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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 below
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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 weeks
Treatment ~ Varies
Follow Up ~change from baseline within-brain functional connectivity at 10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline within-brain functional connectivity at 10 weeks for reporting.

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 more

RE-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
173 Previous Clinical Trials
10,633 Total Patients Enrolled
Soha Saleh, PhDPrincipal InvestigatorKessler Foundation
1 Previous Clinical Trials
19 Total Patients Enrolled
Karen J. Nolan, PhDPrincipal InvestigatorKessler Foundation

Media Library

EksoGT™ (Exoskeleton) Clinical Trial Eligibility Overview. Trial Name: NCT04309305 — Phase 1
Hemiplegic Gait Research Study Groups: Stroke RE, Stroke SOC, Healthy Control
Hemiplegic Gait Clinical Trial 2023: EksoGT™ Highlights & Side Effects. Trial Name: NCT04309305 — Phase 1
EksoGT™ (Exoskeleton) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04309305 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it feasible for me to partake in this clinical experiment?

"This investigation seeks 75 individuals, aged between 21 and 80 who are suffering from hemiplegic gait. Other prerequisites for inclusion include: stroke survivors < 4 weeks since the last episode, unilateral weakness in their limbs, adequate strength to use a hemiwalker or similar device with the exoskeleton on, no past injury/pathology of the unaffected side, physical stature within specified parameters (height below 60 inches or above 76 inches; weight higher than 220 lbs), doctor's approval that they can fit into the robotic suit as well as joint range of motion meeting usual functional limits."

Answered by AI

Is this clinical trial inclusive of people aged 30 or older?

"The guidelines for this clinical trial state that those hoping to take part must fall within the age range of 21 to 80 years old. Moreover, there are 4 studies available for minors and a different 70 trials designated towards seniors."

Answered by AI

Has the FDA sanctioned EksoGT™, manufactured by Ekso Bionics in Berkley, CA?

"EksoGT™, produced by Ekso Bionics in Berkley, CA, USA is still undergoing its initial clinical trial. Thus far limited data exists supporting the safety and efficacy of this product; it has been given a score of 1 on our scale from 1 to 3."

Answered by AI

Is this experiment still recruiting participants?

"This investigation, initially published on the 30th of January 2020, is not presently recruiting participants. The trial was most recently modified on October 15th 2021 but there are 72 other studies which are currently receiving applicants."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Robotic Exoskeleton Assisted Gait Post Stroke
Karen J. Nolan, PhD 2020. "Robotic Exoskeleton Assisted Gait Post Stroke". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04309305.
~0 spots leftby May 2024
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