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

4. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

24

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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).
Adfærdsmæssigt: Perception-Action Approach
A physiotherapy intervention based on the Perception-Action Approach, emphasizing active exploration, self-initiated movement, and variability within meaningful tasks.
Aktiv komparator: 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).
Adfærdsmæssigt: Neurodevelopmental Therapy (Bobath)
A physiotherapy intervention based on Neurodevelopmental Therapy (Bobath), using therapeutic handling and facilitation to support alignment, postural organization, and movement quality during functional activities.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Gross Motor Function Measure-66 (GMFM-66)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Parental Stress Scale (PSS)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Tuba Derya Doğan

Efterforskere

  • Studieleder: Dilek Çokar, PHd, Istinye University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. marts 2027

Studieafslutning (Anslået)

1. april 2027

Datoer for studieregistrering

Først indsendt

4. maj 2026

Først indsendt, der opfyldte QC-kriterier

4. maj 2026

Først opslået (Faktiske)

8. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2026/55

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Kliniske forsøg med Cerebral Parese

Kliniske forsøg med Perception-Action Approach

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