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Recruiting Observational

Predicting Fall Risk in Stroke Patients Using a Machine Learning Model and Multi-Sensor Data

NCT06380049 · tracked via the Priya Life Science South Korea tracker
Phase
Observational
Started
2024-05-20
Last updated
2025-06-02

Condition(s) studied

StrokeFall

Investigational drug(s) / intervention(s)

EMG Analysis Software

EMG Analysis Software: Surface electromyography devices are non-invasive tools that measure electrical activity produced by skeletal muscles through sensors placed on the skin.

Study summary

The study assesses a machine learning model developed to predict fall risk among stroke patients using multi-sensor signals. This prospective, multicenter, open-label, sponsor-initiated confirmatory trial aims to validate the safety and efficacy of the model which utilizes electromyography (EMG) signals to categorize patients into high-risk or low-risk fall categories. The innovative approach hopes to offer a predictive tool that enhances preventative strategies in clinical settings, potentially reducing fall-related injuries in stroke survivors.

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
Accepted
Stroke Participants Inclusion Criteria: * 19 years and older * the onset of the stroke is less than 3months ago * Lower extremity weakness due to stroke (MMT =\< 4 grade) * Cognitive ability to follow commands Exclusion Criteria: * stroke recurrence * other neurological abnormalities (e.g. parkinson's disease). * severely impaired cognition * serious and complex medical conditions(e.g. active cancer) * cardiac pacemaker or other implanted electronic system Health Participants Inclusion Criteria: * 19 years and older * Individuals who fully understand the necessity of the study and have voluntarily consented to participate as subjects Exclusion Criteria: * other neurological abnormalities (e.g. parkinson's disease). * severely impaired cognition * serious and complex medical conditions(e.g. active cancer) * cardiac pacemaker or other implanted electronic system

Primary outcome measure(s)

  • Sensitivity of the Machine Learning Model — At the time of the single visit
    The primary outcome measure is the sensitivity of the machine learning model, which refers to its ability to correctly identify patients who are at high risk of falls. Sensitivity is defined as the proportion of actual positives that are correctly identified.

Trial sites (1)

FacilityCityRegionStatus
Seoul National University Hospital Seoul Jongno Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06380049 on ClinicalTrials.gov ↗ ← All trials in South Korea