Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
15 participants
INTERVENTIONAL
2022-01-04
2025-01-31
Brief Summary
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Participants will use the HandMate device in clinic and in the home. They will also complete clinical upper extremity assessments.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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HandMate Use
HandMate device fitted for a stroke participant.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
21 Years
ALL
No
Sponsors
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Medstar Health Research Institute
OTHER
Responsible Party
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Principal Investigators
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Pete Lum, PhD
Role: PRINCIPAL_INVESTIGATOR
MedStar RI
Locations
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MedStar National Rehabilitation Hospital
Washington D.C., District of Columbia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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00004431
Identifier Type: -
Identifier Source: org_study_id
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