Hand Exoskeleton Training Study
ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorMedstar Health Research Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
HandMate
DeviceHandMate device is used for 20 hours in 4 weeks. Device is then used in the home for 3 months at discretion of participant.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: HandMate UseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 weeks2
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 weeks3
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 weeksSponsors and contacts
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Source ClinicalTrials.gov