Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-27 @ 11:15 PM
Study NCT ID:
NCT01157494
Status:
COMPLETED
Last Update Posted:
2010-07-07
First Post:
2010-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validity of Manipulation Taxonomy of Spastic Hemiplegic Cerebral Palsy (CP) Forms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006429', 'term': 'Hemiplegia'}, {'id': 'D002547', 'term': 'Cerebral Palsy'}], 'ancestors': [{'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-06', 'studyFirstSubmitDate': '2010-07-06', 'studyFirstSubmitQcDate': '2010-07-06', 'lastUpdatePostDateStruct': {'date': '2010-07-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assisting Hand Assessment (AHA)', 'timeFrame': 'the 2 assessment has to be registered within 6 months', 'description': 'correlation between the new classification of hand manipulation function and the AHA which measures the bi-manual performance, i.e. what the child usually does with the plegic hand'}], 'secondaryOutcomes': [{'measure': 'Melbourne Assessment of Unilateral Upper Limb Function (Melbourne Assessment)', 'timeFrame': 'the 2 assessment has to be registered within 6 months', 'description': 'correlation between the new classification of hand manipulation function and the Melbourne Assessment which measures the bi-manual performance, i.e. what the child usually does with the plegic hand'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cerebral palsy', 'hemiplegia', 'upper limb', 'assessment', 'classification system'], 'conditions': ['Hemiplegia', 'Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'In recent years Ferrari et al. proposed a new classification of manipulation in children with spastic hemiplegia which describes five different classes by analyzing and integrating the kinematic patterns of the hand and its functional use.\n\nThe investigators believe that this classification provides the clinician with clinically meaningful information, by identifying the useful strategies spontaneously adopted by the children during manipulation tasks.\n\nThe aim of this study is to determine the criterion validity of the new classification of the pattern of manipulation in children with spastic hemiplegia by correlating hand manipulation classes with both the scores of the Assisting Hand Assessment and the scores of the Melbourne Assessment of Unilateral Upper Limb Function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We retrospectively studied children with hemiplegia 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* clinical and instrumental (TC or RMN) diagnosis of child hemiplegia\n* age \\> 5 years\n\nExclusion criteria:\n\n* acquired hemiplegia at the age \\> 3 years\n* anti-spastic drug inoculations or functional surgery on the plegic UE 6 months prior to the video recordings\n* severe mental retardation attested by the Diagnostic and Statistical Manual of mental disorders IV\n* pharmaco-resistant epilepsy\n* behavioural disorders'}, 'identificationModule': {'nctId': 'NCT01157494', 'briefTitle': 'Validity of Manipulation Taxonomy of Spastic Hemiplegic Cerebral Palsy (CP) Forms', 'organization': {'class': 'OTHER', 'fullName': 'University of Modena and Reggio Emilia'}, 'officialTitle': 'Validity of Manipulation Taxonomy of Spastic Hemiplegic Cerebral Palsy Forms Proposed by Ferrari A et.al.', 'orgStudyIdInfo': {'id': 'UDGEE_2010_hand_class'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'children with hemiplegia', 'description': 'To determine the criterion validity of the classification of the pattern of manipulation proposed by Ferrari et al. we correlated hand manipulation classes with both the scores of the two standard criteria chosen (AHA and Melbourne Assessment).', 'interventionNames': ['Other: classification of hand manipulation function']}], 'interventions': [{'name': 'classification of hand manipulation function', 'type': 'OTHER', 'description': 'To determine the criterion validity of the classification of the pattern of manipulation proposed by Ferrari et al. we correlated hand manipulation classes with both the scores of the two standard criteria chosen (AHA and Melbourne Assessment).', 'armGroupLabels': ['children with hemiplegia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42100', 'city': 'Reggio Emilia', 'state': 'RE', 'country': 'Italy', 'facility': 'Hospital Azienda Santa Maria Nuova in Reggio Emilia', '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': 'Giulia Borelli, PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azienda USL Reggio Emilia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Modena and Reggio Emilia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Azienda USL Reggio Emilia - IRCCS', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Adriano Ferrari', 'oldOrganization': 'University of Modena and Reggio Emilia and Hospital Azienda Santa Maria Nuova Reggio Emilia'}}}}