Cerebral Palsy, Cerebral Palsy Early Intervention
Conditions
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
Brief 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). 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.
Interventions
BEHAVIORALPerception-Action Approach
A physiotherapy intervention based on the Perception-Action Approach, emphasizing active exploration, self-initiated movement, and variability within meaningful tasks.
BEHAVIORALNeurodevelopmental 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.
Sponsors
Tuba Derya Doğan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
6 Months to 36 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gross Motor Function Measure-66 (GMFM-66) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) | 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. |
| Infant Motor Profile (IMP) | 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. |
| Pediatric Evaluation of Disability Inventory (PEDI) | 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. |
Contacts
CONTACTTuba D Doğan, PT, MSc, PhD(c)
CONTACTTurgay Altunalan, PHd
STUDY_DIRECTORDilek Çokar, PHd
İstinye University
Outcome results
None listed