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

Sponsor
Seyoung Shin (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06035198
Collaborator
(none)
1,000
Enrollment
39
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Stroke

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Developement of Prognosis Predictive Precision Medicine Based on a Digital Twin Reflecting the Motor Patterns in Stroke Patients
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2026
Anticipated Study Completion Date :
Dec 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Stroke patients

Patients diagnosed with stroke at four hospitals in Korea

Other: Stroke
No intervention

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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)

  2. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Seyoung Shin

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Seyoung Shin, Principal Investigator, CHA University
ClinicalTrials.gov Identifier:
NCT06035198
Other Study ID Numbers:
  • RS-2023-00262005
First Posted:
Sep 13, 2023
Last Update Posted:
Sep 13, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Stroke

Study Results

No Results Posted as of Sep 13, 2023