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

NCT07482579 | Recruiting

• 1 other identifier: 2025-09-038
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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 transformation of patient medical information in the era of digital healthcare.

Conditions

Stroke

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Stroke patients

Patients diagnosed with stroke at two hospitals in Korea

Other: Stroke

Interventions

Stroke OTHER

No intervention

Stroke patients

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stroke patients receiving treatment at two hospitals in Korea

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Seyoung Shin: lead

Study Sites (1)

Bundang CHA Medical Center

Gyeonggi-do, Gyeonggi-do, 13497, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Seyoung Shin, MD

  CHA University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seyoung Shin, MD

CONTACT

+82437505000; seyoung0706@chamc.co.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 19, 2026
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 25, 2026

Record last verified: 2025-10

Locations

KR (1)