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NCT Number: NCT07482579

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

To collect large-scale, high-quality clinical data, daily activity and movement patterns, and genomic information from stroke patients spanning the subacute to chronic stages.

This study aims to establish the foundation for personalized precision medicine in stroke care and to develop a visual and digital transformation of patient medical information in the era of digital healthcare.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bundang CHA Medical Center

Gyeonggi-do, 13497, South Korea

Location status: Recruiting

Location contact

Seyoung Shin, MD

CONTACT

[email protected]

+82427305000

About this study

This study aims to establish a comprehensive, high-quality dataset that captures the longitudinal characteristics of stroke recovery from the subacute to chronic stages. By integrating clinical data, daily activity and movement patterns, and genomic information, the study reflects the multidimensional nature of stroke in a real-world setting.

The collected data will support data-driven approaches in stroke care by enabling a better understanding of individual variability in recovery trajectories and facilitating the development of predictive models for functional outcomes.

In addition, this study seeks to contribute to personalized precision medicine by enabling individualized interpretation of patient data. It also supports the digital transformation of healthcare by facilitating structured, visual, and data-driven representations of patient medical information for improved clinical and research applications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 20 years or older with a confirmed diagnosis of stroke.
  • Within 1 month after stroke onset.
  • Patients scoring between 0 and 3 points on the Functional Ambulatory Category (FAC) test.
  • Patients or their legally authorized representatives who have fully understood the details of this study, voluntarily decided to participate, and provided written informed consent to comply with the study instructions.

Exclusion criteria

  • Patients with impaired ability to provide consent (MMSE score less than 10) who are not accompanied by a caregiver.
  • Any other cases deemed inappropriate for participation by the investigator. (This study is non-interventional; therefore, patients who are currently participating in or have participated in another clinical study or research within the past 30 days may still be included.)

Treatment and study plan

stroke

Other

No intervention

Primary outcomes

  1. Modified Barthel Index (MBI)

    Time frame: minimum <1 months to maximum 6 months

    A scale to measure disability or dependence in activities of daily living (ADL) of stroke survivors (range 0-100)

  2. Mini Mental Status Examination (MMSE)

    Time frame: minimum <1 months to maximum 6 months

    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)

  3. Functional Ambulatory Category (FAC)

    Time frame: minimum <1 months to maximum 6 months

    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)

  4. Fugl-Meyer Assessment (FMA)

    Time frame: minimum <1 months to maximum 6 months

    The Fugl-Meyer Assessment (FMA) is a performance-based scale used to evaluate motor functioning, balance, sensation, and joint functioning in patients who have experienced a stroke. The motor domain (score range 0-100) assesses movement, coordination, and reflexes of the upper and lower extremities, with higher scores indicating better motor recovery.

Study contacts

Contact information is provided by the study sponsor or research team.

Seyoung Shin, MD

CONTACT

[email protected]

+82437505000

Sponsors and collaborators

Lead sponsor

Seyoung Shin

Other

Registry information

Official study title

A Study for the Development of Prognosis Predictive Precision Medicine Based on a Digital Twin Reflexing the Motor Patterns in Stroke Patients: a Prospective Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 19, 2026
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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