NCT05553457NARecruitingAccepts Healthy Volunteers
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Columbia University
Start Date
10/4/2022
Completion Date
9/1/2027
Summary
The purpose of this study is to develop and test the hardware and software components of the MyHand-SCI device to assist with hand function for individuals with C6-C7 spinal cord injury.
Detailed Description
The purpose of this study is to develop and test the hardware and software components of the MyHand-SCI device to assist with hand function for individuals with C6-C7 spinal cord injury. This is a non-randomized exploratory study to determine feasibility of device use, provide user feedback on device features and function to allow further refinement of the device, and assess the utility and responsiveness of several clinical outcome measures.
Eligibility Criteria
Age Range: 18 years to No maximum
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
Interventions
DEVICE
Testing of MyHand-SCI Device
Conditions
Spinal Cord InjuriesTetraplegia
Locations
Columbia University Irving Medical Center
New York, New York 10032
United States