Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT04669327
Status:
COMPLETED
Last Update Posted:
2020-12-16
First Post:
2020-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hip and Knee Moments Normal and With Scoliosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077107', 'term': 'Gait Analysis'}], 'ancestors': [{'id': 'D005684', 'term': 'Gait'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D000076604', 'term': 'Physical Functional Performance'}, {'id': 'D010809', 'term': 'Physical Fitness'}, {'id': 'D006262', 'term': 'Health'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-13', 'studyFirstSubmitDate': '2020-12-05', 'studyFirstSubmitQcDate': '2020-12-13', 'lastUpdatePostDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hip and knee abductor moment', 'timeFrame': 'one session of 40 minutes.', 'description': 'peak abductor moment normalized to body weight'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Idiopathic scoliosis-gait-moment'], 'conditions': ['Scoliosis Idiopathic']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Karol L., Halliday, Gourineni P (2000).: Gait and function after intraarticular hip arthrodesis during a dolescence. J. Bone Joint Surg Am 82: 561-569. Stephen J. and Stricker M. (2002): The Malaligned Adolescent SpinePart 1: Idiopathic Adolescent Scoliosis.International Pediatrics (17): 43-47. Sucato D., Hedequist D. and Karol L(1998).: Gait analysis in idiopathic scoliosis before and after surgery: a comparison of the pre- and postoperative muscle activation pattern. Eur Spine J 7(1): 6-11. Allington N. and Bowen J. (1996): Adolescent idiopathic scoliosis: treatment with the Wilmington brace: A comparison of full-time and part-time use. J Bone Joint Surg 78: 1056-1062. Burwell R., Cole A., Cook T., Grivas T., Kiel A., Moulton A., Thirlwall A., Upadhyay S., Webb J. andWemyss S (2004).: Pathogenesis of idiopathic scoliosis. J Bone Joint Surg 86(9): 2005-2014.'}]}, 'descriptionModule': {'briefSummary': 'Kinetic analysis appears to be useful in providing objective information regarding the gait abilities of scoliotic patients which is difficult to be observed in a clinical setting. Objective: the aim of the study was to analyze the hip and knee peak abductor moments during gait in subjects with idiopathic scoliosis.', 'detailedDescription': "The hip and knee abductors' moments normalized to body weight have been investigated in normal subjects and subjects with idiopathic scoliosis. The scoliosis group included a twenty-two-moderate idiopathic dorso-lumbar single scoliotic curve. The control group contained a normal twenty-two subjects. 3D motion analysis system and force plat were used for data collection for hip and knee abductor moment. MANOVA was used to study the difference between normal and scoliotic groups' hip and knee abductor moments in both lower limbs. at alpha level of significance of 0.05."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'normal subjects and subjects with moderate idiopathic scoliosis', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* normal subjects free from any musculoskeletal problems\n* subjects with moderate idiopathic scoliosis (cobb angle 25-35)\n\nExclusion Criteria:\n\n* any musculoskeletal affection rather than scoliosis, neurological manifestations, or previous major surgeries'}, 'identificationModule': {'nctId': 'NCT04669327', 'briefTitle': 'Hip and Knee Moments Normal and With Scoliosis', 'organization': {'class': 'OTHER', 'fullName': 'Taif University'}, 'officialTitle': 'Hip and Knee Abductor Moments in Normal Subjects and Subjects With Idiopathic Scoliosis: Comparative Study', 'orgStudyIdInfo': {'id': '331'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal', 'description': 'normal subjects', 'interventionNames': ['Other: gait analysis']}, {'label': 'Scoliosis', 'description': 'subjects with moderate idiopathic scoliosis', 'interventionNames': ['Other: gait analysis']}], 'interventions': [{'name': 'gait analysis', 'type': 'OTHER', 'description': 'Vicon nexus with MTI force plate form', 'armGroupLabels': ['Normal', 'Scoliosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62552', 'city': "Ta'if", 'state': 'Mecca Region', 'country': 'Saudi Arabia', 'facility': 'College of Applied Medical Sciences', 'geoPoint': {'lat': 21.27028, 'lon': 40.41583}}], 'overallOfficials': [{'name': 'HAtem H Allam, Ass. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'the used consent form indicated that the IPD would be confidential and cannot be published.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taif University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cairo University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Hatem Allam', 'investigatorAffiliation': 'Taif University'}}}}