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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD075813 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| North Carolina State University | OTHER |
| Marquette University | OTHER |
| Medical University of South Carolina | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
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Evaluation of a new EMG controlled game to improve hand function in chronic stroke survivors.
Increased impairment of the hand is commonly reported as an outcome occurring after a stroke. This impairment is due mainly to the decreased ability to modulate appropriate muscle activation patterns. Issues with appropriately modifying activation patterns can profoundly affect tasks of daily living. This study is evaluating a novel software focusing on retraining hand muscle activation patterns through an Electromyographic (EMG) controlled game. Stroke survivors with chronic, severe hemiparesis of the hand will participate in a longitudinal study consisting of 3 weeks of training. We hypothesize that stroke survivors will experience a decrease in time to complete a test of EMG control, as well as improvement in hand motor control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bilateral | Experimental | Participants will control game using EMG from both upper limbs. |
|
| Unilateral | Active Comparator | Participants will control game using the more impaired upper limb. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilateral | Other | Participants will control game using EMG from both upper limbs. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Completion Time for Timed Test | Time to complete movement to 16 randomized targets | Baseline and 3 weeks (immediately post intervention) |
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Inclusion Criteria:
Exclusion Criteria:
Children, prisoners, or adult unable to provide consent will not be recruited. As the procedures pose no increased risk for pregnant women, we will not specifically exclude them.
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| Name | Affiliation | Role |
|---|---|---|
| Elliot Roth, MD | Shirley Ryan AbilityLab | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shirley Ryan AbilityLab | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35320135 | Derived | Seo NJ, Barry A, Ghassemi M, Triandafilou KM, Stoykov ME, Vidakovic L, Roth E, Kamper DG. Use of an EMG-Controlled Game as a Therapeutic Tool to Retrain Hand Muscle Activation Patterns Following Stroke: A Pilot Study. J Neurol Phys Ther. 2022 Jul 1;46(3):198-205. doi: 10.1097/NPT.0000000000000398. Epub 2022 Mar 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bilateral | Participants will control game using EMG from both upper limbs. Bilateral: Participants will control game using EMG from both upper limbs. |
| FG001 | Unilateral | Participants will control game using the more impaired upper limb. Unilateral: Participants will control game using EMG from the more impaired upper limb. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bilateral | Participants will control game using EMG from both upper limbs. Bilateral: Participants will control game using EMG from both upper limbs. |
| BG001 | Unilateral | Participants will control game using the more impaired upper limb. Unilateral: Participants will control game using EMG from the more impaired upper limb. |
| 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 | Change in Mean Completion Time for Timed Test | Time to complete movement to 16 randomized targets | Posted | Mean | Standard Error | Minutes | Baseline and 3 weeks (immediately post intervention) |
|
At completion of intervention, 3 weeks from baseline
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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 | Bilateral | Participants will control game using EMG from both upper limbs. Bilateral: Participants will control game using EMG from both upper limbs. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexander Barry | Shirley Ryan AbilityLab | 3122381435 | abarry@sralab.org |
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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 8, 2018 | Oct 16, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D018908 | Muscle Weakness |
| D001259 | Ataxia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| NIH |
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| Unilateral |
| Other |
Participants will control game using EMG from the more impaired upper limb. |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Chedoke Stage of Hand Score | A measure of Hand Impairment following a stroke on a scale of 1-7. A score of 1 indicates complete paralysis of the tested hand, a score of 7 indicates no impairments of the tested hand. A score of 4 indicates the presence of some finger or thumb extension A score of 5 indicates the presence of some finger or thumb abduction or opposition, as well as extension following flexion | Count of Participants | Participants |
|
| Side of Impairment | Which side of the body was affected by the stroke | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Unilateral | Participants will control game using the more impaired upper limb. Unilateral: Participants will control game using EMG from the more impaired upper limb. | 0 | 10 | 0 | 10 | 0 | 10 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D020820 | Dyskinesias |