Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-31 @ 2:25 PM
Study NCT ID:
NCT01158833
Status:
COMPLETED
Last Update Posted:
2014-06-27
First Post:
2010-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validity of the Kinematic Classification of Gait in Diplegic Children With Cerebral Palsy (CP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-26', 'studyFirstSubmitDate': '2010-07-06', 'studyFirstSubmitQcDate': '2010-07-07', 'lastUpdatePostDateStruct': {'date': '2014-06-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional Mobility Scale (FMS)', 'timeFrame': 'at the age of 12 to 17 years', 'description': 'correlation between the new classification of diplegic gait and the FMS which classifies the functional mobility in children'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cerebral palsy', 'diplegia', 'gait', 'classification'], 'conditions': ['Cerebral Palsy', 'Diplegia, Spastic']}, 'referencesModule': {'references': [{'pmid': '18418341', 'type': 'BACKGROUND', 'citation': 'Pascale R, Perazza S, Borelli G, Bianchini E, Alboresi S, Paolicelli PB, Ferrari A, Cioni G. The term diplegia should be enhanced. Part III: inter-observer reliability of the new rehabilitation oriented classification. Eur J Phys Rehabil Med. 2008 Jun;44(2):213-20.'}, {'pmid': '18418340', 'type': 'BACKGROUND', 'citation': 'Cioni G, Lodesani M, Pascale R, Coluccini M, Sassi S, Paolicelli PB, Perazza S, Ferrari A. The term diplegia should be enhanced. Part II: contribution to validation of the new rehabilitation oriented classification. Eur J Phys Rehabil Med. 2008 Jun;44(2):203-11.'}, {'pmid': '18418339', 'type': 'BACKGROUND', 'citation': 'Ferrari A, Alboresi S, Muzzini S, Pascale R, Perazza S, Cioni G. The term diplegia should be enhanced. Part I: a new rehabilitation oriented classification of cerebral palsy. Eur J Phys Rehabil Med. 2008 Jun;44(2):195-201.'}]}, 'descriptionModule': {'briefSummary': 'In recent years Ferrari et al. proposed a new classification of gait in diplegic children with spastic diplegia that describes four different patterns of gait by analyzing the strategies that each children adopts to need his/her needs to walk. The investigators believe that this classification provides the clinician with clinically meaningful information in terms of coping strategies adopted to maximize the ability to walk.\n\nThe aim of this study is to determine the criterion validity of the new classification of the pattern of gait in children with spastic diplegia by correlating pattern of diplegic gait with the score of the Functional performance measure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We retrospectively studied children with diplegia and CP who are followed by the Unit for Severe Disability in the Developmental Age at the Hospital of Reggio Emilia (Italy);', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diplegia and CP;\n\nExclusion Criteria:\n\n* severe mental retardation attested by the Diagnostic and Statistical Manual of mental disorders IV\n* pharmaco-resistant epilepsy\n* behavioural disorders'}, 'identificationModule': {'nctId': 'NCT01158833', 'briefTitle': 'Validity of the Kinematic Classification of Gait in Diplegic Children With Cerebral Palsy (CP)', 'organization': {'class': 'OTHER', 'fullName': 'University of Modena and Reggio Emilia'}, 'officialTitle': 'Validity of the Kinematic Classification of Gait in Diplegic Children With Cerebral Palsy', 'orgStudyIdInfo': {'id': 'UDGEE_2010_classdipl'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'spastic diplegia due to Cerebral Palsy', 'interventionNames': ['Other: classification of gait in diplegic children with CP']}], 'interventions': [{'name': 'classification of gait in diplegic children with CP', 'type': 'OTHER', 'description': 'To determine the criterion validity of the classification of the pattern of diplegic gait proposed by Ferrari et al. we correlated gait patterns with the score of the FMS.', 'armGroupLabels': ['spastic diplegia due to Cerebral Palsy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42100', 'city': 'Reggio Emilia', 'state': 'RE', 'country': 'Italy', 'facility': 'Arcispedale Santa Maria Nuova', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}], 'overallOfficials': [{'name': 'Adriano Ferrari, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Modena and Reggio Emilia and Hospital Santa Maria Nuova'}, {'name': 'Stefania Costi, PT', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Modena and Reggio Emilia'}, {'name': 'Rita Neviani, PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azienda USL Reggio Emilia - IRCCS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Modena and Reggio Emilia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Azienda USL Reggio Emilia - IRCCS', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physical Therapist', 'investigatorFullName': 'Stefania Costi', 'investigatorAffiliation': 'University of Modena and Reggio Emilia'}}}}