Clinical trial Recruiting at 1 site Observational Ages 19 and up

Predicting fall risk in stroke patients using machine learning on multi-sensor EMG data

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

Run by Seoul National University Hospital · NCT06380049 · Data updated 2026-11-12

This project tests whether a machine-learning model that analyzes EMG sensor signals can tell which stroke patients are at high risk of falling.

Quick facts

Study typeObservational
Ages19 Years and up
SexAll
Enrollment90 (estimated)
SponsorSeoul National University Hospital
Academic / other
Locations1 site (Seoul, Jongno)
StatusRecruiting
StartedMay 20, 2024
Main results expectedMarch 12, 2025
Study endsApril 28, 2026
Registry record updatedJune 2, 2025
Trial IDNCT06380049 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 19 or older within three months of a first stroke with lower-extremity weakness (MMT ≤ 4) who can follow commands are the intended participants.

Probably not a fit

Patients with recurrent stroke, other major neurological disorders (e.g., Parkinson's), severe cognitive impairment, serious comorbidities, or implanted electronic devices are excluded and are unlikely to benefit from this validation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, multicenter, open-label effort collects lower-limb EMG signals from 80 recent stroke patients and 10 healthy adults while they perform standardized movements. Features extracted from the multi-sensor recordings will train and validate a machine-learning model to classify patients as high or low fall risk. The model's sensitivity and specificity will be compared against conventional clinical tools such as the Berg Balance Scale. The goal is a confirmatory validation of an EMG-based predictive tool suitable for clinical use.

Why it matters

Potential benefit: If successful, the model could identify high-risk stroke survivors earlier so clinicians can target fall-prevention interventions and potentially reduce fall-related injuries.

How similar studies have gone: Previous work using wearable sensors and machine learning has shown promise for fall-risk prediction, but multicenter EMG-based confirmatory validation in early post-stroke patients remains relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Seoul National University Hospital
    Seoul, Jongno, South Korea
    Recruiting

Study contacts

  • Principal investigator: Woo Hyung Lee, prof — Seoul National University Hospital
  • Study coordinator: JungHyun Kim, prof
  • Email: kiking0@naver.com
  • Phone: 82+1088632341

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.