Ireland
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Recruiting Observational

ML-Based Multi-Sensor Fall Risk Screening in DMD

NCT07015632 · tracked via the Priya Life Science South Korea tracker
Phase
Observational
Started
2024-07-18
Last updated
2025-06-13

Condition(s) studied

DMD

Investigational drug(s) / intervention(s)

Performance of the Upper Limb, Brooke Scale, grip strength test

Performance of the Upper Limb, Brooke Scale, grip strength test: Thirty patients will be evaluated at three time points (baseline, 6 months, 12 months) using clinical assessments (PUL 2.0, Brooke Scale, grip strength), computer vision-based video analysis, and machine learning algorithms.

Study summary

This prospective observational study aims to analyze changes in upper extremity functional movement over time in children with Duchenne Muscular Dystrophy (DMD). Thirty patients will be evaluated at three time points (baseline, 6 months, 12 months) using clinical assessments (PUL 2.0, Brooke Scale, grip strength), computer vision-based video analysis, and machine learning algorithms. The goal is to improve future upper limb evaluation methods for non-ambulatory DMD patients. The study includes safety monitoring and adheres to ethical standards, ensuring patient data confidentiality and providing compensation if adverse effects occur.

Eligibility

Sex
ALL
Min age
10 Years
Max age
30 Years
Healthy volunteers
No
Inclusion Criteria: 1. Individuals with a confirmed genetic diagnosis of Duchenne Muscular Dystrophy (DMD) 2. Age over 10 and under 30 years 3. Brooke Scale score between 2 and 5 4. Manual muscle test grade below 3 for shoulder abduction muscles Exclusion Criteria: 1. Individuals who are unable or unwilling to provide informed consent 2. Brooke Scale score of 1 or 6 3. Individuals with cognitive impairments that significantly limit their ability to participate in assessments

Primary outcome measure(s)

  • Performance of the upper limb module 2.0 — baseline - 6 months - 12 months
    The Performance of the Upper Limb (PUL) Module 2.0 is a validated assessment tool designed to evaluate upper limb function in individuals with Duchenne Muscular Dystrophy. The PUL 2.0 consists of 22 items covering three domains: shoulder level, mid-level (elbow), and distal level (hand). Each item is scored based on task performance, and the total score ranges from 0 to 42, with higher scores indicating better upper limb function.

Trial sites (1)

FacilityCityRegionStatus
Seoul National University Hospital Seoul Jongno Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07015632 on ClinicalTrials.gov ↗ ← All trials in South Korea