- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06035198
Developement of Stroke Prognosis Predictive Precision Medicine Based on a Digital Twin
Developement of Prognosis Predictive Precision Medicine Based on a Digital Twin Reflecting the Motor Patterns in Stroke Patients
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.
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Gyeonggi-do
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Gyeonggi-do, Gyeonggi-do, South Korea, 13497
- Bundang CHA Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Stroke patients
Patients diagnosed with stroke at four hospitals in Korea
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No intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified Barthel Index (MBI)
Time Frame: 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)
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minimum 6 months to maximum 6 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mini Mental Status Examination (MMSE)
Time Frame: 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)
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minimum 6 months to maximum 6 years
|
|
Functional Ambulatory Category (FAC)
Time Frame: minimum 6 months to maximum 6 years
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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)
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minimum 6 months to maximum 6 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Seyoung Shin, MD, CHA University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RS-2023-00262005
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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