ML-Based Multi-Sensor Fall Risk Screening in DMD
ConditionDMD
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age10-30
SponsorSeoul National University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
South Korea
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Performance of the Upper Limb, Brooke Scale, grip strength test
Other interventionThirty 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Performance of the upper limb module 2.0
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.
Time frame
baseline - 6 months - 12 monthsSecondary outcomes
1
Brooke score
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.
Time frame
baseline - 6 months - 12 months2
grip strength
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.
Time frame
baseline - 6 months - 12 monthsSponsors and contacts
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Source ClinicalTrials.gov