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

NCT06755138 | Recruiting

• 1 other identifier: 0420240390
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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:
• Participants: Patients diagnosed with Duchenne Muscular Dystrophy will be recruited for this study.
• Assessments:
• Scoliosis Evaluation:
• Cobb angle measurement via X-ray imaging.
• Upper Limb Function Assessment:
• Performance of the Upper Limb Module 2.0 (PUL 2.0).
• Brooke Upper Extremity Functional Classification Score.
• Korean version of the Duchenne Muscular Dystrophy Functional Ability Self-Assessment Tool (K-DMDSAT).
• Pain Measurement:
• Korean version of the PainDETECT Questionnaire (KPD-Q).
• Short Form McGill Pain Questionnaire.
• Quality of Life Assessment:
• Duchenne Muscular Dystrophy Quality of Life Questionnaire (DMD-QoL).
• 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:
• Deltoid
• Pectoralis major
• Trapezius
• Biceps brachii ii. Muscles for assessing trunk compensatory actions:
• Sternocleidomastoid
• Longissimus muscle
• External oblique abdominal muscle

Conditions

Duchenne Muscular Dystrophy (DMD)

Outcome Measures

Primary Outcomes (2)

• Surface Electromyography (sEMG)

  The purpose of using surface electromyography (sEMG) in this study is to measure and analyze the activation levels and patterns of trunk compensatory muscles during the performance of functional upper limb movements. This assessment aims to understand how trunk muscles compensate for upper limb movements, particularly in relation to task performance efficiency.

  enrollment, 6 months after, and 12 months after since the enrollment

• Computer Vision-Based Video Analysis

  Videos are recorded simultaneously with surface electromyography (sEMG) while participants perform functional upper limb movements. Recordings are taken from two perspectives: the front view and the dominant arm side view, with synchronized matching of the videos. Video recording is conducted using a video camera mounted on a fixed tripod. The recorded videos are analyzed using a convolutional neural network (CNN)-based body part detection model, producing skeleton-based outputs for movement analysis. The relative trunk motion of the participant is extracted as positional coordinates over time, which are further processed to calculate velocity, acceleration, and jerk. These time-series signals are analyzed for smoothness and sample entropy. By matching the movement data with corresponding sEMG signals, biomechanical compensatory parameters are identified and key compensatory features are derived. Comparative analyses with healthy controls are performed to validate these parameters.

  enrollment, 6 months after, and 12 months after since the enrollment

Secondary Outcomes (6)

• Brooke Score

  enrollment, 6 months after, and 12 months after since the enrollment

• Performance of the Upper Limb Module 2.0 (PUL 2.0)

  enrollment, 6 months after, and 12 months after since the enrollment

• Korean version of the Duchenne Muscular Dystrophy Functional Ability Self-Assessment Tool (K-DMDSAT)

  enrollment, 6 months after, and 12 months after since the enrollment

• Korean version of the PainDETECT Questionnaire (KPD-Q)

  enrollment, 6 months after, and 12 months after since the enrollment

• Short Form McGill Pain Questionnaire (SF-MPQ) Korean version

  enrollment, 6 months after, and 12 months after since the enrollment

Study Arms (2)

DMD group

Duchenne muscular dystrophy group for analysis

Other: Observational Assessment

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

Other: Observational Assessment

Interventions

Observational Assessment 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

DMD group; Healthy control group

Eligibility Criteria

• Age: 11 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study will recruit participants from two populations: individuals with Duchenne Muscular Dystrophy (DMD) and age-matched healthy controls. The DMD group includes subjects aged 10-30 years with a confirmed genetic diagnosis, Brooke Scale scores of 2-5, and shoulder abduction strength below grade 3 on the Manual Muscle Test (MMT). These participants represent a population with progressive neuromuscular decline and compensatory trunk muscle activity. The healthy control group consists of subjects aged 10-30 years matched to recruited DMD groups, with no history of musculoskeletal or neuromuscular disorders and shoulder strength of grade 4+ or higher on the MMT. Both groups must understand study procedures and provide informed consent. This population ensures a meaningful comparison of trunk compensatory movement patterns between DMD patients and healthy individuals, offering valuable insights into functional adaptations and their implications for care.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Sungbae Jo Research professor, Ph. D

CONTACT

82-10-9381-2299; rew277@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: January 1, 2025
• Study Start: December 24, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: January 1, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)