About this trial
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 criteria
Qualifiers
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
Disqualifiers
stroke recurrence
other neurological abnormalities (e.g. parkinson's disease).
severely impaired cognition
serious and complex medical conditions(e.g. active cancer)
Trial design
Treatments tested in this trial
- EMG Analysis Software
Treatment groups
Sponsors and collaborators
Seoul National University Hospital
Lead sponsor
Ministry of Trade, Industry & Energy, Republic of Korea
Collaborator