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Completed
NCT06670014
Evaluate the Efficacy and Safety of the Digital Therapeutics Repeech for the Post-Stroke Dysarthria.
Conditions: Post-stroke Dysarthria
Sex: All
Ages: 19 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 108
Sponsor: HAII corp.ltd
Location: Yongin Severance Hospital Yongin Gyeonggi-do
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. The study aims to assess improvement in speech intelligibility in individuals affected by post-stroke dysarthria using the DTx intervention.
Eligibility Criteria
Inclusion Criteria:
1. Participants must be 19 years of age or older.
2. Participants must be neurologically stable after stroke, as determined by a qualified physician.
3. 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).
4. Participants must have a Korean Mini-Mental State Examination (K-MMSE) score of 26 or higher within 1 month before study entry.
5. Participants must have sufficient vision, hearing, and motor function to complete the study procedures.
6. Participants must be able to use a tablet PC without difficulty.
7. Participants must provide voluntary written informed consent.
Exclusion Criteria:
1. Participants with structural problems in the oral or neck area that could interfere with accurate speech assessment.
2. Participants diagnosed with dementia or who used medication for dementia within 3 months before screening.
3. Participants who are illiterate.
4. Participants with severe psychiatric illness, such as major depression, schizophrenia, or drug dependence.
5. Participants with severe language impairment that would prevent use of the digital application.
6. Participants with any other clinical reason that, in the investigator's judgment, would make participation unsuitable.
Source: ClinicalTrials.gov (NCT06670014). StuddyBuddy aggregates publicly available trial information.