Passive Tactile Stimulation for Stroke Rehabilitation

NCT03814889 | Completed Results FDA Device

• 1 other identifier: 49330
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

spasticity; tone; hemiplegia; hemiparesis; arm; hand; vibration

Outcome Measures

Primary Outcomes (8)

• Change in 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 from Baseline Modified Ashworth at 12 weeks

• Change in 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 from Baseline Modified Ashworth at 8 weeks

• Change in Range of Motion at 8 Weeks

  Finger extension range.

  Change from Baseline Range of Motion at 8 weeks

• Change in Range of Motion at 12 Weeks

  Finger extension range.

  Change from Baseline Range of Motion at 12 weeks

• Change in Modified Ashworth During Stimulation (Pattern 1).

  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

  20 minutes after stimulation start

• Change in Modified Ashworth During Stimulation (Pattern 2).

  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

  20 minutes after stimulation start

• Change in Modified Ashworth During Stimulation (Pattern 3).

  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

  20 minutes after stimulation start

• Change in Modified Ashworth During Stimulation (Sham Control).

  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

  20 minutes after stimulation start

Study Arms (2)

Acute Stimulation: Vibration pattern 1-3 and sham control

ACTIVE COMPARATOR

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.

Device: Vibration pattern; Device: No vibration

Longitudinal Stimulation: Vibration pattern 4

ACTIVE COMPARATOR

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.

Device: Vibration pattern

Interventions

Vibration pattern DEVICE

Vibration patterns applied to the affected limb based on pilot study results.

Acute Stimulation: Vibration pattern 1-3 and sham control; Longitudinal Stimulation: Vibration pattern 4

No vibration DEVICE

These patients will wear a glove with a blinking light instead of feeling vibrations.

Acute Stimulation: Vibration pattern 1-3 and sham control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Neuroscience Health Center

Palo Alto, California, 94304, United States

Location

Related Publications (1)

• Seim C, Chen B, Han C, Vacek D, Wu LS, Lansberg M, Okamura A. Relief of post-stroke spasticity with acute vibrotactile stimulation: controlled crossover study of muscle and skin stimulus methods. Front Hum Neurosci. 2023 Aug 29;17:1206027. doi: 10.3389/fnhum.2023.1206027. eCollection 2023.

  PMID: 37706171 DERIVED

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Hemorrhagic Stroke; Muscle Spasticity; Hemiplegia; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Paralysis

Results Point of Contact

• Title: Allison Okamura
• Organization: Stanford University

aokamura@stanford.edu

(650) 723-3148

Study Officials

• Allison M Okamura, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 16, 2019
• First Posted: January 24, 2019
• Study Start: May 15, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 8, 2024
• Results First Posted: April 8, 2024

Record last verified: 2024-04

Locations

US (1)