Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT06349434
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06349434
Study Brief:
Protocol Section:
NCT06349434