Passive Tactile Stimulation for Stroke Rehabilitation

Not Applicable

Completed

• Conditions: Spasticity as Sequela of Stroke; Stroke; Stroke, Ischemic; Stroke Hemorrhagic
• Interventions: Device: Vibration pattern; Device: No vibration

• Registration Number: NCT03814889
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-16
• Study First Submitted QC: 2019-01-18
• Study First Posted: 2019-01-24
• Study Start: 2019-05-15
• Results First Submitted: 2022-08-26
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2024-04
• Results First Submitted QC: 2024-04-05
• Last Update Submitted: 2024-04-05
• Results First Posted: 2024-04-08
• Last Update Posted: 2024-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

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Exclusion Criteria

• Patients with severe contracture that precludes Modified Ashworth Score (MAS) testing.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Longitudinal Stimulation: Vibration pattern 4	Vibration pattern	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.
Acute Stimulation: Vibration pattern 1-3 and sham control	Vibration pattern	All participants try on several wearable prototypes in our laboratory that provide vibration or sham stimulation 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.
Acute Stimulation: Vibration pattern 1-3 and sham control	No vibration	All participants try on several wearable prototypes in our laboratory that provide vibration or sham stimulation 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.

Primary Outcome Measures

Name	Time	Method
Change in Modified Ashworth at 8 Weeks	Change from Baseline Modified Ashworth at 8 weeks	Modified Ashworth Scale (from https://www.sralab.org/rehabilitation-measures/ashworth-scale-modified-ashworth-scale) Lower Modified Ashworth scale values indicate a better outcome.; Measures spastic hypertonia by manually moving an affected joint at set velocities.; Scores: 0 (0) - No increase in muscle tone; 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension; 1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM (range of movement) 2 (3) - More marked increase in musce tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension
Change in Range of Motion at 8 Weeks	Change from Baseline Range of Motion at 8 weeks	Finger extension range.
Change in Modified Ashworth During Stimulation (Pattern 2).	20 minutes after stimulation start	Modified Ashworth Scale (from https://www.sralab.org/rehabilitation-measures/ashworth-scale-modified-ashworth-scale). Lower Modified Ashworth scale values indicate a better outcome.; Measures spastic hypertonia by manually moving an affected joint at set velocities.; Scores: 0 (0) - No increase in muscle tone; 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension; 1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM (range of movement) 2 (3) - More marked increase in musce tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension
Change in Modified Ashworth at 12 Weeks	Change from Baseline Modified Ashworth at 12 weeks	Modified Ashworth Scale (from https://www.sralab.org/rehabilitation-measures/ashworth-scale-modified-ashworth-scale). Lower Modified Ashworth scale values indicate a better outcome.; Measures spastic hypertonia by manually moving an affected joint at set velocities.; Scores: 0 (0) - No increase in muscle tone; 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension; 1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM (range of movement) 2 (3) - More marked increase in musce tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension
Change in Range of Motion at 12 Weeks	Change from Baseline Range of Motion at 12 weeks	Finger extension range.
Change in Modified Ashworth During Stimulation (Pattern 1).	20 minutes after stimulation start	Modified Ashworth Scale (from https://www.sralab.org/rehabilitation-measures/ashworth-scale-modified-ashworth-scale). Lower Modified Ashworth scale values indicate a better outcome.; Measures spastic hypertonia by manually moving an affected joint at set velocities.; Scores: 0 (0) - No increase in muscle tone; 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension; 1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM (range of movement) 2 (3) - More marked increase in musce tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension
Change in Modified Ashworth During Stimulation (Pattern 3).	20 minutes after stimulation start	Modified Ashworth Scale (from https://www.sralab.org/rehabilitation-measures/ashworth-scale-modified-ashworth-scale). Lower Modified Ashworth scale values indicate a better outcome.; Measures spastic hypertonia by manually moving an affected joint at set velocities.; Scores: 0 (0) - No increase in muscle tone; 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension; 1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM (range of movement) 2 (3) - More marked increase in musce tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension
Change in Modified Ashworth During Stimulation (Sham Control).	20 minutes after stimulation start	Modified Ashworth Scale (from https://www.sralab.org/rehabilitation-measures/ashworth-scale-modified-ashworth-scale). Lower Modified Ashworth scale values indicate a better outcome.; Measures spastic hypertonia by manually moving an affected joint at set velocities.; Scores: 0 (0) - No increase in muscle tone; 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension; 1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM (range of movement) 2 (3) - More marked increase in musce tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension

Trial Locations

Locations (1)

Stanford Neuroscience Health Center; 🇺🇸 Palo Alto, California, United States