The Effectiveness of Neurodevelopmental Treatment (Bobath) and Functional Physiotherapy in Children With Cerebral Palsy.

Официальное название

The Effectiveness of Neurodevelopmental Treatment (Bobath) and Functional Physiotherapy on Upper Arm Strength and Trunk Control in Children With Cerebral Palsy.

Обзор

Cerebral palsy is one of the most common causes of physical disability in childhood and is often associated with impaired trunk control, reduced upper limb strength, and limitations in functional mobility and daily activities. Trunk control is essential for postural stability and directly influences upper limb function and the ability to perform goal-directed tasks. Neurodevelopmental Treatment (NDT/Bobath) and functional physiotherapy are widely used approaches in pediatric neurorehabilitation. NDT/Bobath focuses on facilitating postural control and promoting efficient movement patterns, while functional physiotherapy emphasizes task-specific training and the improvement of motor performance through meaningful activities. However, evidence comparing the effectiveness of these approaches on trunk control and upper arm strength remains limited. This study aims to investigate and compare the effectiveness of Neurodevelopmental Treatment (NDT/Bobath) and functional physiotherapy on upper arm strength and trunk control in children with cerebral palsy. Participants will be allocated to different intervention groups, with each group receiving one of the two therapeutic approaches. Additionally, wearable Inertial Measurement Units (IMUs) will be used to provide objective and quantitative assessment of trunk movement under both static (sitting) and dynamic (functional movement) conditions. We hypothesize that both intervention groups will demonstrate improvements in trunk control and upper arm strength, with potential differences in the magnitude of improvement between the two approaches. Furthermore, IMU-based measurements are expected to detect subtle changes in movement quality that may not be captured by traditional clinical assessment tools. The findings of this study may contribute to a better understanding of the comparative effectiveness of commonly used therapeutic approaches and support evidence-based decision-making in pediatric rehabilitation.

Вмешательства

• Другое Neurodevelopmental Treatment
  The intervention consists of Neurodevelopmental Treatment (NDT/Bobath) focused on optimizing sensorimotor function through task-specific training and therapeutic handling. The approach emphasizes the inhibition of abnormal reflex patterns and the facilitation of normal postural control and voluntary movement. Dosage/Intensity: Sessions will last 60' Frequency: Participants will receive treatment 2 times a week Total Duration: The intervention period will span 12 weeks
• Другое Functional Physiotherapy
  The intervention focuses on Functional Physiotherapy (FP), a task-oriented approach aimed at improving the performance of specific daily activities. Unlike neurofacilitation techniques, FP emphasizes repetitive practice of functional tasks in a real-world context. Dosage/Intensity: Sessions will last 60' Frequency: Participants will receive treatment 2 times a week Total Duration: The intervention period will span 12 weeks

Первичные конечные точки

• Change from Baseline in trunk control during Static Sitting and Static Standing at 12 Weeks using IMU's sensors [Срок оценки: Baseline and 12 weeks]
• Change from Baseline in Handgrip Strength at 12 Weeks [Срок оценки: Baseline and 12 weeks]

Вторичные конечные точки (5)

• Change from Baseline in Upper Limb Muscle Strength (Push) at 12 Weeks [Срок оценки: Baseline and 12 weeks]
• Change from Baseline in Sitting Assessment Scale (SAS) Score at 12 Weeks [Срок оценки: Baseline and 12 weeks]
• Change from Baseline in Trunk Control Measurement Scale (TCMS) Score at 12 Weeks [Срок оценки: Baseline and 12 weeks]
• Change from Baseline in Pediatric Balance Scale (PBS) Score at 12 Weeks [Срок оценки: Baseline and 12 weeks]
• Change from Baseline in Timed Up and Go (TUG) Test Time at 12 Weeks [Срок оценки: Baseline and 12 weeks]

Критерии участия

Критерии включения

• Age 4-12 years
• Diagnosis of Cerebral Palsy
• Ability to understand simple commands (cooperative child)
• Classification in GMFCS (Levels I-IV)
• Physical therapy interventions in Pediatric Physiotherapy Laboratories throughout Greece
• Signed parental consent within one week of notification

Критерии исключения

• Botulinum toxin (Botox) injection within the last 3 months
• Selective dorsal rhizotomy within the last 1 year
• Uncontrolled epilepsy
• Co-existing pathologies affecting the trunk and functionality
• Age outside the range of 4-12 years

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07496151 · PHD-VASSOU-CP-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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