NCT06755138 Research on the Relationship Between Scoliosis, Pain, Quality of Life, and Trunk Muscle Compensation Patterns Among Patients with Duchenne Muscular Dystrophy.
| NCT ID | NCT06755138 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Seoul National University Hospital |
| Condition | Duchenne Muscular Dystrophy (DMD) |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-12-24 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2024-12-24 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
* Objective: The objective of this observational study is to evaluate and quantify trunk muscle compensatory movement patterns in patients with Duchenne Muscular Dystrophy (DMD) using computer vision technology. Additionally, the study seeks to explore the relationship between these compensatory patterns and scoliosis, upper limb function, pain levels, and quality of life during functional upper limb movements. * Key Research Questions: 1\) Can trunk compensatory movement patterns be accurately measured using computer vision analysis? 2) Are these compensatory patterns correlated with scoliosis, upper limb function levels, pain, and quality of life? 3) Do these patterns and their correlations change over time? * Methodology: 1. Participants: Patients diagnosed with Duchenne Muscular Dystrophy will be recruited for this study. 2. Assessments: * Scoliosis Evaluation: 1. Cobb angle measurement via X-ray imaging. 2. Upper Limb Function Assessment: 3. Performance of the Upper Limb Module 2.0 (PUL 2.0). 4. Brooke Upper Extremity Functional Classification Score. 5. Korean version of the Duchenne Muscular Dystrophy Functional Ability Self-Assessment Tool (K-DMDSAT). * Pain Measurement: 1. Korean version of the PainDETECT Questionnaire (KPD-Q). 2. Short Form McGill Pain Questionnaire. 3. Quality of Life Assessment: * Duchenne Muscular Dystrophy Quality of Life Questionnaire (DMD-QoL). 1. Trunk Compensation Analysis: * Surface electromyography (sEMG) to measure muscle activation. * Video analysis using computer vision to quantify trunk compensatory movement patterns. * The following tasks will be evaluated using the dominant arm for sEMG and video analysis: i. Pouring water into a cup. ii. Lifting a cup to drink water. iii. Grooming the front of the hair. iv. Moving small blocks within one minute (Box and Block Test). v. Reaching toward nearby objects in the front, left, and right directions. * Front: Directly in front of the participant's line of sight. * Left and right: Approximately 45 degrees to the left and right from the participant's front. * Nearby objects: A water bottle or cup weighing approximately 250g, placed at arm's length. vi. Reaching toward distant objects in the front, left, and right directions. * Distant objects: A water bottle or cup weighing approximately 250g, placed at 1.5 times the participant's arm length. * The sEMG attachment sites are as follows: i. Muscles for assessing upper limb functional movements: 1. Deltoid 2. Pectoralis major 3. Trapezius 4. Biceps brachii ii. Muscles for assessing trunk compensatory actions: <!-- --> 1. Sternocleidomastoid 2. Longissimus muscle 3. External oblique abdominal muscle
Eligibility Criteria
1. Inclusion Criteria (1) Duchenne Muscular Dystrophy (DMD) Group * Individuals with a confirmed genetic diagnosis of Duchenne Muscular Dystrophy. * Aged over 10 years but under 30 years. * Brooke Scale score between 2 and 5. * Shoulder abductor muscle strength below grade 3 on the Manual Muscle Test (MMT). (2) Healthy Control Group * Individuals with no history or current diagnosis of musculoskeletal or neuromuscular disorders. * Aged over 10 years but under 30 years. * Shoulder muscle strength of grade 4+ or higher on the Manual Muscle Test (MMT). * Individuals capable of understanding a detailed explanation of the study procedures and voluntarily providing written informed consent. 2. Exclusion Criteria (1) Duchenne Muscular Dystrophy (DMD) Group * Individuals unable or unwilling to provide informed consent. * Brooke Scale score of 1 or 6. * Severe cognitive impairment preventing the performance of simple tasks. (2) Healthy Control Group * Individuals unable or unwilling to provide informed consent. * Shoulder muscle strength of grade 4 or lower on the Manual Muscle Test (MMT).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06755138 clinical trial?
This trial is open to participants of all sexes, aged 11 Years or older, up to 30 Years, studying Duchenne Muscular Dystrophy (DMD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06755138 currently recruiting?
Yes, NCT06755138 is actively recruiting participants. Contact the research team at rew277@gmail.com for enrollment information.
Where is the NCT06755138 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT06755138 clinical trial?
NCT06755138 is sponsored by Seoul National University Hospital. The trial plans to enroll 30 participants.