Stroke Clinical Trial
— POETSOfficial title:
Use of a Powered Orthotic Exoskeleton to Promote Mobility Through Improved Squat, Knee Flexion and Loading of the Paretic Leg in Persons With Chronic Stroke
Verified date | October 2023 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 20 |
Est. completion date | June 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 89 Years |
Eligibility | 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 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 device or walking (e.g., cardiovascular disorders, pressure ulcers, open wounds, lower limb vascular disorders, or other medical conditions); and - Pregnant or planning to become pregnant (Females only). |
Country | Name | City | State |
---|---|---|---|
United States | James J. Peters VA Medical Center, Bronx, NY | Bronx | New York |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Five Times Sit to Stand Test (5xSTS) | The 5xSTS is used to determine leg power and an aspect of transfer skill. This test will be used to assess a level of improved function while wearing the device. | Change from Baseline after completing 36 training sessions (approximately 3 months time) | |
Secondary | Ratio of stance time of each limb during ambulation | Stepping parameters will be assessed using an instrumented carpet to determine if the paretic limb has more equitable and symmetrical load. | Change from Baseline after completing 36 training sessions (approximately 3 months time) | |
Secondary | energy expenditure | A portable metabolic cart will assess oxygen consumption during the two ambulation conditions (i.e., with and without the device) over a 6-minute period. | Change from Baseline after completing 36 training sessions (approximately 3 months time) |
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