NCT05908994招募中不适用
A Study for the Collection of Clinical Data for Stroke Patients and Healthy Subjects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Changes in motion analysis
研究概览
简要总结
This study aimes to medical data, musculoskeletal data and functional data over time of stroke patients and healthy subjects to compared the clinical differences between stroke and healthy subjects.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults over 20 years of age
- •More than 1 month after onset of stroke
- •After hearing a detailed explanation of this study and fully understanding it, the subject or legal representative voluntarily decides to participate and agrees in writing to observe the precautions 2) Exclusion criteria:
- •Patients who correspond to one or more of the following cannot participate in the study.
- •Patients with systemic infectious symptoms at the time of participation in the study
- •In the case of a person with impaired ability to consent (less than 10 points on the MMSE), a person who is not accompanied by a guardian
- •Those with severe medical conditions such as unstable conditions in the cardiovascular system, digestive system, respiratory system, endocrine system, etc., and those with poor general health
- •Other cases where the researcher judges that participation in this study is not suitable(Patients who are participating in other clinical trials or studies, or who have participated in other clinical trials or studies within the past 30 days can also participate in this study.)
- •For healthy voluteers 1) Inclusion Criteria:
- •Over 20 years of age
- •A person who is performing an independent daily life
- •A person who voluntarily decides to participate and agrees in writing to abide by the precautions after hearing a detailed explanation of this study and fully understanding it
- •Exclusion criteria:
- •Patients who correspond to one or more of the following cannot participate in the study.
- •MMSE score less than 20 points (from 19 points onwards excluded from study)
- •Those who remain disabled due to brain disease (stroke, brain tumor, cerebral palsy, dementia, Parkinson's disease, etc.)
- •Those with severe medical conditions such as unstable conditions in the cardiovascular system, digestive system, respiratory system, endocrine system, etc., and those with poor general health
- •Other cases where the researcher judges that participation in this study is not suitable (Patients who are participating in other clinical trials or studies, or who have participated in other clinical trials or studies within the past 30 days can also participate in this study.)
排除标准
- 未提供
结局指标
主要结局
Changes in motion analysis
时间窗: Change from baseline to 6 months, 12 months, 18 months and 24 months
Motion analysis is a process of measuring and evaluating gait function in kinetic and kinematic parameters
次要结局
- Changes in Fugl-meyer assessement (FMA)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
- Changes in X-ray radiography(Change from baseline to 6 months, 12 months, 18 months and 24 months)
- Changes in motor assessment scale (MAS)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
- Changes in magnetic resonanace imaging (MRI)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
- Changes in motricity index (MI)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
- Changes in Gait rite(Change from baseline to 6 months, 12 months, 18 months and 24 months)
- Changes in time up and go test (TUG)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
- Changes in computed tomogrphy (CT)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
- Changes in manual muscle test (MMT)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
- Changes in range of motion (ROM)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
- Changes in berg balance scale (BBS)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
- Changes in trunk impairment scale (TIS)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
- Changes in functional ambulatory category (FAC)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
- Changes in action research arm test (ARAT)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
- Changes in fuctional independence meausure (FIM)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
- Changes in modified barthel-index (MBI)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
- Changes in national institute of health care stroke scale (NIHSS)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
- Changes in stroke specific quality of life (SS-QoL)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
- Changes in Korean version of Montreal cognitive assessment (K-MoCA)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
- Changes in Korean version of mini-mental state examination (K-MMSE)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
- Changes in global deterioration scale (GDS)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
- Changes in Oxford cognitive screen (OCS)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
- Changes in clinical dementia rating (CDR)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
- Changes in geriatric depression scale (GDS)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
- Changes in stroop test(Change from baseline to 6 months, 12 months, 18 months and 24 months)
- Changes in evoked potentials (EP)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
- Changes in Korean version of Wechsler adult intelligence scale 4th edition (K-WAIS-IV)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
- Changes in Rey-kim test(Change from baseline to 6 months, 12 months, 18 months and 24 months)
- Changes in digit span test(Change from baseline to 6 months, 12 months, 18 months and 24 months)
- Changes in electroencephalogrphy (EEG)(Change from baseline to 6 months, 12 months, 18 months and 24 months)
研究者
MinYoung Kim, MD, PhD
Principle investigator
Bundang CHA Hospital
研究点 (1)
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