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| ID | Type | Description | Link |
|---|---|---|---|
| U54GM104941 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
| University of Delaware | OTHER |
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After stroke, it is common for individuals to experience hand impairment. This deficit can severely restrict functional ability and independence. Recovery of hand function following stroke is highly variable. In this study, the investigators will use brain imaging to predict individual response to treatment. Survivors of stroke will receive upper extremity therapy while they concurrently receive imperceptible vibration to the wrist aimed to enhance therapy outcomes.
The ability to predict individuals' responses to treatment can enable effective allocation of a treatment to likely responders. The long-term goal is to determine whether acute changes in brain functional connectivity immediately after one treatment session can predict ultimate gains in motor function after completing multiple treatment sessions. The objective of this study is to determine feasibility and to examine association between change in brain functional connectivity after one session and motor gains after completion of all treatment sessions. This study is a prospective single-cohort longitudinal study. The treatment is task-practice therapy (3d/wk, 18-session) accompanied with concurrent imperceptible wrist vibration that is intended to prime the cortical sensorimotor network and enhance hand functional recovery in chronic stroke survivors. Hand function will be assessed before/after therapy and at 1-month follow-up. Connectivity will be assessed using fMRI and EEG before and after a treatment session.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| therapy + vibration | Experimental | Imperceptible vibration applied to the wrist during a standardized hand task practice therapy program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| task-practice therapy | Behavioral | Standardized hand therapy program |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Hand Motor Function | Change in hand motor function as measured by the Box and Block Test. The test measures the number of blocks that a participant moves within one minute. The scale ranges from 0 to a positive number. Higher numbers represent better outcomes. | Baseline to approximately 1 week after the completion of 18 therapy sessions. |
| Mean Change in Hand Motor Function | Change in hand motor function as measured by the Box and Block Test. The test measures the number of blocks that a participant moves within one minute. The scale ranges from 0 to a positive number. Higher numbers represent better outcomes. | Baseline to approximately 4 weeks after the completion of 18 therapy sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Hand Motor Function | Change in hand motor function as measured by the Wolf Motor Function Test Time. This test measures time to complete upper extremity movements in seconds. More negative values represent a greater reduction in time, thus better outcomes. | Baseline to approximately 1 week after the completion of 18 therapy sessions. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steve Kautz, PhD | Medical University of South Carolina | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29403 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Therapy + Vibration | Imperceptible vibration applied to the wrist during a standardized hand task practice therapy program. Task-Practice Therapy: Standardized hand therapy program Vibration: Peripheral vibration applied to the wrist skin at an imperceptible level |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Therapy + Vibration | Imperceptible vibration applied to the wrist during a standardized hand task practice therapy program. Task-Practice Therapy: Standardized hand therapy program Vibration: Peripheral vibration applied to the wrist skin at an imperceptible level |
| 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 | Mean Change in Hand Motor Function | Change in hand motor function as measured by the Box and Block Test. The test measures the number of blocks that a participant moves within one minute. The scale ranges from 0 to a positive number. Higher numbers represent better outcomes. | Posted | Mean | Standard Deviation | blocks | Baseline to approximately 1 week after the completion of 18 therapy sessions. |
|
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Baseline through one month follow-up (10 weeks).
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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 | Therapy + Vibration | Imperceptible vibration applied to the wrist during a standardized hand task practice therapy program. Task-Practice Therapy: Standardized hand therapy program Vibration: Peripheral vibration applied to the wrist skin at an imperceptible level |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Root Canal | Surgical and medical procedures | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amanda Vatinno | Medical University of South Carolina | 8437924840 | vatinno@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 8, 2018 | Jan 5, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D014732 | Vibration |
| ID | Term |
|---|---|
| D055595 | Mechanical Phenomena |
| D055585 | Physical Phenomena |
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| Vibration |
| Other |
Peripheral vibration applied to the wrist skin at an imperceptible level |
|
| Mean Change in Hand Motor Function | Change in hand motor function as measured by the Wolf Motor Function Test Time. This test measures time to complete upper extremity movements in seconds. More negative values represent a greater reduction in time, thus better outcomes. | Baseline to approximately 4 weeks after the completion of 18 therapy sessions. |
| 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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| Counts |
|---|
| Participants |
|
|
| Primary | Mean Change in Hand Motor Function | Change in hand motor function as measured by the Box and Block Test. The test measures the number of blocks that a participant moves within one minute. The scale ranges from 0 to a positive number. Higher numbers represent better outcomes. | Posted | Mean | Standard Deviation | blocks | Baseline to approximately 4 weeks after the completion of 18 therapy sessions. |
|
|
|
| Secondary | Mean Change in Hand Motor Function | Change in hand motor function as measured by the Wolf Motor Function Test Time. This test measures time to complete upper extremity movements in seconds. More negative values represent a greater reduction in time, thus better outcomes. | Posted | Mean | Standard Deviation | seconds | Baseline to approximately 1 week after the completion of 18 therapy sessions. |
|
|
|
| Secondary | Mean Change in Hand Motor Function | Change in hand motor function as measured by the Wolf Motor Function Test Time. This test measures time to complete upper extremity movements in seconds. More negative values represent a greater reduction in time, thus better outcomes. | Posted | Mean | Standard Deviation | seconds | Baseline to approximately 4 weeks after the completion of 18 therapy sessions. |
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| 0 |
| 5 |
| 0 |
| 5 |
| 4 |
| 5 |
| Cold | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Fall | General disorders | Non-systematic Assessment |
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| Temporary increase in muscle tone | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Bumped affected upper extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Temporary upper extremity numbness | Nervous system disorders | Non-systematic Assessment |
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| Temporary skin irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Worsening Monofilament Score | Nervous system disorders | Systematic Assessment |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |