Clinical Efficacy of Exoskeleton Assistance for Individuals Post-Stroke

Starting soon · Not applicable

Conditions studied: Stroke

In brief

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 segments that assists humans through different body movements with the use of actuators. These devices are controlled by an onboard computer that determines the timing and magnitude of assistance deployed to the user. Exoskeleton controller performance is key to providing beneficial assistance that does not inhibit the user's movement. Preceding work will compare the benefit of personalized hip versus ankle joint exoskeleton assistance for improvement of post-stroke gait. It will combine exoskeleton technology with the user's movement feedback to improve wearable robotic assistance to an individual stroke survivor's gait pattern. For the clinical trial research covered under this protocol, the investigator will test various exoskeleton technologies with stroke survivors in real-world contexts, indoors and outdoors, and measure clinically meaningful outcomes and user perceptions regarding technology usability and adoption. The long-term goal is to deploy self-adaptive, adoptable exoskeletons for personalized assistance during community ambulation.

Key facts

Study ID

NCT06064604

Run by

Georgia Institute of Technology

People needed

20

Starts

2027-01-01

Expected to finish

2028-12-31

Last updated by the study team

2025-11-26

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Exoskeleton and Prosthetic Intelligent Controls Lab — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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