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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vibration pattern | Device | Vibration patterns applied to the affected limb based on pilot study results. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Allison M Okamura, PhD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Neuroscience Health Center | Palo Alto | California | 94304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37706171 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Acute Stimulation: Vibration Pattern 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Acute Testing |
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| Longitudinal Testing |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | This measure was conducted on only one group. | Posted | Mean | Standard Error | units on a scale | Change from Baseline Modified Ashworth at 12 weeks |
|
Adverse Events monitored/assessed up to one month for Vibration Pattern 1-3 and Sham Control Arms and up to three-six months for Vibration Pattern 4 Arm
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vibration Pattern 1 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Allison Okamura | Stanford University | (650) 723-3148 | aokamura@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 26, 2022 | Aug 29, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| D000083302 | Hemorrhagic Stroke |
| D009128 | Muscle Spasticity |
| D006429 | Hemiplegia |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| No vibration | Device | These patients will wear a glove with a blinking light instead of feeling vibrations. |
|
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 |
| NOT COMPLETED |
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| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG000 | 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. |
| OG001 | 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. |
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| 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 | This measure was conducted on only one group. | Posted | Mean | Standard Error | units on a scale | Change from Baseline Modified Ashworth at 8 weeks |
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| Primary | Change in Range of Motion at 8 Weeks | Finger extension range. | This measure was conducted on only one group. | Posted | Mean | Standard Error | degrees of finger extension | Change from Baseline Range of Motion at 8 weeks |
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| Primary | Change in Range of Motion at 12 Weeks | Finger extension range. | This measure was conducted on only one group. | Posted | Mean | Standard Error | degrees of finger extension | Change from Baseline Range of Motion at 12 weeks |
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| 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 | This measure was only taken for one group of patients. | Posted | Mean | Standard Deviation | units on a scale | 20 minutes after stimulation start |
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| 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 | This measure was only taken for one group of patients. | Posted | Mean | Standard Deviation | units on a scale | 20 minutes after stimulation start |
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| 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 | This measure was only taken for one group of patients. | Posted | Mean | Standard Deviation | units on a scale | 20 minutes after stimulation start |
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| 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 | This measure was only taken for one group. | Posted | Mean | Standard Deviation | units on a scale | 20 minutes after stimulation start |
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| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Vibration Pattern 2 | 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. | 0 | 14 | 0 | 14 | 0 | 14 |
| EG002 | Vibration Pattern 3 | 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. | 0 | 14 | 0 | 14 | 0 | 14 |
| EG003 | 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. | 0 | 14 | 0 | 14 | 0 | 14 |
| EG004 | 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. | 0 | 21 | 0 | 21 | 0 | 21 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010243 | Paralysis |