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

NCT06035198 | Completed

• 1 other identifier: RS-2023-00262005
• Study Type: observational
• Target: 1,192
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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 (2)

• Mini Mental Status Examination (MMSE)

  minimum 6 months to maximum 6 years

• Functional Ambulatory Category (FAC)

  minimum 6 months to maximum 6 years

Study Arms (1)

Stroke patients

Patients diagnosed with stroke at four 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 four hospitals in Korea

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seyoung Shin: lead

Study Sites (1)

Bundang CHA Medical Center

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

Location

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

Study Design

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

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: September 13, 2023
• Study Start: October 5, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 18, 2026

Record last verified: 2025-02

Locations

KR (1)