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Powered Orthotic Exoskeleton

Powered Orthotic Exoskeleton for Stroke (POETS Trial)

N/A

Waitlist Available

Led By Ann M Spungen, EdD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to walk between 0.15-0.75m/s

Hemiplegia or hemiparesis due to stroke (>6 months);

Must not have

Lower thigh circumference less than 27 cm or greater than 40 cm

Calf circumference less than 33 cm or greater than 49 cm

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline after completing 36 training sessions (approximately 3 months time)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new battery-powered device, called the Keeogo, which is worn around the legs and helps with knee movement, sitting, and standing. The device is easy to use and could help improve the ability to walk, muscle mass and strength, and quality of life.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

While specific side effects are not listed here, potential risks may include discomfort from wearing the device, skin irritation where it contacts the body or strain from unfamiliar movements. Any unexpected reactions will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can walk at a slow to moderate pace.

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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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I have difficulty moving or walking because of stiffness and limited movement in my knee.

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I am between 18 and 89 years old.

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I have difficulty moving or walking because of stiffness and limited movement in my knee.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

Select...

I cannot stand or walk due to paralysis.

Select...

My ankle circumference is either below 27 cm or above 40 cm.

Select...

I have stiff joints in my legs that limit my ability to move or sit.

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My upper thigh circumference is either below 55 cm or above 75 cm.

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I can walk at a normal speed or faster.

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My waist is either under 71 cm or over 107 cm.

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My femur length is either below 36 cm or above 45 cm.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline after completing 36 training sessions (approximately 3 months time)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline after completing 36 training sessions (approximately 3 months time)

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline after completing 36 training sessions (approximately 3 months time) for reporting.