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Идёт набор NCT06755138

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

Наблюдательное Duchenne Muscular Dystrophy (DMD)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Observational Assessment.
Кому может быть актуально
Состояния в реестре: Duchenne Muscular Dystrophy (DMD). Базовые параметры: 11 лет — 30 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
South Korea
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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.

Обзор

* 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

Вмешательства

  • Другое 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

Первичные конечные точки

  • Surface Electromyography (sEMG) [Срок оценки: enrollment, 6 months after, and 12 months after since the enrollment]
  • Computer Vision-Based Video Analysis [Срок оценки: enrollment, 6 months after, and 12 months after since the enrollment]
Вторичные конечные точки (6)
  • Brooke Score [Срок оценки: enrollment, 6 months after, and 12 months after since the enrollment]
  • Performance of the Upper Limb Module 2.0 (PUL 2.0) [Срок оценки: 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) [Срок оценки: enrollment, 6 months after, and 12 months after since the enrollment]
  • Korean version of the PainDETECT Questionnaire (KPD-Q) [Срок оценки: enrollment, 6 months after, and 12 months after since the enrollment]
  • Short Form McGill Pain Questionnaire (SF-MPQ) Korean version [Срок оценки: enrollment, 6 months after, and 12 months after since the enrollment]
  • Duchenne Muscular Dystrophy Quality of Life Questionnaire (DMD-QoL) [Срок оценки: enrollment, 6 months after, and 12 months after since the enrollment]

Критерии участия

  • 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.
  • 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

South Korea · 1 центр
  • Seoul National University Hospital — Seoul

Идентификаторы

NCT: NCT06755138 · 0420240390

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗