Clinical trial NCT06755138: Research on the Relationship Between Scoliosis, Pain, Quality of Life, and Trunk Muscle Compensation Patterns Among Patients with Duchenne Muscular Dystrophy.
Official title: 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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Duchenne Muscular Dystrophy (DMD)
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2025-01-01
Enrollment: 30
Sex: ALL
Minimum age (years): 11
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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


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).

Primary outcomes:
measure: Surface Electromyography (sEMG)
timeFrame: enrollment, 6 months after, and 12 months after since the enrollment
measure: Computer Vision-Based Video Analysis
timeFrame: enrollment, 6 months after, and 12 months after since the enrollment
Secondary outcomes:
measure: Brooke Score
timeFrame: enrollment, 6 months after, and 12 months after since the enrollment
measure: Performance of the Upper Limb Module 2.0 (PUL 2.0)
timeFrame: enrollment, 6 months after, and 12 months after since the enrollment
measure: Korean version of the Duchenne Muscular Dystrophy Functional Ability Self-Assessment Tool (K-DMDSAT)
timeFrame: enrollment, 6 months after, and 12 months after since the enrollment
measure: Korean version of the PainDETECT Questionnaire (KPD-Q)
timeFrame: enrollment, 6 months after, and 12 months after since the enrollment
measure: Short Form McGill Pain Questionnaire (SF-MPQ) Korean version
timeFrame: enrollment, 6 months after, and 12 months after since the enrollment
measure: Duchenne Muscular Dystrophy Quality of Life Questionnaire (DMD-QoL)
timeFrame: enrollment, 6 months after, and 12 months after since the enrollment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: