StrokeNCT06035198
Developement of Stroke Prognosis Predictive Precision Medicine Based on a Digital Twin
An observational study of Stroke, run by Seyoung Shin at 1 site in South Korea.
Trial summary
The purpose of this study is to realize customized precision medicine for stroke patients and the visual digitization of patient medical information required in the era of digital transformation. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Stroke
- How many people
- 1,192 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Oct 2023to 31 Dec 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stroke patients receiving treatment at four hospitals in Korea
Who may be able to join
- Adults over 20 years of age with a history of stroke onset between 2018.01.01 to 2023.07.31.
- Patients who exist rehabilitation medical evaluation after stroke onset
- Patients who voluntarily decide to participate in this study
Who cannot join
- Those who have severe internal diseases such as unstable conditions of the cardiovascular system, digestive system, respiratory system, endocrine system, etc. and are in poor overall condition.
- Those who have impaired ability to consent (MMSE score less than 10 points) and not accompanied by a care-giver.
- In any other cases where the researcher determines that participation in this study is not appropriate.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Bundang CHA Medical Center
Gyeonggi-do, Gyeonggi-do, 13497
About this study
Official title: Developement of Prognosis Predictive Precision Medicine Based on a Digital Twin Reflecting the Motor Patterns in Stroke Patients
The purpose of this study is to realize customized precision medicine for stroke patients and the visual digitization of patient medical information required in the era of digital transformation.
This study will collect large-scale, high-quality clinical data and daily life exercise pattern data covering the subacute to chronic stages of stroke patients. Based on this, we will use artificial intelligence analysis technology to predict the functional status of stroke patients in the chronic stage after their disability is fixed. We aim to develop the next generation of personalized digital twins by creating a prognostic prediction model.
- Conditions
- Stroke
- Being tested
- Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StrokeOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Stroke patients | Patients diagnosed with stroke at four hospitals in Korea Receives: Other: Stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Barthel Index (MBI)
A scale to measure disability or dependence in activities of daily living (ADL) of stroke survivors (range 0-100)
Measured: minimum 6 months to maximum 6 years
Secondary outcomes (2)
Mini Mental Status Examination (MMSE)
Mini-Mental State Examination (MMSE) is a 30-question assessment of cognitive function that evaluates attention and orientation, memory, registration, recall, calculation, language and ability to draw a complex polygon (range 0-30)
Measured: minimum 6 months to maximum 6 years
Functional Ambulatory Category (FAC)
The Functional Ambulation Categories (FAC) is a 6-point functional walking test that evaluates ambulation ability, determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device. (range 0-5)
Measured: minimum 6 months to maximum 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start5 Oct 2023
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
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.
- 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
- Other
- Enrolment
- 1,192 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Seyoung Shin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Seyoung Shin, CHA University
- Investigators
- Seyoung Shin, MD, Principal investigator, CHA University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035198
- Sponsor's protocol ID
- RS-2023-00262005
- Status last verified
- Feb 2025
- First submitted
- 30 Aug 2023
- Last updated
- 18 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developement of Prognosis Predictive Precision Medicine Based on a Digital Twin Reflecting the Motor Patterns in Stroke Patients
- ClinicalTrials.gov ID
- NCT06035198
- Acronym / sponsor ID
- RS-2023-00262005
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,192 participants (actual)
- Lead sponsor
- Seyoung ShinUniversity, hospital or other
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 13 Sep 2023 (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.
The purpose of this study is to realize customized precision medicine for stroke patients and the visual digitization of patient medical information required in the era of digital transformation.
This study will collect large-scale, high-quality clinical data and daily life exercise pattern data covering the subacute to chronic stages of stroke patients. Based on this, we will use artificial intelligence analysis technology to predict the functional status of stroke patients in the chronic stage after their disability is fixed. We aim to develop the next generation of personalized digital twins by creating a prognostic prediction model.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke patients | – | Other: StrokePatients diagnosed with stroke at four hospitals in Korea |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patients receiving treatment at four hospitals in Korea
Key inclusion criteria (3 listed)
- Adults over 20 years of age with a history of stroke onset between 2018.01.01 to 2023.07.31.
- Patients who exist rehabilitation medical evaluation after stroke onset
- Patients who voluntarily decide to participate in this study
Key exclusion criteria (3 listed)
- Those who have severe internal diseases such as unstable conditions of the cardiovascular system, digestive system, respiratory system, endocrine system, etc. and are in poor overall condition.
- Those who have impaired ability to consent (MMSE score less than 10 points) and not accompanied by a care-giver.
- In any other cases where the researcher determines that participation in this study is not appropriate.
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 |
|---|---|---|
| StrokeNo intervention | Other | Stroke patients |
Primary outcome
Modified Barthel Index (MBI)
Time frame: minimum 6 months to maximum 6 years
A scale to measure disability or dependence in activities of daily living (ADL) of stroke survivors (range 0-100)
2 secondary outcomes
Mini Mental Status Examination (MMSE)
Time frame: minimum 6 months to maximum 6 years
Functional Ambulatory Category (FAC)
Time frame: minimum 6 months to maximum 6 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
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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.
Seyoung Shin, MD principal investigator
CHA University
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 Seyoung Shin 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 3 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: finished, as of the sponsor's last update on 18 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Modified Barthel Index (MBI) (time frame: minimum 6 months to maximum 6 years). 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 18 Mar 2026.