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NCT Number: NCT04976894

Korean Stroke Cohort for Functioning and Rehabilitation-II

Korean Stroke Cohort for functioning and rehabilitation (KOSCO)-II 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 as previous similar stroke cohort with KOSCO. The main objectives of this study are to identify and compare the factors that influence residual disability and long-term quality of life in first-ever acute stroke patients with KOSCO. The secondary objectives of this study are to determine and compare the risk of mortality and recurrent vascular events in first-ever acute stroke patients with KOSCO. 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

open

Other

open

Primary outcomes

  1. Change in Korean modified Barthel Index

    Time frame: 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 Minimum: 0, Maximum: 100 Higher scores means a better.

  2. Change in Euro Quality of Life-5 Dimensions measurement for quality of life

    Time frame: 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 Minimum: 0, Maximum: 1 Higher scores means a better.

  3. Change in Functional Independence Measurement

    Time frame: 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 Minimum: 0, Maximum: 126 Higher scores means a better.

  4. Change in Korean Mini-Mental State Examination

    Time frame: 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 Minimum: 0, Maximum: 30 Higher scores means a better.

  5. Change in Korean Version of Frenchay Aphasia Screening Test

    Time frame: 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 Minimum: 0, Maximum: 30 Higher scores means a better.

  6. Change in modified Rankin Scale

    Time frame: 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

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

    Time frame: 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.

  8. Change in Geriatric depression scale-short form

    Time frame: 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.

    Minimum: 0, Maximum: 15. Lower scores means a better.

  9. Change in Functional Ambulatory Category

    Time frame: 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 Minimum: 0, Maximum: 5 Higher scores means a better.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Acronym: KOSCO-II

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Jul 26, 2021
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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