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.

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.

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.

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.