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

NCT07496151 | Not Yet Recruiting

• 1 other identifier: PHD-VASSOU-CP-01
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cerebral Palsy (CP)

Outcome Measures

Primary Outcomes (2)

• Change from Baseline in trunk control during Static Sitting and Static Standing at 12 Weeks using IMU's sensors

  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.

  Baseline and 12 weeks

• Change from Baseline in Handgrip Strength at 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.

  Baseline and 12 weeks

Secondary Outcomes (5)

• 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

Study Arms (2)

Bobath Therapy Group

EXPERIMENTAL

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.

Other: Neurodevelopmental Treatment

Functional Physiotherapy Group

ACTIVE COMPARATOR

Other: Functional Physiotherapy

Interventions

Neurodevelopmental Treatment OTHER

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

Also known as: Bobath, NDT

Bobath Therapy Group

Functional Physiotherapy OTHER

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

Also known as: FP, Task-Specific Training

Functional Physiotherapy Group

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Thessaly: lead

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Christina Vassou

CONTACT

+306978045467; cvassou@uth.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Study Record Dates

• First Submitted: March 21, 2026
• First Posted: March 27, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04