The Effectiveness of Neurodevelopmental Treatment (Bobath) and Functional Physiotherapy on Upper Arm Strength and Trunk Control in Children With Cerebral Palsy.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Change from Baseline in trunk control during Static Sitting and Static Standing at 12 Weeks using IMU's sensors
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Bobath Therapy Group
Participants in this group will receive physical therapy based on the Neurodevelopmental Treatment (Bobath) approach. The sessions will focus on motor control, postural alignment, and facilitation of normal movement patterns. Treatment will be tailored to individual needs and performed by a certified therapist.
干预措施: Neurodevelopmental Treatment (Other)
Functional Physiotherapy Group
干预措施: Functional Physiotherapy (Other)
结局指标
主要结局
Change from Baseline in trunk control during Static Sitting and Static Standing at 12 Weeks using IMU's sensors
时间窗: Baseline and 12 weeks
Trunk kinematic data will be collected using Inertial Measurement Unit (IMU) sensors placed on T2-T4, L1 and S1. The measure evaluates the range of trunk sway (in degrees) during a standardized quiet sitting and static standing test for 30 seconds. A decrease in trunk sway range indicates improved postural stability and better trunk control.
Change from Baseline in Handgrip Strength at 12 Weeks
时间窗: Baseline and 12 weeks
Handgrip strength will be measured in kilograms (kg) using the Kinvent K-Grip digital dynamometer. Participants perform two maximal isometric contractions, and the peak force is recorded.
次要结局
- Change from Baseline in Upper Limb Muscle Strength (Push) at 12 Weeks(Baseline and 12 weeks)
- Change from Baseline in Sitting Assessment Scale (SAS) Score at 12 Weeks(Baseline and 12 weeks)
- Change from Baseline in Trunk Control Measurement Scale (TCMS) Score at 12 Weeks(Baseline and 12 weeks)
- Change from Baseline in Pediatric Balance Scale (PBS) Score at 12 Weeks(Baseline and 12 weeks)
- Change from Baseline in Timed Up and Go (TUG) Test Time at 12 Weeks(Baseline and 12 weeks)
研究者
Christina Vassou
PhD Candidate
University of Thessaly