KCT0008505尚未招募Unknown
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 个研究点目标入组 68 人开始时间: 待定最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 68
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
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