Back to resultsSpeech Hero Home Therapy for Aphasia
Primary Purpose
Broca Aphasia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
At home Speech Hero therapy app
Sponsored by
About this trial
This is an interventional device feasibility trial for Broca Aphasia
Eligibility Criteria
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
Sites / Locations
- Callier Center at University of Texas Dallas
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
At home Speech Hero therapy
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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).
Full Information
NCT ID
NCT04471935
First Posted
July 7, 2020
Last Updated
January 12, 2022
Sponsor
Flint Rehabilitation Devices, LLC
Collaborators
University of Texas
1. Study Identification
Unique Protocol Identification Number
NCT04471935
Brief Title
Speech Hero Home Therapy for Aphasia
Official Title
Speech Hero: a Rhythm-based Speech Therapy App for Individuals With Aphasia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
July 20, 2021 (Actual)
Primary Completion Date
October 15, 2021 (Actual)
Study Completion Date
October 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Flint Rehabilitation Devices, LLC
Collaborators
University of Texas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Broca Aphasia
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
At home Speech Hero therapy
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
At home Speech Hero therapy app
Intervention Description
Participants will be instructed to use the Speech Hero therapy app for three hours per week over a 4-week period.
Primary Outcome Measure Information:
Title
Number of Participants That Used the Device for at Least Ten Hours Over the Course of Four Weeks
Description
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
Secondary Outcome Measure Information:
Title
Change in Score on Western Aphasia Battery
Description
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
Title
Change in Score on Boston Naming Test
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yune Lee, PhD
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Callier Center at University of Texas Dallas
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Speech Hero Home Therapy for Aphasia
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