Passive Tactile Stimulation for Stroke Rehabilitation

Study Overview
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Brief Summary
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Stroke can lead to weakness and spasticity in the arm or hand. The purpose of this study is to optimize the design of gentle vibratory stimulation delivered to the hands of individuals with chronic stroke, and explore the effect on range of movement and spasticity.

Official Title
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Passive Tactile Stimulation for Stroke Rehabilitation

Conditions
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Stroke, Stroke, Ischemic, Stroke Hemorrhagic, Spasticity as Sequela of Stroke

Intervention / Treatment
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* Device: Vibration pattern
* Device: No vibration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 and older. 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: Patients with severe contracture that precludes Modified Ashworth Score (MAS) testing.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Vibration pattern 1<br>Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies. | Device: Vibration pattern<br>* PHASE 1 and PHASE 2 are pilot studies not included in the clinical trial. Phase 2b: All participants try on several wearable prototypes in our laboratory that provide vibration 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. PHASE 3: Patients will be given a wearable device to take home. The patient will wear the device daily. At the beginning and end of the phase, arm function will be tested. PHASE 4: This study takes 3 or 6 months. 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.<br>|
| Active Comparator: Vibration pattern 2<br>Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies. | Device: Vibration pattern<br>* PHASE 1 and PHASE 2 are pilot studies not included in the clinical trial. Phase 2b: All participants try on several wearable prototypes in our laboratory that provide vibration 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. PHASE 3: Patients will be given a wearable device to take home. The patient will wear the device daily. At the beginning and end of the phase, arm function will be tested. PHASE 4: This study takes 3 or 6 months. 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.<br>|
| Active Comparator: Vibration pattern 3<br>Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies. | Device: Vibration pattern<br>* PHASE 1 and PHASE 2 are pilot studies not included in the clinical trial. Phase 2b: All participants try on several wearable prototypes in our laboratory that provide vibration 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. PHASE 3: Patients will be given a wearable device to take home. The patient will wear the device daily. At the beginning and end of the phase, arm function will be tested. PHASE 4: This study takes 3 or 6 months. 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.<br>|
| Active Comparator: Vibration pattern 4<br>Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies. | Device: Vibration pattern<br>* PHASE 1 and PHASE 2 are pilot studies not included in the clinical trial. Phase 2b: All participants try on several wearable prototypes in our laboratory that provide vibration 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. PHASE 3: Patients will be given a wearable device to take home. The patient will wear the device daily. At the beginning and end of the phase, arm function will be tested. PHASE 4: This study takes 3 or 6 months. 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.<br>|
| Active Comparator: Vibration pattern 5<br>Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies. | Device: Vibration pattern<br>* PHASE 1 and PHASE 2 are pilot studies not included in the clinical trial. Phase 2b: All participants try on several wearable prototypes in our laboratory that provide vibration 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. PHASE 3: Patients will be given a wearable device to take home. The patient will wear the device daily. At the beginning and end of the phase, arm function will be tested. PHASE 4: This study takes 3 or 6 months. 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.<br>|
| Active Comparator: Vibration pattern 6<br>Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies. | Device: Vibration pattern<br>* PHASE 1 and PHASE 2 are pilot studies not included in the clinical trial. Phase 2b: All participants try on several wearable prototypes in our laboratory that provide vibration 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. PHASE 3: Patients will be given a wearable device to take home. The patient will wear the device daily. At the beginning and end of the phase, arm function will be tested. PHASE 4: This study takes 3 or 6 months. 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.<br>|
| Active Comparator: Vibration pattern 7<br>Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies. | Device: Vibration pattern<br>* PHASE 1 and PHASE 2 are pilot studies not included in the clinical trial. Phase 2b: All participants try on several wearable prototypes in our laboratory that provide vibration 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. PHASE 3: Patients will be given a wearable device to take home. The patient will wear the device daily. At the beginning and end of the phase, arm function will be tested. PHASE 4: This study takes 3 or 6 months. 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.<br>|
| Active Comparator: Vibration pattern 8<br>Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies. | Device: Vibration pattern<br>* PHASE 1 and PHASE 2 are pilot studies not included in the clinical trial. Phase 2b: All participants try on several wearable prototypes in our laboratory that provide vibration 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. PHASE 3: Patients will be given a wearable device to take home. The patient will wear the device daily. At the beginning and end of the phase, arm function will be tested. PHASE 4: This study takes 3 or 6 months. 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.<br>|
| Active Comparator: Vibration pattern 9<br>Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies. | Device: Vibration pattern<br>* PHASE 1 and PHASE 2 are pilot studies not included in the clinical trial. Phase 2b: All participants try on several wearable prototypes in our laboratory that provide vibration 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. PHASE 3: Patients will be given a wearable device to take home. The patient will wear the device daily. At the beginning and end of the phase, arm function will be tested. PHASE 4: This study takes 3 or 6 months. 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.<br>|
| Active Comparator: Vibration pattern 10<br>Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies. | Device: Vibration pattern<br>* PHASE 1 and PHASE 2 are pilot studies not included in the clinical trial. Phase 2b: All participants try on several wearable prototypes in our laboratory that provide vibration 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. PHASE 3: Patients will be given a wearable device to take home. The patient will wear the device daily. At the beginning and end of the phase, arm function will be tested. PHASE 4: This study takes 3 or 6 months. 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.<br>|
| Placebo Comparator: No vibration<br>A light will blink instead of a vibration pattern being displayed. | Device: No vibration<br>* These patients will wear a glove with a blinking light instead of feeling vibrations.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Modified Ashworth at 12 weeks | Modified Ashworth Scale for Spasticity (upper limb) | Change from Baseline Modified Ashworth at 12 weeks | 
| Change in Modified Ashworth at 8 weeks | Modified Ashworth Scale for Spasticity (upper limb) | Change from Baseline Modified Ashworth at 8 weeks | 
| Change in Range of Motion at 12 weeks | Workspace of voluntary movement of arm will be measured | Change from Baseline Range of Motion at 12 weeks | 
| Change in Range of Motion at 8 weeks | Workspace of voluntary movement of arm will be measured | Change from Baseline Range of Motion at 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spasticity, tone, hemiplegia, hemiparesis, arm, hand, vibration