Development of Stroke Prognosis Predictive Precision Medicine Based on a Digital Twin

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: Stroke

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 Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

• Study Contact: Name: Seyoung Shin, MD; Phone Number: +82437505000; Email: seyoung0706@chamc.co.kr

Study Locations

• South Korea
  • Gyeonggi-do
    • Gyeonggi-do, Gyeonggi-do, South Korea, 13497
      • Recruiting
      • Bundang CHA Medical Center
      • Contact: Seyoung Shin, MD; Phone Number: +82427305000; Email: seyoung0706@chamc.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Stroke patients receiving treatment at two hospitals in Korea

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Stroke patients; Patients diagnosed with stroke at two hospitals in Korea	Other: Stroke; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 <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)	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)	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.	minimum <1 months to maximum 6 months

Collaborators and Investigators

• Sponsor: Seyoung Shin
• Investigators: Principal Investigator: Seyoung Shin, MD, CHA University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 16, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 19, 2026

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 22, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: 2025-09-038

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No