MyHand 2: An Active Hand Orthosis for Stroke Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MyHand Device.
- Who it may be relevant to
- Registry conditions: Stroke, Hemiparesis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
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.
Interventions
- Device MyHand Device
These subjects may be asked to attend 1-40 sessions (approximately 90 mins) to trial a variety of device controls and/or components.
Primary outcome measures
- Device Usability and Utility Questionnaire Score [Time frame: Up to 1 year at study completion]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Columbia University Irving Medical Center — New York
Identifiers
NCT: NCT04436042 · AAAS8104 · R01NS115652