Using powered wearable orthotics to improve arm function in people with spinal cord injuries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of a powered upper extremity assistive device called MyoPro in enhancing upper extremity function and activities of daily living (ADL) in individuals with incomplete spinal cord injuries. The study aims to assess how well this device can assist with wrist, hand, and upper extremity movement capabilities, ultimately improving the quality of life for participants. The MyoPro orthosis utilizes built-in motors activated by the user's intended muscle movements, detected through sensors, to provide support. The research is supported by the Department of Defense and seeks to advance the application of orthotic technologies in rehabilitation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Be between ages 18-80
* Be able to activate certain muscles in my arm and forearm on my own a sufficient amount as measured by EMG amplitude. This will be determined by the study OT/PT.
* Be diagnosed with spinal cord injury (SCI) with level C1-C8 and ASIA Impairment Scale (AIS) C or D, as determined by study staff. If I have not had an exam to determine my injury level and impairment scale recently, I may participate in an examination of my sensation and strength in my arms, legs, trunk and rectum as was done in the hospital soon after my injury.
* Be at least 1-year post injury
* Have sufficient ability to move my shoulder (active shoulder flexion of 30 degrees and active shoulder abduction 20 degrees), as determined by study staff
* Be medically stable
* Have sufficient learning and memory abilities and abilities to communicate in English to be able to participate and follow directions during my rehabilitation
* Continue to take all prescribed medication (e.g., oral or via pump baclofen) without any dosing changes
* Be able to tolerate functional tasks for 60 minutes with periodic rests without excessive fatigue
* Have minimal strength in the muscles that bend and straighten my elbow, as determined by study staff
* Have full range of motion in my elbow when it is moved by the study therapist

Exclusion Criteria:

* Be younger than 18 years old or older than 80
* Have excessive pain in my arm, wrist, or hand that limits providing rehabilitation
* Have excessive spasticity in my elbow or wrist, as determined by study staff
* Be participating in any experimental rehabilitation or drug studies
* Have history of nervous system disorder other than SCI
* Have difficulty following multiple step directions
* Have severe cognitive or psychiatric problems might be contraindications to start training.
* Have skin issues or severe sensory deficits that would prevent wearing the Myo-Pro device safely
* Be pregnant
* Have other conditions or circumstances that, in the opinion of the investigators, would affect the safety or effectiveness of the training in which I would participate

Where it's running

• Kessler Foundation
  West Orange, New Jersey, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.