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Набор скоро начнётся NCT07474818

Loaded and Task Specific Training in Spastic Diaplegic CP to Improve Gait and Functional Mobility.

Без фазы С лечением Spastic Diplegia Cerebral Palsy

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: Loaded Treadmill Training, Task specific Training.
Кому может быть актуально
Состояния в реестре: Spastic Diplegia Cerebral Palsy. Базовые параметры: 6 лет — 12 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
Пакистан
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Effects of Loaded Treadmill and Task Specific Training on Gait and Functional Mobility in Children With Spastic Diplegic Cerebral Palsy

Обзор

Cerebral Palsy is a non-progressive condition caused by early brain injury that affects movement, posture, and muscle tone. Spastic diplegia mainly involves the lower limbs, leading to stiffness, weakness, and abnormal gait patterns. These impairments reduce functional independence and increase caregiver burden. Loaded Treadmill Training and Task Specific Training are two rehabilitation approaches used to improve strength and Gait function. This study compares their effectiveness in improving gait and functional mobility in children with spastic diplegic CP.

Подробное описание

Cerebral Palsy (CP) is the most common non-progressive neurological disorder of childhood, resulting from injury to the developing brain. It is characterized by impaired posture, abnormal movement patterns, and increased muscle tone. Globally, CP affects 2-3.5 per 1000 live births, with an estimated prevalence of 2.5 per 1000 live births in Pakistan. Major risk factors include prematurity, low birth weight, multiple gestations, neonatal jaundice, fetal trauma, hypoxic brain injury, and exposure to toxic substances. Spastic CP is the most common type, frequently affecting the lower limbs. Spasticity, defined as velocity-dependent increase in muscle tone, interferes with voluntary control and increases energy expenditure, leading to muscle weakness, contractures, and skeletal deformities. It results from impaired regulation of motor pathways, particularly corticospinal, reticulospinal, and vestibulospinal tracts. In children with spastic diplegia, altered neural signaling affects muscle growth and morphology, reducing muscle volume, length, and strength. Studies report a 18-50% reduction in muscle size, contributing significantly to muscle weakness around the knee and ankle joints. Spastic diplegia primarily affects the lower extremities, producing gait abnormalities such as toe walking, crouch gait, scissoring, persistent knee flexion, reduced dorsiflexion, decreased stride length, slower walking velocity, and prolonged double limb support. These impairments limit functional independence, restrict participation in daily activities, and reduce quality of life, while also increasing caregiver burden. Improving gait is therefore a major goal of pediatric rehabilitation. Strengthening of lower limb muscles has shown a positive relationship with ambulatory function. Loaded Treadmill Training (LTT) is a resisted strength training approach in which external loads (e.g., ankle weights) are applied during treadmill walking to enhance muscle effort, motor learning, sensory feedback, and walking performance. Resistance is progressively increased, typically around 60% of lower limb weight, according to tolerance. Task-Specific Training (TST) is based on principles of neuroplasticity and motor learning. It involves repetitive practice of functional tasks such as standing, walking, and balance activities in real-life environments. TST enhances muscle strength, coordination, balance, and participation by progressively increasing task difficulty. Two scales are used, Gross Motor Function Measure -88; The interrater and intra-rater reliability of the GMFM-88 total score, assessed with the intra-class correlation coefficient (ICC), are both 0.99. Validity was confirmed by a correlation of 0.82, Jakes Analysis; Observational gait analysis has high validity of 0.94. Inter observer reliability is moderately high and is 0.76 while the intra observer reliability is also high that is 0.89. Both interventions are commonly combined with routine physiotherapy and neurodevelopmental treatment (NDT) approaches to improve motor control. Although both LTT and TST demonstrate beneficial effects on gait and functional mobility in children with spastic diplegic CP, there is limited evidence directly comparing their effectiveness. Therefore, this study aims to determine and compare the effects of Loaded Treadmill Training and Task-Specific Training on gait parameters and functional mobility in children with spastic diplegic cerebral palsy, with the goal of enhancing independence and reducing caregiver burden.

Вмешательства

  • Устройство Loaded Treadmill Training
    loaded treadmill training is a gait rehabilitation approach in which children walk on a treadmill while external loads (such as ankle weights) are applied to the lower limbs. The load is gradually increased to enhance muscle strength, motor learning, and walking performance. This intervention helps improve stride length, cadence, gait velocity, and overall functional mobility in children with spastic diplegic cerebral palsy.
  • Другое Task specific Training
    Task-specific training is a rehabilitation approach based on repetitive practice of functional activities. Children perform tasks such as standing, walking, stepping, and balance activities in a structured therapy program. This approach aims to enhance coordination, strength, motor control, and functional mobility in children with spastic diplegic cerebral palsy.

Первичные конечные точки

  • Change in Gait Parameter: Cadence [Срок оценки: Baseline and after 6 weeks]
  • Change in Gait Parameter: Velocity [Срок оценки: Baseline and 6 weeks]
  • Change in Gait Parameter: Stride Length [Срок оценки: Baseline and after 6 weeks]
  • Change in Functional Mobility [Срок оценки: Baseline and after 6 weeks]

Критерии участия

Критерии включения

  • Confirmed diagnosis of Spastic Diplegic Cerebral Palsy
  • 6 to 12 years
  • Gross Motor Function Classification System Level I to III
  • Stand independently or with support

Критерии исключения

  • Diagnosed with any type other then Spastic Diplegic
  • Presence of Comorbidities
  • Severe Cognitive and Communicative impairments
  • Classified as Gross Motor Function Classification System Level IV and V

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Пакистан · 1 центр
  • Lahore University of Biological Applied Health Sciences — Lahore

Идентификаторы

NCT: NCT07474818 · DPT/ERB/34 · U1111-1335-7052

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗