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Идёт набор NCT06363357

The Effect of a Muscle-mimicking, Fabric-type Shoulder Orthosis on Functional Movements of the Upper Limb in Patients With Neuromuscular Disorder

Без фазы С лечением Muscular Dystrophy, Duchenne Orthotic Devices Upper Extremity Neuromuscular Diseases (NMD)

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: Shoulder orthosis.
Кому может быть актуально
Состояния в реестре: Muscular Dystrophy, Duchenne, Orthotic Devices, Upper Extremity, Neuromuscular Diseases (NMD). Базовые параметры: от 10 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 →

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Обзор

The goal of this clinical trial is to investigate the effect of a muscle-mimicking, fabric-type shoulder orthosis on functional movements of the upper limb in patients with neuromuscular disorder. The main questions it aims to answer are: * What is the impact of the muscle-mimicking, fabric-type shoulder orthosis on upper limb functional movements in patients with neuromuscular disorder? * Are there observable differences in upper limb function when the shoulder orthosis is worn versus when it is not? Participants will: * Receive education on how to wear and use the shoulder orthosis. * Undergo evaluations, including assessment of upper limb performance, shoulder muscle strength testing, active range of motion measurements, assessment of functional workspace, goal attainment scale evaluation, surface electromyography, physiological measurements such as blood pressure and heart rate, fatigue assessment, and assessment for any musculoskeletal or skin-related issues. Researchers will compare neuromuscular disorder patients before and while wearing and operating the shoulder orthosis to see if there are any significant effects on variables such as upper limb function, range of motion, functional workspace, goal attainment scale, and surface electromyography.

Вмешательства

  • Устройство Shoulder orthosis
    muscle-mimicking, fabric-type shoulder orthosis

Первичные конечные точки

  • Performance of the upper limb module 2.0 (PUL 2.0) [Срок оценки: Before orthosis wear & After orthosis wear and operation]
  • Active Range of motion [Срок оценки: Before orthosis wear & After orthosis wear and operation]
  • Functional workspace [Срок оценки: Before orthosis wear & After orthosis wear and operation]
  • Goal Attainment Scale (GAS) [Срок оценки: Before orthosis wear & After orthosis wear and operation]
  • Surface electromyography (sEMG) [Срок оценки: Before orthosis wear & After orthosis wear and operation]
  • Heart rate [Срок оценки: Baseline and immediately after completing the standard task with the orthosis (approximately 3-4 hour)]
  • Blood pressure [Срок оценки: Baseline and immediately after completing the standard task with the orthosis (approximately 3-4 hour)]
  • Numeral Rating Scale for Pain [Срок оценки: Baseline and immediately after completing the standard task with the orthosis (approximately 3-4 hour)]
  • Box and block test [Срок оценки: Baseline and immediately after completing the standard task with the orthosis (approximately 3-4 hour)]

Критерии участия

Критерии включения

  • Patients with a confirmed diagnosis of a neuromuscular disease (NMD) by genetic testing, muscle biopsy, or electrodiagnostic studies, presenting with prominent upper limb muscle weakness. Examples include:
  • Muscular Dystrophies: Duchenne/Becker Muscular Dystrophy (DMD/BMD), Limb-Girdle Muscular Dystrophy (LGMD), Facioscapulohumeral Muscular Dystrophy (FSHD), etc.
  • Motor Neuron Diseases: Spinal Muscular Atrophy (SMA, Types 2 and 3), Amyotrophic Lateral Sclerosis (ALS, upper limb-dominant), etc.
  • Peripheral Neuropathies: Charcot-Marie-Tooth (CMT) disease, etc.
  • Other Neuromuscular Conditions: Including but not limited to cervical spinal cord injury.
  • Aged over 10 years.
  • A score of 2 to 5 on the Brooke Upper Extremity Functional Rating Scale.
  • Manual Muscle Test (MMT) grade of less than 3 for shoulder abduction.
  • Ability to provide written informed consent from the participant and/or their legal representative, indicating willingness to participate in the study.

Критерии исключения

  • Unwillingness or inability to provide informed consent.
  • A score of 1 or 6 on the Brooke Upper Extremity Functional Rating Scale.
  • Cognitive impairment severe enough to interfere with the proper use of a shoulder orthosis.
  • Any other condition which, in the opinion of the investigator, would make study participation inappropriate or unsafe for the patient.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

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

Идентификаторы

NCT: NCT06363357 · 24B-007-0000

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗