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.

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NCT06786858

Hand Exoskeleton Training Study

Recruiting
NAAges 21+Interventional
Medstar Health Research Institute
~15 participants
Updated 2025-01-22 on ClinicalTrials.gov
What's tested:HandMate

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Fugl-Meyer Upper Extremity (FMA-UE) Test
Measured over Change from baseline Fugl-Meyer score at 6 weeks
+2 more outcomes measured
Stroke

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.

  • Pete Lum, PhD · PRINCIPAL_INVESTIGATOR · MedStar RI

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Eligibility criteria

Inclusion

Age of 21 or older
diagnosis of stroke more than 6 months prior confirmed from MRI or CT
voluntary hand activity (score of 1 or more, finger extension item, Fugl-Meyer Test)
adequate cognitive status
Impaired ability to open affected hand

Exclusion

hemispatial neglect
severe sensory loss (2 or more on the sensory item, NIH Stroke Scale/Score)
receiving or planning to receive antispasticity medications during enrollment into the study
less than full passive range of motion in finger joints
receiving physical or occupational therapy outside of study protocols
have excessive pain in any joint of the affected extremity that could limit ability to cooperate with the protocols
  • 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.).