RecruitingNCT06380049

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

Seoul National University Hospital

Enrollment

90 participants

Start Date

May 20, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 19 Years

Inclusion Criteria7

  • Stroke Participants
  • 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
  • years and older
  • Individuals who fully understand the necessity of the study and have voluntarily consented to participate as subjects

Exclusion Criteria10

  • 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
  • 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

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Interventions

DEVICEEMG Analysis Software

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


Locations(1)

Seoul National University Hospital

Seoul, Jongno, South Korea

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NCT06380049


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