MyHand 2: An Active Hand Orthosis for Stroke Patients
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: MyHand Treatment Participants will use the MyHand device during repetitive grasp and release tasks. |
Device: MyHand Device
These subjects may be asked to attend 1-10 sessions (approximately 90 mins) to trial a variety of device controls and/or components.
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Outcome Measures
Primary Outcome Measures
- Device Usability and Utility Questionnaire Score [Up to 1 year at study completion]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adults over 18 years old
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History of stroke(s) with most recent stroke at least six months ago
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Upper extremity weakness with impaired ability to complete daily activities with affected hand
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Full passive range of motion in all digits
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Intact cognition to follow directions
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Gross control of proximal upper extremity musculature
Exclusion Criteria:
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Other neurological conditions besides stroke
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Other orthopedic conditions to affected upper extremity
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Significant spasticity in affected upper extremity that impairs device fit
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Columbia University Irving Medical Center | New York | New York | United States | 10032 |
Sponsors and Collaborators
- Columbia University
- National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
- Principal Investigator: Joel Stein, Columbia University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AAAS8104
- R01NS115652