Cerebral Palsy (CP)
Conditions
Brief summary
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.
Interventions
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
OTHERFunctional 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
Sponsors
University of Thessaly
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in trunk control during Static Sitting and Static Standing at 12 Weeks using IMU's sensors | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Upper Limb Muscle Strength (Push) at 12 Weeks | Baseline and 12 weeks | Muscle strength of the upper limb will be measured using the Kinvent K-Push handheld dynamometer. The peak force (kg) during a standardized push task will be recorded. |
| Change from Baseline in Sitting Assessment Scale (SAS) Score at 12 Weeks | Baseline and 12 weeks | The SAS evaluates postural control in a sitting position, focusing on head, trunk, and foot control. Higher scores indicate better postural stability in sitting. |
| Change from Baseline in Trunk Control Measurement Scale (TCMS) Score at 12 Weeks | Baseline and 12 weeks | The TCMS evaluates static and dynamic sitting balance and trunk coordination. It consists of 15 items. Total score ranges from 0 to 58, with higher scores indicating better trunk control. |
| Change from Baseline in Pediatric Balance Scale (PBS) Score at 12 Weeks | Baseline and 12 weeks | The PBS is a modified version of the Berg Balance Scale for children. It consists of 14 items assessing functional balance during everyday activities. Total score ranges from 0 to 56, with higher scores indicating better balance. |
| Change from Baseline in Timed Up and Go (TUG) Test Time at 12 Weeks | Baseline and 12 weeks | The TUG test measures the time (in seconds) taken by a participant to stand up from a chair, walk 3 meters, turn around, walk back, and sit down. A decrease in time indicates improved functional mobility and balance. |
Contacts
CONTACTChristina Vassou
Outcome results
None listed