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
• 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
• 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

Related Conditions & MeSH terms

• Quadriplegia
• Spinal Cord Injuries
• Tetraplegia
• Wounds and Injuries

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