NCT06670014Completed
Evaluate the Efficacy and Safety of the Digital Therapeutics Repeech for the Post-Stroke Dysarthria.
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.
Source: ClinicalTrials.gov · Last updated 7 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 108 (actual)
- First submitted
- 22 Oct 2024
- Start date
- 20 Nov 2024
- Primary completion date
- 17 Oct 2025
- Lead sponsor
- HAII corp.ltd
- Diseases
- Stroke
- NCT number
- NCT06670014
What you commit to
- Study type: Interventional
- Participants enrolled: 108
- From 20 Nov 2024 to the primary completion date, 17 Oct 2025
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants diagnosed with dementia or who used medication for dementia within 3 months before screening.
Other illness
- 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.
Other
- Participants with structural problems in the oral or neck area that could interfere with accurate speech assessment.
- Participants who are illiterate.
- Participants with any other clinical reason that, in the investigator's judgment, would make participation unsuitable.
Who the study is looking for
- 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.
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kyunghee university hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| National Rehabilitation Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Ewha Womans University Mokdong Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Ewha Womans University Seoul Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Yongin Severance Hospital Coordinator of this site? Confirm its status | Yŏngin | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.