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The purpose of this study is to evaluate a touch screen application designed to help pediatric patients with cerebral palsy communicate. The study will test how well patients type on two different tools: one tool is already on the market , and the second tool is a newly developed App.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dynavox Maestro and Experimental App | Experimental | Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dynavox Maestro | Device | Receives commercially available communication device Dynavox Maestro to test speed and quality of communication. |
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| Measure | Description | Time Frame |
|---|---|---|
| Speed of Communication | Measure time (in minutes) to type 3 pre-set sentences | Immediately |
| Measure | Description | Time Frame |
|---|---|---|
| Error Rate of Communication | Amount of typing errors per sentence | At time of experiment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's National | Washington D.C. | District of Columbia | 20010 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dynavox Maestro and Experimental App | Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned. Dynavox Maestro: Receives commercially available communication device Dynavox Maestro to test speed and quality of communication. Experimental App: Participant receives experimental app to test speed and error rate of communication. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Age 7-21
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| ID | Title | Description |
|---|---|---|
| BG000 | Dynavox Maestro and Experimental App | Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned. Dynavox Maestro: Receives commercially available communication device Dynavox Maestro to test speed and quality of communication. Experimental App: Participant receives experimental app to test speed and error rate of communication. |
| 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 | Speed of Communication | Measure time (in minutes) to type 3 pre-set sentences | Posted | Mean | Standard Error | minutes | Immediately |
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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 | Dynavox Maestro and Experimental App | Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned. Dynavox Maestro: Receives commercially available communication device Dynavox Maestro to test speed and quality of communication. Experimental App: Participant receives experimental app to test speed and error rate of communication. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Axel Krieger | Children's National | 2024761284 | akrieger@childrensnational.org |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Experimental App | Device | Participant receives experimental app to test speed and error rate of communication. |
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| years |
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| Gender | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Error Rate of Communication | Amount of typing errors per sentence | Posted | Mean | Standard Deviation | errors | At time of experiment |
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