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

Stroke Clinical Trial

Official title:

Developement of Prognosis Predictive Precision Medicine Based on a Digital Twin Reflecting the Motor Patterns in Stroke Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06035198
• Other study ID #: RS-2023-00262005
• Status: Recruiting
• Start date: October 5, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: October 2023
• Source: CHA University
• Contact: Seyoung Shin, MD
• Phone: +821094113333
• Email: seyoung0706[@]chamc.co.kr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Stroke
No intervention

Locations

Country	Name	City	State
Korea, Republic of	Bundang CHA Medical Center	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seyoung Shin

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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 6 months to maximum 6 years