Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2026-03-01 @ 9:53 PM
Study NCT ID:
NCT06634212
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-09
First Post:
2024-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Dubousset Functional Test in Total Knee Arthloplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-08', 'studyFirstSubmitDate': '2024-10-08', 'studyFirstSubmitQcDate': '2024-10-08', 'lastUpdatePostDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dubousset Functional Test', 'timeFrame': '10 minutes', 'description': 'The four test components included the Up and Walking Test (unassisted sit-to-stand from a chair, walk forward/backward 5 meters \\[no turn\\], then unassisted stand-to-sit), Steps Test (ascend three steps, turn, descend three steps), Down and Sitting Test (stand-to-ground, followed by ground-to-stand, with assistance as needed), and Dual-Tasking Test (walk 5 meters forwards and back while counting down from 50 by 2).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Arthroplasty']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the validity and reliability of Dubousset Functional Test in the patients with Total Knee Prothesis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 50-70 years who had Total Knee Arthroplasty', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients who had Total Knee Arthroplasty\n* Patients aged 50-70 years.\n\nExclusion Criteria:\n\n* Patients who didn't have any Total Kne arthroplasty\n* hose with fractures, pregnancy, a disease that would prevent physical exertion, those with a body mass index (BMI) of 40 kg/m2 and above, and those with major musculoskeletal or neurological disorders that cause gait disturbance will be excluded from the study."}, 'identificationModule': {'nctId': 'NCT06634212', 'acronym': 'DFT-TKA', 'briefTitle': 'The Dubousset Functional Test in Total Knee Arthloplasty', 'organization': {'class': 'OTHER', 'fullName': 'Alanya Alaaddin Keykubat University'}, 'officialTitle': 'Validity and Reliability of Dubousset Functional Test in Total Knee Arthloplasty', 'orgStudyIdInfo': {'id': '2024/DFT-TKA'}}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alanya Alaaddin Keykubat University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Asistant Professor, Physiotherapist', 'investigatorFullName': 'Ayça Araci', 'investigatorAffiliation': 'Alanya Alaaddin Keykubat University'}}}}