Research on the Relationship Between Scoliosis, Pain, Quality of Life, and Trunk Muscle Compensation Patterns Among Patients with Duchenne Muscular Dystrophy.

NCT ID: NCT06755138

Last Updated: 2025-01-01

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-24
• Study Completion Date: 2026-08-31

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:

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1. Sternocleidomastoid

2. Longissimus muscle

3. External oblique abdominal muscle

Conditions

Duchenne Muscular Dystrophy (DMD)

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

DMD group

Duchenne muscular dystrophy group for analysis

Observational Assessment

Intervention Type: OTHER

This study includes the use of surface electromyography (sEMG), video analysis, and questionnaires to assess trunk compensation patterns and their relationship with scoliosis, functional, quality-of-life, and pain parameters

Healthy control group

Healthy age-matched group to compare scoliosis, upper limb function level, pain, quality of life, and trunk muscle compensation patterns using sEMG and computer vision

Observational Assessment

Intervention Type: OTHER

This study includes the use of surface electromyography (sEMG), video analysis, and questionnaires to assess trunk compensation patterns and their relationship with scoliosis, functional, quality-of-life, and pain parameters

Interventions

Observational Assessment

This study includes the use of surface electromyography (sEMG), video analysis, and questionnaires to assess trunk compensation patterns and their relationship with scoliosis, functional, quality-of-life, and pain parameters

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Woo Hyung Lee

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seoul National University Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Sungbae Jo Research professor, Ph. D

Role: CONTACT

rew277@gmail.com

82-10-9381-2299

Facility Contacts

Sungbae Jo Research professor, Ph. D

Role: primary

rew277@gmail.com

82-10-9381-2299

Other Identifiers

0420240390

Identifier Type: -

Identifier Source: org_study_id