A prospective, randomized, multi-centered clinical trial to investigate the effectiveness of the digital therapeutic device 'StroKcare' for speech rehabilitation for people with post-stroke dysarthria
- Conditions
- Symptoms, signs and abnormal clinical and laboratory findings, NEC
- Registration Number
- KCT0008505
- Lead Sponsor
- Korea Technology & Information Promotion Agency for SMEs
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 68
1. Adults over 19 years of age
2. Neurologically stable stroke patients as judged by doctors
3. Patients with paralysis due to stroke objectively from the doctor's judgment
4. A person with a cognitive function who has no problem using this digital treatment with a score of 21 or higher on the examination within one month of application of the digital treatment device
5. A person who has sufficient vision, hearing, language ability, motor function, and understanding to follow the test procedure
6. Those who have no difficulty using the mobile application of this study using general purpose equipment (smartphone)
7. A person who has heard and understood sufficient explanation of this clinical trial, has voluntarily decided to participate and has agreed in writing to comply with the precautions
1. Patients with organic problems in oral and cervical structures, making it difficult to accurately measure
2. Patients diagnosed with dementia (including Alzheimer's disease, vascular dementia, infections of the central nervous system (e.g., HIV, syphilis, etc.), Crozfeldt-Jacob disease, Pixie disease, Huntington's disease, Parkinson's disease, etc.)
3. Those who have a CDR score of 1 or higher evaluated at the time of screening
4. A person who has administered dementia treatment within the past three months as of the time of screening
5. A person who is illiterate
6. A person with serious mental illnesses such as severe depression, schizophrenia, alcoholism, and drug dependence
7. A person who is unable to use a digital treatment due to severe speech impairment when judged by a doctor
8. Those who have difficulty using a smartphone
9. A person who determines that the tester is unfit to participate in a clinical trial due to other reasons
10. Those who refused to participate in this study
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Speech Intelligibility
- Secondary Outcome Measures
Name Time Method Maximum Phonation Time;Diadochokinesis;Percentage of Phonemes Correct;Patient Health Questionnaire-9;Quality of Life in the Dysarthric Speaker;Communicative Effectiveness Survey