Korean Stroke Cohort for Functioning and Rehabilitation

Stroke Clinical Trial

Official title:

Korean Stroke Cohort for Functioning and Rehabilitation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03402451
• Other study ID #: 2012-06-016-001
• Status: Active, not recruiting
• Start date: August 1, 2012
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2021
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7858
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. 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.

2. Age = 19 years at onset of stroke.

3. Onset of symptoms within seven days prior to inclusion.

Exclusion Criteria:

1. Transient ischemic attack.

2. History of stroke.

3. Traumatic intracerebral hemorrhage.

4. Not Korean.

Related Conditions & MeSH terms

• Burden
• Disability
• Function
• Rehabilitation
• Stroke

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	Korean Center for Disease Control and Prevention

References & Publications (8)

Chang WH, Sohn MK, Lee J, Kim DY, Lee SG, Shin YI, Oh GJ, Lee YS, Joo MC, Han EY, Kang C, Kim YH. Predictors of functional level and quality of life at 6 months after a first-ever stroke: the KOSCO study. J Neurol. 2016 Jun;263(6):1166-77. doi: 10.1007/s0 — View Citation

Chang WH, Sohn MK, Lee J, Kim DY, Lee SG, Shin YI, Oh GJ, Lee YS, Joo MC, Han EY, Kim JH, Kim YH. Return to work after stroke: The KOSCO Study. J Rehabil Med. 2016 Mar;48(3):273-9. doi: 10.2340/16501977-2053. — View Citation

Chang WH, Sohn MK, Lee J, Kim DY, Lee SG, Shin YI, Oh GJ, Lee YS, Joo MC, Han EY, Kim MS, Jang SY, Kim JH, Kim YH. Long-term functional outcomes of patients with very mild stroke: does a NIHSS score of 0 mean no disability? An interim analysis of the KOSC — View Citation

Chang WH, Sohn MK, Lee J, Kim DY, Lee SG, Shin YI, Oh GJ, Lee YS, Joo MC, Han EY, Kim YH. Korean Stroke Cohort for functioning and rehabilitation (KOSCO): study rationale and protocol of a multi-centre prospective cohort study. BMC Neurol. 2015 Mar 25;15:42. doi: 10.1186/s12883-015-0293-5. — View Citation

Jang SY, Shin YI, Kim DY, Sohn MK, Lee J, Lee SG, Oh GJ, Lee YS, Joo MC, Han EY, Chang WH, Kang C, Kim YH. Effect of obesity on functional outcomes at 6 months post-stroke among elderly Koreans: a prospective multicentre study. BMJ Open. 2015 Dec 18;5(12) — View Citation

Jang SY, Sohn MK, Lee J, Kim DY, Lee SG, Shin YI, Oh GJ, Lee YS, Joo MC, Han EY, Chang WH, Lee A, Kim JH, Kim YH. Chronic Kidney Disease and Functional Outcomes 6 Months after Ischemic Stroke: A Prospective Multicenter Study. Neuroepidemiology. 2016;46(1) — View Citation

Yoon JA, Kim DY, Sohn MK, Lee J, Lee SG, Lee YS, Han EY, Joo MC, Oh GJ, Han J, Lee SW, Park M, Chang WH, Shin YI, Kim YH. Effect of stress hyperglycemia and intensive rehabilitation therapy in non-diabetic hemorrhagic stroke: Korean Stroke Cohort for Func — View Citation

Yoon JA, Kim DY, Sohn MK, Lee J, Lee SG, Lee YS, Han EY, Joo MC, Oh GJ, Han J, Park M, Park KP, Noh KH, Chang WH, Shin YI, Kim YH. Factors associated with improvement or decline in cognitive function after an ischemic stroke in Korea: the Korean stroke co — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Korean modified Barthel Index	measurement for activities of daily living	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
Primary	Change in Euro Quality of Life-5 Dimensions	measurement for quality of life	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
Primary	Change in Functional Independence Measurement	measurement for activities of daily living	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
Primary	Change in Korean Mini-Mental State Examination	measurement for cognitive function	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
Primary	Change in Korean Version of Frenchay Aphasia Screening Test	measurement for language function	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
Primary	Change in modified Rankin Scale	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 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
Primary	Change in American Speech-Language-Hearing Association National Outcome Measurement System Swallowing Scale	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.	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
Primary	Change in Geriatric depression scale-short form	measurement for depression. The scale is 0 to 15. 0 is normal whereas 15 indicates severe depression.	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
Primary	Change in Fugl-Meyer Assessment	measurement for motor function	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
Primary	Change in Functional Ambulatory Category	measurement for gait function	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