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| ID | Type | Description | Link |
|---|---|---|---|
| P20GM109040 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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More than 4 million stroke survivors in the U.S. suffer from post-stroke sensorimotor hand disability, which is typically permanent and difficult to treat. Hand disability has a profound negative impact on functional ability and independence. One way to improve hand function is to use peripheral sensory stimulation. Sensory stimulation in conjunction with therapy has been shown to improve motor outcomes more than therapy alone. While promising, most modalities of sensory stimulation interfere with natural hand tasks. To address these practical limitations, we have developed a new stimulation, imperceptible random-frequency vibration applied to wrist skin via a watch. In this study, we will determine if use of this vibration increases hand functional recovery.
The study design is a double-blinded randomized controlled study. Subjects will wear the device for at least 8 hours/day every day for a month, during which they will come to the laboratory for weekly evaluation. Follow-up evaluation will occur 3 months after. The device will deliver vibration (treatment) or no vibration (control).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stimulation + therapy | Experimental | The participant receives stimulation and home therapy. |
|
| no stimulation + therapy | Sham Comparator | The participant receives no stimulation and receives home therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| peripheral vibration stimulation | Other | wearing a wristband that delivers imperceptible vibratory stimulation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Short-latency Afferent Inhibition | motor evoked potential suppression by conditioning electrical stimulation | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Action Research Arm Test | standardized clinical upper extremity function score | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Stroke Impact Scale Hand Subscale | standardized patient-reported hand function assessment | 1 month |
| Stoke Impact Scale Hand Subscale | standardized patient-reported hand function assessment |
Inclusion Criteria:
Exclusion Criteria:
If a participant has contraindications for Transcranial Magnetic Stimulation (TMS), the participant will not do TMS.
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| Name | Affiliation | Role |
|---|---|---|
| Steven Kautz, PhD | Medical University of South Carolina | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Caorlina | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36936523 | Derived | Scronce G, Ramakrishnan V, Vatinno AA, Seo NJ. Effect of Self-Directed Home Therapy Adherence Combined with TheraBracelet on Poststroke Hand Recovery: A Pilot Study. Stroke Res Treat. 2023 Mar 8;2023:3682898. doi: 10.1155/2023/3682898. eCollection 2023. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stimulation + Therapy | The participant receives stimulation and home therapy. peripheral vibration stimulation: wearing a wristband that delivers imperceptible vibratory stimulation. therapy: practice of daily living tasks |
| FG001 | no Stimulation + Therapy | The participant receives no stimulation and receives home therapy. therapy: practice of daily living tasks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stimulation + Therapy | The participant receives stimulation and home therapy. peripheral vibration stimulation: wearing a wristband that delivers imperceptible vibratory stimulation. therapy: practice of daily living tasks |
| BG001 | no Stimulation + Therapy |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Short-latency Afferent Inhibition | motor evoked potential suppression by conditioning electrical stimulation | Posted | Mean | Standard Deviation | % of unconditioned motor evoked potentia | 1 month |
|
4 months
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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 | Stimulation + Therapy | The participant receives stimulation and home therapy. peripheral vibration stimulation: wearing a wristband that delivers imperceptible vibratory stimulation. therapy: practice of daily living tasks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| gallbladder removal | Surgical and medical procedures | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| increased muscle tone | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Na Jin Seo | Medical University of South Carolina | 8437920084 | seon@musc.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 | Mar 20, 2020 | Jul 28, 2021 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 24, 2019 | Jan 20, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| therapy | Behavioral | practice of daily living tasks |
|
| 4 month |
| Timing of Reactive Force Generation Per Perturbation | time of reactive force | 1 month |
| Timing of Reactive Force Generation Per Perturbation | time of reactive force | 4 month |
| Fugl-Meyer Upper Limb Assessment | standardized clinical upper extremity function score | 1 month |
| Fugl-Meyer Upper Limb Assessment | standardized clinical upper extremity function score | 4 month |
| Grip Force Direction | angle of the grip force vector from the normal direction | 1 month |
| Grip Force Direction | angle of the grip force vector from the normal direction | 4 month |
| In-home Hand Use Amount | affected hand use amount as measured by accelerometers | 1 month |
| In-home Hand Use Amount | affected hand use amount as measured by accelerometers | 4 month |
| Reactive Force Magnitude Per Perturbation | magnitude of reactive grip force | 1 month |
| Reactive Force Magnitude Per Perturbation | magnitude of reactive grip force | 4 month |
| Safety Margin | additional force used during grip | 1 month |
| Safety Margin | additional force used during grip | 4 month |
| Corticomotor Excitability | motor evoked potential amplitude | 1 month |
| Corticomotor Excitability | motor evoked potential amplitude | 4 month |
| Spectral Power Perturbation During Grip | EEG spectral power perturbation during grip | 1 month |
| Spectral Power Perturbation During Grip | EEG spectral power perturbation during grip | 4 month |
| Connectivity | EEG coherence within the sensorimotor network | 1 month |
| Connectivity | EEG coherence within the sensorimotor network | 4 month |
| Short-latency Afferent Inhibition | motor evoked potential suppression by conditioning electrical stimulation | 4 month |
| Box and Block Test | number of blocks moved in a minute | 1 month |
| Box and Block Test | number of blocks moved in a minute | 4 month |
| Wolf Motor Function Test | standardized clinical upper extremity function score | 1 month |
| Wolf Motor Function Test | standardized clinical upper extremity function score | 4 month |
| Action Research Arm Test | standardized clinical upper extremity function score | 4 month |
The participant receives no stimulation and receives home therapy. therapy: practice of daily living tasks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Action Research Arm Test | standardized clinical upper extremity function score | Not Posted | 1 month | Participants |
| Other Pre-specified | Stroke Impact Scale Hand Subscale | standardized patient-reported hand function assessment | Not Posted | 1 month | Participants |
| Other Pre-specified | Stoke Impact Scale Hand Subscale | standardized patient-reported hand function assessment | Not Posted | 4 month | Participants |
| Other Pre-specified | Timing of Reactive Force Generation Per Perturbation | time of reactive force | Not Posted | 1 month | Participants |
| Other Pre-specified | Timing of Reactive Force Generation Per Perturbation | time of reactive force | Not Posted | 4 month | Participants |
| Other Pre-specified | Fugl-Meyer Upper Limb Assessment | standardized clinical upper extremity function score | Not Posted | 1 month | Participants |
| Other Pre-specified | Fugl-Meyer Upper Limb Assessment | standardized clinical upper extremity function score | Not Posted | 4 month | Participants |
| Other Pre-specified | Grip Force Direction | angle of the grip force vector from the normal direction | Not Posted | 1 month | Participants |
| Other Pre-specified | Grip Force Direction | angle of the grip force vector from the normal direction | Not Posted | 4 month | Participants |
| Other Pre-specified | In-home Hand Use Amount | affected hand use amount as measured by accelerometers | Not Posted | 1 month | Participants |
| Other Pre-specified | In-home Hand Use Amount | affected hand use amount as measured by accelerometers | Not Posted | 4 month | Participants |
| Other Pre-specified | Reactive Force Magnitude Per Perturbation | magnitude of reactive grip force | Not Posted | 1 month | Participants |
| Other Pre-specified | Reactive Force Magnitude Per Perturbation | magnitude of reactive grip force | Not Posted | 4 month | Participants |
| Other Pre-specified | Safety Margin | additional force used during grip | Not Posted | 1 month | Participants |
| Other Pre-specified | Safety Margin | additional force used during grip | Not Posted | 4 month | Participants |
| Other Pre-specified | Corticomotor Excitability | motor evoked potential amplitude | Not Posted | 1 month | Participants |
| Other Pre-specified | Corticomotor Excitability | motor evoked potential amplitude | Not Posted | 4 month | Participants |
| Other Pre-specified | Spectral Power Perturbation During Grip | EEG spectral power perturbation during grip | Not Posted | 1 month | Participants |
| Other Pre-specified | Spectral Power Perturbation During Grip | EEG spectral power perturbation during grip | Not Posted | 4 month | Participants |
| Other Pre-specified | Connectivity | EEG coherence within the sensorimotor network | Not Posted | 1 month | Participants |
| Other Pre-specified | Connectivity | EEG coherence within the sensorimotor network | Not Posted | 4 month | Participants |
| Other Pre-specified | Short-latency Afferent Inhibition | motor evoked potential suppression by conditioning electrical stimulation | Not Posted | 4 month | Participants |
| Other Pre-specified | Box and Block Test | number of blocks moved in a minute | Not Posted | 1 month | Participants |
| Other Pre-specified | Box and Block Test | number of blocks moved in a minute | Not Posted | 4 month | Participants |
| Other Pre-specified | Wolf Motor Function Test | standardized clinical upper extremity function score | Not Posted | 1 month | Participants |
| Other Pre-specified | Wolf Motor Function Test | standardized clinical upper extremity function score | Not Posted | 4 month | Participants |
| Other Pre-specified | Action Research Arm Test | standardized clinical upper extremity function score | Not Posted | 4 month | Participants |
| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | no Stimulation + Therapy | The participant receives no stimulation and receives home therapy. therapy: practice of daily living tasks | 0 | 6 | 1 | 6 | 1 | 6 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |