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

Not Applicable

Recruiting

• Conditions: Spinal Cord Injuries; Tetraplegia
• Interventions: Device: Testing of MyHand-SCI Device

• Registration Number: NCT05553457
• Lead Sponsor: Columbia University

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.

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.

Study Timeline

• Study First Submitted: 2022-09-21
• Study First Submitted QC: 2022-09-21
• Study First Posted: 2022-09-23
• Study Start: 2022-10-04
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12
• Primary Completion: 2026-09-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MyHand-SCI Device Testing	Testing of MyHand-SCI Device	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

Primary Outcome Measures

Name	Time	Method
System Usability Scale	Up to 2 years at study completion	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).

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States