Stroke Clinical Trial
Official title:
TREAT Foot Drop After Stroke With Ankle Robot
Researchers at the University of Maryland Rehabilitation and Orthopaedic Institute are
looking for individuals who have suffered a stroke and have leg and ankle weakness
(foot-drop), to participate in a pilot study to examine the safety and effectiveness of an
ankle robot walking program on walking function
This is the first in human test of walking training over-ground using a wearable,
lightweight, battery operated ankle robot exoskeleton; with assistance by trained research
personnel for safety. This exercise device is aimed at assisting the foot during walking to
reduce foot drop and improve walking safety in chronic, mild to moderately impaired stroke
survivors who have foot drop.
Possible risks of participating in this study are described in this document. The greatest
risks include the risk of falling, muscle soreness, skin irritation, or cardiovascular
complications. Before starting, you will have a medical history and medical assessments
performed to determine if this study is safe for you. All sessions will be assisted by
trained research personnel under supervision of a physical therapist, with medical personnel
locally on call.
This study is designed to see if the ankle robot is safe and effective to use in restoring
gait function in individuals with foot drop.
This research project will be conducted at the University of Maryland Rehabilitation and
Orthopaedic Institute (UM Rehab). There will be approximately 10 individuals from the
Baltimore, Maryland area recruited to voluntarily participate in this study.
If you take part in this research, you will be asked:
- To participate in this study for approximately 10 weeks total.
- Attend at least 6 ankle robot gait training sessions that will last 45-60 minutes each
session, 3 times a week for 2 weeks at UM Rehab.
- Undergo a medical and neurological evaluation at screening.
- Perform balance and walking tests with and without your usual assistive walking device.
- Walk on a treadmill with the ankle robot on your foot.
- Report to the research team any changes to assistive walking device usage between
training sessions, and any health-related issues or changes.
- Maintain your current medications at their current doses and schedules throughout this
study, or inform the study physician about any medication changes.
- Not to participate in any other study that would affect our results.
- You will be seated and fitted with the ankle robot before each testing visit and each
gait training session. During the fitting process, the ankle robot will be secured to
the stroke affected lower leg using a modified shin guard that has Velcro straps.
Regular shoes will be worn. The "shoe covered" affected foot will be inserted into a
modified slipper. Comfort and fit will be noted. Should you have any discomfort or
feeling like the ankle robot device is rubbing on skin, padding will be applied to
protect the skin.
- A gait belt will be worn around the waist and research staff will use this belt to
provide support, and to protect against falls during the balance/walking tests and
during ankle robot gait training sessions.
- Gait training sessions will be conducted with usual assistive devices for balance and
with the ankle robot turned on and turned off.
- The research team will periodically collect heart rate and blood pressure measurements
to determine how hard you are working during various tasks. You will be asked how you
feel while performing these tasks. Researchers will use this information to guide the
gait training program.
Tests will be completed at 3 points: baseline (before beginning training), after the 2-week
gait training program, and then 6 weeks after the program.
- 3 tests of balance, mobility and gait.
- Timed walking tests (10 meter and 6-minute walks) to determine functional capacity with
and without assistive walking devices, and with the ankle robot both turned on and
turned off.
- Walking on a treadmill (wearing a safety harness) to assess walking patterns while
wearing the ankle robot both turned on and turned off.
- Walking stability tests while wearing the ankle robot device both turned on and turned
off. Usual assistive walking devices (cane or walker) will be used, if necessary. The
testing tasks will be performed with and without your ankle foot orthosis, if one is
worn.
In some instances, if sessions are canceled due to personal or other uncontrollable factors,
time in the study may exceed 10 weeks. We do not expect time commitments to exceed 14 weeks.
If there are medical or other reasons that require time away from the study for more than one
month, baseline tests will be repeated, and training will resume starting at session #1.
The investigator will ask if data can be collected from your routine medical care. If agreed
upon, this data will be handled the same as research data.
If granted permission, we will photograph/videotape training sessions and test visits, to
provide feedback on progress during the study.
There is an option to allow these photographs/recordings to be kept by the research team for
use in future presentations (slideshows, conferences, etc.) and to educate others about this
research study.
POTENTIAL RISKS/DISCOMFORTS:
This study exposes you to several risks:
- Skin irritation: There is a risk that wearing the ankle robot may cause skin irritation
with repeated ankle movements. The research team will check skin before and after each
training session for signs of skin redness or irritation. Foam padding will be used to
provide protection to skin if needed. The padding will be adjusted if any discomfort
develops during any training visits or testing sessions.
- Fall risk: Falls could occur during the gait training, balance or walking tests. We will
reduce the likelihood of falling by having 2 research team members present at all
sessions. One team member (spotter) will walk behind you providing support by holding
onto the gait belt worn around the waist. The other team member will assist the spotter
and will monitor the room for potential trip hazards. A safety harness will be worn to
protect against falls during walking tests performed on the treadmill.
- Muscle discomfort: Muscle soreness may be experienced. This risk is greatest during the
early stages of this study before familiarization with the study-related activities. We
will monitor muscle soreness during and between sessions. We will address muscle
soreness by adjusting training by providing more frequent or longer rest breaks. Muscle
soreness will also be addressed by applying ice to sore muscles and teaching appropriate
stretching exercises.
- Joint pain: There is a very slight risk that the robot could move the foot in the wrong
direction, causing joint discomfort. This is extremely unlikely, as maximal force
outputs by the robot are not sufficient to cause injury to a muscle, tendon, or
ligament. Further protection is provided by fail-safe switches that quickly turn the
robot off in 2 milliseconds. An engineer technician will perform service checks
(calibration and operational) to the robot device before and after each session. We will
address joint soreness by adjusting training by providing more frequent or longer rest
breaks. Joint soreness will also be addressed by applying ice to sore regions.
- Cardiac risks: This ankle robot training program is considered low intensity exercise.
Exercise training can be associated with the risk of cardiovascular complications such
as chest pain, heart attack, or sudden death and complications related to stress and
strains of muscles, twisted ankles, or falls. This risk is increased in people who have
heart disease, poor circulation to the legs, or stroke. The risk of heart attack in
these people is one in 300,000 hours of exercise, and risk of death is one in 800,000
hours of exercise.
- To minimize this risk, you will first undergo a medical evaluation. All walking training
sessions will be supervised by personnel trained in cardiopulmonary resuscitation (CPR),
and a clinical provider will be on call. Heart rate and blood pressure will be assessed
by trained study team members before and after each training session or more frequently,
if indicated.
- If blood pressure or heart rate go too high or an irregular heart rate, chest pain, or
leg cramps develop, the training session will be stopped immediately. An AED (automatic
external defibrillator) is available on site. A "rapid response" medical team will be
contacted if a medical emergency occurs during a session. This team will evaluate a
participant's condition and determine if they should be transported to the nearest
hospital. Heart rate and blood pressure will be periodically monitored during each
session. Instructions about warning signs of cardiac events will be given (for example:
chest pain, shortness of breath, lightheadedness, and pain in the arms) and reminded
about these symptoms during the study.
- Privacy and confidentiality: Research staff will collect personal information during
this study. This information will be protected, however, we cannot be assured of
absolute privacy. This data will be kept locked in the Rehabilitation Research Center at
the University of Maryland Rehabilitation and Orthopaedic Institute (UM Rehab). Personal
data (name, address, and other identifiers) will remain strictly confidential. Data will
be coded to protect privacy. This coded data will be used in scientific publications and
presentations, and will not be personally identified. The risk of loss confidentiality
will be minimized by storing data, photos, and any recorded imaging in a secure location
in a locked office within a locked cabinet, with access restricted to research staff.
- Unknown risks: In addition to the risks described in this form, there may be unknown
mild risks/discomforts involved in participating in this study. The research staff will
update you on any new information that may affect health, welfare, or decision to stay
in the study.
POTENTIAL BENEFITS
There is no guarantee that a direct benefit from participation in this study will be
received. Participation may help in the development of new robotic therapies for persons with
foot drop, and to learn more about how to identify those who can successfully use this
robotic approach to address their foot drop.
ALTERNATIVES TO PARTICIPATION
Participation is voluntary, and the alternative is not to participate. Conventional therapy
may be an alternative to taking part in this study.
COSTS TO PARTICIPANTS
There will be no uncovered research-related costs. If you are injured because of study
participation, you will receive emergency medical care if needed, and assistance in getting
other medical care as needed. You or your carrier will be billed for the cost of care, just
as you would be billed for any other medical care. It is not the University's policy to pay
compensation to research subjects for injuries resulting from a study. The study staff can
give more information about this if there is a study injury. Legal compensation for any
injury that may occur during the study as a result of an error by a member of the research
staff or by the sponsor may be sought.
RIGHT TO WITHDRAW
Participation in this study is voluntary. You are free to withdraw their consent at any time.
Refusal to take part or to stop taking part in the study will involve no penalty or loss of
benefits to which they are otherwise entitled. There are no other adverse consequences
(physical, social, economic, legal, or psychological), if choosing to withdraw from the
research.
REMOVAL FROM RESEARCH
The investigator or sponsor can decide to withdraw you from the study at any time without
your approval. Removal from the study can be for reasons related solely to you, for example,
not following study-related directions to related to research participation, a new treatment
becomes available for foot drop, or a new medical illness occurs. Also, the research study
may be stopped by the sponsor, the Investigator, or the Institutional Review Board. The
research staff will discuss all details of a study withdrawal or the study closure with
participants. Questions can be asked, should this happen. The sponsor may also decide to stop
the Investigator's participation in the study. In that case, participation will end unless
another investigator is identified and approved by the sponsor and the Institutional Review
Board. Any significant new findings which develop during the study which may affect your
willingness to participate in the study will be given.
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