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临床试验/NCT03402451
NCT03402451Unknown不适用

Korean Stroke Cohort for Functioning and Rehabilitation

Samsung Medical Center0 个研究点目标入组 7,858 人开始时间: 2012年8月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
7,858
主要终点
Change in Functional Ambulatory Category

研究概览

简要总结

Korean Stroke Cohort for functioning and rehabilitation (KOSCO) is a large, multi-centre prospective cohort study for all acute first-ever stroke patients admitted to participating hospitals in nine distinct areas of Korea. This study is designed as a 10-year, longitudinal follow-up investigating the residual disabilities, activity limitations, and quality of life issues arising in patients suffering from first-ever stroke. The main objectives of this study are to identify the factors that influence residual disability and long-term quality of life. The secondary objectives of this study are to determine the risk of mortality and recurrent vascular events in patients with acute first-ever stroke. Investigators will investigate longitudinal health behaviors and patterns of healthcare utilization, including stroke rehabilitation care. Investigators will also investigate the long-term health status, mood, and quality of life in stroke patient caregivers. In addition, investigators will identify baseline and ongoing characteristics that are associated with secondary outcomes.

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
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • First-ever acute stroke (ischemic stroke or intracerebral hemorrhage) with corresponding lesion and/or evidence of acute arterial occlusion on CT (A)- or MRI/A-scan.
  • Age ≥ 19 years at onset of stroke.
  • Onset of symptoms within seven days prior to inclusion.

排除标准

  • Transient ischemic attack.
  • History of stroke.
  • Traumatic intracerebral hemorrhage.
  • Not Korean.

结局指标

主要结局

Change in Functional Ambulatory Category

时间窗: 7 days, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months after stroke onset

measurement for gait function

Change in Korean Mini-Mental State Examination

时间窗: 7 days, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months after stroke onset

measurement for cognitive function

Change in American Speech-Language-Hearing Association National Outcome Measurement System Swallowing Scale

时间窗: 7 days, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months after stroke onset

Measurement for swallowing function. Range of scale is 0 to 7, and greater value means better function. For example, 7 means no swallowing difficulty at all.

Change in Euro Quality of Life-5 Dimensions

时间窗: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months after stroke onset

measurement for quality of life

Change in Korean Version of Frenchay Aphasia Screening Test

时间窗: 7 days, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months after stroke onset

measurement for language function

Change in Geriatric depression scale-short form

时间窗: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months after stroke onset

measurement for depression. The scale is 0 to 15. 0 is normal whereas 15 indicates severe depression.

Change in Korean modified Barthel Index

时间窗: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months after stroke onset

measurement for activities of daily living

Change in Functional Independence Measurement

时间窗: 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months after stroke onset

measurement for activities of daily living

Change in modified Rankin Scale

时间窗: 7 days, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months after stroke onset

Measurement for disability. Range of total score 0 to 6. 0 is no disability at all and 6 is death. Therefore, greater value means worse functional status

Change in Fugl-Meyer Assessment

时间窗: 7 days, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months, 72 months, 84 months, 96 months, 108 months after stroke onset

measurement for motor function

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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