Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT05877950
Eligibility Criteria:
Inclusion Criteria:
1. Aged 18 or over.
2. Neurologically stable stroke patients diagnosed by a stroke specialist neurologist.
3. Diagnosis of dysarthria caused by stroke as confirmed by a stroke specialty neurologist.
4. First-ever stroke patients without previous stroke history.
5. Patients with sufficient cognitive abilities to operate the smartphone-based speech therapy application (Mini-Mental State Exam score ≥ 26)
6. As judged by the neurology specialists: patients with sufficient vision, hearing, communication skills, and motor skills to participate in this study
7. Must have voluntarily understood the trial and signed a consent form agreeing to comply with precautions.
Exclusion Criteria:
1. Co-existing language disorder (e.g., aphasia). Aphasia will be determined by a stroke specialist.
2. Co-existing progressive neurological disorders that can affect dysarthria (e.g., dementia, Pick's disease, Huntington's disease, Parkinson's disease, or Parkinsonism).
3. Diagnosis of severe mental disorders as determined by a clinician (e.g., depression, schizophrenia, alcohol addiction, or drug addiction).
4. Patients taking concomitant medications that could affect the trial results during the study period (e.g., cognitive dysfunction medications, anticholinergics, anti-epileptic drugs, anti-anxiety drugs, antidepressants, antipsychotics, and hypnotics).
5. Patients unable to use/access smartphone technology.
6. Illiterate patients.
7. Patients unable to communicate in Korean.
8. Is unsuitable for participation due to other reasons, as determined by the investigator.
9. Has refused to participate in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05877950
Study Brief:
Protocol Section:
NCT05877950