Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2026-02-21 @ 10:02 AM
Study NCT ID:
NCT04024592
Status:
COMPLETED
Last Update Posted:
2019-07-18
First Post:
2019-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reliability and Validity of Strength Measurement of the Lower Limbs in Typically Developing Children
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': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-17', 'studyFirstSubmitDate': '2019-01-24', 'studyFirstSubmitQcDate': '2019-07-17', 'lastUpdatePostDateStruct': {'date': '2019-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Isokinetic strength assessment with Biodex System 4 device', 'timeFrame': '90 minutes', 'description': 'Isokinetic strength measurements of the lower limb (Max and Mean Newton Meter of 3 consecutive movements)'}], 'secondaryOutcomes': [{'measure': 'Functional strength assessment', 'timeFrame': '30 minutes', 'description': '30 second tests (number of trials in 30 seconds)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['child', 'dynamometry', 'knee joint', 'reproducability of results', 'strength testing'], 'conditions': ['Children', 'Muscle Strength', 'Reproducibility of Results', 'Muscle Strength Dynamometer', 'Knee']}, 'descriptionModule': {'briefSummary': 'Reliability of isokinetic strength measurement of the knee in typically developing children has yet been studied and seems to be good. Because in daily life activities strength of the hip- and ankle-joint muscles are also important, the investigators aim to study the reliability and validity of isokinetic strength measurements of the hip and ankle.', 'detailedDescription': 'Intra-tester reliability of isokinetic strength measurements of the knee, hip and ankle in a Biodex System 4 device will be studied. Children will be assessed at different movement velocities using the test-positions as proposed by the manufacturer. Maximum peak torque will be established.\n\nChildren will also perform functional strength assessments and the relation with the results of isokinetic strength measurements will be analysed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy children with good intellectual capacities\n\nExclusion Criteria:\n\n* children with chronic disease or intellectual deficiency'}, 'identificationModule': {'nctId': 'NCT04024592', 'briefTitle': 'Reliability and Validity of Strength Measurement of the Lower Limbs in Typically Developing Children', 'organization': {'class': 'OTHER', 'fullName': 'University Ghent'}, 'officialTitle': 'Reliability and Validity of Strength Measurement of the Lower Limbs in Typically Developing Children', 'orgStudyIdInfo': {'id': 'B670201834766'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'children', 'interventionNames': ['Device: Biodex System 4']}], 'interventions': [{'name': 'Biodex System 4', 'type': 'DEVICE', 'description': 'Reliability and validity of isokinetic strength measurement of the knee, hip and ankle in typically developing children.', 'armGroupLabels': ['children']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Ghent University', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Christine Van den Broeck, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Ghent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}