Cerebral Palsy (CP)NCT07496151
The Effectiveness of Neurodevelopmental Treatment (Bobath) and Functional Physiotherapy in Children With Cerebral Palsy.
A study testing Neurodevelopmental Treatment and Functional Physiotherapy in people with Cerebral Palsy (CP), run by University of Thessaly.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- Neurodevelopmental Treatment and Functional Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effectiveness of Neurodevelopmental Treatment (Bobath) and Functional Physiotherapy on Upper Arm Strength and Trunk Control 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.
Read more
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)
- Being tested
- Neurodevelopmental Treatment, Functional Physiotherapy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurodevelopmental TreatmentOther
Also called Bobath, NDT
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
Functional PhysiotherapyOther
Also called FP, Task-Specific Training
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Neurodevelopmental Treatment |
| Functional Physiotherapy Group | Active comparator | Not described Receives: Other: Functional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 12 weeks
Secondary outcomes (5)
Change from Baseline in Upper Limb Muscle Strength (Push) at 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.
Measured: Baseline and 12 weeks
Change from Baseline in Sitting Assessment Scale (SAS) Score at 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.
Measured: Baseline and 12 weeks
Change from Baseline in Trunk Control Measurement Scale (TCMS) Score at 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.
Measured: Baseline and 12 weeks
Change from Baseline in Pediatric Balance Scale (PBS) Score at 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.
Measured: Baseline and 12 weeks
Change from Baseline in Timed Up and Go (TUG) Test Time at 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.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start15 Apr 2026 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Vassou, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496151
- Sponsor's protocol ID
- PHD-VASSOU-CP-01
- Status last verified
- Apr 2026
- First submitted
- 21 Mar 2026
- Last updated
- 5 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Neurodevelopmental Treatment (Bobath) and Functional Physiotherapy on Upper Arm Strength and Trunk Control in Children With Cerebral Palsy.
- ClinicalTrials.gov ID
- NCT07496151
- Acronym / sponsor ID
- PHD-VASSOU-CP-01
- Conditions
- Cerebral Palsy (CP)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bobath Therapy Group | Experimental | Other: Neurodevelopmental TreatmentParticipants 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. |
| Functional Physiotherapy Group | Active comparator | Other: Functional Physiotherapy |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurodevelopmental TreatmentAlso: Bobath, NDTThe 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 | Bobath Therapy Group |
| Functional PhysiotherapyAlso: FP, Task-Specific TrainingThe 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 | Functional Physiotherapy Group |
Primary outcome
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.
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.
5 secondary outcomes
Change from Baseline in Upper Limb Muscle Strength (Push) at 12 Weeks
Time frame: Baseline and 12 weeks
Change from Baseline in Sitting Assessment Scale (SAS) Score at 12 Weeks
Time frame: Baseline and 12 weeks
Change from Baseline in Trunk Control Measurement Scale (TCMS) Score at 12 Weeks
Time frame: Baseline and 12 weeks
Change from Baseline in Pediatric Balance Scale (PBS) Score at 12 Weeks
Time frame: Baseline and 12 weeks
Change from Baseline in Timed Up and Go (TUG) Test Time at 12 Weeks
Time frame: Baseline and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Neurodevelopmental Treatment and Functional Physiotherapy in people with Cerebral Palsy (CP), run by University of Thessaly.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christina Vassou (+306978045467, cvassou@uth.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.