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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COMPLETED
NA
40 participants
INTERVENTIONAL
2019-07-17
2020-01-03
Brief Summary
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Detailed Description
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One way to augment hand function recovery is peripheral sensory stimulation. Afferent input is a powerful driver of change in the motor cortex. Sensory stimulation has been shown to improve motor recovery in previous studies. In particular, promising preliminary results have been obtained by using imperceptible random-frequency vibration applied via a watch. However, the laboratory prototype device for delivering this vibration must be improved in the form factor for patient adoption.
Therefore, we developed an App that can be installed in smartwatches and control the vibrator within the smartwatch to deliver vibratory stimulation to the user. The objective of this study is to determine if the acute effect of vibration from a smartwatch on hand function is comparable to the effect of an existing laboratory prototype.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Real stimulation
The smartwatch produces vibration stimulation.
real stimulation
The smartwatch generates imperceptible vibratory stimulation.
No stimulation
The smartwatch produces no vibration.
no stimulation
The smartwatch generates no stimulation.
Interventions
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real stimulation
The smartwatch generates imperceptible vibratory stimulation.
no stimulation
The smartwatch generates no stimulation.
Eligibility Criteria
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Inclusion Criteria
* At least 6 months post stroke
* The ability to perform The Box and Block Test with a score greater than zero and less than 40.
Exclusion Criteria
* Complete upper limb deafferentation
* Comorbidity (peripheral neuropathy, orthopaedic conditions in the hand that limit ranges of motion, premorbid neurologic conditions, compromised skin integrity of the hand/wrist due to long-term use of blood thinners)
* Language barrier or cognitive impairment that precludes following instructions and/or providing consent.
18 Years
ALL
No
Sponsors
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MUSC Foundation for Research Development
UNKNOWN
Medical University of South Carolina
OTHER
Responsible Party
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Locations
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Medical University of South Caorlina
Charleston, South Carolina, United States
Countries
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Other Identifiers
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Pro00088976
Identifier Type: -
Identifier Source: org_study_id
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