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NCT Number: NCT07575659

Early Intervention in Cerebral Palsy: Perception-Action vs Neurodevelopmental Therapy

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Early Intervention Nervous System Diseases

Age range

6 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Perception-Action Approach

Behavioral

A physiotherapy intervention based on the Perception-Action Approach, emphasizing active exploration, self-initiated movement, and variability within meaningful tasks.

Neurodevelopmental Therapy (Bobath)

Behavioral

A physiotherapy intervention based on Neurodevelopmental Therapy (Bobath), using therapeutic handling and facilitation to support alignment, postural organization, and movement quality during functional activities.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tuba D Doğan, PT, MSc, PhD(c)

CONTACT

[email protected]

+905324090941

Turgay Altunalan, PHd

CONTACT

[email protected]

+90 506 593 88 82

Sponsors and collaborators

Lead sponsor

Tuba Derya Doğan

Other

Registry information

Official study title

Efficacy of the Perception-Action Approach Versus Neurodevelopmental Therapy in Early Intervention for Children With Cerebral Palsy: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 8, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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