Using powered wearable orthotics to improve arm function in people with spinal cord injuries
The Utilization Effects of Powered Wearable Orthotics in Improving Upper Extremity Function and ADL in Persons With SCI
This study is testing a powered arm device called MyoPro to see if it can help people with spinal cord injuries improve their arm movement and daily activities.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Kessler Foundation Academic / other |
| Locations | 1 site (West Orange, New Jersey) |
| Trial ID | NCT06349434 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 18-80 with spinal cord injuries at levels C1-C8 and ASIA Impairment Scale classifications C or D, who can activate certain muscles in their arms and forearms.
Not a fit: Patients with complete spinal cord injuries or those unable to activate the necessary muscles in their arms and forearms may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the independence and quality of life for individuals with spinal cord injuries by enhancing their upper extremity function.
How similar studies have performed: Other studies have shown promise in using assistive devices for upper extremity rehabilitation, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
West Orange, New Jersey
- Kessler Foundation — West Orange, New Jersey, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.