Меню
Идёт набор NCT05649930

Effect of Functional Power Training on Calf Muscle Length and Strength in Children With Spastic Paresis

— Наблюдательное Cerebral Palsy, Spastic

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: Functional power training.
Кому может быть актуально
Состояния в реестре: Cerebral Palsy, Spastic. Базовые параметры: 4 лет — 18 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
Нидерланды
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Effect of Functional Power Training on Muscle Morphology and Strength of the Medial Gastrocnemius in Children With Spastic Paresis

Обзор

Spastic paresis (SP) is a common motor condition in children and is often caused by cerebral palsy. Skeletal muscles develop differently in children with SP due to brain damage in early development; muscle strength and muscle length are reduced compared to typically developing (TD) children. Especially, the calf muscles are affected, which particularly affects their ability to walk and to run, hindering participation in society. There are several treatments aimed to increase the range of motion of the joint by lengthening the muscle, for example botulinum toxin injections. However, these treatments can have a weakening effect on the muscle due to deconditioning from immobilization and due to paralysis. In rehabilitation centers in the Netherlands functional power training (MegaPower) is offered to children with SP who want to walk and run better. It has been shown that this training improves calf muscle strength and performance during functional walking tests. However, the effect of MegaPower training on muscle morphology (i.a. muscle volume and length) is still unknown. Therefore, the aim of this study is to assess the effect of MegaPower training on the muscle morphology of the medial gastrocnemius in children with SP using 3D ultrasonography. It is expected that MegaPower training results in an increase of muscle volume as well as elongation of the muscle belly. Muscle volume could increase due to hypertrophy of the muscle fibers induced by the training, which could elongate the muscle belly length due to the pennate structure of the medial gastrocnemius. A double-baseline design will be applied for this study with three different measurement times (T0-T1-T2) to compare the training period (12 weeks) with a period (12 weeks) of usual care.

Вмешательства

  • Другое Functional power training
    The training consists of weighted running and walking exercises performed at high-velocity and is given three times a week for 12 weeks.

Первичные конечные точки

  • Muscle volume in dm^3 [Срок оценки: 12 weeks before start training (week -12)]
  • Muscle volume in dm^3 [Срок оценки: At the start of training (week 0)]
  • Muscle volume in dm^3 [Срок оценки: At the end of the training (week 12)]
  • Muscle belly length in mm [Срок оценки: 12 weeks before start training (week -12)]
  • Muscle belly length in mm [Срок оценки: At the start of training (week 0)]
  • Muscle belly length in mm [Срок оценки: At the end of the training (week 12)]
  • Tendon length in mm [Срок оценки: 12 weeks before start training (week -12)]
  • Tendon length in mm [Срок оценки: At the start of training (week 0)]
  • Tendon length in mm [Срок оценки: At the end of the training (week 12)]
  • Fascicle length in mm [Срок оценки: 12 weeks before start training (week -12)]
Вторичные конечные точки (12)
  • Isometric muscle strength of the medial gastrocnemius [Срок оценки: At the start of training (week 0)]
  • Isometric muscle strength of the medial gastrocnemius [Срок оценки: At the end of the training (week 12)]
  • Dynamic muscle strength [Срок оценки: At the start of training (week 0)]
  • Dynamic muscle strength [Срок оценки: At the end of the training (week 12)]
  • Functional Strength Measure (FSM) [Срок оценки: At the start of training (week 0)]
  • Functional Strength Measure (FSM) [Срок оценки: At the end of the training (week 12)]
  • 1-minute-walk-test [Срок оценки: At the start of training (week 0)]
  • 1-minute-walk-test [Срок оценки: At the end of the training (week 12)]
  • 10m Shuttle run test [Срок оценки: At the start of training (week 0)]
  • 10m Shuttle run test [Срок оценки: At the end of the training (week 12)]
  • 6x15m sprint [Срок оценки: At the start of training (week 0)]
  • 6x15m sprint [Срок оценки: At the end of the training (week 12)]

Критерии участия

Критерии включения

  • Gross Motor Function Classification System I-III
  • Children should be able to lie on their stomach for min. one minute
  • Children should be able to follow instructions.

Критерии исключения

  • Received (one of) the following interventions within six months:
  • Casting
  • Botulinum toxin type-A injections
  • Orthopedic surgery.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Нидерланды · 1 центр
  • Reade — Amsterdam

Идентификаторы

NCT: NCT05649930 · MegaMuscle · 2021015 · 20210088 · AMS-2021-Innovatiecall-P5

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗