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

Stroke Clinical Trial

Official title:

Development and Validation of a Machine Learning-based Model to Predict a High-risk Group for Falls Using Multi-sensor Signals in Stroke Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06380049
• Other study ID #: 0720242110
• Secondary ID: 20240012366
• Status: Not yet recruiting
• Start date: April 29, 2024
• Est. completion date: April 28, 2026

Study information

• Verified date: April 2024
• Source: Seoul National University Hospital
• Contact: JungHyun Kim, prof
• Phone: 82+1088632341
• Email: kiking0[@]naver.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Objective: The primary objective is to develop and validate a machine learning-based model that uses multi-sensor (EMG) signals to identify stroke patients at high risk of falls. This model aims to improve on traditional fall risk assessments which rely heavily on physical assessments and patient history.

Study Design: This is a prospective, multicenter, open-label, confirmatory clinical trial. It involves collecting EMG data from stroke patients and applying machine learning techniques to predict fall risk. The study will compare the predictive accuracy of the machine learning model against conventional fall risk assessment tools.

Methods:

1. Participants:

• Sample Size: 80 stroke patients and 10 healthy adults to establish baseline EMG readings.

2. Interventions:

• Participants will undergo EMG signal collection from key lower limb muscles while performing standardized movements.

3. Outcome Measures:

• Primary Outcome: Sensitivity and specificity of the machine learning model in predicting high-risk fall patients.

• Secondary Outcomes: Comparison of the machine learning model's predictive performance with traditional fall risk assessment tools (e.g., Berg Balance Scale).

Data Collection:

• EMG sensors will be attached to the patients' muscles of the lower limbs. Sensors will record muscle activity during movement, which will then be analyzed using the machine learning model.

• The predictive model will be trained using features extracted from the EMG signals, and its performance will be validated against actual fall incidents reported during the follow-up period.

Statistical Analysis:

• The machine learning model's efficacy will be measured through its sensitivity (ability to correctly identify high-risk patients) and specificity (ability to correctly identify low-risk patients).

• Receiver Operating Characteristic (ROC) curves and Area Under the Curve (AUC) statistics will be used to assess model performance.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: April 28, 2026
• Est. primary completion date: April 28, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fall
• Stroke

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Ministry of Trade, Industry & Energy, Republic of Korea

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Area Under the Receiver Operating Characteristic Curve	This is a performance measurement for classification problems at various threshold settings. ROC is a probability curve, and AUC represents the degree or measure of separability. It tells how much the model is capable of distinguishing between classes.	At the time of the single visit
Other	Matthews Correlation Coefficient	The MCC is used in machine learning as a measure of the quality of binary classifications. It takes into account true and false positives and negatives and is generally regarded as a balanced measure which can be used even if the classes are of very different sizes.	At the time of the single visit
Primary	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
Secondary	Specificity of the Machine Learning Model	Specificity measures the proportion of actual negatives that are correctly identified.	At the time of the single visit