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NCT Number: NCT07496151

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

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.

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Key information

Conditions

Cerebral Palsy (CP) Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Bobath, NDT

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

Other names: FP, Task-Specific Training

Primary outcomes

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

    Time frame: 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.

  2. Change from Baseline in Handgrip Strength at 12 Weeks

    Time frame: 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 outcomes

  1. Change from Baseline in Upper Limb Muscle Strength (Push) at 12 Weeks

    Time frame: 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.

  2. Change from Baseline in Sitting Assessment Scale (SAS) Score at 12 Weeks

    Time frame: 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.

  3. Change from Baseline in Trunk Control Measurement Scale (TCMS) Score at 12 Weeks

    Time frame: 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.

  4. Change from Baseline in Pediatric Balance Scale (PBS) Score at 12 Weeks

    Time frame: 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.

  5. Change from Baseline in Timed Up and Go (TUG) Test Time at 12 Weeks

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christina Vassou

CONTACT

[email protected]

+306978045467

Sponsors and collaborators

Lead sponsor

University of Thessaly

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2026
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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