ML-Based Multi-Sensor Fall Risk Screening in DMD

Recruiting

• Conditions: DMD

• Registration Number: NCT07015632
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-18
• Status Verified: 2025-05
• Study First Submitted: 2025-06-03
• Study First Submitted QC: 2025-06-03
• Last Update Submitted: 2025-06-10
• Study First Posted: 2025-06-11
• Last Update Posted: 2025-06-13
• Primary Completion: 2025-07-30
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Brooke score	baseline - 6 months - 12 months	The Brooke Upper Extremity Functional Rating Scale is a 6-point scale used to evaluate upper limb functional ability, primarily in patients with neuromuscular disorders such as Duchenne Muscular Dystrophy. Scores range from 1 to 6, where: 1 = Able to abduct arms in a full circle until they touch above the head 6 = Cannot raise hands to the mouth and has no useful function of the hands; Lower scores indicate better upper limb function.
grip strength	baseline - 6 months - 12 months	Grip strength will be measured using the Jamar Plus+ Digital Hand Dynamometer, a validated and widely used device for quantifying hand grip strength in kilograms (kg). Participants will be instructed to sit upright with the shoulder adducted and neutrally rotated, elbow flexed at 90 degrees, forearm in neutral position, and wrist in 0 to 30 degrees extension. The average of three consecutive trials will be recorded for each assessment. Higher values indicate greater grip strength.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Jongno, Korea, Republic of