Passive Tactile Stimulation for Stroke Rehabilitation

Stroke Clinical Trial

— PTS  

Official title:

Passive Tactile Stimulation for Stroke Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03814889
• Other study ID #: 49330
• Status: Completed
• Phase: N/A
• Start date: May 15, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhagic Stroke
• Ischemic Stroke
• Muscle Spasticity
• Spasticity as Sequela of Stroke
• Stroke
• Stroke Hemorrhagic
• Stroke, Ischemic

Intervention

Device:
• Vibration pattern
Vibration patterns applied to the affected limb based on pilot study results.
• No vibration
These patients will wear a glove with a blinking light instead of feeling vibrations.

Locations

Country	Name	City	State
United States	Stanford Neuroscience Health Center	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Change in Range of Motion at 8 Weeks	Finger extension range.	Change from Baseline Range of Motion at 8 weeks
Primary	Change in Range of Motion at 12 Weeks	Finger extension range.	Change from Baseline Range of Motion at 12 weeks
Primary	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
Primary	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
Primary	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
Primary	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