MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Testing of MyHand-SCI Device.
- Who it may be relevant to
- Registry conditions: Spinal Cord Injuries, Tetraplegia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
MyHand-SCI: A Wearable Robotic Hand Orthosis for C6-C7 Spinal Cord Injury
Overview
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.
Interventions
- Device Testing of MyHand-SCI Device
Subjects will attend 1-20 sessions (approximately 90 minutes) to trial the MyHand-SCI device, including a variety of controls and components.
Primary outcome measures
- System Usability Scale [Time frame: Up to 2 years at study completion]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Columbia University Irving Medical Center — New York
Identifiers
NCT: NCT05553457 · AAAU2339 · R01NS115652