The Utilization Effects of Powered Wearable Orthotics in Improving Upper Extremity Function and ADL in Persons With SCI

Launched by KESSLER FOUNDATION · Apr 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a special device called MyoPro, which is designed to help people with spinal cord injuries (SCI) improve the use of their arms and upper body. Researchers want to see how effective this wearable device is in helping individuals regain better control and function in their daily activities. The study is open to individuals aged 18 to 80 who have some muscle activity in their arms and have been diagnosed with a specific level of spinal cord injury.

Participants in the trial will undergo assessments to determine their eligibility. They can expect to wear the MyoPro device and participate in rehabilitation activities designed to enhance their upper extremity function. It’s important to note that the study is looking for individuals who are at least a year post-injury, are medically stable, and can follow instructions in English. Those who have significant pain, cognitive issues, or other specific medical conditions may not be eligible. This trial is supported by the Department of Defense and aims to assess how this innovative technology can improve the quality of life for people living with spinal cord injuries.

Gender

ALL

Eligibility 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