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

Sponsor

Columbia University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05553457

Collaborator

National Institute of Neurological Disorders and Stroke (NINDS) (NIH)

Enrollment

Location

Arm

46.9

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injuries Tetraplegia	Device: Testing of MyHand-SCI Device	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Oct 4, 2022

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Sep 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
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	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.

Arm

Intervention/Treatment

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

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.

Outcome Measures

Primary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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