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Recruiting NCT07015632

ML-Based Multi-Sensor Fall Risk Screening in DMD

Observational DMD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Performance of the Upper Limb, Brooke Scale, grip strength test.
Who it may be relevant to
Registry conditions: DMD. Basic parameters: 10 years — 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Performance of the upper limb module 2.0 [Time frame: baseline - 6 months - 12 months]
Secondary outcome measures (2)
  • Brooke score [Time frame: baseline - 6 months - 12 months]
  • grip strength [Time frame: baseline - 6 months - 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

South Korea · 1 center
  • Seoul National University Hospital — Seoul

Identifiers

NCT: NCT07015632 · 0420232060

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗