Quantitative Analysis of Upper Extremity Functional Movement of the Upper Extremity in Patients With Duchenne Muscular Dystrophy
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Performance of the upper limb module 2.0
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 10 Years to 30 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Performance of the upper limb module 2.0
Time Frame: 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 Outcomes
- Brooke score(baseline - 6 months - 12 months)
- grip strength(baseline - 6 months - 12 months)
Investigators
Woo Hyung Lee
Clinical Assistant Professor
Seoul National University Hospital