An interventional study of HandMate in Stroke, sponsored by Medstar Health Research Institute. Recruiting at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-01-22.
Sponsored by Medstar Health Research Institute · Not applicable, Interventional, and Other
The goal of this study is to evaluate the HandMATE device's effectiveness in the rehabilitation of stroke patients and asses if the HandMATE application is received well by stroke survivors.
Participants will use the HandMate device in clinic and in the home. They will also complete clinical upper extremity assessments.
This study will evaluate the effectiveness of novel device and its potential to help stroke victims regain functional use of their hand and regain independent living. The study will also evaluate the potential of the device to be used at home, this would allow increased therapy intensity and decreased overall treatment costs (fewer therapist hours required and decreased travel costs).
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 15 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Medstar Health Research Institute is the lead sponsor of 160 studies on the registry; 32 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 6 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
HandMate device fitted for a stroke participant.
Device: HandMate
HandMate device is used for 20 hours in 4 weeks. Device is then used in the home for 3 months at discretion of participant.
Fugl-Meyer Upper Extremity (FMA-UE) Test
Evaluates and measures recovery in post-stroke hemiplegic patients. The FMA-UE Test will assess upper limb motor impairments for this study. It is a 33-item test that measures motor and reflex function in the upper body. Each item is scored on a scale of 0-2, with 0 indicating inability, 1 indicating beginning ability, and 2 indicating normal. The total score ranges from 0-66, highest score indicating no disability.
Time frame: Change from baseline Fugl-Meyer score at 6 weeks
Action Research Arm Test (ARAT)
The ARAT is 19-item clinical assessment used to measure the functional ability of the upper extremity, particularly in individuals recovering from a stroke, by evaluating their performance on tasks like grasping, gripping, pinching, and gross arm movements. It is scored on a four-level ordinal scale (0-3). Highest score indicating normal movement.
Time frame: Change from baseline ARAT score at 6 weeks
Motor Activity Log
The Motor Activity Log will be used to assess use of the limb at home. Respondents rate how they use their more-impaired arm for activities of daily living (ADLs) in the home (brushing teeth, buttoning a shirt, etc.).
Time frame: Change from baseline MAL score at 6 weeks
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Medstar Health Research Institute