Post-stroke DysarthriaNCT06670014
Evaluate the Efficacy and Safety of the Digital Therapeutics Repeech for the Post-Stroke Dysarthria.
A study testing repeech and Workbook in people with Post-stroke Dysarthria, run by HAII corp.ltd at 5 sites in South Korea.
Trial summary
The goal of this interventional study is to evaluate the efficacy and safety of a digital therapeutic (DTx) application, \'repeech\', for the treatment of post-stroke dysarthria. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Post-stroke Dysarthria
- What is being tested?
- repeech and Workbook
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 20 Nov 2024to 14 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be 19 years of age or older.
- Participants must be neurologically stable after stroke, as determined by a qualified physician.
- Participants must have objective post-stroke dysarthria, defined as a score of 1 or 2 on the dysarthria item of the National Institutes of Health Stroke Scale (NIHSS).
- Participants must have a Korean Mini-Mental State Examination (K-MMSE) score of 26 or higher within 1 month before study entry.
- Participants must have sufficient vision, hearing, and motor function to complete the study procedures.
- Participants must be able to use a tablet PC without difficulty.
- Participants must provide voluntary written informed consent.
Who cannot join
- Participants with structural problems in the oral or neck area that could interfere with accurate speech assessment.
- Participants diagnosed with dementia or who used medication for dementia within 3 months before screening.
- Participants who are illiterate.
- Participants with severe psychiatric illness, such as major depression, schizophrenia, or drug dependence.
- Participants with severe language impairment that would prevent use of the digital application.
- Participants with any other clinical reason that, in the investigator's judgment, would make participation unsuitable.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Ewha Womans University Mokdong Medical Center
Seoul
Ewha Womans University Seoul Medical Center
Seoul
KyungHee University Hospital
Seoul
National Rehabilitation Center
Seoul
Yongin Severance Hospital
Yongin, Gyeonggi-do
About this study
Official title: A Randomized, Parallel-Group, Assessor-Blind, Multi-Center, Non-Inferiority Pivotal Study to Evaluate the Efficacy and Safety of the Digital Therapeutics 'Repeech' for the Post-Stroke Dysarthria.
The goal of this interventional study is to evaluate the efficacy and safety of a digital therapeutic (DTx) application, \'repeech\', for the treatment of post-stroke dysarthria. The study aims to assess improvement in speech intelligibility in individuals affected by post-stroke dysarthria using the DTx intervention.
Read the detailed description
This study will evaluate a digital therapeutic (DTx), \'repeech\', designed to complement tradtional speech therapy by addressing challenges such as accessibility, frequency of sessions, and personalized feedback. The \'repeech\' offers an at-home, customzied intervention, providing patients with more flexible and accessible therapy options. It also encourage greater patient engagement in their treatment and promotes self-care.
The study is designed to assess the efficacy of the \'repeech\' in improving speech function, especially speech intelligibility in individuals with post-stroke dysarthria. The clinical trial will be conducted across multiple sites to gather comprehensive data on the intervention\'s effectiveness and usability.
- Conditions
- Post-stroke Dysarthria
- Being tested
- repeech, Workbook
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repeechDevice
Participants in this group will use the repeech application for a period of 4 weeks, with recommended usage of 5 days per week for 30 to 60 minutes per session. A designated speech-language pathologist (SLP) will set individualized treatment goals and customize the content of the therapy sessions based on each participant's baseline assessment. The repeech intervention will be tailored to meet the specific needs of each participant to improve speech intelligibility and communication abilities.
WorkbookOther
Participants in the control group will use a workbook provided by the sponsor for the treatment of dysarthria, due to the lack of a standardized care protocol for this condition. The recommended usage is the same as the treatment group: 5 days per week, for 30 to 60 minutes per session over a period of 4 weeks. After each self-treatment session, participants will record their activities on a checklist to monitor adherence and ensure compliance with the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| 'repeech' Intervention Group | Experimental | Participants in this group will use the 'repeech' for treatment. Receives: Device: repeech |
| Control Group | Other | Participants in the control group will use a workbook provided by the sponsor for the treatment of dysarthria. Receives: Other: Workbook |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech Intelligibility
Speech intelligibility refers to how well a listener can understand the participant's speech. Participants will read a standardized Korean passage developed to assess speech intelligibility. Speech samples will be evaluated by three blinded speech-language pathologists (SLPs), who will independently assess intelligibility using a scale from 0 to 100, where 0 represents completely unintelligible speech and 100 represents fully intelligible speech. The average score from the three evaluations will be used for analysis. The primary outcome is the change in speech intelligibility from baseline to 4 weeks.
Measured: Baseline, 4 weeks (post-treatment), 8 weeks (Follow-up)
Secondary outcomes (6)
Maximum Phonation Time (MPT)
Maximum Phonation Time (MPT) refers to the longest duration for which a participant can sustain the vowel /a/ after a deep inhalation. The task is performed twice, and the longest duration is recorded in seconds.
Measured: Baseline, 4 weeks (post-treatment), 8 weeks (Follow-up)
Diadochokinetic Rate (DDK)
Diadochokinetic rate (DDK) measures the speed and accuracy of repetitive speech movements. Participants repeat /pa/, /ta/, /ka/, and /pataka/ as quickly and accurately as possible. The number of correctly repeated syllables or syllable sequences per second is recorded.
Measured: Baseline, 4 weeks (post-treatment), 8 weeks (Follow-up)
Percentage of Consonants Correct (PCC)
Percentage of Consonants Correct (PCC) assesses consonant articulation accuracy during a standardized 30-word reading task. Accuracy is calculated as the percentage of correctly produced consonants out of the total intended consonants.
Measured: Baseline, 4 weeks (post-treatment), 8 weeks (Follow-up)
Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 is a self-administered questionnaire used to assess depressive symptoms. It consists of 9 items, with higher scores indicating more severe depressive symptoms. Participants complete the PHQ-9 through the study application.
Measured: Baseline, 4 weeks (post-treatment), 8 weeks (Follow-up)
Quality of Life of Dysarthric Speakers (QoL-Dys)
The QoL-Dys is a self-reported questionnaire used to assess disease-specific quality of life in individuals with dysarthria. It evaluates the impact of dysarthria-related communication difficulties on daily life. Participants complete the Korean version of the QoL-Dys through the study application.
Measured: Baseline, 4 weeks (post-treatment), 8 weeks (Follow-up)
Treatment Adherence
Treatment adherence is defined as the number of completed sessions divided by the 20 prescribed sessions, expressed as a percentage. In the treatment group, completed sessions are recorded through application logs. In the control group, completed sessions are recorded through workbook checklists reviewed by study staff.
Measured: 4 weeks (post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start20 Nov 2024
- Primary completion17 Oct 2025
- Study completion14 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-stroke DysarthriaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two-arm, randomized, parallel-group, assessor-blinded, multicenter, non-inferiority interventional study comparing digital speech therapy using the repeech application with workbook-based home treatment in participants with post-stroke dysarthria. * Intervention group: Participants assigned to the experimental group will use the repeech application for 4 weeks. They will be instructed to practice for 30 to 60 minutes per day, 5 days per week. * Control group: Participants assigned to the active comparator group will receive workbook-based home treatment consisting of conventional behavioral speech-therapy exercises. They will be instructed to practice with the same frequency and duration as the experimental group: 30 to 60 minutes per day, 5 days per week, for 4 weeks.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- HAII corp.ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670014
- Sponsor's protocol ID
- RDKC00
- Status last verified
- Aug 2026
- First submitted
- 22 Oct 2024
- Last updated
- 7 Aug 2026
- Results posted
- No
- 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 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel-Group, Assessor-Blind, Multi-Center, Non-Inferiority Pivotal Study to Evaluate the Efficacy and Safety of the Digital Therapeutics 'Repeech' for the Post-Stroke Dysarthria.
- ClinicalTrials.gov ID
- NCT06670014
- Acronym / sponsor ID
- RDKC00
- Conditions
- Post-stroke Dysarthria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- HAII corp.ltdIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 17 Oct 2025 (actual)
- Study completion
- 14 Nov 2025 (actual)
- First posted
- 1 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this interventional study is to evaluate the efficacy and safety of a digital therapeutic (DTx) application, \'repeech\', for the treatment of post-stroke dysarthria. The study aims to assess improvement in speech intelligibility in individuals affected by post-stroke dysarthria using the DTx intervention.
Detailed description
This study will evaluate a digital therapeutic (DTx), \'repeech\', designed to complement tradtional speech therapy by addressing challenges such as accessibility, frequency of sessions, and personalized feedback. The \'repeech\' offers an at-home, customzied intervention, providing patients with more flexible and accessible therapy options. It also encourage greater patient engagement in their treatment and promotes self-care.
The study is designed to assess the efficacy of the \'repeech\' in improving speech function, especially speech intelligibility in individuals with post-stroke dysarthria. The clinical trial will be conducted across multiple sites to gather comprehensive data on the intervention\'s effectiveness and usability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a two-arm, randomized, parallel-group, assessor-blinded, multicenter, non-inferiority interventional study comparing digital speech therapy using the repeech application with workbook-based home treatment in participants with post-stroke dysarthria. * Intervention group: Participants assigned to the experimental group will use the repeech application for 4 weeks. They will be instructed to practice for 30 to 60 minutes per day, 5 days per week. * Control group: Participants assigned to the active comparator group will receive workbook-based home treatment consisting of conventional behavioral speech-therapy exercises. They will be instructed to practice with the same frequency and duration as the experimental group: 30 to 60 minutes per day, 5 days per week, for 4 weeks.
| Arm | Type | Receives |
|---|---|---|
| 'repeech' Intervention Group | Experimental | Device: repeechParticipants in this group will use the 'repeech' for treatment. |
| Control Group | Other | Other: WorkbookParticipants in the control group will use a workbook provided by the sponsor for the treatment of dysarthria. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants must be 19 years of age or older.
- Participants must be neurologically stable after stroke, as determined by a qualified physician.
- Participants must have objective post-stroke dysarthria, defined as a score of 1 or 2 on the dysarthria item of the National Institutes of Health Stroke Scale (NIHSS).
- Participants must have a Korean Mini-Mental State Examination (K-MMSE) score of 26 or higher within 1 month before study entry.
- Participants must have sufficient vision, hearing, and motor function to complete the study procedures.
Key exclusion criteria (6 listed)
- Participants with structural problems in the oral or neck area that could interfere with accurate speech assessment.
- Participants diagnosed with dementia or who used medication for dementia within 3 months before screening.
- Participants who are illiterate.
- Participants with severe psychiatric illness, such as major depression, schizophrenia, or drug dependence.
- Participants with severe language impairment that would prevent use of the digital application.
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 |
|---|---|---|
| repeechParticipants in this group will use the repeech application for a period of 4 weeks, with recommended usage of 5 days per week for 30 to 60 minutes per session. A designated speech-language pathologist (SLP) will set individualized treatment goals and customize the content of the therapy sessions based on each participant's baseline assessment. The repeech intervention will be tailored to meet the specific needs of each participant to improve speech intelligibility and communication abilities. | Device | 'repeech' Intervention Group |
| WorkbookParticipants in the control group will use a workbook provided by the sponsor for the treatment of dysarthria, due to the lack of a standardized care protocol for this condition. The recommended usage is the same as the treatment group: 5 days per week, for 30 to 60 minutes per session over a period of 4 weeks. After each self-treatment session, participants will record their activities on a checklist to monitor adherence and ensure compliance with the study protocol. | Other | Control Group |
Primary outcome
Speech Intelligibility
Time frame: Baseline, 4 weeks (post-treatment), 8 weeks (Follow-up)
Speech intelligibility refers to how well a listener can understand the participant's speech. Participants will read a standardized Korean passage developed to assess speech intelligibility. Speech samples will be evaluated by three blinded speech-language pathologists (SLPs), who will independently assess intelligibility using a scale from 0 to 100, where 0 represents completely unintelligible speech and 100 represents fully intelligible speech. The average score from the three evaluations will be used for analysis. The primary outcome is the change in speech intelligibility from baseline to 4 weeks.
6 secondary outcomes
Maximum Phonation Time (MPT)
Time frame: Baseline, 4 weeks (post-treatment), 8 weeks (Follow-up)
Diadochokinetic Rate (DDK)
Time frame: Baseline, 4 weeks (post-treatment), 8 weeks (Follow-up)
Percentage of Consonants Correct (PCC)
Time frame: Baseline, 4 weeks (post-treatment), 8 weeks (Follow-up)
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline, 4 weeks (post-treatment), 8 weeks (Follow-up)
Quality of Life of Dysarthric Speakers (QoL-Dys)
Time frame: Baseline, 4 weeks (post-treatment), 8 weeks (Follow-up)
Treatment Adherence
Time frame: 4 weeks (post-treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repeech and Workbook in people with Post-stroke Dysarthria, run by HAII corp.ltd at 5 sites in South Korea.
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 7 inclusion and 6 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 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Speech Intelligibility (time frame: Baseline, 4 weeks (post-treatment), 8 weeks (Follow-up)). 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 Aug 2026.