Recruiting

MyHand-SCI

Sponsor:

Columbia University

Code:

NCT05553457

Conditions

Spinal Cord Injuries

Tetraplegia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Testing of MyHand-SCI Device

Study Details

Brief 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.

Conditions

Spinal Cord Injuries

Tetraplegia

Study ID

NCT05553457

Start date

Oct 4, 2022

Status verified date

Feb, 2026

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: MyHand-SCI Device Testing

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

Interventions

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 measure

  • System Usability Scale [ Time Frame: Up to 2 years at study completion ]

Central Contacts and Locations

Central contacts

Lauren Winterbottom, EdD

212-305-6722lbw2136@cumc.columbia.edu

Joel Stein, MD

212-305-4818

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Lauren Winterbottom, EdD

212-305-6722lbw2136@cumc.columbia.edu

More Information

Sponsor

Columbia University

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

  • Spinal Cord Injuries
  • Tetraplegia
  • Rehabilitation
  • Robotics
  • Assistive Technology
  • Wearable Devices

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-02-27.