Early Intervention in Cerebral Palsy: Perception-Action vs Neurodevelopmental Therapy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-36
SponsorTuba Derya Doğan
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Perception-Action Approach
BehavioralA physiotherapy intervention based on the Perception-Action Approach, emphasizing active exploration, self-initiated movement, and variability within meaningful tasks.
Neurodevelopmental Therapy (Bobath)
BehavioralA physiotherapy intervention based on Neurodevelopmental Therapy (Bobath), using therapeutic handling and facilitation to support alignment, postural organization, and movement quality during functional activities.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Perception-Action Approach (PA)Experimental treatment 1 intervention
Group B: Neurodevelopmental Therapy (NDT-Bobath)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (pre-intervention) and after 12 weeks of interventionSecondary outcomes
1
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.
Time frame
Baseline (pre-intervention) and after 12 weeks of intervention2
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.
Time frame
Baseline (pre-intervention) and after 12 weeks of intervention3
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.
Time frame
Baseline (pre-intervention) and after 12 weeks of interventionOther outcomes
1
The Parental Stress Scale (PSS)
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.
Time frame
Baseline (pre-intervention) and after 12 weeks of interventionLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Tuba Derya Doğan
Lead sponsor
Istinye University
Sponsor institution
Source ClinicalTrials.gov
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