Evaluate the Efficacy and Safety of the Digital Therapeutics Repeech for the Post-Stroke Dysarthria. (NCT06670014) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluate the Efficacy and Safety of the Digital Therapeutics Repeech for the Post-Stroke Dysarthria.
South Korea92 participantsStarted 2024-11-20
Plain-language 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.
Who can participate
Age range19 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Participants must be 19 years of age or older.
✓. Participants must be neurologically stable post-stroke, as determined by a qualified physician.
✓. Participants must have dysarthria due to stroke, with a National Institutes of Health Stroke Scale (NIHSS) score 1 (mild) or 2 (moderate) for dysarthria.
✓. participants must have a Korean-Modified Mini-Mental State Examination (K-MMSE) score of 26 or higher within 1 month prior to enrollment in the study.
✓. Participants must have sufficient visual, auditory, langauge, and motor abilities to understand and follow the assessment procedures, as determined by the Principal Investigator.
✓. Participants must be able to use general-purpose digital equipment and comfortable with using the digital therapeutics(DTx) platform for this study.
✓. Participants must provide informed consent after receiving a thorough explanation of the study, including potential risks and benefits. They must understand and agree to follow the study protocol.
Exclusion criteria
✕. Participants with sigificant structural problems affecting the oral cavity and cervial region that would hinder accurate assessment.
✕. Participants diagnosed with dementia, including Alzheimer's disease, Vascular dementia, Dementia due to Central Nervous System(CNS) infections (e.g., HIV, syphilis), Creutzfeldt-Jakob disease, Pick's disease, Huntington's disease, Parkinson's disease.
. Participants currently receiving treatment for dementia within 3 months prior to study screening.
✕. Participants who are unable to read or write in the language of the study.
✕. Participants with severe mental health conditions including severe depression, schizophrenia, alcohol addicsion, drug dependence.
✕. Participants with a severe langauge disorder, as determined by the physician(MD), that would significantly hinder their abiity to use digital therapeutics platform.
✕. Participants deemed by the MD as unable to use general-purpose digital equipment.
✕. Participants with additional medical or social concerns that, in the opinion of the Prindipal Investigator(PI), would make their participation in the clinical trial unsuitable or pose siginficant risks.