Neuroplasticity With Daily Use of a Sensorimotor Priming Vibration System to Improve Hand Function After Stroke

Study Overview
=================
Brief Summary
-----------------
More than 4 million stroke survivors in the U.S. suffer from post-stroke sensorimotor hand disability, which is typically permanent and difficult to treat. Hand disability has a profound negative impact on functional ability and independence. One way to improve hand function is to use peripheral sensory stimulation. Sensory stimulation in conjunction with therapy has been shown to improve motor outcomes more than therapy alone. While promising, most modalities of sensory stimulation interfere with natural hand tasks. To address these practical limitations, we have developed a new stimulation, imperceptible random-frequency vibration applied to wrist skin via a watch. In this study, we will determine if use of this vibration increases hand functional recovery.

Detailed Description
-----------------
The study design is a double-blinded randomized controlled study. Subjects will wear the device for at least 8 hours/day every day for a month, during which they will come to the laboratory for weekly evaluation. Follow-up evaluation will occur 3 months after. The device will deliver vibration (treatment) or no vibration (control).

Official Title
-----------------
Neuroplasticity With Daily Use of a Sensorimotor Priming Vibration System to Improve Hand Function After Stroke

Conditions
-----------------
Stroke, Physical Disability

Intervention / Treatment
-----------------
* Other: peripheral vibration stimulation
* Behavioral: therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic stroke survivor (>= 6 months post stroke) Ability to move an object with the paretic hand Fingertip sensory deficits Ability to put on a watch daily (by oneself or with help) Exclusion Criteria: Currently undergoing other upper extremity rehabilitation therapy Upper limb botulinum toxin within 3 months prior to or during enrollment Change in neurological disorder medications during the enrollment Complete upper limb deafferentation Rigidity (Modified Ashworth Scale=5) Brainstem stroke 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 If a participant has contraindications for Transcranial Magnetic Stimulation (TMS), the participant will not do TMS.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stimulation + therapy<br>The participant receives stimulation and home therapy. | Other: peripheral vibration stimulation<br>* wearing a wristband that delivers imperceptible vibratory stimulation.<br>Behavioral: therapy<br>* practice of daily living tasks<br>|
| Sham Comparator: no stimulation + therapy<br>The participant receives no stimulation and receives home therapy. | Behavioral: therapy<br>* practice of daily living tasks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-latency Afferent Inhibition | motor evoked potential suppression by conditioning electrical stimulation | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Action Research Arm Test | standardized clinical upper extremity function score | 1 month | 

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