StrokeKOSCO-IINCT04976894
Korean Stroke Cohort for Functioning and Rehabilitation-II
An observational study of Stroke, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- open
- How many people
- 2,431 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2020to 31 Dec 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Adult, Older adult
Study population: All consecutive patients with an acute first-ever stroke, admitted to the representative hospitals in the nine distinct areas of Korea, will be asked to participate in the study. Participating study centres are Samsung Medical Center, Seoul; Severance Hospital, Seoul; Konkuk University Hospital, Seoul; Chungnam National University Hospital, Daejeon; Chonnam National University Hospital, Gwangu; Pusan National University Yangsan Hospital, Yangsan; Kyungpook National University Hospital, Deagu; Wonkwang University Hospital, Iksan; and Jeju National University Hospital, Jeju.
Who may be able to join
- 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.
Who cannot join
- Transient ischemic attack.
- History of stroke.
- Traumatic intracerebral hemorrhage.
- Not Korean.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Stroke
- Being tested
- open
- Keywords
- Stroke, Disability, Function, Rehabilitation, Burden
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
openOther
open
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Korean modified Barthel Index
measurement for activities of daily living Minimum: 0, Maximum: 100 Higher scores means a better.
Measured: 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.
Change in Euro Quality of Life-5 Dimensions measurement for quality of life
measurement for quality of life Minimum: 0, Maximum: 1 Higher scores means a better.
Measured: 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.
Change in Functional Independence Measurement
measurement for activities of daily living Minimum: 0, Maximum: 126 Higher scores means a better.
Measured: 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.
Change in Korean Mini-Mental State Examination
measurement for language function Minimum: 0, Maximum: 30 Higher scores means a better.
Measured: 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.
Change in Korean Version of Frenchay Aphasia Screening Test
measurement for language function Minimum: 0, Maximum: 30 Higher scores means a better.
Measured: 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.
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
Measured: 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
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.
Measured: 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
Change in Geriatric depression scale-short form
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.
Measured: 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
Change in Functional Ambulatory Category
measurement for gait function Minimum: 0, Maximum: 5 Higher scores means a better.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start1 Jan 2020
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,431 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yun-Hee Kim, Samsung Medical Center
- Investigators
- Yun-Hee Kim, MD.,PhD., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04976894
- Sponsor's protocol ID
- 2019-11-095
- Acronym
- KOSCO-II
- Status last verified
- Apr 2026
- First submitted
- 16 Jul 2021
- Last updated
- 28 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Korean Stroke Cohort for Functioning and Rehabilitation-II
- ClinicalTrials.gov ID
- NCT04976894
- Acronym / sponsor ID
- KOSCO-II / 2019-11-095
- Conditions
- Stroke
- Keywords
- Stroke, Disability, Function, Rehabilitation, Burden
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,431 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 26 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients with an acute first-ever stroke, admitted to the representative hospitals in the nine distinct areas of Korea, will be asked to participate in the study. Participating study centres are Samsung Medical Center, Seoul; Severance Hospital, Seoul; Konkuk University Hospital, Seoul; Chungnam National University Hospital, Daejeon; Chonnam National University Hospital, Gwangu; Pusan National University Yangsan Hospital, Yangsan; Kyungpook National University Hospital, Deagu; Wonkwang University Hospital, Iksan; and Jeju National University Hospital, Jeju.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Transient ischemic attack.
- History of stroke.
- Traumatic intracerebral hemorrhage.
- Not Korean.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| openopen | Other | – |
Primary outcome
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.
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.
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.
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.
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.
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
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yun-Hee Kim, MD.,PhD. principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.