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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Tetraplegia, Spinal Cord Injuries

Intervention / Treatment
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* Device: Testing of MyHand-SCI Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MyHand-SCI Device Testing<br>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<br>* Subjects will attend 1-20 sessions (approximately 90 minutes) to trial the MyHand-SCI device, including a variety of controls and components.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal Cord Injuries, Tetraplegia, Rehabilitation, Robotics, Assistive Technology, Wearable Devices