Predicting Fall Risk in Stroke Patients Using a Machine Learning Model and Multi-Sensor Data
Development and Validation of a Machine Learning-based Model to Predict a High-risk Group for Falls Using Multi-sensor Signals in Stroke Patients
Sponsor study identifier
Secondary identifiers
OTHER · Ministry of Food and Drug Safety
observational
90
1 country
1
Study Start
May 20, 2024
Actual (reported)Primary Completion
March 12, 2025
Actual (reported)Study Completion
April 28, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 28, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 15, 2024
Actual (reported)April 23, 2024
Actual (reported)May 20, 2024
Actual (reported)March 12, 2025
Actual (reported)April 28, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Sensitivity of the Machine Learning Model
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.
At the time of the single visit
Specificity of the Machine Learning Model
At the time of the single visit
Area Under the Receiver Operating Characteristic Curve
At the time of the single visit
Matthews Correlation Coefficient
At the time of the single visit
Surface electromyography devices are non-invasive tools that measure electrical activity produced by skeletal muscles through sensors placed on the skin.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The study aims to enroll approximately 80 stroke patients and 10 healthy adults to facilitate a comprehensive analysis of the EMG-based machine learning model's effectiveness.
Seoul National University Hospital
Seoul, Jongno, 03080, South Korea
Woo Hyung Lee, prof
Seoul National University Hospital
Byung-Mo Oh, prof
Seoul National University Hospital
Han Gil Seo, prof
Seoul National University Hospital
Sung Eun Hyun, prof
Seoul National University Hospital
First Submitted
April 15, 2024
First Posted
April 23, 2024
Study Start
May 20, 2024
Actual (reported)Primary Completion
March 12, 2025
Actual (reported)Effects of a Cognitive Gait Dual Task With Smartglasses in Stroke Patients
Contact the study team to confirm eligibility.
Hyunmi Oh, prof
National Traffic Injury Rehabilitation Hospital
Sumin Oh, B.S.
National Traffic Injury Rehabilitation Hospital
SO YEON JEON, B.S.
Seoul National University Hospital
Study Completion
April 28, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 2, 2025
Record last verified: 2025-05
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