Developement of Stroke Prognosis Predictive Precision Med... | NCT06035198

Studies
Developement of Stroke Prognosis Predictive Precision Medicine Based on a Digital Twin

NCT06035198

Sponsor

Seyoung Shin

Status

Completed

Last Update Posted

Mar 18, 2026Actual

Enrollment

1,192Actual

Phase

Not provided

Conditions

Stroke

Interventions

Stroke

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 5, 2023Actual

Primary Completion Date

Dec 31, 2025Actual

Completion Date

Dec 31, 2025Actual

First Submitted Date

Aug 30, 2023

First Submission Date that Met QC Criteria

Sep 6, 2023

First Posted Date

Sep 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2026

Last Update Posted Date

Mar 18, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,192Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stroke patients		Patients diagnosed with stroke at four hospitals in Korea	Other: Stroke

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Stroke	Other	No intervention	Stroke patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Modified Barthel Index (MBI)	A scale to measure disability or dependence in activities of daily living (ADL) of stroke survivors (range 0-100)	minimum 6 months to maximum 6 years

Secondary Outcomes

Measure	Description	Time Frame
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)	minimum 6 months to maximum 6 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Stroke patients receiving treatment at four hospitals in Korea

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Seyoung Shin, MD	CHA University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bundang CHA Medical Center		Gyeonggi-do	Gyeonggi-do	13497	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided