Broca Aphasia
Conditions
Brief summary
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.
Interventions
DEVICEAt home Speech Hero therapy app
Participants will be instructed to use the Speech Hero therapy app for three hours per week over a 4-week period.
Sponsors
University of Texas
Flint Rehabilitation Devices, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Used the Device for at Least Ten Hours Over the Course of Four Weeks | Immediately Post-Treatment, an average of 4 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Score on Western Aphasia Battery | Immediately Post-Treatment, an average of 4 weeks | 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). |
| Change in Score on Boston Naming Test | Immediately Post-Treatment, an average of 4 weeks | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Deemed ineligible to participate | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | At Home Speech Hero Therapy | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 2 Participants | — |
| Age, Categorical Between 18 and 65 years | 6 Participants | — |
| Age, Continuous | 47 years STANDARD_DEVIATION 19 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 8 participants | — |
| Sex: Female, Male Female | 2 Participants | — |
| Sex: Female, Male Male | 6 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
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.
Time frame: Immediately Post-Treatment, an average of 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| At Home Speech Hero Therapy | Number of Participants That Used the Device for at Least Ten Hours Over the Course of Four Weeks | 7 Participants |
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).
Time frame: Immediately Post-Treatment, an average of 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| At Home Speech Hero Therapy | Change in Score on Boston Naming Test | 5 score on a scale | Standard Deviation 9 |
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).
Time frame: Immediately Post-Treatment, an average of 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| At Home Speech Hero Therapy | Change in Score on Western Aphasia Battery | Spontaneous Speech | 3 score on a scale | Standard Deviation 7 |
| At Home Speech Hero Therapy | Change in Score on Western Aphasia Battery | Auditory Verbal Comprehension | -1 score on a scale | Standard Deviation 7 |
| At Home Speech Hero Therapy | Change in Score on Western Aphasia Battery | Repetition | 2 score on a scale | Standard Deviation 10 |
| At Home Speech Hero Therapy | Change in Score on Western Aphasia Battery | Naming and Word Finding | 6 score on a scale | Standard Deviation 4 |