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NCT Number: NCT07015632

ML-Based Multi-Sensor Fall Risk Screening in DMD

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.

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Key information

Conditions

DMD

Age range

10 year–30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, Jongno, 03080, South Korea

Location status: Recruiting

Location contact

junghyun kim, Ph. D.

CONTACT

[email protected]

82+1021740890

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

JungHyun Kim, prof

CONTACT

[email protected]

82+1088632341

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jun 11, 2025
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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