MyHand 2: An Active Hand Orthosis for Stroke Patients

Study Overview
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Brief Summary
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This study is designed to further develop and test the hardware and software components of the MyHand device based on user feedback and results from our pilot study. The goal is to refine the device so that is more effective and easier for stroke patients to use to increase their hand function.

Detailed Description
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From previous experimentation with the MyHand device, the investigators have determined that the device can improve the grasping ability of stroke patients. The investigators now aim to make the controls more intuitive and accurate for the users, to enable subjects to grasp a wider array of objects, to make the donning and doffing of the device easier, and to continue to assess the MyHand as it helps subjects in functional tasks.

Official Title
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MyHand 2: An Active Hand Orthosis for Stroke Patients

Conditions
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Stroke, Hemiparesis

Intervention / Treatment
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* Device: MyHand Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults over 18 years old History of stroke(s) with most recent stroke at least six months ago Upper extremity weakness with impaired ability to complete daily activities with affected hand Full passive range of motion in all digits Intact cognition to follow directions Gross control of proximal upper extremity musculature Exclusion Criteria: Other neurological conditions besides stroke Other orthopedic conditions to affected upper extremity Significant spasticity in affected upper extremity that impairs device fit

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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No

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 Treatment<br>Participants will use the MyHand device during repetitive grasp and release tasks. | Device: MyHand Device<br>* These subjects may be asked to attend 1-40 sessions (approximately 90 mins) to trial a variety of device controls and/or components.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Usability and Utility Questionnaire Score | Subjects will provide feedback about their perceptions of the device's usability and utility for post-stroke upper extremity recovery. Four questions will be rated on a 5-point Likert scale (1) strongly agree to (5) strongly disagree. Five questions will be rated on a 5-point reverse Likert scale (1) strongly disagree to (5) strongly agree. The 9 question survey has a score range of 9-45 with higher scores indicating higher levels of device usability and utility. | Up to 1 year at study completion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Rehabilitation, Hemiparesis, Robotics