A Study for the Development of Prognosis Predictive Precision Medicine Based on a Digital Twin Reflexing the Motor Patterns in Stroke Patients: a Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Modified Barthel Index (MBI)
研究概览
简要总结
To collect large-scale, high-quality clinical data, daily activity and movement patterns, and genomic information from stroke patients spanning the subacute to chronic stages.
This study aims to establish the foundation for personalized precision medicine in stroke care and to develop a visual and digital transformation of patient medical information in the era of digital healthcare.
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
- 否
入选标准
- •Adults aged 20 years or older with a confirmed diagnosis of stroke.
- •Within 1 month after stroke onset.
- •Patients scoring between 0 and 3 points on the Functional Ambulatory Category (FAC) test.
- •Patients or their legally authorized representatives who have fully understood the details of this study, voluntarily decided to participate, and provided written informed consent to comply with the study instructions.
排除标准
- •Patients with impaired ability to provide consent (MMSE score less than 10) who are not accompanied by a caregiver.
- •Any other cases deemed inappropriate for participation by the investigator. (This study is non-interventional; therefore, patients who are currently participating in or have participated in another clinical study or research within the past 30 days may still be included.)
研究组 & 干预措施
Stroke patients
Patients diagnosed with stroke at two hospitals in Korea
干预措施: Stroke (Other)
结局指标
主要结局
Modified Barthel Index (MBI)
时间窗: minimum 6 months to maximum 6 years
A scale to measure disability or dependence in activities of daily living (ADL) of stroke survivors (range 0-100)
Mini Mental Status Examination (MMSE)
时间窗: minimum 6 months to maximum 6 years
Mini-Mental State Examination (MMSE) is a 30-question assessment of cognitive function that evaluates attention and orientation, memory, registration, recall, calculation, language and ability to draw a complex polygon (range 0-30)
Functional Ambulatory Category (FAC)
时间窗: minimum 6 months to maximum 6 years
The Functional Ambulation Categories (FAC) is a 6-point functional walking test that evaluates ambulation ability, determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device. (range 0-5)
Fugl-Meyer Assessment (FMA)
时间窗: minimum 6 months to maximum 6 years
The Fugl-Meyer Assessment (FMA) is a performance-based scale used to evaluate motor functioning, balance, sensation, and joint functioning in patients who have experienced a stroke. The motor domain (score range 0-100) assesses movement, coordination, and reflexes of the upper and lower extremities, with higher scores indicating better motor recovery.
次要结局
未报告次要终点
研究者
Seyoung Shin
Principal Investigator
CHA University