
Medlink Technical Corporation
Respiratory Treatments
730 N. Pueblo Drive, #108
Taos, NM 87571
505-751-0133
Products- Stimulator
Description- U.S. distributor of Atrostim, JUKKA - Phrenic nerve stimulator. See also Atrotech.
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189
Medtronic
Treatment Applications
Bladder Control
Medtronic Nortech Division
Bowel Control
5255 East River Drive
Cardiovascular Exercise
Minneapolis, MN 55421
Lower Limb Movement
800-669-8355
Upper
Limb Movement
Medtronic Neurological Division
Circulatory / Skin Treatments
7000 Central Avenue, NE
Sensory Aids
Minneapolis, MN 55432-4000
Sexual Function
612-574-4879
Products- Stimulator; Electrode: Transcutaneous/surface; Implanted
Description- Interstim - Implantable bladder stimulation product. ITRELII - Implantable spinal cord
stimulator for pain.
Mettler Electronics Corporation
Treatment Applications
1333 South Claudina Street
Neuromuscular Treatments
Anaheim, CA 92805
714-533-2221; 800-654-9305
Products- Stimulator; Electrode: Transcutaneous/surface
Description- EZ-trode, SYS*Stim 207A.
NEC Corporation
NEC San-ei Instruments, Ltd.
NKD Building, 42-6
Hongo 3-Chome
Bunkyo-ku, Tokyo 113 JAPAN
Tel: 03-5684-1417
Treatment Applications
Bladder Control
Lower Limb Movement
Upper Limb Movement
Neuromuscular Treatments
Orthopaedic Treatments
Respiratory Treatments
Sensory Aids
190
Sigmedics Inc.
Treatment Applications
One Northfield Plaza, Suite 410
Lower Limb Movement
Northfield, IL 60093
708-501-3500; 800-582-9255
Products- Stimulator; Electrode: Transcutaneous/surface
Description- Parastep TM I System - Enables skeletally mature spinal cord injured persons (levels
C6-t12) to stand and attain limited ambulation and/or take steps, with assistance if required.
---
Treatment Applications
Neuromuscular Treatments
Treatment Applications
Stimwear, Inc.
476 Arroyo Chico
Cardiovascular Exercise
Lower Limb Movement
Laguna Beach, CA 92651
Neuromuscular Treatments
714-494-9423
Products- Electrode: Transcutaneous/surface
Description- Electrode-enhanced garments meant to simplify muscle stimulation for routine exercise.
These garments use no tape or other irritants. Stated benefits include reduced spasticity, increased
Treatment Applications
Stratec Electronic
Lower Limb Movement
Gewerbestr.10 7534 Birkenfeld -2
Neuromuscular Treatments
Grafenhausen GERMANY
Tel: 07082/50081
Products- Stimulator
Description- BIOCY-8 - Training of paralyzed or immobilized muscles, stimulation of functions for
standing, walking, and gripping. Four independent stimulation channels, battery monitoring.
Treatment Applications
Bladder Control
Bowel Control
Upper Limb Movement
Neuromuscular Treatments
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This part contains a glossary with more than 200 entries to assist you in learning
more about functional electrical stimulation. Each entry is a bolded word,
acronym, or phrase, followed by its definition. They are listed alphabetically.
Some entries are cross-referenced to others.
The entries were chosen because they appear elsewhere in this book, or
because you are likely to come in contact with them in your conversations with
FES professionals or consumers, or if you do further reading on the topic.
A glossary is meant to provide assistance with understanding the meaning of a
word or phrase in a given context. It should never take the place of medical
advice from a licensed professional. Also keep in mind that the usage of certain
words may differ from person to person. A medical dictionary can provide
additional clarification if necessary.
191
192
Bone stress. A condition caused by external
force applied to the bone; excess force could
cause bone fracture.
Bowel evacuation. The process of emptying the
bowels. May be enhanced by applying electrical
stimulation to specific skin areas of the low back
(lumbar and sacral dermatomes) if voluntary
control of the bowel has been lost. See also
Penile erection.
Candidate referral. The process by which an
individual is referred to an electrical stimulation
program on the basis of program type, medical
condition, geographic location, etc.
Cardiovascular exercise. A stage of exercise
during which the heart rate is raised to a level
sufficient to improve fitness. May be induced
using electrical stimulation to contract muscles,
as in bicycle ergometry.
CARF. Commission on the Accreditation of
Rehabilitation Facilities.
Cathode. An electrically negative electrode. One
cathode is required in a stimulation system for
each muscle or nerve group to be activated.
See also Anode.
Central nervous system (CNS). The part of the
nervous system comprising the brain and spinal
cord. Diseases of the CNS include cerebral
palsy, multiple sclerosis, spinal cord injury,
stroke, and head injury.
Cerebrovascular accident (CVA). See Stroke.
CFES. See Computerized Functional Electrical
Stimulation.
Channel. A speCification of electrical stimulators,
referring to the number of separate
nerve/muscle groups which can be activated by
the stimulator. Each channel requires an
anode-cathode electrical pair.
Circulatory pooling. Collection of the blood due
to inadequate circulation. May be reduced by
the use of electrical stimulation to muscles in
the vicinity of the pooling to produce a pumping
action.
Clinical research. The stage of development of
FES at which techniques are being evaluated in
small numbers of human subjects, as opposed
to animal or computer models. 'Also called
clinical feasibility studies. Preceded by basic
research.
Clinical service. In theory, any use of FES
offered as a service, typically for a fee, that is
not in any way considered experimental. In
practice, certain aspects of the treatment may in
fact be experimental.
Closed-loop control. See Control.
CNS. See Central nervous system.
Command. The Signal whose value determines
the onset, duration, & level of stimulus applied.
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GLOSSARY ON FES
193
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194
Feedback. Information about what is taking place
in response to a stimulus that is returned to the
stimulus controller; e.g., force and position
information. See also Control; Sensors.
FES. See Functional Electrical Stimulation.
Flexion. A movement which decreases the angle
between two adjoining bones of the skeletal
system. See also Extension.
Floor reaction orthosis. A rigid ankle foot
orthosis developed in the 1960s which uses the
ground reaction vector to provide stability for
standing. See also Hybrid orthosis.
FNS. See Functional neuromuscular stimulation.
Food and Drug Administration. The federal
agency responsible for regulating the safety and
efficacy of medical devices sold in the U.S.
Foot-drop. An abnormal neuromuscular condition
which is characterized by the inability to
dorsi-flex or invert the foot due to peroneal
nerve interruption, often resulting from stroke.
May be corrected by orthoses or electrical
stimulation of the peroneal nerve.
Force. Energy or "pressure" applied in such a way
that it initiates motion or alters the size or shape
of an object.
Frequency. The rate of occurrence of stimulus
pulses.
Functional Electrical Stimulation (FES). As
defined by the FES Information Center: a
rehabilitation technique where low-level
electrical current is applied to an individual with
a disability to enhance that person's ability to
function and live independently. Usually refers
to applications which provide long term
assistance or replacement of a miSSing or
impaired body function. The term often has
different meanings in different communities; if
the definition is not clear, ask for clarification.
See also Therapeutic electrical stimulation.
Functional evaluation. A clinical evaluation of a
person based on the completion of tasks, often
including the activities of daily living.
Functional neuromuscular stimulation (FNS).
The application of electrical stimulation to the
neuromuscular system for the purpose of
completing functional tasks. Sometimes used
interchangeably with FES. Typically refers to the
use of electrical stimulation to provide long term
assistance or replacement of an impaired
neuromuscular function.
Funding. Financial support for a research project;
e.g., grants from the government or private
foundations.
Gait. The act of walking or ambulation. Can be
assisted by electrical stimulation and/or
orthoses. See also Hybrid orthosis.
--
--
--
GLOSSARY ON FES
195
disease, electrical stimulation of the nerve and
muscle will be impOSSible. Lower motor neuron
damage may be present in spinal cord injury,
spina bifida, and ALS. See also Denervation;
Peripheral nervous system; Upper motor
neuron.
Lymph. Clear liquid that flows in lymphatic
vessels throughout the body. Contains protein,
some white blood cells, and few red blood cells.
Micturition. Elimination of urine from the bladder;
urination.
Motor training. See Facilitation.
MS. See Multiple sclerosis.
Multicenter clinical trials. A stage of FES
development characterized by well-controlled
studies in two or more clinics involving large
numbers of human subjects.
Multiple sclerosis (MS). A progressive CNS
disease characterized by destruction of the
myelin sheath that insulates nerve cell axons,
causing interruption of neural signals. There is
some indication that FES may be used to
improve function in individuals with MS.
Muscle conditioning. The process of converting
a muscle fiber type from fast-twitch fibers to
slow- twitch fibers by electrical stimulation to
decrease the likelihood of muscle fatigue.
Muscle contraction. See Contraction.
Muscle exercise. See Muscle strengthening.
Muscle reeducation. See Facilitation.
Muscle strengthening. The use of electrical
stimulation to cause repeated contractions of
muscles which have become weak and
atrophied. Causes a change in muscle fiber type
which results in a muscle less likely to fatigue.
May increase muscle bulk, thereby changing the
appearance of the extremities. Portable
stimulators with surface electrodes are typically
used in physical therapy clinics for this purpose.
See also Muscle conditioning; Atrophy;
Hypertrophy.
Musculoskeletal. Related to the function of the
bones, muscles, and their interactions.
National Center for Medical Rehabilitation
Research (NCMRR). A center of the National
Institutes of Health devoted to improving the
quality of life of individuals with medical
disabilities.
National Institute of Neurological Disorders
and Stroke (NINDS). One of the National
Institutes of Health devoted to the study of
neurological diseases and disorders.
National Institute on I;>isability and
Rehabilitation Research (NIDRR). A federal
agency of the Department of Education, Office
of Special Education and Rehabilitative
Services to support the development of devices
196
and programs which improve the ability of
individuals with disabilities to live independently.
National Institutes of Health (NIH). A group of
agencies commissioned by the Department of
Health and Human Services to oversee
research into health-related problems. Includes
the NINDS and NCMRR which sponsor a large
portion of FES research.
NCMRR. See National Center for Medical
Rehabilitation Research.
Needle electrode. A surgical-grade needle used
to record or deliver electrical impulses.
Nerve. One or more bundles of fibers which carry
electrical impulses. The fibers connect the brain
and spinal cord with other parts of the body.
See a/so Axon; Neuron.
Nerve electrode. An electrode surgically placed
in, near or around the nerve. Also known as
nerve cuff, intraneural, or epineural electrodes.
See a/so cuff electrode.
Neural prosthesis. A device which acts to
replace or improve the function of an impaired
nervous system.
Neural regeneration. The use of electrical
stimulation to enhance the regeneration of
nerve fibers that have been severed due to
accident or disease.
Neurological level. In spinal injury, refers to the
most caudal segment of the spinal cord with
normal sensory and motor function on both
sides of the body.
Neuromodulation. A method of reducing
spasticity and improving motor control by
stimulating sensory nerves.
Neuromuscular. Related to the function of nerves
and muscles.
Neuromuscular electrical stimulation (NMES).
Electrical stimulation of nerves to produce
muscle contraction.
Neuron. The basic nerve cell of the nervous
system. See a/so Axon; Nerve.
Neurophysiology. The study of the processes
and functions of the nervous system.
Neuroprosthesis. See Neural prosthesis.
NIDRR. See National Institute on Disability and
Rehabilitation Research.
NIH. See National Institutes of Health.
NINDS. See National Institute of Neurological
Disorders and Stroke.
NMES. See Neuromuscular electrical stimulation.
Open-loop control. See Control.
Orthosis. A device used to support or brace a
weak or disabled joint or muscle.
Osteoarthritis. Chronic disease involving the
jOints. Involves degeneration of cartilage,
overgrowth of bone, and impaired function.
Almost alwa~s occurs with aging.
---
GLOSSARY ON FES
Pressure sore relief. The periodic use of surface
electrical stimulation to increase circulation and
shift the load on weight-bearing tissues in an
area prone to pressure sores.
Proprioception. Awareness of posture,
movement, changes in balance, and knowledge
of position, weight and resistance of objects in
relation to the body.
Prosthesis. A device used as a substitute for a
missing or dysfunctional part of the body.
Pulse. A brief injection of electrical current,
typically lasting only microseconds. Most
stimulation systems produce many pulses in a
sequence to cause nerve activation. See a/so
Impulse.
Quadriplegia. Paralysis of the arms, legs and
trunk that occurs with an injury to the spine in
the cervical (neck) area. Also known as
tetraplegia.
Range of motion. The extent to which a jOint can
move in all possible directions. A type of
exercise, active or passive, used to assess the
condition of the muscles and joints by body
movement. Electrical stimulation can be used
to move limbs through their range of motion.
Reciprocal walking. A gait pattern where one leg
is sequentially placed in front of the other.
Reciprocating gait orthosis (RGO). A
hip-knee-ankle-foot orthosis with coupling such
that hip extension in one leg causes hip flexion
in the other, causing reciprocal walking.
Recruitment. The relationship between the
electrical charge injected into a stimulating
electrode and the resulting force generated by
the activated muscle. In general, force
increases as the charge, or intensity, increases.
See also Threshold.
Rectum. Lower part of the bowel, just inside the
anus.
Reflex. An action that occurs subconsciously
when certain signals that start in a nerve ending
travel to the spinal cord or brain. An example is
the automatic kicking of the lower leg when the
knee is tapped with a rubber hammer.
Regulatory approval. Treatment and any
associated medical devices that have received
approval from the Food and Drug Administration
(FDA) in the United States, or a comparable
regulatory agency in other countries.
Rehabilitation engineering. The systematic
application of technologies or scientific
principles to meet the needs of, and address
barriers confronted by, individuals with
disabilities. This includes areas such as
education, rehabilitation, employment,
transportation, communication, independent
living and recreation.
197
Rehabilitation technology. Any technology used
to restore or improve function in an individual
after a disabling disease or injury. Also known
as assistive technology.
Respiratory assist. A system that enhances the
act of breathing. Examples are an iron lung or a
phrenic nerve pacer.
Restoration. The return of function by direct or
indirect means after the loss of function.
RGO. See Reciprocating gait orthosis.
Rhizotomy. Cutting of a spinal nerve root.
SCI. See Spinal cord injury.
SCS. See Spinal cord stimulation.
Sensation. A feeling, impression, or awareness of
a bodily state or condition that results from
stimulation of a sensory nerve fiber.
Sensor. A device that provides electronic
information about a situation, such as force or
position information. Also known as transducer.
Sensory electrode. An electrode or electrode
array with the purpose of providing substitute
sensory information or system information to the
user.
Sensory feedback. Providing sensory information
to help describe what is happening (usually to
the FES system) during a certain situation; e.g.,
tactile stimulation to represent grasp force.
Sensory substitution. The use of one human
sense to receive information normally received
by another sense. In FES, typically
electrotactile information is substituted for an
impaired sense.
Sexual function. See Electroejaculation; Penile
erection.
Skeletal muscle. Muscle tissue conSisting of
bundles of parallel fibers. Normally contraction
is under voluntary control, as in the muscles that
control upper and lower extremity movement.
Also known as striated muscle. See also
Smooth muscle.
Smooth muscle. Muscle tissue composed of
elongated, spindle-shaped cells not under
voluntary control, as in the muscles of the
stomach and intestines. See a/so Skeletal
muscle.
Spasm. Involuntary, sudden movement or muscle
contraction. May be sustained (toniC) or
alternately contracting and relaxing (clonic).
When strong and painful, spasms are called
cramps.
Spasticity. A condition caused by involuntary
contraction of muscles due to a spinal cord
lesion or other central nervous system disorder.
Electrical stimulation may, in some cases, be
used to counteract the involuntary contractions,
thereby reducing spasticity.
bn
198
Spinal cord injury (SCI). Injury to the neural
structures of the spinal column, often due to
traumatic accident, resulting in upper and lower
motor neuron lesions. Typically leads to
paralysis and loss of sensation in parts of the
body controlled through the spinal cord below
the level where the injury occurred. Some
central nervous system diseases have similar
effects.
Spinal cord stimulation (SCS). Stimulation of the
spinal neural axis to treat pain and various
disorders of the motor system. Typically
involves insertion of electrodes into the epidural
space with subcutaneous placement of a
stimulator/receiver. Also known as dorsal
column stimulation. See also Implantable
stimulator.
Stimulation. Application of stimuli to activate
sensory and/or motor nerves.
Stimulator. A device used to apply an electrical
or magnetic stimulus through an electrode to a
nerve or muscle. May have single or multiple
channels. See also Channel; Implantable
stimulator; laboratory-based equipment;
Portable stimulator.
Stimulus. A current or voltage pulse or pulse
train, characterized by amplitude, shape,
duration, and frequency, that excites nerves and
muscles when applied to the body. See also
Parameters.
Stimulus intensity. The amount of stimulation
applied to the body, usually a combination of
frequency, pulse duration, and amplitude. See
also Parameters.
Strengthening. See Muscle conditioning.
Stroke. Sudden paralysis caused by interruption
(transient ischemic attack - TIA) or blocking
(cerebral infarction) of circulation to a part of the
brain or by sudden bleeding into the substance
of the brain (intracerebral hemorrhage). Also
known as CVA.
Subcutaneous. Under the skin.
Surface electrode. An electrode placed on the
surface of the skin over a muscle, peripheral
nerve, or skin afferents (sensory receptors that
carry impulses towards the CNS) to be
stimulated. The electrode is held to the skin by
adhesive, tape, bandaging or tight-fitting
garments. Surface electrodes are used with
electrode gel or paste to enhance electrical
conductivity between the skin and the electrode.
Swing-through walking. A gait pattern which
results when the trunk and legs follow an initial
forward movement by the arms using a walker,
crutches, or other stabilizing device. See also
Reciprocal walking.
Tactile. See Electrotactile.
--
--
PART 5. INDEX
This part contains index entries to help you locate a topic of interest in this book. The index
is divided into two sections -- a Topical Index and an Organizational Index. The Topical
Index contains pOinters to information in the book that covers a certain subject. For
example, if you are interested in bicycle ergometry, you can look for that entry under the
B's in the Topical Index. The Organizational Index contains pointers to information in the
book about a certain organization. For example, if you are interested in information about
the Food and Drug Administration, you can look for that entry under the F's in the
Organizational Index.
Entries in each index appear in alphabetical order. Each entry may point to either a page
number or a Program/Application Identification number from Part 2. Page numbers appear
in a regular type face. Program/Application Identification numbers appear in a balded type
face, have the format n.nn and always refer to identification numbers (not pages !) in Part
2.
For example, if the entry looked like the following:
Spinal cord injury, 15,27-30,6.00,6.01,8.00,8.03
you could turn to either page 15 or pages 27 through 30, or, in Part 2, to
Programs/Applications 6.00, 6.01, 8.00, or 8.03 to find information about spinal cord injury.
You can also use the Table of Contents at the beginning of the book to help you locate the
pages that cover your topic of interest.
INDEX
201
Improving circulation
See Circulation
Improving voluntary control of movement
See Movement control
In-vitro fertilization, 32
See also Electroejaculation
Incomplete injury, 1, 11, 17, 19,21,22,23,24,25,
28,29,30,31,37,44
Information centers, 181-82
Informed consent, 8, 66
Insurance,8,13,32,53,64,65
See also Cost
Intercostal muscles, 14
See also Diaphragm
Investigational device exemption (IDE), 8
Investigational, status, 7, 8, 9, 22, 23, 49
-L
Leads, electrode 5, 6, 22, 48
Lower limb movement, 186, 187, 188, 189, 190,1.03,
2.04,3.01,10.01,12.01,13.01,16.01,21.01,
24.01,27.01,29.02,29.04,32.01,32.02,35.03,
40.01,41.01,42.02,43.01,43.02,43.03,49.01,
51.04, 52.01, 55.02, 56.01, 57.02, 58.01, 60.01,
60.02,61.03,63.03,66.01,68.01,70.01,70.02,
71.03,74.01,76.01,77.01,78.01,79.01,80.01,
80.02,83.01,85.01,88.01,93.01,94.01,95.01,
96.01,97.01,98.04,99.01,100.01,101.01,101.02,
102.01,104.01,104.02,105.01
See also Standing, Stepping, Transfers, Walking
Lower motor neuron, 2, 15, 42
Lumbar, 26
Lung, 11, 16, 17, 19,25,29,47
- MManufacturers, 187-90
Medicare, 8
Medication, 36, 55
Motor nerve, 1,2, 12, 15,21,36,37,42,48,56
Movement control, 47, 48, 50, 51, 63-64
Multicenter clinical trial, 8, 9, 20, 31,62, 10.01, 10.02,
10.03,17.01,19.01,20.01,21.01,21.02,26.01,
27.01,28.01,30.01,35.05,37.01,38.01,39.02,
42.02, 43.02, 45.02, 45.03, 50.01, 51.03, 53.01,
55.02,62.01,67.01,71.01,71.02,73.02,74.01,
81.01, 84.01, 104.03
Multiple sclerosis, 46-64,175,179,180,181,2.01,
2.02,2.03,2.04,4.01,6.01,9.01,13.01,15.03,
19.01,20.01,23.01,28.01,31.02,34.01,34.04,
35.02,35.04,35.05,36.01,37.01,38.01,42.01,
42.02, 42.03, 42.04, 48.01, 49.01, 49.02, 49.03,
53.01, 55.01, 55.02, 58.01, 59.03, 60.02, 60.04,
65.01, 69.01, 71.02, 73.01, 73.02, 73.03, 76.01,
82.01,92.01,93.01,93.02,95.02,95.03,100.01,
104.02
- NNervous system, 1, 2, 3
- 0
Organizations, professional, 183-85
OrthopaediC treatments, 189,47.03,69.01,88.01
See also Contractu res, Osteoporosis
Orthoses, 18,24,26,27,29,30
See also Braces
Osteoporosis, 3,13,14,26,28,29,39,40,41,51,
59-60, 176, 47.03
See also Orthopaedic treatments
-p
Pacemakers, 1,3,6,17,19,37,56
Pain, 1,3,5, 14, 19,21,22,24,25,28,29,37,46,
47,48,49,50,51,56,63,176,42.04
Paralysis, 2
Paraplegia, 11, 26, 30, 40, 1.01, 1.02, 1.03, 1.04,
2.01, 2.02, 2.03, 2.04, 3.01, 4.01, 5.01, 6.01, 8.01,
9.01,10.01,10.03,12.01,14.01,15.02,15.03,
15.04,16.01,18.01,21.01,23.01,24.01,25.01,
26.01, 28.01, 29.02, 29.04, 31.01, 31.02, 32.01,
32.02, 33.01, 33.02, 33.03, 34.01, 34.02, 34.03,
34.04, 35.01, 35.02, 35.03, 35.04, 35.05, 36.01,
39.02,40.01,41.01,43.01,43.02,43.03,45.03,
47.01,47.02,47.03,47.04,48.01,48.02,49.01,
49.02, 49.03, 51.04, 52.01, 53.01, 55.01, 56.01,
58.01, 59.01, 59.03, 60.01, 60.03, 61.01, 61.02,
61.03,63.01,63.02,63.03,66.01,67.03,68.01,
68.02, 68.03, 69.01, 70.01, 70.02, 71.03, 72.01,
73.01,73.02,73.03,74.01,75.01,77.01,77.05,
78.01, 79.01, 80.01, 80.02, 81.01, 83.01, 85.01,
85.02, 85.03, 88.01, 90.01, 92.01, 92.02, 93.01,
93.02, 95.01, 95.02, 95.03, 96.01, 97.01, 97.02,
97.03,97.04,98.01,98.02,98.03,98.04,99.01,
101.01,101.02,102.01,103.01,104.01,105.01,
105.02
Participating in programs, 64
Pediatrics, 179
See also Child
Pelvic floor stimulation, 22,49
Peripheral nerve, 2, 3, 25, 28, 51, 63
Peripheral nervous system, 1, 2, 3, 25, 28, 44, 51, 63
Phrenic pacer, 14, 16,66.02
See also Breathing assistance
Physical therapy, 13,33,35,36,37,39,42,54,55,
56,58,61
Pregnancy, 11, 47
br
202
Pressure sores, 3, 32, 34, 35, 36, 42, 53, 54, 55, 61,
179
See also Preventing pressure sores, Treating
pressure sores
Preventing pressure sores, 34-35, 53-54, 61.01
See also Treating pressure sores
Preventing! Treating contractu res
See Contractu res
Preventing! Treating osteoporosis
See Osteoporosis
Products, electrical stimulation
See Equipment
Pudendal nerve, 23
Rhizotomy, 21
- S
SCS
See Spinal cord stimulation
Secondary complications, 3, 11, 13
See also Neuromuscular treatments
Sensation, 12, 17, 19,21,22,31,38,43-44,45,46,
49,52,53,56,63,64,68.03
See also Sensory substitution
Sensors, 5,6, 7,19,20,28,30,44
Sensory nerve, 1,6, 19, 21, 36, 37, 43, 44, 48, 56
Sensory substitution, 43, 67.03, 68.03, 69.01, 88.01
Sexual function, 21,187,189,4.01,9.01,10.03,
19.01,20.01,23.01,28.01,35.05,37.01,38.01,
39.02,53.01,54.01,55.01,65.01,73.03,77.04,
89.01,95.05,98.03
See also Electroejaculation, Erection
Spasticity, 3,13,19,20,21,22,24,26,28,29,36
38,45,47,48,50,55-57,58,59,60,42.01,60.04,
61.01, 63.02, 82.01, 85.02
See also Neuromuscular treatments
Sperm, 30, 31,32,52, 53
Spinal cord injury, 11-45, 175, 176, 177, 178, 179,
181, 182, 183, 184, 1.01, 1.02, 1.03, 1.04, 2.01,
2.02,2.03,2.04,3.01,5.01,6.01,7.01,8.01,9.01,
10.01,10.02,10.03,11.01,12.01,13.01,14.01,
15.01,15.02,15.03,15.04,16.01,17.01,18.01,
19.01, 20.01, 21.01, 21.02, 21.03, 22.01, 23.01,
24.02,25.01,26.01,27.01,28.01,29.01,29.02,
29.03, 29.04, 30.01, 31.01, 31.02, 32.01, 32.02,
33.01, 33.02, 33.03, 34.01, 34.02, 34.03, 34.04,
35.01, 35.02, 35.03, 35.04, 35.05, 36.01, 37.01,
38.01, 39.01; 39.02, 40.01, 41.01, 43.01, 43.02,
43.03,44.01,45.02,45.03,46.01,47.01,47.02,
47.03,47.04,48.01,48.02,49.01,49.02,49.03,
50.01,51.01,51.02,51.03,51.04,52.01,53.01,
54.01,55.01,55.02,56.01,57.01,57.02,58.01,
59.01, 59.02, 59.03, 60.01, 60.03, 60.04, 60.05,
61.01,61.02,61.03,62.01,63.01,63.02,63.03,
64.01,65.01,66.01,66.02, ,67.01,67.02,67.03,
68.01, 68.02, 68.03, 68.04, 69.01, 70.01, 70.02,
71.01,71.03,72.01,73.01,73.02,73.03,74.01,
75.01, 76.01, 77.01, 77.02, 77.03, 77.04, 77.05,
78.01,79.01,80.01,80.02,81.01,83.01,84.01,
85.01, 85.02, 85.03, 86.01, 87.01, 88.01, 89.01,
90.01, 91.01, 91.02, 92.01, 92.02, 93.01, 93.02,
95.01,95.02,95.03,95.04,95.05,96.01,97.01,
97.02,97.03,97.04,98.01,98.02,98.03,98.04,
99.01,101.01,101.02,102.01,103.01,104.01,
104.03,105.01,105.02
Spinal cord stimulation (SCS), 19,22,24,28,37,45,
46,47,48,49,50,51,56,57,60,63,64
Spinal nerve, 1, 2, 21, 48
Splints, 17, 18,38,58
INDEX
203
3
Transfers, 24, 25, 35, 38, 40, 42, 50, 56, 59, 60, 61,
176, 178,2.04, 12.01, 16.01,29.04,43.01,49.01,
58.01,63.03,70.02,93.01,98.04,101.01,104.01
See also Lower limb movement, Standing
Treating pressure sores, 19,35-36,54-55,29.03,
35.02, 61.01, 95.02
See also Preventing pressure sores
Treating weak atrophied muscles
See Atrophied muscles, Weak muscles
Treatments, 11-64
Tremor, 3, 43, 62, 179, 49.02, 71.02, 85.02
See also Neuromuscular treatments
Tumors, 11,31,47
- UUnlabelled use, 22, 28, 37, 46, 49, 51, 56, 63
Upper limb movement, 186, 187, 189, 190,10.02,
17.01,21.02,30.01,39.01,44.01,45.02,50.01,
51.01,51.02,51.03,59.02,60.05,61.01,62.01,
64.01,67.01,68.04,69.01,71.01,77.01,77.02,
77.03, 84.01, 86.01, 88.01, 91.01, 104.03
See also Grasping, Reaching
Upper motor neuron, 2, 12,42
Urinary tract infections, 11,21,23, 26, 29, 48, 51
-v
Ventilator, 14, 16
Veteran, 181, 182, 185,5.00,6.00,15.00,17.00,
21.00,27.00,31.00,37.00,43.00,44.00,45.00,
47.00, 53.00, 57.00
Voluntary movement
See Regaining voluntary function
Volunteer, 66
See also Research subject
-wWalking, 26,50-52,56,59,60,61,176,178,1.03,
2.04,3.01,10.01,12.01,21.01,24.01,27.01,
29.02,32.01,32.02,35.03,40.01,41.01,42.02,
43.02,43.03,49.01,51.04,52.01,55.02,56.01,
57.02,58.01,60.01,60.02,61.03,63.03,66.01,
68.01, 70.01, 71.03, 74.01, 76.01, 79.01, 80.01,
83.01,85.01,93.01,94.01,95.01,96.01,97.01,
98.04, ,99.01,100.01,101.02,102.01,104.02,
105.01
CONTINUED
bs
204
IOrganizational Index
3M Health Care, 186
-A
ABLEDATA. 180
American Neuromodulation Society. 184
American Physical Therapy Association, 183
American Spinal Injury Association, 183
Asah MedicoNS, 186
Association for the Advancement of Medical
Instrumentation, 183
Atrotech Co., 186
Austin Hospital, 62.00
Avery Laboratories Inc., 186
Axelgaard Manufacturing Co., Ltd., 186
-E
ECRI,180
ElectroLogic Of America, Inc., 187
Electrostim USA, 187
Emory University Department of Rehabilitation
Medicine, 11.00
EMPI, Inc., 187
-8
Baltimore Veterans Affairs Medical Center. 17.00
Baylor College of Medicine, 53.00
Bioelectrical Repair and Growth Society. 185
Bioflex, Inc., 186
Biomech DeSigns Ltd., 186
Biomedical Engineering Society, 183
Boston University School of Medicine, 20.00
Brockton! West Roxbury VA Medical Center, 21.00
Burke Rehabilitation Center, 40.00
-cCAllES, 78.00
CARF,78
Case Western Reserve University, 45.00
Center for Motor Rehabilitation, 67.00
Center for Physical Rehabilitation, 30.00
Centre for Implantable Technology and Sensors,
94.00
Centre for Spinal Cord Injured, 77.00
Centre Propara, 78.00
Chattanooga Group, Inc., 187
Cleveland Clinic Foundation, 42.00
Cleveland FES Center, 43.00, 44.00, 45.00
Cleveland VA Medical Center, 43.00
Colon and Rectal Surgical Associates, Ltd., 26.00
Commission on the Accreditation of Rehabilitation
Facilities, 78
Consortium of Multiple Sclerosis Centers, 180
Cornell Medical Center, 38.00
-0
Dallas Rehabilitation Institute - HealthSouth, 52.00
Dalzell USA Medical Systems, 187
Detroit Medical Center, 24.00
Dobelle Institute, 186
Duke of Cornwall Spinal Injured Centre, 103.00
Duke of Cornwall Spinal Treatment Centre, 104.00
Dynatronics, 187
-F
FES Centre, 62.00
FES Information Center, 46
Finetech Limited, 188
Flower Hospital! Rehabilitation Center, 49.00
Food and Drug Administration, 8, 55,181
Free University Hospital, 89.00
- G
G.F. Strong Centre, 74.00
Good Samaritan Hospital, 41.00
Grand Valley State University School of Health
Sciences, 22.00
Grass Instrument Company, 188
-HHampstead Centre Spinal Injuries Clinic, 61.00
HealthSouth Rehabilitation Hospital of Greater
Pittsburgh, 50.00
Help Them Walk Again Foundation, Inc., 33.00
Henley International Inc, 188
Hines VA Hospital, Rehabilitation R&D Center,
15.00
Hope Hospital, 102.00
Hospital Das Clinicas Da Faculdade de Medicina,
69.00
Hospital Geral St Antonio, 93.00
Hospital Juan Canalejo, 99.00
Hunter Holmes McGuire VA Medical Center, 57.00
-I
IEEE Engineering in Medicine and Biology Society,
183
Illinois Institute of Technology, 14.00
Immanuel Rehabilitation Center, 32.00
Institut Guttmann, 98.00
International FES Society, 184
International Neuromodulation Society, 184
International Therapeutic Technology, 97.00
ITIS d.o.o. Ljubljana, 94.00
"."...-~
. - -.......
--~.--
...-
-...... -
INDEX
205
-0
Ohio State University, 46.00
Osaka Rosai Hospital, 87.00
- p
Paralyzed Veterans of America, 182
PEERS Program, 1.00
Petrofsky Center for Rehabilitation and Research,
2.00
Pritzker Institute of Medical Engineering, 14.00
Public Hospital, 85.00
-8
S.M.1. Center for Sensory-Motor Interaction, 76.00
Sendai FES Project, 88.00
Shake-a-Leg FES Research Program, 63.00
Shepherd Center, 12.00
Shriners Hospitals Philadelphia Unit, 51.00
Sigmedics Inc., 190
Sinties Scientific, Inc., 190
Society for Physical Regulation in Biology and
Medicine, 185
Southwest Fertility Center, 54.00
Spinal Cord Injury Hotline, 182
S1. Francis Health Care Centre, 48.00
Strong Memorial Hospital, 39.00
Staodyn, Inc., 190
Stimtech Products Inc., 190
Stimwear, Inc., 190
Stratec Electronic, 190
-T
TherapeutiC Alliances, Inc., 190
Therapeutic Technologies, Inc, 190
------------------------------------------------------------------------------------------~
206
5.00
Veterans Administration - St. Louis, 31.00
Veterans Affairs Rehabilitation Research and
Development Service, 185
Vienna Working Group FES, 66.00
1stEdition
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