Broca Aphasia Clinical Trial
Official title:
Speech Hero: a Rhythm-based Speech Therapy App for Individuals With Aphasia
| Verified date | January 2022 |
| Source | Flint Rehabilitation Devices, LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 10 |
| Est. completion date | October 20, 2021 |
| Est. primary completion date | October 15, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility | Inclusion Criteria: - Diagnosis of Broca's aphasia due to stroke, - >6 months post stroke - sufficient motor function of the unaffected upper extremity to tap on a table while speaking Exclusion Criteria: - Incidence of other neurological diseases (though individuals with apraxia will be included) - age <85 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Callier Center at University of Texas Dallas | Richardson | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Flint Rehabilitation Devices, LLC | University of Texas |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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. | Immediately Post-Treatment, an average of 4 weeks | |
| 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). | 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). | Immediately Post-Treatment, an average of 4 weeks |