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Exoskeleton
Robotic Exoskeleton-Assisted Gait Training for Stroke Recovery (RE-Assist Trial)
Phase 1
Waitlist Available
Led By Soha Saleh, PhD
Research Sponsored by Kessler Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Physically fit within the RE: Height below 60" or above 76" and weight above 220 lbs.
Adequate cognitive function to give informed consent, understand the training, instructions, use investigational devices and give adequate feedback
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline 6mwt at 10 weeks
Awards & highlights
RE-Assist Trial Summary
This trial is testing a new way to help people with spinal cord injuries learn to walk again, using a machine to assist them.
Who is the study for?
This trial is for stroke survivors aged 21-80, within 4 weeks post-stroke, who can understand instructions and use an exoskeleton device. They must fit certain height (below 60" or above 76") and weight (above 220 lbs) requirements, have unilateral hemiparesis, normal limb range of motion for walking with assistive devices, and no severe cognitive issues. Excluded are those with recent heart issues, uncontrolled conditions affecting movement or full weight bearing ability, skin problems preventing device wear, exercise intolerance due to pre-existing conditions like severe cardiac disease or metal implants not MRI-compatible.Check my eligibility
What is being tested?
The study tests the EksoGT™ robotic exoskeleton's effectiveness in aiding gait rehabilitation post-stroke compared to standard care without intervention. It aims to leverage neuroplasticity through massed practice using the exoskeleton for potential improvements in independent walking abilities.See study design
What are the potential side effects?
While specific side effects aren't listed for this type of physical therapy aid, possible risks may include discomfort while wearing the device, skin irritation at contact points with the exoskeleton, muscle fatigue from training sessions and potential falls during use.
RE-Assist Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can understand and follow study instructions and provide feedback.
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My other limb has no injuries or diseases.
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I can physically fit into the exoskeleton device.
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I can follow directions and communicate in English well enough for rehabilitation.
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I am between 21 and 80 years old.
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I have weakness on one side of my body.
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I can move my joints well enough to walk.
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I can use a walking aid like a cane or walker effectively.
RE-Assist Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline within-brain functional connectivity at 10 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline within-brain functional connectivity at 10 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
10MWT (aims 1-3)
6MWT (aims 1-3)
Functional Independence Measure (FIM) (aim 1)
+6 moreRE-Assist Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Stroke REExperimental Treatment1 Intervention
After discharge from the acute rehabilitation facility, participants in the stroke RE group will participate 3 days a week for 10 weeks in robotic exoskeleton gait training provided by a trained, licensed physical therapist. Participants will be permitted to participate in additional prescribed standard physical therapy on their own.
Group II: Healthy ControlExperimental Treatment1 Intervention
Participants in the healthy control group will not participate in any gait training. Healthy control participants will only be asked to complete 3 testing sessions.
Group III: Stroke SOCActive Control1 Intervention
After discharge from the acute rehabilitation facility, participants in the stroke SOC group will participate 3 days a week for 10 weeks in standard of care gait training provided by a licensed physical therapist. Participants will be permitted to participate in additional prescribed standard physical therapy on their own.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Kessler FoundationLead Sponsor
174 Previous Clinical Trials
10,663 Total Patients Enrolled
Soha Saleh, PhDPrincipal InvestigatorKessler Foundation
1 Previous Clinical Trials
19 Total Patients Enrolled
Karen J. Nolan, PhDPrincipal InvestigatorKessler Foundation
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not been hospitalized for a heart attack, surgery, or acute failure in the last 3 months.If you have serious memory or thinking problems, or have trouble controlling your bladder, you may not be able to start training with a RE.I have a condition like Parkinson's or MS that affects my movement or walking.I can understand and follow study instructions and provide feedback.My other limb has no injuries or diseases.I have had serious heart problems like a heart attack or heart failure.I do not have any bone or joint problems that affect my ability to walk or move my legs.I had a stroke less than 4 weeks ago.I have severe muscle stiffness or joint issues that affect my ability to walk, even with help.You have metal implants that cannot be used in an MRI.I can physically fit into the exoskeleton device.I have seizures that are not controlled by medication.I do not have skin conditions that would stop me from wearing a device.I have a heart condition that makes it hard for me to exercise.I can follow directions and communicate in English well enough for rehabilitation.I am between 21 and 80 years old.I have weakness on one side of my body.I can move my joints well enough to walk.I can use a walking aid like a cane or walker effectively.I cannot fully bear weight or walk due to a medical issue.
Research Study Groups:
This trial has the following groups:- Group 1: Stroke RE
- Group 2: Stroke SOC
- Group 3: Healthy Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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