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Exoskeleton

Exoskeleton Mobility Training for Stroke

N/A
Waitlist Available
Led By Arun Jayaraman, PT, PhD
Research Sponsored by Shirley Ryan AbilityLab
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must have sufficient upper extremity strength and balance to allow ambulation with device
Subjects must be between 18-85 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up session 1 (pre test, initial visit), session 12 (week 4), session 22 (week 7), session 10 (post test, 10 weeks) and session 33 (3 month follow-up visit)
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of the Ekso robotic exoskeleton for people who have had a severe stroke. The primary objectives are to see if the exoskeleton can help improve walking speed and function, and if it is more effective than traditional rehabilitation. Secondary objectives are to see if the exoskeleton can improve functional endurance, balance, and stroke recovery.

Who is the study for?
This trial is for individuals aged 18-85 who have had a severe stroke. They must be able to stand for 30 minutes, fit into the exoskeleton device, and have enough upper body strength to use it. Walking speed should be less than 0.4m/s. Participants need a mental status score above 17, medical clearance, and the ability to follow study procedures.Check my eligibility
What is being tested?
The study tests if high-dose training with an Ekso robotic exoskeleton helps people recover walking abilities after a severe stroke better than traditional rehab programs. It looks at how timing and severity of strokes affect recovery and whether improvements last with continued training or traditional rehab.See study design
What are the potential side effects?
Potential side effects may include discomfort from wearing the exoskeleton, skin issues where the device fits on the body, muscle fatigue due to intensive training sessions, joint pain or strain from repeated movements during rehabilitation exercises.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can walk using a device thanks to my arm strength and balance.
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I am between 18 and 85 years old.
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I can fit into and move around using a medical device designed for walking.
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I can stand upright for 30 minutes without assistance.
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I walk slower than 0.4 meters per second or cannot walk.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~session 1 (pre test, initial visit), session 12 (week 4), session 22 (week 7), session 10 (post test, 10 weeks) and session 33 (3 month follow-up visit)
This trial's timeline: 3 weeks for screening, Varies for treatment, and session 1 (pre test, initial visit), session 12 (week 4), session 22 (week 7), session 10 (post test, 10 weeks) and session 33 (3 month follow-up visit) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in 10 Meter Walk Test
Change in 6 Minute Walk Test With VO2 Analysis
Secondary outcome measures
Change in 5 Times Sit to Stand Test
Change in Activities Specific Balance Confidence Scale
Change in Berg Balance Scale
+15 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Ekso Training Safety and EfficacyExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

U.S. Department of EducationFED
86 Previous Clinical Trials
54,672 Total Patients Enrolled
7 Trials studying Stroke
904 Patients Enrolled for Stroke
Shirley Ryan AbilityLabLead Sponsor
192 Previous Clinical Trials
14,825 Total Patients Enrolled
69 Trials studying Stroke
6,285 Patients Enrolled for Stroke
Arun Jayaraman, PT, PhDPrincipal InvestigatorShirley Ryan AbilityLab
22 Previous Clinical Trials
2,842 Total Patients Enrolled
9 Trials studying Stroke
1,492 Patients Enrolled for Stroke

Media Library

Ekso exoskeleton (Exoskeleton) Clinical Trial Eligibility Overview. Trial Name: NCT02128152 — N/A
Stroke Research Study Groups: Ekso Training Safety and Efficacy
Stroke Clinical Trial 2023: Ekso exoskeleton Highlights & Side Effects. Trial Name: NCT02128152 — N/A
Ekso exoskeleton (Exoskeleton) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02128152 — N/A

Frequently Asked Questions

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

Who else is applying?

What state do they live in?
New Jersey
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Mobility Training Using Exoskeletons for Functional Recovery After Stroke
Arun Jayaraman, PT, PhD 2014. "Mobility Training Using Exoskeletons for Functional Recovery After Stroke". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02128152.
~3 spots leftby Dec 2024
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