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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

Recruiting
18 - 80 years of age
Both
Phase N/A

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Overview

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

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 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.

Study details

SCI - Spinal Cord Injury

NCT05386537

Kessler Foundation

25 January 2024

Step 1 Get in touch with the nearest study center
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  • You can expect the study team to contact you via email or phone in the next few days.
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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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