Spasticity as Sequela of Stroke, Stroke, Stroke Hemorrhagic, Stroke, Ischemic
Conditions
Keywords
spasticity, tone, hemiplegia, hemiparesis, arm, hand, vibration
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.
Interventions
DEVICEVibration pattern
Vibration patterns applied to the affected limb based on pilot study results.
DEVICENo vibration
These patients will wear a glove with a blinking light instead of feeling vibrations.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Acute Stimulation: Vibration Patterns 1-3 and Sham Control 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. | 14 |
| Longitudinal Stimulation: Vibration Pattern 4 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. | 21 |
| Total | 35 |
Baseline characteristics
| Characteristic | Acute Stimulation: Vibration Patterns 1-3 and Sham Control | Total | Longitudinal Stimulation: Vibration Pattern 4 |
|---|---|---|---|
| Age, Continuous | 60 years STANDARD_DEVIATION 10.3 | 56.8 years STANDARD_DEVIATION 11.3 | 54.4 years STANDARD_DEVIATION 13.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 34 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 14 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 18 Participants | 12 Participants |
| Region of Enrollment United States | 14 participants | 35 participants | 21 participants |
| Sex: Female, Male Female | 5 Participants | 19 Participants | 14 Participants |
| Sex: Female, Male Male | 9 Participants | 16 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 | 0 / 14 | 0 / 14 | 0 / 21 |
| other Total, other adverse events | 0 / 14 | 0 / 14 | 0 / 14 | 0 / 14 | 0 / 21 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 | 0 / 14 | 0 / 14 | 0 / 21 |
Outcome results
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
Time frame: Change from Baseline Modified Ashworth at 12 weeks
Population: This measure was conducted on only one group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Longitudinal Stimulation: Vibration Pattern 4 | Change in Modified Ashworth at 12 Weeks | 1.1 units on a scale | Standard Error 0.22 |
p-value: 0.00025Wilcoxon Signed-Rank
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
Time frame: Change from Baseline Modified Ashworth at 8 weeks
Population: This measure was conducted on only one group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Longitudinal Stimulation: Vibration Pattern 4 | Change in Modified Ashworth at 8 Weeks | 0.9 units on a scale | Standard Error 0.28 |
p-value: 0.0014Wilcoxon Signed-Rank
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
Time frame: 20 minutes after stimulation start
Population: This measure was only taken for one group of patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acute Stimulation: Vibration Patterns 1-3 and Sham Control | Change in Modified Ashworth During Stimulation (Pattern 1). | 0.39 units on a scale | Standard Deviation 0.96 |
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
Time frame: 20 minutes after stimulation start
Population: This measure was only taken for one group of patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acute Stimulation: Vibration Patterns 1-3 and Sham Control | Change in Modified Ashworth During Stimulation (Pattern 2). | 0.25 units on a scale | Standard Deviation 0.86 |
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
Time frame: 20 minutes after stimulation start
Population: This measure was only taken for one group of patients.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acute Stimulation: Vibration Patterns 1-3 and Sham Control | Change in Modified Ashworth During Stimulation (Pattern 3). | 1.11 units on a scale | Standard Deviation 0.84 |
p-value: 0.001Wilcoxcon Signed-Ranks
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
Time frame: 20 minutes after stimulation start
Population: This measure was only taken for one group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acute Stimulation: Vibration Patterns 1-3 and Sham Control | Change in Modified Ashworth During Stimulation (Sham Control). | 0 units on a scale | Standard Deviation 0.56 |
Primary
Change in Range of Motion at 12 Weeks
Finger extension range.
Time frame: Change from Baseline Range of Motion at 12 weeks
Population: This measure was conducted on only one group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Longitudinal Stimulation: Vibration Pattern 4 | Change in Range of Motion at 12 Weeks | 18.4 degrees of finger extension | Standard Error 4.3 |
p-value: 0.001t-test, 1 sided
Primary
Change in Range of Motion at 8 Weeks
Finger extension range.
Time frame: Change from Baseline Range of Motion at 8 weeks
Population: This measure was conducted on only one group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Longitudinal Stimulation: Vibration Pattern 4 | Change in Range of Motion at 8 Weeks | 11.6 degrees of finger extension | Standard Error 5.2 |
p-value: 0.02t-test, 1 sided