Concomitant Sensory Stimulation During Therapy to Enhance Hand Functional Recovery Post Stroke

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to determine if combining vibration with hand task practice is superior to hand task practice alone.

Detailed Description
-----------------
Stroke is a leading cause of disability in the U.S., with more than 4 million stroke survivors in the U.S. who suffer from post-stroke hand disability. Post-stroke hand disability impairs stroke survivors' abilities and independence with self-care, hygiene, employment, and leisure, frequently resulting in diminished quality of life. Rehabilitation can often be limited, but research suggests that the effects of therapy is improved by the addition of sensory stimulation. To fully leverage the potential therapeutic benefits of sensory stimulation, we have developed a new stimulation that is imperceptible random-frequency vibration applied to wrist skin. The objective of this study is to determine if this treatment is superior to task-practice alone in improving hand functional recovery, sensorimotor grip control, and neural communication.

Official Title
-----------------
Concomitant Sensory Stimulation During Therapy to Enhance Hand Functional Recovery Post Stroke

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

Intervention / Treatment
-----------------
* Device: real stimulation
* Device: No stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years old or older At least 6 months since stroke Wolf Motor Function Test (WMFT) total average time >10 seconds WFMT hand task average time <120 s Exclusion Criteria: Currently undergoing other upper limb therapy Change in spasticity medication or upper limb botulinum toxin injection within 3 months prior to or during enrollment Severe spasticity that limits participation in task practice therapy (e.g., Modified Ashworth Scale=4-5) Comorbidity affecting the upper limb function such as complete upper extremity deafferentation, orthopaedic conditions limiting motion, premorbid neurologic conditions, premorbid peripheral neuropathy, compromised skin integrity of the wrist due to burn or long-term use of blood thinners, or significant new neurological symptoms Language barrier or cognitive impairment that precludes following instructions and/or providing consent

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 |
| --- | --- |
| Active Comparator: Vibration<br>The device will deliver imperceptible vibration for the treatment group. | Device: real stimulation<br>* Participants will undergo standardized hand task practice therapy (3 sessions/week for 6 weeks) with the watch worn on the paretic wrist. Participants will be randomized into two groups: The device will deliver vibration for the treatment group.<br>|
| Sham Comparator: No Vibration<br>The device will deliver no vibration for the control group. | Device: No stimulation<br>* Participants will undergo standardized hand task practice therapy (3 sessions/week for 6 weeks) with the watch worn on the paretic wrist. Participants will be randomized into two groups: The device will deliver no vibration for the control group during therapy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Score of Wolf Motor Function Test (WMFT) | Timed test of upper extremity function with a variety of tasks. | Baseline and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Score of Box and Blocks Test | Timed test of upper extremity function by moving blocks. | Baseline and 6 weeks | 
| Change in Score of Action Research Arm Test | Timed test of upper extremity function through a variety of tasks. | Baseline and 6 weeks | 

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