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Korean Stroke Cohort for Functioning and Rehabilitation-II

Korean Stroke Cohort for Functioning and Rehabilitation-II

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04976894
Acronym
KOSCO-II
Enrollment
2431
Registered
2021-07-26
Start date
2020-01-01
Completion date
2030-12-31
Last updated
2024-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Stroke, Disability, Function, Rehabilitation, Burden

Brief summary

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.

Interventions

OTHERopen

open

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Korean modified Barthel Index3 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.
Change in Euro Quality of Life-5 Dimensions measurement for quality of life3 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.
Change in Functional Independence Measurement3 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.
Change in Korean Mini-Mental State Examination7 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.
Change in Korean Version of Frenchay Aphasia Screening Test7 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.
Change in modified Rankin Scale7 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 onsetMeasurement 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 American Speech-Language-Hearing Association National Outcome Measurement System Swallowing Scale7 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 onsetMeasurement 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 Geriatric depression scale-short form3 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 onsetmeasurement 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.
Change in Functional Ambulatory Category7 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 onsetmeasurement for gait function Minimum: 0, Maximum: 5 Higher scores means a better.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026