Status:
NOT_YET_RECRUITING
Clinical Efficacy of Exoskeleton Assistance for Individuals Post-Stroke
Lead Sponsor:
Georgia Institute of Technology
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Stroke
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
An exoskeleton device is a robotic system designed to improve an individual's ability to move and perform tasks encountered in everyday situations. These devices consist of external rigid limb segment...
Detailed Description
Participants will serve as their own control in this study. This study will be divided into 2 sessions that will occur on 2 separate days: 1) Hip Exoskeleton session and 2) Ankle Exoskeleton session. ...
Eligibility Criteria
Inclusion
- Between 18-85 years of age
- Stroke at least 6 months prior to study involvement
- Community dwelling (participant does not live in an assisted living facility)
- Able to provide informed consent to participate in the study activities
- Can safely participate in the study activities (per self-report)
- Must have a Functional Ambulation Category (FAC) score of 3 or above (the participant can walk without the assistance of another person)
Exclusion
- Requires a walker to walk independently
- Has a shuffling gait pattern overground
- Has a Functional Ambulation Category (FAC) score of 2 or lower (the participant requires the assistance of another person in order to walk)
- Has a significant secondary deficit beyond stroke (e.g. amputation, legal blindness or other severe impairment or condition) that in the opinion of the Principal Investigator (PI), would likely affect the study outcome or confound the results
- For exoskeleton-only studies, the exoskeleton device does not fit appropriately or safely, as determined by the research team during the fitting assessment.
Key Trial Info
Start Date :
January 1 2027
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06064604
Start Date
January 1 2027
End Date
December 31 2028
Last Update
November 26 2025
Active Locations (1)
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1
Exoskeleton and Prosthetic Intelligent Controls Lab
Atlanta, Georgia, United States, 30332