StrokeNCT07482579
Development 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
To collect large-scale, high-quality clinical data, daily activity and movement patterns, and genomic information from stroke patients spanning the subacute to chronic stages. This study aims to establish the foundation for personalized precision medicine in stroke care and to develop a visual and digital… 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
- 70 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2025to 31 Dec 2026
- How long will I take part?
- 6 Months
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stroke patients receiving treatment at two hospitals in Korea
Who may be able to join
- Adults aged 20 years or older with a confirmed diagnosis of stroke.
- Within 1 month after stroke onset.
- Patients scoring between 0 and 3 points on the Functional Ambulatory Category (FAC) test.
- Patients or their legally authorized representatives who have fully understood the details of this study, voluntarily decided to participate, and provided written informed consent to comply with the study instructions.
Who cannot join
- Patients with impaired ability to provide consent (MMSE score less than 10) who are not accompanied by a caregiver.
- Any other cases deemed inappropriate for participation by the investigator. (This study is non-interventional; therefore, patients who are currently participating in or have participated in another clinical study or research within the past 30 days may still be included.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Bundang CHA Medical Center
Gyeonggi-do, Gyeonggi-do, 13497
Seyoung Shin, MD, +82427305000, seyoung0706@chamc.ac.kr
About this study
Official title: A Study for the Development of Prognosis Predictive Precision Medicine Based on a Digital Twin Reflexing the Motor Patterns in Stroke Patients: a Prospective Study
To collect large-scale, high-quality clinical data, daily activity and movement patterns, and genomic information from stroke patients spanning the subacute to chronic stages.
This study aims to establish the foundation for personalized precision medicine in stroke care and to develop a visual and digital transformation of patient medical information in the era of digital healthcare.
Read the detailed description
This study aims to establish a comprehensive, high-quality dataset that captures the longitudinal characteristics of stroke recovery from the subacute to chronic stages. By integrating clinical data, daily activity and movement patterns, and genomic information, the study reflects the multidimensional nature of stroke in a real-world setting.
The collected data will support data-driven approaches in stroke care by enabling a better understanding of individual variability in recovery trajectories and facilitating the development of predictive models for functional outcomes.
In addition, this study seeks to contribute to personalized precision medicine by enabling individualized interpretation of patient data. It also supports the digital transformation of healthcare by facilitating structured, visual, and data-driven representations of patient medical information for improved clinical and research applications.
- 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 two 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 <1 months to maximum 6 months
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 <1 months to maximum 6 months
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 <1 months to maximum 6 months
Fugl-Meyer Assessment (FMA)
The Fugl-Meyer Assessment (FMA) is a performance-based scale used to evaluate motor functioning, balance, sensation, and joint functioning in patients who have experienced a stroke. The motor domain (score range 0-100) assesses movement, coordination, and reflexes of the upper and lower extremities, with higher scores indicating better motor recovery.
Measured: minimum <1 months to maximum 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start1 Nov 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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.
- 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
- 70 participants (estimated)
- 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
- NCT07482579
- Sponsor's protocol ID
- 2025-09-038
- Status last verified
- Oct 2025
- First submitted
- 16 Mar 2026
- Last updated
- 25 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 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study for the Development of Prognosis Predictive Precision Medicine Based on a Digital Twin Reflexing the Motor Patterns in Stroke Patients: a Prospective Study
- ClinicalTrials.gov ID
- NCT07482579
- Acronym / sponsor ID
- 2025-09-038
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Seyoung ShinUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Mar 2026 (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.
To collect large-scale, high-quality clinical data, daily activity and movement patterns, and genomic information from stroke patients spanning the subacute to chronic stages.
This study aims to establish the foundation for personalized precision medicine in stroke care and to develop a visual and digital transformation of patient medical information in the era of digital healthcare.
Detailed description
This study aims to establish a comprehensive, high-quality dataset that captures the longitudinal characteristics of stroke recovery from the subacute to chronic stages. By integrating clinical data, daily activity and movement patterns, and genomic information, the study reflects the multidimensional nature of stroke in a real-world setting.
The collected data will support data-driven approaches in stroke care by enabling a better understanding of individual variability in recovery trajectories and facilitating the development of predictive models for functional outcomes.
In addition, this study seeks to contribute to personalized precision medicine by enabling individualized interpretation of patient data. It also supports the digital transformation of healthcare by facilitating structured, visual, and data-driven representations of patient medical information for improved clinical and research applications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke patients | – | Other: StrokePatients diagnosed with stroke at two 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 two hospitals in Korea
Key inclusion criteria (4 listed)
- Adults aged 20 years or older with a confirmed diagnosis of stroke.
- Within 1 month after stroke onset.
- Patients scoring between 0 and 3 points on the Functional Ambulatory Category (FAC) test.
- Patients or their legally authorized representatives who have fully understood the details of this study, voluntarily decided to participate, and provided written informed consent to comply with the study instructions.
Key exclusion criteria (2 listed)
- Patients with impaired ability to provide consent (MMSE score less than 10) who are not accompanied by a caregiver.
- Any other cases deemed inappropriate for participation by the investigator. (This study is non-interventional; therefore, patients who are currently participating in or have participated in another clinical study or research within the past 30 days may still be included.)
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 <1 months to maximum 6 months
A scale to measure disability or dependence in activities of daily living (ADL) of stroke survivors (range 0-100)
Mini Mental Status Examination (MMSE)
Time frame: minimum <1 months to maximum 6 months
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)
Functional Ambulatory Category (FAC)
Time frame: minimum <1 months to maximum 6 months
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)
Fugl-Meyer Assessment (FMA)
Time frame: minimum <1 months to maximum 6 months
The Fugl-Meyer Assessment (FMA) is a performance-based scale used to evaluate motor functioning, balance, sensation, and joint functioning in patients who have experienced a stroke. The motor domain (score range 0-100) assesses movement, coordination, and reflexes of the upper and lower extremities, with higher scores indicating better motor recovery.
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 25 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.
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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 25 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?
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?
Contact Seyoung Shin, MD (+82437505000, seyoung0706@chamc.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Barthel Index (MBI) (time frame: minimum <1 months to maximum 6 months). The study lists 4 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 25 Mar 2026.