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

4 mei 2026 bijgewerkt door: Tuba Derya Doğan

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.

Studie Overzicht

Studietype

Ingrijpend

Inschrijving (Geschat)

24

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Actieve vergelijker: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Gross Motor Function Measure-66 (GMFM-66)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
The Parental Stress Scale (PSS)
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Studie directeur: Dilek Çokar, PHd, Istinye University

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juni 2026

Primaire voltooiing (Geschat)

1 maart 2027

Studie voltooiing (Geschat)

1 april 2027

Studieregistratiedata

Eerst ingediend

4 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

4 mei 2026

Eerst geplaatst (Werkelijk)

8 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

8 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

4 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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