Study Results
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View full resultsBasic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2019-05-15
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Acute Stimulation: Vibration pattern 1-3 and sham control
All participants try on several wearable prototypes in our laboratory that provide vibration or sham stimulation to the arm. Sensors or electrodes taped onto the arm and hand will sense muscle activity and record any changes during periods of vibration and periods with vibration turned off.
Vibration pattern
Vibration patterns applied to the affected limb based on pilot study results.
No vibration
These patients will wear a glove with a blinking light instead of feeling vibrations.
Longitudinal Stimulation: Vibration pattern 4
1\) If the patient gets Botox injections in their hand and arm, their arm function will be measured for three months during this standard care. 2) Next, all patients will be given a wearable device to take home. The patient will wear the device while feeling vibrations for 3 hours during the day while awake for two months. During this time and 1 month after this intervention, arm function will be tested.
Vibration pattern
Vibration patterns applied to the affected limb based on pilot study results.
Interventions
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Vibration pattern
Vibration patterns applied to the affected limb based on pilot study results.
No vibration
These patients will wear a glove with a blinking light instead of feeling vibrations.
Eligibility Criteria
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Inclusion Criteria
* diagnosis of stroke with upper extremity spasticity or other movement deficits that affect strength and range of movement.
* willing to participate in the vibrotactile stimulation sessions for consecutive days and willing to return for follow up visits as needed for the PHASE in progress.
* able to provide informed consent.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Stanford University
OTHER
Responsible Party
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Allison Okamura
Professor
Principal Investigators
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Allison M Okamura, PhD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford Neuroscience Health Center
Palo Alto, California, United States
Countries
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References
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Seim C, Chen B, Han C, Vacek D, Wu LS, Lansberg M, Okamura A. Relief of post-stroke spasticity with acute vibrotactile stimulation: controlled crossover study of muscle and skin stimulus methods. Front Hum Neurosci. 2023 Aug 29;17:1206027. doi: 10.3389/fnhum.2023.1206027. eCollection 2023.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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49330
Identifier Type: -
Identifier Source: org_study_id
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