- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07575659
Early Intervention in Cerebral Palsy: Perception-Action vs Neurodevelopmental Therapy
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:
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tuba D Doğan, PT, MSc, PhD(c)
- Phone Number: +905324090941
- Email: tubaderyadogan@gmail.com
Study Contact Backup
- Name: Turgay Altunalan, PHd
- Phone Number: +90 506 593 88 82
- Email: turgay.altunalan@ktu.edu.tr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Perception-Action Approach (PA)
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). |
A physiotherapy intervention based on the Perception-Action Approach, emphasizing active exploration, self-initiated movement, and variability within meaningful tasks.
|
|
Active Comparator: Neurodevelopmental Therapy (NDT-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). |
A physiotherapy intervention based on Neurodevelopmental Therapy (Bobath), using therapeutic handling and facilitation to support alignment, postural organization, and movement quality during functional activities.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline (pre-intervention) and after 12 weeks of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III)
Time Frame: Baseline (pre-intervention) and after 12 weeks of intervention
|
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.
|
Baseline (pre-intervention) and after 12 weeks of intervention
|
|
Infant Motor Profile (IMP)
Time Frame: Baseline (pre-intervention) and after 12 weeks of intervention
|
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.
|
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
|
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.
|
Baseline (pre-intervention) and after 12 weeks of intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Parental Stress Scale (PSS)
Time Frame: Baseline (pre-intervention) and after 12 weeks of intervention
|
The Parental Stress Scale (PSS-18), developed by Berry and Jones, is an 18-item self-report questionnaire designed to measure the level of stress associated with parenting.
It assesses both positive and negative aspects of the parent-child relationship, and total scores indicate overall parental stress.
|
Baseline (pre-intervention) and after 12 weeks of intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Dilek Çokar, PHd, Istinye University
Publications and helpful links
General Publications
- Hadders-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.
- Damiano 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.
- 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.
- Butler 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026/55
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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