Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 4:43 AM
Study NCT ID:
NCT07485894
Status:
COMPLETED
Last Update Posted:
2026-03-20
First Post:
2026-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of the Petö Method on Gross Motor Function in Children With Cerebral Palsy: a Quasi-experimental Pilot Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}, 'targetDuration': '5 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2026-03-13', 'studyFirstSubmitQcDate': '2026-03-17', 'lastUpdatePostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'GMFM 66', 'timeFrame': 'Five months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cerebral palsy', 'conductive education', 'petö method', 'motor skills'], 'conditions': ['Cerebral Palsy']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': '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).'}]}, 'descriptionModule': {'briefSummary': '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.\n\nOur 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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '4 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "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.\n\nThe exclusion of a control group from this study was due to recruitment issues, as it was not possible to obtain a sample wit", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age between 4 and 9 years (inclusive)\n* Diagnosis of spastic cerebral palsy, with motor impairment of level III and IV (Gross Motor Function Classification System - GMFCS)\n* 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).\n\nExclusion Criteria:\n\n* The presence of severe sensory deficits and serious behavioral disorders that could interfere with the group dynamics of the intervention."}, 'identificationModule': {'nctId': 'NCT07485894', 'acronym': 'Petö method', 'briefTitle': 'Effectiveness of the Petö Method on Gross Motor Function in Children With Cerebral Palsy: a Quasi-experimental Pilot Study.', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Almeria'}, 'officialTitle': 'EFFECTIVENESS OF THE PETÖ METHOD ON GROSS MOTOR FUNCTION IN CHILDREN WITH CEREBRAL PALSY: A QUASI-EXPERIMENTAL PILOT STUDY.', 'orgStudyIdInfo': {'id': 'UALBIO2023/045'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Education', 'type': 'OTHER', 'otherNames': ['Conductive education'], 'description': "This methodology is distinguished by its hybrid nature: it is not defined solely as a medical therapy, but as a comprehensive educational system. Conductive Education is implemented by the 'conductor,' a professional with three to four years of transdisciplinary training in physiotherapy, speech therapy, psychology, and pedagogy, working in close collaboration with other health specialists."}]}, 'contactsLocationsModule': {'locations': [{'zip': '04120', 'city': 'Almería', 'country': 'Spain', 'facility': 'University of Almería', 'geoPoint': {'lat': 36.83814, 'lon': -2.45974}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Patient´s information is subject to the laws of the country'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Almeria', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ph D Lecturer', 'investigatorFullName': 'SAGRARIO PÉREZ DE LA CRUZ', 'investigatorAffiliation': 'Universidad de Almeria'}}}}