Status:
UNKNOWN
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
Lead Sponsor:
Kessler Foundation
Conditions:
SCI - Spinal Cord Injury
Eligibility:
All Genders
18-80 years
Phase:
EARLY_PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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 study
- Have skin issues that would prevent wearing the Myo-Pro device
- Have had history of recurrent epilepsy, seizure or convulsion
- Have a past or current history of treated ringing in the ears known as tinnitus or severe hearing problems.
- Be taking any drugs that would increase my risk of having a seizure while undergoing brain stimulation. Study staff and physician will review my medications to see if I am taking any of these drugs. If I am taking one of these drugs, I will not be enrolled in this study.
- Because of potential risk to the fetus, women of child-bearing potential will be required to have a pregnancy test before they can enroll in this study. If I am female, and have a positive pregnancy test, I will not be enrolled.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05386537
Start Date
April 1 2021
End Date
October 1 2024
Last Update
May 6 2023
Active Locations (1)
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1
Kessler Foundation
West Orange, New Jersey, United States, 07052