A device to assist hand function for people with spinal cord injuries
MyHand-SCI: A Wearable Robotic Hand Orthosis for C6-C7 Spinal Cord Injury
This study is testing a new device called MyHand-SCI to see if it can help people with C6-C7 spinal cord injuries improve their hand function and daily activities.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05553457 on ClinicalTrials.gov |
What this trial studies
This study focuses on developing and testing the MyHand-SCI device, which aims to enhance hand function in individuals with C6-C7 spinal cord injuries. It is a non-randomized exploratory study designed to assess the feasibility of using the device, gather user feedback for further refinement, and evaluate various clinical outcome measures. Participants will engage with the device to provide insights into its functionality and effectiveness in improving their daily activities.
Who should consider this trial
Good fit: Ideal candidates are individuals with C6-C7 spinal cord injuries who have impaired upper limb function and are at least six months post-injury.
Not a fit: Patients with fixed upper limb contractures, severe spasticity, or persistent severe pain in their upper limbs may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could significantly improve hand function and independence for individuals with spinal cord injuries.
How similar studies have performed: Other studies have shown promise in using assistive robotic devices for rehabilitation in spinal cord injury patients, indicating a potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals with C6-C7 spinal cord injury, at least 6-months post-injury with impaired upper limb function * Substantially reduced motor control and strength below the level of their SCI with regard to hand and finger function * Able to provide informed consent Exclusion Criteria: * Fixed upper limb contractures that limit functional use of the hand and arm or ability to use the device * Severe spasticity (modified Ashworth \>2) at elbow, wrist, or fingers * Any open wounds or unusual skin fragility * Persistent severe pain in their upper limb
Where this trial is running
New York, New York
- Columbia University Irving Medical Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Joel Stein, MD — Columbia University
- Study coordinator: Lauren Winterbottom, EdD
- Email: lbw2136@cumc.columbia.edu
- Phone: 212-305-6722
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.