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

Recruiting

• Conditions: Stroke
• Interventions: Other: Stroke

• Registration Number: NCT06035198
• Lead Sponsor: Seyoung Shin

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 available

Study Timeline

• Study First Submitted: 2023-08-30
• Study First Submitted QC: 2023-09-06
• Study First Posted: 2023-09-13
• Status Verified: 2023-10
• Study Start: 2023-10-05
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-02
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Stroke patients	Stroke	Patients diagnosed with stroke at four hospitals in Korea

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Mini Mental Status Examination (MMSE)	minimum 6 months to maximum 6 years	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)	minimum 6 months to maximum 6 years	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)

Trial Locations

Locations (1)

Bundang CHA Medical Center; 🇰🇷 Gyeonggi-do, Korea, Republic of