Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2026-01-05 @ 5:59 PM
Study NCT ID:
NCT06671366
Status:
COMPLETED
Last Update Posted:
2025-06-15
First Post:
2024-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Test-retest Correlation in Isokinetic Shoulder Testing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-11', 'studyFirstSubmitDate': '2024-10-30', 'studyFirstSubmitQcDate': '2024-10-31', 'lastUpdatePostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between each measurement at peak torque', 'timeFrame': '1hour', 'description': 'Correlation between each measurement at peak torque below, and for each arm (12 correlations) in seated position abduction at 45 and 30 degrees anterior elevation.\n\n* Concentric internal rotation 60degrees/sec\n* Concentric external rotation 60 degrees/sec\n* Concentric internal rotation 180 degrees/sec\n* Concentric external rotation 180 degrees/sec\n* Eccentric internal rotation 60degrees/sec\n* Eccentric external rotation 60degrees/sec\n\nEvaluation of results using an intraclass correlation coefficient (ICC).'}], 'secondaryOutcomes': [{'measure': 'Data in healthy patients', 'timeFrame': '1hour', 'description': 'Evaluation of the peak torque of each measurement in healthy patients, have a database.'}, {'measure': "Establishing the test's external validity", 'timeFrame': '1hour', 'description': 'Validated external test :\n\n1\\) External validity\n\n* Differences between dominant arm / weak arm measurements\n* Differences between eccentric and concentric measurements\n* Difference between "test" and "retest" measurements'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Isokinetic']}, 'descriptionModule': {'briefSummary': 'This study is a prospective, monocentric interventional clinical study in 30 healthy volunteers.\n\nThe aim is to objectively assess shoulder external and internal rotation strength using a Cybex dynamometer in a specific position (seated with the arm at 45° abduction and 30° elevation).\n\nThe investigator would like here to determine the reproducibility of measurements in this precise evaluation position, but also to determine reference values in healthy subjects.\n\nThe results of this study will enable us to improve our management and establish a database for comparison with pathological subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Student of the Montpellier School of Physical Therapy\n* Adult having received informed information about the study and signed the consent form\n\nExclusion Criteria:\n\n* Any history of shoulder pathology in the year preceding the tests.'}, 'identificationModule': {'nctId': 'NCT06671366', 'acronym': 'ISO2024', 'briefTitle': 'Test-retest Correlation in Isokinetic Shoulder Testing', 'organization': {'class': 'OTHER', 'fullName': 'Clinique Saint Jean, France'}, 'officialTitle': 'Evaluation of Test-retest Correlation in Isokinetic Shoulder Testing', 'orgStudyIdInfo': {'id': '2024-A01269-38'}, 'secondaryIdInfos': [{'id': '2024-A01269-38', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'External and internal shoulder rotation force', 'description': 'shoulder external and internal rotation force objectively using a Cybex dynamometer in a specific position (seated with the arm at 45° abduction and 30° elevation)', 'interventionNames': ['Device: external and internal shoulder rotation using a Cybex dynamometer']}], 'interventions': [{'name': 'external and internal shoulder rotation using a Cybex dynamometer', 'type': 'DEVICE', 'description': 'Measurement of the reproducibility, in this precise evaluation position, of the results obtained between the different tests carried out 30 minutes apart, and thus the reliability of each measurement in this test.\n\nmeasures :\n\n* Concentric internal rotation 60degrees/sec\n* Concentric external rotation 60 degrees/sec\n* Concentric internal rotation 180 degrees/sec\n* Concentric external rotation 180 degrees/sec\n* Eccentric internal rotation 60degrees/sec\n* Eccentric external rotation 60degrees/sec', 'armGroupLabels': ['External and internal shoulder rotation force']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34430', 'city': 'Saint-Jean-de-Védas', 'country': 'France', 'facility': 'Clinique St Jean Sud de France', 'geoPoint': {'lat': 43.57759, 'lon': 3.82603}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinique Saint Jean, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}