ML-Based Multi-Sensor Fall Risk Screening in DMD

NCT ID: NCT07015632

Last Updated: 2025-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-18

Study Completion Date

2026-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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DMD

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Individuals with a confirmed genetic diagnosis of Duchenne Muscular Dystrophy (DMD)
2. Age over 10 and under 30 years
3. Brooke Scale score between 2 and 5
4. Manual muscle test grade below 3 for shoulder abduction muscles

Exclusion Criteria

1. Individuals who are unable or unwilling to provide informed consent
2. Brooke Scale score of 1 or 6
3. Individuals with cognitive impairments that significantly limit their ability to participate in assessments
Minimum Eligible Age

10 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Woo Hyung Lee

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Hospital

Seoul, Jongno, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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JungHyun Kim, prof

Role: CONTACT

82+1088632341

Facility Contacts

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junghyun kim, Ph. D.

Role: primary

82+1021740890

Other Identifiers

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0420232060

Identifier Type: -

Identifier Source: org_study_id

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