KCT0008505
Not yet recruiting
未知
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
Korea Technology & Information Promotion Agency for SMEs0 sites68 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Korea Technology & Information Promotion Agency for SMEs
- Enrollment
- 68
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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