ML-Based Multi-Sensor Fall Risk Screening in DMD

NCT07015632 | Recruiting DMC

• 1 other identifier: 0420232060
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

DMD

Outcome Measures

Primary Outcomes (1)

• Performance of the upper limb module 2.0

  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.

  baseline - 6 months - 12 months

Secondary Outcomes (2)

• Brooke score

  baseline - 6 months - 12 months

• grip strength

  baseline - 6 months - 12 months

Interventions

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

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.

Eligibility Criteria

• Age: 10 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

South Korea

You may qualify if:

• Individuals with a confirmed genetic diagnosis of Duchenne Muscular Dystrophy (DMD)
• Age over 10 and under 30 years
• Brooke Scale score between 2 and 5
• Manual muscle test grade below 3 for shoulder abduction muscles

You may not qualify if:

• Individuals who are unable or unwilling to provide informed consent
• Brooke Scale score of 1 or 6
• Individuals with cognitive impairments that significantly limit their ability to participate in assessments

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno, 03080, South Korea

RECRUITING

Central Study Contacts

JungHyun Kim, prof

CONTACT

82+1088632341; kiking0@naver.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 11, 2025
• Study Start: July 18, 2024
• Primary Completion: July 30, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)