NCT07575659

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
10mo left

Started Jun 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
24 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

9 months

First QC Date

May 4, 2026

Last Update Submit

May 4, 2026

Conditions

Keywords

Cerebral PalsyEarly InterventionPediatric PhysiotherapyNeurodevelopmental TherapyBobath ConceptPerception-Action ApproachNeuro-Developmental Treatment (NDT)GMFM-66Infant Motor ProfileBayley IIIPediatric Evaluation of Disability Inventory

Outcome Measures

Primary Outcomes (1)

  • Gross Motor Function Measure-66 (GMFM-66)

    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

Secondary Outcomes (3)

  • Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III)

    Baseline (pre-intervention) and after 12 weeks of intervention

  • Infant Motor Profile (IMP)

    Baseline (pre-intervention) and after 12 weeks of intervention

  • Pediatric Evaluation of Disability Inventory (PEDI)

    Baseline (pre-intervention) and after 12 weeks of intervention

Other Outcomes (1)

  • The Parental Stress Scale (PSS)

    Baseline (pre-intervention) and after 12 weeks of intervention

Study Arms (2)

Perception-Action Approach (PA)

EXPERIMENTAL

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).

Behavioral: Perception-Action Approach

Neurodevelopmental Therapy (NDT-Bobath)

ACTIVE COMPARATOR

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).

Behavioral: Neurodevelopmental Therapy (Bobath)

Interventions

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

Perception-Action Approach (PA)

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

Neurodevelopmental Therapy (NDT-Bobath)

Eligibility Criteria

Age6 Months - 36 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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

    BACKGROUND
  • 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.

    PMID: 20966212BACKGROUND
  • 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.

    PMID: 27925172BACKGROUND
  • 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.

    PMID: 33825199BACKGROUND
  • 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.

    PMID: 11730153BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Dilek Çokar, PHd

    İstinye University

    STUDY DIRECTOR

Central Study Contacts

Tuba D Doğan, PT, MSc, PhD(c)

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to one of two parallel intervention groups: the Perception-Action Approach group or the Neurodevelopmental Treatment (Bobath) group. Each participant will receive only one of the two interventions, delivered once weekly for 12 weeks, and outcomes will be assessed before and after the intervention period.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

May 4, 2026

First Posted

May 8, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

May 8, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share