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

December 24, 2024 updated by: Woo Hyung Lee, Seoul National University Hospital

Research on the Relationship Between Scoliosis, Pain, Quality of Life, and Trunk Muscle Compensation Patterns During Functional Upper Extremity Movements Among Patients with Duchenne Muscular Dystrophy Using Surface Electromyography and Computer Vision Analysis.

  • 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

Study Overview

Status

Recruiting

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sungbae Jo Research professor, Ph. D
  • Phone Number: 82-10-9381-2299
  • Email: rew277@gmail.com

Study Locations

      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Sungbae Jo Research professor, Ph. D
          • Phone Number: 82-10-9381-2299
          • Email: rew277@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

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.

Description

  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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
DMD group
Duchenne muscular dystrophy group for analysis
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surface Electromyography (sEMG)
Time Frame: enrollment, 6 months after, and 12 months after since the enrollment
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
Time Frame: enrollment, 6 months after, and 12 months after since the enrollment

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brooke Score
Time Frame: enrollment, 6 months after, and 12 months after since the enrollment

The Brooke Score is a functional assessment tool specifically designed to evaluate upper limb abilities in patients with Duchenne Muscular Dystrophy (DMD). An occupational therapist or physical therapist instructs participants to perform specific movements, and the assessment is based on the participant's ability to successfully complete these tasks.

The scale ranges from 1 to 6, with lower scores indicating better upper limb function

enrollment, 6 months after, and 12 months after since the enrollment
Performance of the Upper Limb Module 2.0 (PUL 2.0)
Time Frame: enrollment, 6 months after, and 12 months after since the enrollment
A functional scale specifically designed to evaluate upper limb abilities in patients with Duchenne Muscular Dystrophy (DMD), assessed by an occupational or physical therapist. It consists of 22 items divided into three levels: shoulder level (6 items, maximum score 12), mid-level (9 items, maximum score 17), and distal level (7 items, maximum score 13), with a total possible score of 44. Each level is scored separately, and participants are instructed to perform specific tasks, with their performance evaluated accordingly.
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)
Time Frame: enrollment, 6 months after, and 12 months after since the enrollment
A patient-reported outcome measure designed to evaluate and describe the functional status of individuals with Duchenne Muscular Dystrophy (DMD) across the disease progression. It comprises four domains: arm function, walking, mobility, and respiratory support. Patients are asked to select the most difficult task they can still perform. The tool demonstrates excellent reliability, with inter-rater and test-retest reliability scores (ICC 0.958 and 0.987, respectively). Scoring ranges from 0-8 for arm function and walking, 0-10 for mobility, and 0-2 for respiratory support, with a total maximum score of 28.
enrollment, 6 months after, and 12 months after since the enrollment
Korean version of the PainDETECT Questionnaire (KPD-Q)
Time Frame: enrollment, 6 months after, and 12 months after since the enrollment
A tool developed to assess neuropathic pain and is also applicable for evaluating other types of pain. It evaluates four domains: pain intensity, location, pattern, and radiating pain, with a total maximum score of 38. Based on the score, pain can be classified into nociceptive pain, unclear pain, or neuropathic pain categories
enrollment, 6 months after, and 12 months after since the enrollment
Short Form McGill Pain Questionnaire (SF-MPQ) Korean version
Time Frame: enrollment, 6 months after, and 12 months after since the enrollment
a self-reported tool designed to assess both the quality and intensity of subjective pain. It includes 11 adjectives describing the sensory aspects of pain and 4 adjectives related to its emotional impact. Participants also rate their current pain intensity on a scale from 0 (no pain) to 5 (worst possible pain) and indicate the overall intensity of their pain on a 10 cm visual analog scale (VAS).
enrollment, 6 months after, and 12 months after since the enrollment
Duchenne Muscular Dystrophy Quality of Life Questionnaire (DMD-QoL)
Time Frame: enrollment, 6 months after, and 12 months after since the enrollment
Specifically designed to reflect the unique needs and experiences of individuals with Duchenne Muscular Dystrophy (DMD). It comprises 14 items across key domains, including physical health, emotional well-being, social functioning, school and academics, pain and symptom management, and independence and autonomy. Participants respond using a Likert scale to indicate the degree of agreement or frequency for each item. While the questionnaire is intended to be self-reported, caregivers or guardians may complete it on behalf of the patient if age or cognitive function limits independent completion.
enrollment, 6 months after, and 12 months after since the enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 24, 2024

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

December 24, 2024

First Submitted That Met QC Criteria

December 24, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 24, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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