Combining Wearable Robotic Orthosis With Visual and Haptic Feedback to Enhance the Recovery of Up… (NCT05386537) | Clinical Trial Compass
UnknownEarly Phase 1
Combining Wearable Robotic Orthosis With Visual and Haptic Feedback to Enhance the Recovery of Upper Extremity Motor Function and ADL in Persons With Acute SCI
United States20 participantsStarted 2021-04-01
Plain-language summary
This randomized clinical trial (RCT) is evaluating the usefulness of combining MyoMo robotic orthosis with visual and haptic feedback in ameliorating wrist/hand/UE movement capability, and increasing ADL and quality of life in people with acute SCI.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Be between the ages of 18-80
* Be able to activate the muscles of my upper arm and forearm with enough strength as determined by the therapist.
* Be diagnosed with a spinal cord injury (iSCI (ASIA Impairment Scale (AIS) C and D) and be less than 3 months post initial injury at the start of the study
* Be medically stable
* Be able to follow study directions and communicate in English as determined by the study staff
* Continue to take all prescribed medication (example: baclofen: oral or via pump) without any major dosing changes
* Be able to tolerate functional tasks for 60min with intermittent rests without excessive fatigue
* Have full passive range of motion at my elbow, as determined by study staff
Exclusion Criteria:
* Be younger than 18 years old or older than 80
* Have excessive pain in my arm or hand that would limit my participation in rehabilitation
* Have excessive spasticity in my elbow or wrist joints as determined by study staff
* Be participating in any experimental rehabilitation or drug studies
* Have a history of neurologic disorder other than spinal cord injury
* Have other conditions that would prevent safe and/or effective participation using the study device. Examples of these conditions include: severe sensory deficits, skin conditions, joint contractures, etc.
* Have difficulty following multiple step directions
* Have severe psychiatric problems or difficulty thinking clearly that would prevent me from participating in this s…