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

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

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.

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 States

    Active - Recruiting

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