Powered Orthotic Exoskeleton Training in Stroke (NCT04241848) | Clinical Trial Compass
CompletedNot Applicable
Powered Orthotic Exoskeleton Training in Stroke
United States22 participantsStarted 2020-11-02
Plain-language summary
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.
Who can participate
Age range
18 Years – 89 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Males and female between 18 and 89 years old;
* Hemiplegia or hemiparesis due to stroke (\>6 months);
* \[Able to walk between 0.15-0.75m/s\]
* Self-reported limitations to mobility and walking activities due to paretic side knee stiffness and loss of range of motion;
* Weight under 250lbs
* Desire to increase daily activity levels; and
* Able and willing to commit to participation and follow directions and communicate basic needs.
Exclusion Criteria:
* Neurological paralysis causing an inability to stand, weight bear or take stepping movements;
* Fixed contractures resulting in limited range of motion in the hip, knees, or ankles that prevent sitting, standing, walking, and/or squatting activities;
* Modified Ashworth Scale for spasticity greater than 3 in the lower limbs
* Able to walk at a normal walking speed (1.4 m/s, 3.2 mph) or better during the Six Minute Walk Test (6MWT)
* Anthropometric incompatibility with the device
* Femur length less than 36 cm or greater than 45 cm;
* Upper thigh circumference less than 55 cm or greater than 75 cm;
* Lower thigh circumference less than 27 cm or greater than 40 cm;
* Calf circumference less than 33 cm or greater than 49 cm;
* Ankle circumference less than 27 cm or greater than 40 cm;
* Shin length less than 26 cm;
* Waist circumference less than 71 cm or greater than 107 cm;
* Any medical complication or co-morbidity as judged by the study physician to be contraindicated for wearing the de…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Five Times Sit to Stand Test (5xSTS)
Timeframe: Change from Baseline after completing 36 training sessions (approximately three months time)