Early Intervention in Cerebral Palsy: Perception-Action vs Neurodevelopmental Therapy
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Tuba D Doğan, PT, MSc, PhD(c)
- Número de teléfono: +905324090941
- Correo electrónico: tubaderyadogan@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Turgay Altunalan, PHd
- Número de teléfono: +90 506 593 88 82
- Correo electrónico: turgay.altunalan@ktu.edu.tr
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
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Comparador activo: 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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Gross Motor Function Measure-66 (GMFM-66)
Periodo de tiempo: Baseline (pre-intervention) and after 12 weeks of intervention
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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.
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Baseline (pre-intervention) and after 12 weeks of intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III)
Periodo de tiempo: Baseline (pre-intervention) and after 12 weeks of intervention
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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.
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Baseline (pre-intervention) and after 12 weeks of intervention
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Infant Motor Profile (IMP)
Periodo de tiempo: Baseline (pre-intervention) and after 12 weeks of intervention
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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.
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Baseline (pre-intervention) and after 12 weeks of intervention
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Pediatric Evaluation of Disability Inventory (PEDI)
Periodo de tiempo: Baseline (pre-intervention) and after 12 weeks of intervention
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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.
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Baseline (pre-intervention) and after 12 weeks of intervention
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The Parental Stress Scale (PSS)
Periodo de tiempo: Baseline (pre-intervention) and after 12 weeks of intervention
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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.
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Baseline (pre-intervention) and after 12 weeks of intervention
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Dilek Çokar, PHd, Istinye University
Publicaciones y enlaces útiles
Publicaciones Generales
- Hadders-Algra M, Boxum AG, Hielkema T, Hamer EG. Effect of early intervention in infants at very high risk of cerebral palsy: a systematic review. Dev Med Child Neurol. 2017 Mar;59(3):246-258. doi: 10.1111/dmcn.13331. Epub 2016 Dec 7.
- Damiano DL, Longo E. Early intervention evidence for infants with or at risk for cerebral palsy: an overview of systematic reviews. Dev Med Child Neurol. 2021 Jul;63(7):771-784. doi: 10.1111/dmcn.14855. Epub 2021 Apr 6.
- Pick, H. L. (1994). Eleanor J. Gibson: Learning to perceive and perceiving to learn. In A century of developmental psychology (pp. 527-544). American Psychological Association. https://doi.org/10.1037/10155-018
- Harbourne RT, Willett S, Kyvelidou A, Deffeyes J, Stergiou N. A comparison of interventions for children with cerebral palsy to improve sitting postural control: a clinical trial. Phys Ther. 2010 Dec;90(12):1881-98. doi: 10.2522/ptj.2010132. Epub 2010 Oct 21.
- Butler C, Darrah J. Effects of neurodevelopmental treatment (NDT) for cerebral palsy: an AACPDM evidence report. Dev Med Child Neurol. 2001 Nov;43(11):778-90. doi: 10.1017/s0012162201001414. No abstract available.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026/55
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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