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

NCT05553457 | Recruiting FDA Device

• 2 other identifiers: AAAU2339R01NS115652
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Tetraplegia; Spinal Cord Injuries

Keywords

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

Outcome Measures

Primary Outcomes (1)

• System Usability Scale

  The System Usability Scale (SUS) is a reliable tool for measuring the usability of products, including medical devices. It consists of a 10 item questionnaire with five response options (Strongly agree to Strongly disagree).

  Up to 2 years at study completion

Study Arms (1)

MyHand-SCI Device Testing

EXPERIMENTAL

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

Device: Testing of MyHand-SCI Device

Interventions

Testing of MyHand-SCI Device DEVICE

Subjects will attend 1-20 sessions (approximately 90 minutes) to trial the MyHand-SCI device, including a variety of controls and components.

MyHand-SCI Device Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Quadriplegia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joel Stein, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren Winterbottom, EdD

CONTACT

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

Joel Stein, MD

CONTACT

212-305-4818

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair of the Department of Rehabilitation and Regenerative Medicine

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 23, 2022
• Study Start: October 4, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)