Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2025-12-25 @ 5:19 PM
Study NCT ID:
NCT00961103
Status:
COMPLETED
Last Update Posted:
2025-12-23
First Post:
2009-08-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Motor Development and Orthoses in Spinal Muscular Atrophy (SMA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009134', 'term': 'Muscular Atrophy, Spinal'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2011-04-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2009-08-17', 'studyFirstSubmitQcDate': '2009-08-17', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time and percentage of sitting, standing, walking achievement in SMA II and SMA III', 'timeFrame': 'aug.2009- nov.2009'}], 'secondaryOutcomes': [{'measure': 'characteristics and percentage of orthoses for postural sitting control , standing and walking in SMA II and SMA III', 'timeFrame': 'aug. 2009 - dec.2009'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['spinal muscular atrophy', 'motor development', 'orthoses'], 'conditions': ['Spinal Muscular Atrophy']}, 'referencesModule': {'references': [{'pmid': '17761659', 'type': 'BACKGROUND', 'citation': 'Wang CH, Finkel RS, Bertini ES, Schroth M, Simonds A, Wong B, Aloysius A, Morrison L, Main M, Crawford TO, Trela A; Participants of the International Conference on SMA Standard of Care. Consensus statement for standard of care in spinal muscular atrophy. J Child Neurol. 2007 Aug;22(8):1027-49. doi: 10.1177/0883073807305788.'}]}, 'descriptionModule': {'briefSummary': 'Spinal Muscular Atrophy (SMA) is neurodegenerative disease of anterior horn cells of spinal cord and represents the second more frequent pathology in childhood.\n\nAccording to the age of onset and the maximum motor function the disorder is classified in 4 types. Patients with SMA II and SMA III often use orthoses to achieve postural and dynamic functions.\n\nIn this retrospective observational study the investigators describe the characteristics of sitting position, standing and walking correlated to type and time of orthoses used.', 'detailedDescription': 'We collect data from patients with SMA II and SMA III referred to UDGEE from jan. 1995 to dec. 2008.\n\nWe estimate to achieve informations about 50-70 patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with SMA II and SMA III referred to UDGEE for rehabilitation consultation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical and genetics diagnosis of SMA II and SMA III\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT00961103', 'briefTitle': 'Motor Development and Orthoses in Spinal Muscular Atrophy (SMA)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Azienda USL Reggio Emilia - IRCCS'}, 'officialTitle': 'Assessment of Motor Development Related to Use of Orthoses in SMA II and III', 'orgStudyIdInfo': {'id': 'UDGEE-SMA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SMA II and SMA III', 'description': 'patients with SMA II and SMA III'}]}, 'contactsLocationsModule': {'locations': [{'zip': '42100', 'city': 'Reggio Emilia', 'state': 'RE', 'country': 'Italy', 'facility': 'UDGEE Hospital S.Maria Nuova', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}], 'overallOfficials': [{'name': 'Adriano Ferrari, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital S.Maria Nuova Reggio Emilia Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda USL Reggio Emilia - IRCCS', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}