PTS: Passive Tactile Stimulation for Stroke Rehabilitation

Sponsor

Stanford University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03814889

Collaborator

(none)

Enrollment

Location

Arms

43.6

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Stroke, Ischemic Stroke Hemorrhagic Spasticity as Sequela of Stroke	Device: Vibration pattern Device: No vibration	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Passive Tactile Stimulation for Stroke Rehabilitation

Actual Study Start Date :

May 15, 2019

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Vibration pattern 1 Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.	Device: Vibration pattern 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.
Active Comparator: Vibration pattern 2 Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.	Device: Vibration pattern 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.
Active Comparator: Vibration pattern 3 Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.	Device: Vibration pattern 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.
Active Comparator: Vibration pattern 4 Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.	Device: Vibration pattern 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.
Active Comparator: Vibration pattern 5 Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.	Device: Vibration pattern 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.
Active Comparator: Vibration pattern 6 Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.	Device: Vibration pattern 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.
Active Comparator: Vibration pattern 7 Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.	Device: Vibration pattern 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.
Active Comparator: Vibration pattern 8 Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.	Device: Vibration pattern 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.
Active Comparator: Vibration pattern 9 Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.	Device: Vibration pattern 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.
Active Comparator: Vibration pattern 10 Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.	Device: Vibration pattern 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.
Placebo Comparator: No vibration A light will blink instead of a vibration pattern being displayed.	Device: No vibration These patients will wear a glove with a blinking light instead of feeling vibrations.

Outcome Measures

Primary Outcome Measures

Change in Modified Ashworth at 12 weeks [Change from Baseline Modified Ashworth at 12 weeks]
Modified Ashworth Scale for Spasticity (upper limb)
Change in Modified Ashworth at 8 weeks [Change from Baseline Modified Ashworth at 8 weeks]
Modified Ashworth Scale for Spasticity (upper limb)
Change in Range of Motion at 12 weeks [Change from Baseline Range of Motion at 12 weeks]
Workspace of voluntary movement of arm will be measured
Change in Range of Motion at 8 weeks [Change from Baseline Range of Motion at 8 weeks]
Workspace of voluntary movement of arm will be measured

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.