Smartwatch App for Vibration Stimulation

Study Overview
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Brief Summary
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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.

Detailed Description
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More than 4 million stroke survivors in the U.S. suffer from post-stroke hand disability. As hands are our primary means of interacting with the world, post-stroke hand impairment diminishes stroke survivors' abilities for activities of daily living including self-care, hygiene, employment, and leisure, and lowers independence. Hand impairment is difficult to treat. Limited resources in rehabilitation services and financial burdens make it impractical to simply increase rehabilitation service visits within the current healthcare system. 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.

Official Title
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Development of Wearable Stimulation App to Increase Hand Functional Recovery in Patients With Neurologic Movement

Conditions
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Stroke, Physical Disability

Intervention / Treatment
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* Device: real stimulation
* Device: no stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age = 18 or older 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: Rigidity (Modified Ashworth Scale=5) 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Real stimulation<br>The smartwatch produces vibration stimulation. | Device: real stimulation<br>* The smartwatch generates imperceptible vibratory stimulation.<br>|
| Sham Comparator: No stimulation<br>The smartwatch produces no vibration. | Device: no stimulation<br>* The smartwatch generates no stimulation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Box and Block Test | number of blocks moved | 20 minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nine Hole Peg Test | time it takes to complete the test | 20 minute | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical stimulation, Subliminal stimulation, stroke rehabilitation, upper extremity, paresis, hand function, occupational therapy, physical therapy