Powered Orthotic Exoskeleton for Stroke
(POETS Trial)

Recruiting in Palo Alto (17 mi)

Overseen byAnn M Spungen, EdD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: VA Office of Research and Development

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

Veterans who suffer strokes often have disturbances in the ability to walk that reduces independence and quality of life. Alterations in gait combined with general decreased activity are associated with reduced muscle strength of the paretic leg. This leads to cardiovascular deconditioning and reduced quality of life. There is a new and novel battery powered device (Keeogo powered orthotic exoskeleton) that uses motors that assist knee movement while walking, sitting down, and standing up. The Keeogo monitors hip movement to assist the knee, making it simple to learn how to use. If successful, this project will show how this device will help improve the ability to walk and provide evidence to support larger clinical trials in a home and community setting to improve mobility, increase muscle mass and strength in the legs, as well as improve general health and quality of life. Lastly, this device could be used to increase motivation and confidence in a person to walk for longer periods of time and distance, providing the ability to walk in places that were previously inaccessible.

Research Team

Ann M Spungen, EdD

Principal Investigator

James J. Peters Veterans Affairs Medical Center

Eligibility Criteria

This trial is for adults aged 18-89 who have had a stroke at least 6 months ago, resulting in difficulty walking due to leg weakness or stiffness. Participants should be able to walk slowly but want to improve their mobility and commit to the study requirements. They must weigh under 250lbs and not have severe spasticity, certain range of motion limitations, or conditions that would make using the exoskeleton unsafe.

Inclusion Criteria

I can walk at a slow to moderate pace.

I have weakness or paralysis on one side of my body due to a stroke that occurred over 6 months ago.

I have had partial or full paralysis on one side of my body due to a stroke that occurred over 6 months ago.

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Exclusion Criteria

My lower thigh circumference is either below 27 cm or above 40 cm.

Your body size doesn't match the size of the device.

My calf circumference is either below 33 cm or above 49 cm.

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Treatment Details

Interventions

Ambulation training (Behavioural Intervention)
Keeogo (Powered Orthotic Exoskeleton)

Trial OverviewThe Keeogo powered orthotic exoskeleton is being tested for its ability to assist with knee movement during walking, sitting down, and standing up in individuals affected by stroke. The device aims to improve walking ability, muscle strength, general health, motivation for increased activity levels and access previously inaccessible places.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Powered Orthotic Exoskeleton Training GroupExperimental Treatment2 Interventions

Participant in 36 session ambulation training using a powered orthotic exoskeleton.

Group II: Control GroupActive Control1 Intervention

Participant in 36 session ambulation training without using a powered orthotic exoskeleton.

Keeogo is already approved in Canada for the following indications: