Quantitative Analysis of Upper Extremity Functional Movement of the Upper Extremity in Patients With Duchenne Muscular Dystrophy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Performance of the upper limb module 2.0
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Performance of the upper limb module 2.0
时间窗: 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.
次要结局
- Brooke score(baseline - 6 months - 12 months)
- grip strength(baseline - 6 months - 12 months)
研究者
Woo Hyung Lee
Clinical Assistant Professor
Seoul National University Hospital