Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2026-02-02 @ 8:14 AM
Study NCT ID:
NCT00842218
Status:
UNKNOWN
Last Update Posted:
2009-02-12
First Post:
2009-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Idiopathic Scoliosis and Its Treatment (Orthopaedic and Surgery): Effect of the Severity, the Orthosis and the Arthrodesis on the Gait
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012600', 'term': 'Scoliosis'}], 'ancestors': [{'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2009-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-02-11', 'studyFirstSubmitDate': '2009-02-10', 'studyFirstSubmitQcDate': '2009-02-11', 'lastUpdatePostDateStruct': {'date': '2009-02-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Gait', 'scoliosis', 'energy', 'mechanics'], 'conditions': ['Scoliosis']}, 'referencesModule': {'references': [{'pmid': '6644619', 'type': 'BACKGROUND', 'citation': 'Cavagna GA, Franzetti P, Fuchimoto T. The mechanics of walking in children. J Physiol. 1983 Oct;343:323-39. doi: 10.1113/jphysiol.1983.sp014895.'}, {'pmid': '874922', 'type': 'BACKGROUND', 'citation': 'Cavagna GA, Kaneko M. Mechanical work and efficiency in level walking and running. J Physiol. 1977 Jun;268(2):467--81. doi: 10.1113/jphysiol.1977.sp011866.'}, {'pmid': '16449899', 'type': 'BACKGROUND', 'citation': 'Danielsson AJ, Romberg K, Nachemson AL. Spinal range of motion, muscle endurance, and back pain and function at least 20 years after fusion or brace treatment for adolescent idiopathic scoliosis: a case-control study. Spine (Phila Pa 1976). 2006 Feb 1;31(3):275-83. doi: 10.1097/01.brs.0000197652.52890.71.'}, {'type': 'BACKGROUND', 'citation': 'Davis RB OS, Tyburski D, Gage JR (1991) A gait analysis data collection and reduction technique. Hum Mov Sci 10:575-587'}, {'pmid': '11154935', 'type': 'BACKGROUND', 'citation': 'Detrembleur C, van den Hecke A, Dierick F. Motion of the body centre of gravity as a summary indicator of the mechanics of human pathological gait. Gait Posture. 2000 Dec;12(3):243-50. doi: 10.1016/s0966-6362(00)00081-3.'}, {'pmid': '15760750', 'type': 'BACKGROUND', 'citation': 'Detrembleur C, Vanmarsenille JM, De Cuyper F, Dierick F. Relationship between energy cost, gait speed, vertical displacement of centre of body mass and efficiency of pendulum-like mechanism in unilateral amputee gait. Gait Posture. 2005 Apr;21(3):333-40. doi: 10.1016/j.gaitpost.2004.04.005.'}, {'pmid': '17618198', 'type': 'BACKGROUND', 'citation': 'Karski T. Biomechanical factors in the etiology of idiopathic scoliosis: two etiopathological groups of spinal deformities. Ortop Traumatol Rehabil. 2004 Nov-Dec;6(6):800-8.'}, {'pmid': '15064994', 'type': 'BACKGROUND', 'citation': 'Kramers-de Quervain IA, Muller R, Stacoff A, Grob D, Stussi E. Gait analysis in patients with idiopathic scoliosis. Eur Spine J. 2004 Aug;13(5):449-56. doi: 10.1007/s00586-003-0588-x. Epub 2004 Apr 3.'}, {'pmid': '11507125', 'type': 'BACKGROUND', 'citation': 'Lenke LG, Betz RR, Harms J, Bridwell KH, Clements DH, Lowe TG, Blanke K. Adolescent idiopathic scoliosis: a new classification to determine extent of spinal arthrodesis. J Bone Joint Surg Am. 2001 Aug;83(8):1169-81.'}, {'pmid': '10404572', 'type': 'BACKGROUND', 'citation': 'Leong JC, Lu WW, Luk KD, Karlberg EM. Kinematics of the chest cage and spine during breathing in healthy individuals and in patients with adolescent idiopathic scoliosis. Spine (Phila Pa 1976). 1999 Jul 1;24(13):1310-5. doi: 10.1097/00007632-199907010-00007.'}, {'pmid': '15996612', 'type': 'BACKGROUND', 'citation': 'Mahaudens P, Thonnard JL, Detrembleur C. Influence of structural pelvic disorders during standing and walking in adolescents with idiopathic scoliosis. Spine J. 2005 Jul-Aug;5(4):427-33. doi: 10.1016/j.spinee.2004.11.014.'}, {'type': 'BACKGROUND', 'citation': 'McArdle W, Katch F, Katch V (1996) Exercise physiology: Energy, Nutrition, and Human Performance. Baltimore'}, {'pmid': '4325224', 'type': 'BACKGROUND', 'citation': 'Roche AF, Eyman SL, Davila GH. Skeletal age prediction. J Pediatr. 1971 Jun;78(6):997-1003. doi: 10.1016/s0022-3476(71)80430-4. No abstract available.'}, {'pmid': '8327626', 'type': 'BACKGROUND', 'citation': 'Van Boxtel GJ, Geraats LH, Van den Berg-Lenssen MM, Brunia CH. Detection of EMG onset in ERP research. Psychophysiology. 1993 Jul;30(4):405-12. doi: 10.1111/j.1469-8986.1993.tb02062.x.'}, {'pmid': '7699313', 'type': 'BACKGROUND', 'citation': 'Willems PA, Cavagna GA, Heglund NC. External, internal and total work in human locomotion. J Exp Biol. 1995 Feb;198(Pt 2):379-93. doi: 10.1242/jeb.198.2.379.'}]}, 'descriptionModule': {'briefSummary': "The purposes of this study were as follows: 1) to compare locomotion parameters (kinematic, EMG, mechanical work and energy cost changes during walking in able-bodied subjects and AIS patients,2) to evaluate the effects of the frontal curve's severity of the AIS and 3) the effects of the treatment (orthosis or surgery)on these gait parameters.", 'detailedDescription': 'Introduction X-ray studies and three-dimensional analysis in standing showed that this Adolescent Idiopathic Scoliosis was characterised by stiffness of the affected vertebral levels \\[3, 7, 10\\] with decreased segmental mobilities. The impact of this stiffness was studied during functional activity such as walking to quantify the functional dynamic consequences. During gait, thoracic AIS provided an asymmetrical trunk rotation with a lack of rotation on the convex side \\[8\\] and an excessive paravertebral muscular bilateral activity \\[11\\]. These studies included only moderate scoliosis. There were no studies approaching the effects of the severity of the scoliosis curves on gait parameters.\n\nWe hypothesize first that, the spinal deformations in AIS, producing a stiffness of the trunk, pelvic and hip motions, will deteriorate the gait by reducing the segmental mobilities, increasing the mechanical work and the energy cost and second that the severity of the frontal curves will be more damaging on this parameters. To this end, we hope to gain valuable insight as to the functional effects of the scoliosis aggravation from a more dynamic perspective.\n\nMaterial Fifty-four female adolescents will be included in the study. This sample consists in two groups: healthy girls and girls with adolescent idiopathic scoliosis (divided in 3 subgroups according to the Cobb angle range) \\[9\\].\n\nA standard full spine XRay assessment will be performed to measure the Cobb angle curve, the frontal body balance, the apical vertebral rotation \\[13\\].\n\nGait will be assessed by a three-dimensional analysis, including synchronous kinematic \\[4\\], electromyographic (EMG) \\[14\\], mechanic \\[5, 6, 15\\] and energetic measurements \\[1, 2, 12\\].\n\nThe sessions begins with a rest period, in which the subjects stand barefoot on the motor driven treadmill for the static calibration of kinematic and energetic variables. Thereafter, the subjects will be asked to walk at a constant speed of 4 km h-1 for a few minutes until a steady state will be reached and maintained for at least two minutes. Then, energetic variables will be computed for two minutes. Other variables will simultaneously be recorded for twenty seconds and averaged for ten successive strides. The mean of each value will be used for statistical analysis. Scoliosis patients will be assessed at T0 i.e. before any treatment and at T1 i.e. one year after the starting of the orthosis wearing (scoliosis subgroup 2) or the surgery (scoliosis subgroup 3)'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy subjects girls were recruited in the town and adolescent idiopathic scoliosis attended our outpatient clinic', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy subjects : no scoliosis diagnosed\n* Scoliosis subjects : scoliosis diagnosed by X-Ray assessment\n\nExclusion Criteria:\n\n* Patients with leg length discrepancies higher than 1 cm, any locomotor disorders, low back pain, neurological abnormalities observed on clinical examination or with any previous treatment for their scoliosis'}, 'identificationModule': {'nctId': 'NCT00842218', 'acronym': 'scoliosis', 'briefTitle': 'The Idiopathic Scoliosis and Its Treatment (Orthopaedic and Surgery): Effect of the Severity, the Orthosis and the Arthrodesis on the Gait', 'organization': {'class': 'OTHER', 'fullName': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}, 'officialTitle': 'Effect of the Severity and the Treatment (Orthosis Versus Surgery)of the Idiopathic Scoliosis on the Locomotor Mechanism of the Gait.', 'orgStudyIdInfo': {'id': 'READ-Mahaudens-01'}}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Xavier Banse, MD PhD', 'role': 'CONTACT', 'email': 'Xavier.Banse@uclouvain.be', 'phone': '003227645375'}], 'facility': 'Université Catholique de Louvain - Cliniques universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'centralContacts': [{'name': 'Philippe Mahaudens, Mr', 'role': 'CONTACT', 'email': 'Philippe.Mahaudens@uclouvain.be', 'phone': '003227645375'}, {'name': 'Detrembleur Christine, PhD', 'role': 'CONTACT', 'email': 'Christine.Detrembleur@uclouvain.be', 'phone': '003227645375'}], 'overallOfficials': [{'name': 'Mahaudens Philippe, Mr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université Catholique de Louvain'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Banse Xavier MD, PhD', 'oldOrganization': 'Orthopaedic Research Laboratory , Université catholique de Louvain, Brussels, Belgium'}}}}