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

4 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Tipo di studio

Interventistico

Iscrizione (Stimato)

24

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comparatore attivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Gross Motor Function Measure-66 (GMFM-66)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
The Parental Stress Scale (PSS)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Direttore dello studio: Dilek Çokar, PHd, Istinye University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 marzo 2027

Completamento dello studio (Stimato)

1 aprile 2027

Date di iscrizione allo studio

Primo inviato

4 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

4 maggio 2026

Primo Inserito (Effettivo)

8 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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