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| Name | Class |
|---|---|
| University of Texas | OTHER |
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The investigators will run an at-home usability study of a newly developed speech therapy app called Speech Hero with 10 individuals with Broca's aphasia in the chronic stage of stroke. The Speech Hero app allows users to perform rhythm-based speech exercises at home. For this study participants will be instructed to use Speech Hero for at least 10 hours over a 4-week period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| At home Speech Hero therapy | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| At home Speech Hero therapy app | Device | Participants will be instructed to use the Speech Hero therapy app for three hours per week over a 4-week period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Used the Device for at Least Ten Hours Over the Course of Four Weeks | Number of participants able to use the device on their own at home for at least 10 hours over four weeks without technical or other issues. Speech Hero will be deemed feasible for this population if at least 5 participants are able to use the device on their own at home for at least 10 hours over four weeks without technical or other issues. | Immediately Post-Treatment, an average of 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Score on Western Aphasia Battery | Assessment of language function of adults with suspected neurological disorders as a result of a stroke, head injury, or dementia. The Western Aphasia Battery (WAB) is comprised of 8 subscales. For this study the subscales of spontaneous speech, auditory verbal comprehension, repetition, naming and word finding were used. Results reported as change in score from baseline to post-treatment (each subscale score is on 0-100% scale with higher score representing less impairment). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yune Lee, PhD | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Callier Center at University of Texas Dallas | Richardson | Texas | 75080 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | At Home Speech Hero Therapy | At home Speech Hero therapy app: Participants will be instructed to use the Speech Hero therapy app for three hours per week over a 3-week period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | At Home Speech Hero Therapy | At home Speech Hero therapy app: Participants will be instructed to use the Speech Hero therapy app for three hours per week over a 3-week period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Participants That Used the Device for at Least Ten Hours Over the Course of Four Weeks | Number of participants able to use the device on their own at home for at least 10 hours over four weeks without technical or other issues. Speech Hero will be deemed feasible for this population if at least 5 participants are able to use the device on their own at home for at least 10 hours over four weeks without technical or other issues. | Posted | Count of Participants | Participants | Immediately Post-Treatment, an average of 4 weeks |
|
3 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 | At Home Speech Hero Therapy | At home Speech Hero therapy app: Participants will be instructed to use the Speech Hero therapy app for three hours per week over a 3-week period. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ian Russell | Flint Rehabilitation Devices | 3392232676 | irussell@flintrehab.com |
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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 | Jan 12, 2022 | Jan 12, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 15, 2021 | Dec 15, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001039 | Aphasia, Broca |
| ID | Term |
|---|---|
| D001037 | Aphasia |
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
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| Immediately Post-Treatment, an average of 4 weeks |
| Change in Score on Boston Naming Test | Assessment of language function of adults with suspected neurological disorders as a result of a stroke, head injury, or dementia. Scoring counts the number of spontaneously produced correct responses, the number of cues given, and the number of responses after phonemic cueing and after semantic cueing. Results reported as change in score from baseline to post-treatment (score for Boston Naming Test (BNT) is on 0-100% scale with higher score representing less impairment). | Immediately Post-Treatment, an average of 4 weeks |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
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| Secondary | Change in Score on Western Aphasia Battery | Assessment of language function of adults with suspected neurological disorders as a result of a stroke, head injury, or dementia. The Western Aphasia Battery (WAB) is comprised of 8 subscales. For this study the subscales of spontaneous speech, auditory verbal comprehension, repetition, naming and word finding were used. Results reported as change in score from baseline to post-treatment (each subscale score is on 0-100% scale with higher score representing less impairment). | Posted | Mean | Standard Deviation | score on a scale | Immediately Post-Treatment, an average of 4 weeks |
|
|
|
| Secondary | Change in Score on Boston Naming Test | Assessment of language function of adults with suspected neurological disorders as a result of a stroke, head injury, or dementia. Scoring counts the number of spontaneously produced correct responses, the number of cues given, and the number of responses after phonemic cueing and after semantic cueing. Results reported as change in score from baseline to post-treatment (score for Boston Naming Test (BNT) is on 0-100% scale with higher score representing less impairment). | Posted | Mean | Standard Deviation | score on a scale | Immediately Post-Treatment, an average of 4 weeks |
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| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
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| D019954 |
| Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| Naming and Word Finding |
|