Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-26 @ 1:55 AM
Study NCT ID:
NCT00154505
Status:
COMPLETED
Last Update Posted:
2005-09-12
First Post:
2005-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Lateral Trunk Support on Spinal Alignment in Spinal Cord Injured Persons
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012600', 'term': 'Scoliosis'}, {'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2002-08', 'completionDateStruct': {'date': '2004-11'}, 'lastUpdateSubmitDate': '2005-09-09', 'studyFirstSubmitDate': '2005-09-09', 'studyFirstSubmitQcDate': '2005-09-09', 'lastUpdatePostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spinal aligamnet(Cobb angle)'}]}, 'conditionsModule': {'keywords': ['Scoliosis', 'Spinal Cord Injury', 'Lateral Trunk Support', 'Radiography'], 'conditions': ['Scoliosis', 'Spinal Cord Injury']}, 'descriptionModule': {'briefSummary': 'The effects of lateral trunk supports (LTS) in special seating on the spinal alignment of 17 spinal cord injured (SCI) subjects with scoliosis were studied using bi-planar radiographs. The LTS improved significantly the functional scoliotic spinal alignment in the frontal and sagittal planes regardless of the severity of scoliosis.', 'detailedDescription': 'SCI patients often develop progressive scoliosis due to loss of muscular support to maintain good sitting posture. Special seating with LTS has been widely used in clinical practice to improve their sitting postures. However, little is known as to how this can affect the scoliotic curve.The purpose of this study was to investigate the effects of lateral trunk supports (LTS) in special seating on the spinal alignment of spinal cord injured (SCI) individuals with scoliosis.\n\nTen male and seven female SCI subjects with scoliosis sat on an experimental chair with and without LTS while radiographs of the spine in the anteroposterior and lateral directions were taken. Radiographs of the spine in the A-P and lateral directions were taken with a digital radiographic imaging system (Saturn 9000 M, Comed., Korea). For each direction, the complete image of the spine was obtained from separate x-ray images of the upper and lower trunk due to the limited field of view of the x-ray machine. The Cobb angles and scoliotic indices based on the anteroposterior radiographic images and the angles of the thoracic and lumber spine based on lateral were calculated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1) C4-T12 SCI, (2) onset over 1 year, (3) sitting on the wheelchair more than 4 hours per day, (4) diagnosed thoracic or lumbar scoliosis through A-P radiographs, (5) flexible scoliosis, confirmed by supine and side-lying bending radiographs.\n\nExclusion Criteria:\n\n* inflexible scoliosis'}, 'identificationModule': {'nctId': 'NCT00154505', 'briefTitle': 'Effects of Lateral Trunk Support on Spinal Alignment in Spinal Cord Injured Persons', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Effects of Lateral Trunk Support on Spinal Alignment in Spinal Cord Injured Persons', 'orgStudyIdInfo': {'id': '9261701245'}, 'secondaryIdInfos': [{'id': 'NSC 91-2314-B-002-393'}, {'id': 'NSC 92-2314-B-002-084'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Lateral trunk support of wheelchair seating', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'School of Occupational Therapy, National Taiwan University', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Hui-Fen Mao, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Science and Technology Council, Taiwan', 'class': 'OTHER_GOV'}]}}}