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NCT05553457 Clinical Trial

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

Spinal Cord Injuries Clinical Trial

Official title:
MyHand-SCI: A Wearable Robotic Hand Orthosis for C6-C7 Spinal Cord Injury

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05553457
Other study ID # AAAU2339
Secondary ID R01NS115652
Status Recruiting
Phase N/A
First received
Last updated
Start date October 4, 2022
Est. completion date September 1, 2027

Study information
Verified date February 2024
Source Columbia University
Contact Lauren Winterbottom, MS
Phone 212-305-6722
Email lbw2136@cumc.columbia.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date September 1, 2027
Est. primary completion date September 1, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Columbia University Irving Medical Center New York New York

Sponsors (2)
Lead Sponsor Collaborator
Columbia University National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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