Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-02-06 @ 6:56 AM
Study NCT ID:
NCT02134704
Status:
TERMINATED
Last Update Posted:
2016-08-30
First Post:
2014-05-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MOUVSCO: Kinematic Analysis of the Trunk in Patients With Moderate Scoliosis
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'whyStopped': 'All patients were recruted but it has been difficulte to recrute all volunteers (15/30) . However data should be sufficient for analyse of data.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-29', 'studyFirstSubmitDate': '2014-05-05', 'studyFirstSubmitQcDate': '2014-05-07', 'lastUpdatePostDateStruct': {'date': '2016-08-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative movements, in mm, of the spinous processes in the three planes of space', 'timeFrame': '2 hours', 'description': 'Characterize the kinematic anomalies in scoliosis patients compared with healthy volunteers during typical tasks of trunk flexion.'}], 'secondaryOutcomes': [{'measure': 'Relative rotations of the bi-acromial line, thoracic and pelvic plan.', 'timeFrame': '2 hours', 'description': '* Assess the existence of kinematic differences between the scoliosis patients and healthy volunteers during forward bending.\n* Assess the kinematic differences between the scoliosis patients and healthy volunteers when they sit and up from a stool.\n* Assess the kinematic differences between the scoliosis patients and healthy volunteers during walking.'}, {'measure': 'Walking speed, step length and single stance time.', 'timeFrame': '2 hours', 'description': 'Assess the performance of walking in scoliosis patients.'}, {'measure': 'The surface of displacement of the center of plantar pressure, static relative orientation of the bi-acromial line, thoracic and pelvic plan.', 'timeFrame': '2 hours', 'description': 'Assess balance and static posture of scoliotic patients.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Scoliosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.cic-it-grenoble.fr/', 'label': 'Website of the Grenoble clinical investigation center - Technological Innovation'}]}, 'descriptionModule': {'briefSummary': 'The hypothesis of this study is that moderate scoliosis patients have postural and kinematic differences (static and dynamic) compared with healthy volunteers and it is possible to characterize and quantify.\n\nThe aim of this study is the detailed analysis of postural anomalies in moderate scoliosis patients compared with healthy volunteers', 'detailedDescription': 'Subjects participating in the study must wear sensors that will be arrange at the shoulders, spine, pelvis and legs. Subjects will perform under the direction of the investigator, different tasks of a total duration of 45 minutes.\n\nDuring the period of experimentation, the data collected will be:\n\n* the positions of each one of the sensors in all three planes of space,\n* the ground support forces'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '9 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Scoliosis Group - Inclusion Criteria:\n\n* female children patients from 9 to 16 years old,\n* patients with idiopathic scoliosis lumbar left and / or right thoracic,\n* patients with moderate scoliosis: Cobb angle measured on a radiograph between 10 ° and 25°,\n* both parents of patients must be affiliated to social security or similarly regime.\n\nHealthy Volunteers Group - Inclusion Criteria:\n\n* female children from 9 to 16 years old, matched in age and size with scoliosis patients,\n* children with no neuromuscular disease that may have an influence on the required tasks,\n* both parents of children must be affiliated to social security or similarly regime,\n\nExclusion Criteria:\n\n* refusal to consent: from child's in age to consent or from both parents"}, 'identificationModule': {'nctId': 'NCT02134704', 'acronym': 'MOUVSCO', 'briefTitle': 'MOUVSCO: Kinematic Analysis of the Trunk in Patients With Moderate Scoliosis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Kinematic Analysis of the Trunk in Patients With Moderate Scoliosis', 'orgStudyIdInfo': {'id': 'MOUVSCO-DCIC-1411'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Scoliosis Group', 'interventionNames': ['Other: Data recording with all sensors']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy Volunteers Group', 'interventionNames': ['Other: Data recording with all sensors']}], 'interventions': [{'name': 'Data recording with all sensors', 'type': 'OTHER', 'description': 'The sensors will be placed in the child body and will allow the collection of all the data of the trial.', 'armGroupLabels': ['Healthy Volunteers Group', 'Scoliosis Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38043', 'city': 'Grenoble', 'state': 'Isère', 'country': 'France', 'facility': 'Émilie Chipon', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'overallOfficials': [{'name': 'Aurelien Courvoisier, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Grenoble'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'collaborators': [{'name': 'TIMC-IMAG', 'class': 'OTHER'}, {'name': 'Clinical Investigation Centre for Innovative Technology Network', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}