Broca AphasiaNCT04471935
Speech Hero Home Therapy for Aphasia
A study testing At home Speech Hero therapy app in people with Broca Aphasia, run by Flint Rehabilitation Devices, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Broca Aphasia
- What is being tested?
- At home Speech Hero therapy app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2021to 20 Oct 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Incidence of other neurological diseases (though individuals with apraxia will be included)
- age <85
Trial locations and contacts
1 site in 1 country.
United States1 site
Callier Center at University of Texas Dallas
Richardson, Texas, 75080
About this study
Official title: Speech Hero: a Rhythm-based Speech Therapy App for Individuals With Aphasia
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.
- Conditions
- Broca Aphasia
- Being tested
- At home Speech Hero therapy app
- Medical subject headings
- Aphasia, Broca
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
At home Speech Hero therapy appDevice
Participants will be instructed to use the Speech Hero therapy app for three hours per week over a 4-week period.
| Study group | Role | What they receive |
|---|---|---|
| At home Speech Hero therapy | Other | Not described Receives: Device: At home Speech Hero therapy app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately Post-Treatment, an average of 4 weeks
Secondary outcomes (2)
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).
Measured: 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).
Measured: Immediately Post-Treatment, an average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start20 Jul 2021
- Primary completion15 Oct 2021
- Study completion20 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Broca AphasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Flint Rehabilitation Devices, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Texas
- Responsible party
- Sponsor
- Investigators
- Yune Lee, PhD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471935
- Sponsor's protocol ID
- 1R43DC018771-01
- Status last verified
- Jan 2022
- First submitted
- 7 Jul 2020
- Last updated
- 7 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Speech Hero: a Rhythm-based Speech Therapy App for Individuals With Aphasia
- ClinicalTrials.gov ID
- NCT04471935
- Acronym / sponsor ID
- 1R43DC018771-01
- Conditions
- Broca Aphasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Flint Rehabilitation Devices, LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of Texas
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 20 Oct 2021 (actual)
- First posted
- 15 Jul 2020 (actual)
- Results
- Posted 7 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| At home Speech Hero therapy | Other | Device: At home Speech Hero therapy app |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Incidence of other neurological diseases (though individuals with apraxia will be included)
- age <85
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| At home Speech Hero therapy appParticipants will be instructed to use the Speech Hero therapy app for three hours per week over a 4-week period. | Device | At home Speech Hero therapy |
Primary outcome
Number of Participants That Used the Device for at Least Ten Hours Over the Course of Four Weeks
Time frame: 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.
2 secondary outcomes
Change in Score on Western Aphasia Battery
Time frame: Immediately Post-Treatment, an average of 4 weeks
Change in Score on Boston Naming Test
Time frame: Immediately Post-Treatment, an average of 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Broca Aphasia
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia
Expressive Aphasia, Aphasia Following Cerebral Infarction
Recruiting
Music Therapy for Rehabilitation in Post-stroke Non-fluent Aphasia: the Indian Adaptation
Stroke Rehabilitation, Aphasia, Broca
Recruiting
Sensory-Motor Integration for Speech Rehabilitation in Patients With Post-stroke Aphasia
Aphasia Non Fluent, Stroke
Active, not recruiting
Mirror Speech Entrainment: A Novel Technique for Voice Personalized Speech Entrainment for Nonfluent Aphasia
Aphasia Non Fluent, Stroke
Not yet recruiting
Combined Intervention Program for Non-fluent Aphasia Based on Neuroplasticity
Non-fluent Aphasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yune Lee, PhD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing At home Speech Hero therapy app in people with Broca Aphasia, run by Flint Rehabilitation Devices, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants That Used the Device for at Least Ten Hours Over the Course of Four Weeks (time frame: Immediately Post-Treatment, an average of 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2022.