Hand Exoskeleton Training Study for Stroke Recovery
This study is testing a device called HandMate to see if it can help people who have had a stroke regain movement in their hand. Participants will use the HandMate device for 20 hours over 4 weeks in a clinic, and then can choose to use it at home for 3 months. The study aims to see how well the HandMate helps improve hand function and if stroke survivors find it easy to use. To join, you must be 21 or older, have had a stroke at least 6 months ago, and have some voluntary hand movement but also difficulty opening your affected hand. The study plans to enroll 15 participants, but its current status is unclear.
- Study design
- This is an interventional study planning to enroll 15 participants. The phase of the study is not specified.
- What's involved
- You would use the HandMate device for 20 hours over 4 weeks in a clinic, and then potentially at home for 3 months. You will also complete clinical assessments of your upper arm and hand.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your hand function will be measured at 6 weeks after starting the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Hand Exoskeleton Training Study
At a glance
Conditions
NCT06786858
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
MedStar National Rehabilitation Hospital
Washington D.C., District of Columbiastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Pete Lum, PhD · PRINCIPAL_INVESTIGATOR · MedStar RI
Who to contact
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Inclusion
Exclusion
What this trial measures
- Fugl-Meyer Upper Extremity (FMA-UE) TestChange from baseline Fugl-Meyer score at 6 weeks
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.
- Action Research Arm Test (ARAT)Change from baseline ARAT score at 6 weeks
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.
- Motor Activity LogChange from baseline MAL score at 6 weeks
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.).