Last updated: May 3, 2023
Sponsor: Kessler Foundation
Overall Status: Active - Recruiting
Phase
1
Condition
Spinal Cord Injuries
Treatment
MyoMo orthosis and VR games
MyoPro robot only
Games only
Clinical Study ID
NCT05386537
D-1113-20
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Be between the ages of 18-80
- Be able to activate the muscles of my upper arm and forearm with enough strength asdetermined by the therapist.
- Be diagnosed with a spinal cord injury (iSCI (ASIA Impairment Scale (AIS) C and D) andbe 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 thestudy 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 withoutexcessive fatigue
- Have full passive range of motion at my elbow, as determined by study staff
Exclusion
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 inrehabilitation
- 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 thestudy device. Examples of these conditions include: severe sensory deficits, skinconditions, joint contractures, etc.
- Have difficulty following multiple step directions
- Have severe psychiatric problems or difficulty thinking clearly that would prevent mefrom 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 orsevere hearing problems.
- Be taking any drugs that would increase my risk of having a seizure while undergoingbrain stimulation. Study staff and physician will review my medications to see if I amtaking any of these drugs. If I am taking one of these drugs, I will not be enrolledin this study.
- Because of potential risk to the fetus, women of child-bearing potential will berequired to have a pregnancy test before they can enroll in this study. If I amfemale, and have a positive pregnancy test, I will not be enrolled.
Study Design
Total Participants: 20
Treatment Group(s): 4
Primary Treatment: MyoMo orthosis and VR games
Phase: 1
Study Start date:
April 01, 2021
Estimated Completion Date:
October 01, 2024
Connect with a study center
Kessler Foundation
West Orange, New Jersey 07052
United StatesActive - Recruiting
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