- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07485894
Effectiveness of the Petö Method on Gross Motor Function in Children With Cerebral Palsy: a Quasi-experimental Pilot Study. (Petö method)
EFFECTIVENESS OF THE PETÖ METHOD ON GROSS MOTOR FUNCTION IN CHILDREN WITH CEREBRAL PALSY: A QUASI-EXPERIMENTAL PILOT STUDY.
Cerebral palsy is the most frequent cause of physical disability in childhood. The Petö Method proposes a comprehensive pedagogical-therapeutic approach to improve functionality. Historically, the Petö Method (Conductive Education) has faced skepticism regarding its clinical efficacy. Notable reports, such as the one by the American Academy for Cerebral Palsy and Developmental Medicine (AACPDM), have previously concluded that there was insufficient evidence to support its use. However, these critiques emphasized that prior studies suffered from serious methodological deficiencies and a lack of validated measurement instruments.
Our study directly addresses these gaps by implementing the Gross Motor Function Measure-66 (GMFM-66). Unlike older scales, the GMFM-66 provides a valid and reliable estimate of motor behavior in children with CP, offering the sensitivity required to detect minimal yet clinically relevant changes.
In our results, the Petö Method is shown to be an effective intervention for improving gross motor function in children with significant levels of motor impairment. The observed changes are not only statistically significant but also clinically relevant, exceeding the minimal detectable change and promoting functional autonomy in activities of daily living.
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Almería, Spain, 04120
- University of Almeria
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
The sample consisted of thirteen pediatric patients diagnosed with cerebral palsy (CP). The inclusion criteria were age between 4 and 9 years (inclusive), diagnosis of spastic cerebral palsy, with motor impairment of level III and IV (Gross Motor Function Classification System - GMFCS), sufficient cognitive competence to understand and execute simple commands. In addition, participants were required to have completed a three-month therapeutic rest period without any other type of prior therapy (to ensure the 'novelty' effect of the therapy and avoid contamination with other interventions). Exclusion criteria included the presence of severe sensory deficits and serious behavioral disorders that could interfere with the group dynamics of the intervention. It should be noted that epilepsy under pharmacological control was not a reason for exclusion from this study.
The exclusion of a control group from this study was due to recruitment issues, as it was not possible to obtain a sample wit
Description
Inclusion Criteria:
- Age between 4 and 9 years (inclusive)
- Diagnosis of spastic cerebral palsy, with motor impairment of level III and IV (Gross Motor Function Classification System - GMFCS)
- Sufficient cognitive competence to understand and execute simple commands. - - To have completed a three-month therapeutic rest period without any other type of prior therapy (to ensure the 'novelty' effect of the therapy and avoid contamination with other interventions).
Exclusion Criteria:
- The presence of severe sensory deficits and serious behavioral disorders that could interfere with the group dynamics of the intervention.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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GMFM 66
Time Frame: Five months
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Four areas were distinguished: manipulation, arm mobility, leg mobility, and postural control.
The GMFM-66 scale has been designed and validated in a population of children with CP aged between 5 months and 16 years.
Its purpose is to assess different dimensions of gross motor skills in children with CP and to record changes over time in the characteristics or attributes of gross motor behavior.
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Five months
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Bax, M., Goldstein, M., Rosenbaum, P., Leviton, A., Paneth, N., Dan, B. & Damiano, D. Proposed definition and classification of cerebral palsy. Dev. Med. Child Neurol. 47, 571-576 (2005).
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UALBIO2023/045
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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