Cerebral PalsyNCT07575659
Early Intervention in Cerebral Palsy: Perception-Action vs Neurodevelopmental Therapy
A study testing Perception-Action Approach and Neurodevelopmental Therapy (Bobath) in people with Cerebral Palsy and Cerebral Palsy Early Intervention, run by Tuba Derya Doğan.
Trial summary
The goal of this clinical trial is to compare two different physiotherapy approaches used in early intervention for children with cerebral palsy. These approaches are the Perception-Action Approach and Neurodevelopmental Therapy (Bobath). Read more about this study
- Who is it for?
- Ages 6 to 36 months
- Conditions the study is for
- Cerebral Palsy, Cerebral Palsy Early Intervention
- What is being tested?
- Perception-Action Approach and Neurodevelopmental Therapy (Bobath)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Apr 2027
- 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 6 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of Cerebral Palsy
- Being at high risk for Cerebral Palsy (based on MRI or cranial ultrasound findings and neurological examination)
- Age between 0-36 months (using corrected age for preterm infants)
- Parental agreement to participate in the study and attend all assessment and therapy sessions; signed informed consent form from the parent(s) or legal guardian(s)
Who cannot join
- Presence of severe visual or hearing impairment that would prevent full participation in therapy sessions
- Uncontrolled seizures
- Receipt of botulinum toxin injection or orthopedic surgery within the last 6 months
- Diagnosis of an additional neurometabolic, genetic, or other neurological disorder
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: Efficacy of the Perception-Action Approach Versus Neurodevelopmental Therapy in Early Intervention for Children With Cerebral Palsy: A Randomized Controlled Trial
The goal of this clinical trial is to compare two different physiotherapy approaches used in early intervention for children with cerebral palsy. These approaches are the Perception-Action Approach and Neurodevelopmental Therapy (Bobath). The study aims to understand which approach is more effective in supporting neurodevelopmental outcomes in early childhood in Cerebral Palsy.
The main questions this study aims to answer are:
Read more
How does the Perception-Action Approach affect motor function in young children with cerebral palsy? How does Neurodevelopmental Therapy (Bobath) affect motor function in young children with cerebral palsy? Are there differences in outcomes between these two approaches?
Researchers will compare these two approaches to see which one better supports motor development.
Participants will:
Be children aged 0 to 36 months with cerebral palsy or at high risk Be assigned to one of the two therapy groups Receive one therapy session per week for 12 weeks Be assessed before and after the intervention using standardized tests
The results of this study may help therapists and families choose the most effective early intervention approach for children with cerebral palsy.
- Conditions
- Cerebral Palsy, Cerebral Palsy Early Intervention
- Being tested
- Perception-Action Approach, Neurodevelopmental Therapy (Bobath)
- Keywords
- Cerebral Palsy, Early Intervention, Pediatric Physiotherapy, Neurodevelopmental Therapy, Bobath Concept, Perception-Action Approach, Neuro-Developmental Treatment (NDT), GMFM-66, Infant Motor Profile, Bayley III, Pediatric Evaluation of Disability Inventory
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perception-Action ApproachBehavioural
A physiotherapy intervention based on the Perception-Action Approach, emphasizing active exploration, self-initiated movement, and variability within meaningful tasks.
Neurodevelopmental Therapy (Bobath)Behavioural
A physiotherapy intervention based on Neurodevelopmental Therapy (Bobath), using therapeutic handling and facilitation to support alignment, postural organization, and movement quality during functional activities.
| Study group | Role | What they receive |
|---|---|---|
| Perception-Action Approach (PA) | Experimental | The Perception-Action Approach is grounded in ecological, dynamic systems, and neural group selection theories, emphasizing perception-action coupling and supporting the child's overall development through self-initiated actions.
The intervention promotes variability, adaptability, and exploration in an enriched environment. Therapists primarily structure the environment to encourage independent discovery of functional solutions rather than using hands-on facilitation.
Activities are individualized to support variability, adaptability, and functional problem-solving. Informational touch may be used as task-consistent input to enhance perception of the relationship between the body and environment, inviting new movement possibilities without guiding movement. Variability and adaptability are prioritized over a single ideal movement pattern, and errors are considered part of learning. Sessions are conducted once weekly for 12 weeks (45 minutes each). Receives: Behavioral: Perception-Action Approach |
| Neurodevelopmental Therapy (NDT-Bobath) | Active comparator | Participants receive physiotherapy based on Neurodevelopmental Therapy (Bobath), a holistic and individualized approach to neurorehabilitation. The intervention focuses on the analysis and facilitation of functional movement within meaningful activities to improve participation. Assessment and treatment are closely integrated, with therapy continuously adapted based on the child's responses.
Active participation of the child is emphasized. Therapists may use hands-on facilitation, including key points of control, to support alignment, postural organization, and the regulation of muscle tone, aiming to improve the quality of movement during functional tasks. Activities are individualized and embedded in functional contexts, with assistance adapted to the child's needs. Sessions are conducted once weekly for 12 weeks (45 minutes each). Receives: Behavioral: Neurodevelopmental Therapy (Bobath) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Measure-66 (GMFM-66)
The GMFM-66 is a standardized observational assessment used to evaluate changes in gross motor function in children with cerebral palsy. It provides interval-level measurement of motor abilities and is sensitive to changes over time.
Measured: Baseline (pre-intervention) and after 12 weeks of intervention
Secondary outcomes (3)
Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III)
The Bayley-III is a standardized and widely used developmental assessment tool that evaluates cognitive, language (receptive and expressive), and motor (fine and gross) development in infants and young children. It provides composite scores that allow for the assessment of overall developmental functioning.
Measured: Baseline (pre-intervention) and after 12 weeks of intervention
Infant Motor Profile (IMP)
The IMP is a video-based, standardized assessment that evaluates the quality of motor behavior in infants. It assesses domains including variation, adaptability, symmetry, and performance, providing insight into motor development beyond milestone achievement.
Measured: Baseline (pre-intervention) and after 12 weeks of intervention
Pediatric Evaluation of Disability Inventory (PEDI)
The PEDI is a standardized assessment that evaluates functional performance in children across the domains of self-care, mobility, and social function. It is typically based on caregiver report and provides information about a child's capability and performance in daily life activities.
Measured: Baseline (pre-intervention) and after 12 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study startJun 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two parallel intervention groups: the Perception-Action Approach group or the Neurodevelopmental Treatment (Bobath) group. Each participant will receive only one of the two interventions, delivered once weekly for 12 weeks, and outcomes will be assessed before and after the intervention period.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tuba Derya Doğan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tuba Derya Doğan, Istinye University
- Investigators
- Dilek Çokar, PHd, Study director, İstinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07575659
- Sponsor's protocol ID
- 2026/55
- Status last verified
- May 2026
- First submitted
- 4 May 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pick, H. L. (1994). Eleanor J. Gibson: Learning to perceive and perceiving to learn. In A century of developmental psychology (pp. 527-544). American Psychological Association. https://doi.org/10.1037/10155-018
Harbourne RT, Willett S, Kyvelidou A, Deffeyes J, Stergiou N. A comparison of interventions for children with cerebral palsy to improve sitting postural control: a clinical trial. Phys Ther. 2010 Dec;90(12):1881-98. doi: 10.2522/ptj.2010132. Epub 2010 Oct 21.
PubMed 20966212Hadders-Algra M, Boxum AG, Hielkema T, Hamer EG. Effect of early intervention in infants at very high risk of cerebral palsy: a systematic review. Dev Med Child Neurol. 2017 Mar;59(3):246-258. doi: 10.1111/dmcn.13331. Epub 2016 Dec 7.
PubMed 27925172Damiano DL, Longo E. Early intervention evidence for infants with or at risk for cerebral palsy: an overview of systematic reviews. Dev Med Child Neurol. 2021 Jul;63(7):771-784. doi: 10.1111/dmcn.14855. Epub 2021 Apr 6.
PubMed 33825199Butler C, Darrah J. Effects of neurodevelopmental treatment (NDT) for cerebral palsy: an AACPDM evidence report. Dev Med Child Neurol. 2001 Nov;43(11):778-90. doi: 10.1017/s0012162201001414. No abstract available.
PubMed 11730153
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Perception-Action Approach Versus Neurodevelopmental Therapy in Early Intervention for Children With Cerebral Palsy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07575659
- Acronym / sponsor ID
- 2026/55
- Conditions
- Cerebral Palsy, Cerebral Palsy Early Intervention
- Keywords
- Cerebral Palsy, Early Intervention, Pediatric Physiotherapy, Neurodevelopmental Therapy, Bobath Concept, Perception-Action Approach, Neuro-Developmental Treatment (NDT), GMFM-66
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Tuba Derya DoğanUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 8 May 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.
The goal of this clinical trial is to compare two different physiotherapy approaches used in early intervention for children with cerebral palsy. These approaches are the Perception-Action Approach and Neurodevelopmental Therapy (Bobath). The study aims to understand which approach is more effective in supporting neurodevelopmental outcomes in early childhood in Cerebral Palsy.
The main questions this study aims to answer are:
How does the Perception-Action Approach affect motor function in young children with cerebral palsy? How does Neurodevelopmental Therapy (Bobath) affect motor function in young children with cerebral palsy? Are there differences in outcomes between these two approaches?
Researchers will compare these two approaches to see which one better supports motor development.
Participants will:
Be children aged 0 to 36 months with cerebral palsy or at high risk Be assigned to one of the two therapy groups Receive one therapy session per week for 12 weeks Be assessed before and after the intervention using standardized tests
The results of this study may help therapists and families choose the most effective early intervention approach for children with cerebral palsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel intervention groups: the Perception-Action Approach group or the Neurodevelopmental Treatment (Bobath) group. Each participant will receive only one of the two interventions, delivered once weekly for 12 weeks, and outcomes will be assessed before and after the intervention period.
| Arm | Type | Receives |
|---|---|---|
| Perception-Action Approach (PA) | Experimental | Behavioral: Perception-Action ApproachThe Perception-Action Approach is grounded in ecological, dynamic systems, and neural group selection theories, emphasizing perception-action coupling and supporting the child's overall development through self-initiated actions. The intervention promotes variability, adaptability, and exploration in an enriched environment. Therapists primarily structure the environment to encourage independent discovery of functional solutions rather than using hands-on facilitation. Activities are individualized to support variability, adaptability, and functional problem-solving. Informational touch may be used as task-consistent input to enhance perception of the relationship between the body and environment, inviting new movement possibilities without guiding movement. Variability and adaptability are prioritized over a single ideal movement pattern, and errors are considered part of learning. Sessions are conducted once weekly for 12 weeks (45 minutes each). |
| Neurodevelopmental Therapy (NDT-Bobath) | Active comparator | Behavioral: Neurodevelopmental Therapy (Bobath)Participants receive physiotherapy based on Neurodevelopmental Therapy (Bobath), a holistic and individualized approach to neurorehabilitation. The intervention focuses on the analysis and facilitation of functional movement within meaningful activities to improve participation. Assessment and treatment are closely integrated, with therapy continuously adapted based on the child's responses. Active participation of the child is emphasized. Therapists may use hands-on facilitation, including key points of control, to support alignment, postural organization, and the regulation of muscle tone, aiming to improve the quality of movement during functional tasks. Activities are individualized and embedded in functional contexts, with assistance adapted to the child's needs. Sessions are conducted once weekly for 12 weeks (45 minutes each). |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Diagnosis of Cerebral Palsy
- Being at high risk for Cerebral Palsy (based on MRI or cranial ultrasound findings and neurological examination)
- Age between 0-36 months (using corrected age for preterm infants)
- Parental agreement to participate in the study and attend all assessment and therapy sessions; signed informed consent form from the parent(s) or legal guardian(s)
Key exclusion criteria (4 listed)
- Presence of severe visual or hearing impairment that would prevent full participation in therapy sessions
- Uncontrolled seizures
- Receipt of botulinum toxin injection or orthopedic surgery within the last 6 months
- Diagnosis of an additional neurometabolic, genetic, or other neurological disorder
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 |
|---|---|---|
| Perception-Action ApproachA physiotherapy intervention based on the Perception-Action Approach, emphasizing active exploration, self-initiated movement, and variability within meaningful tasks. | Behavioural | Perception-Action Approach (PA) |
| Neurodevelopmental Therapy (Bobath)A physiotherapy intervention based on Neurodevelopmental Therapy (Bobath), using therapeutic handling and facilitation to support alignment, postural organization, and movement quality during functional activities. | Behavioural | Neurodevelopmental Therapy (NDT-Bobath) |
Primary outcome
Gross Motor Function Measure-66 (GMFM-66)
Time frame: Baseline (pre-intervention) and after 12 weeks of intervention
The GMFM-66 is a standardized observational assessment used to evaluate changes in gross motor function in children with cerebral palsy. It provides interval-level measurement of motor abilities and is sensitive to changes over time.
3 secondary outcomes
Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III)
Time frame: Baseline (pre-intervention) and after 12 weeks of intervention
Infant Motor Profile (IMP)
Time frame: Baseline (pre-intervention) and after 12 weeks of intervention
Pediatric Evaluation of Disability Inventory (PEDI)
Time frame: Baseline (pre-intervention) and after 12 weeks of intervention
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 8 May 2026.
- BackgroundPick, H. L. (1994). Eleanor J. Gibson: Learning to perceive and perceiving to learn. In A century of developmental psychology (pp. 527-544). American Psychological Association. https://doi.org/10.1037/10155-018
- Background: PubMed 20966212Harbourne RT, Willett S, Kyvelidou A, Deffeyes J, Stergiou N. A comparison of interventions for children with cerebral palsy to improve sitting postural control: a clinical trial. Phys Ther. 2010 Dec;90(12):1881-98. doi: 10.2522/ptj.2010132. Epub 2010 Oct 21.
- Background: PubMed 27925172Hadders-Algra M, Boxum AG, Hielkema T, Hamer EG. Effect of early intervention in infants at very high risk of cerebral palsy: a systematic review. Dev Med Child Neurol. 2017 Mar;59(3):246-258. doi: 10.1111/dmcn.13331. Epub 2016 Dec 7.
- Background: PubMed 33825199Damiano DL, Longo E. Early intervention evidence for infants with or at risk for cerebral palsy: an overview of systematic reviews. Dev Med Child Neurol. 2021 Jul;63(7):771-784. doi: 10.1111/dmcn.14855. Epub 2021 Apr 6.
- Background: PubMed 11730153Butler C, Darrah J. Effects of neurodevelopmental treatment (NDT) for cerebral palsy: an AACPDM evidence report. Dev Med Child Neurol. 2001 Nov;43(11):778-90. doi: 10.1017/s0012162201001414. No abstract available.
- Individual participant dataSharing planned: No
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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.
Dilek Çokar, PHd study director
İstinye University
Questions about this trial
What is this clinical trial studying?
A study testing Perception-Action Approach and Neurodevelopmental Therapy (Bobath) in people with Cerebral Palsy and Cerebral Palsy Early Intervention, run by Tuba Derya Doğan.
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 4 inclusion and 4 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 8 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 Tuba D Doğan, PT, MSc, PhD(c) (+905324090941, tubaderyadogan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross Motor Function Measure-66 (GMFM-66) (time frame: Baseline (pre-intervention) and after 12 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07575659, which also lists 5 linked publications.
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 8 May 2026.