ML-Based Multi-Sensor Fall Risk Screening in DMD

June 10, 2025 updated by: Woo Hyung Lee, Seoul National University Hospital

Quantitative Analysis of Upper Extremity Functional Movement of the Upper Extremity in Patients With Duchenne Muscular Dystrophy

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Estimated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: JungHyun Kim, prof
Phone Number: 82+1088632341
Email: kiking0@naver.com

Study Locations

Korea, Republic of
- Jongno
  - Seoul, Jongno, Korea, Republic of, 03080
    - Recruiting
    - Seoul National University Hospital
    - Contact:
      
      junghyun kim, Ph. D.
      
      Phone Number: 82+1021740890
      
      Email: kiking0@naver.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult

Accepts Healthy Volunteers

Sampling Method

Probability Sample

Study Population

South Korea

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline - 6 months - 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brooke score Time Frame: 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.	baseline - 6 months - 12 months
grip strength Time Frame: 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.	baseline - 6 months - 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 18, 2024

Primary Completion (Estimated)

July 30, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 3, 2025

First Submitted That Met QC Criteria