MyHand-SCI: an Active Hand Orthosis for Spinal Cord Injury

Columbia University

Status: Enrolling

Conditions: Tetraplegia; Spinal Cord Injuries

Treatments: Device: Testing of MyHand-SCI Device

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05553457

R01NS115652 (U.S. NIH Grant/Contract)

AAAU2339

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

MyHand-SCI Device Testing

Experimental group

Description:

Subjects will attend 1-20 sessions (of approximately 90 mins) to trial a variety of the MyHand-SCI device controls and/or components. Participants will practice various grasp and release activities with the device

Treatment:

Device: Testing of MyHand-SCI Device