Ignite Creation Date:
2025-12-24 @ 11:48 AM
Ignite Modification Date:
2026-02-21 @ 5:12 PM
Study NCT ID:
NCT05440461
Status:
COMPLETED
Last Update Posted:
2024-01-30
First Post:
2022-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reliability and Validity Study of Urdu Version of Oxford Knee Score in Patients With Knee Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2022-11-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-28', 'studyFirstSubmitDate': '2022-06-27', 'studyFirstSubmitQcDate': '2022-06-27', 'lastUpdatePostDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxford knee score', 'timeFrame': 'day 1', 'description': 'Oxford knee score is 12 items self-evaluation form which is used to evaluate the knee Osteoarthritis. Oxford knee score is used to evaluate pain and physical disability.'}, {'measure': 'Western Ontario McMaster universities osteoarthritis index', 'timeFrame': 'day 1', 'description': 'Western Ontario McMaster universities osteoarthritis index is a 24 items to evaluate knee Osteoarthritis. First 5 items are used to evaluate pain, 6 and 7 items are used to evaluate stiffness and next 8 to 24 questions are used to access physical function.'}, {'measure': 'International Knee Documentation Committee', 'timeFrame': 'day 1', 'description': 'International Knee Documentation Committee has 19 items. It is used to evaluate knee Osteoarthritis and ligament injuries. The International Knee Documentation Committee is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Oxford Knee Score', 'Urdu Version', 'Reliability', 'Validity', 'Knee Osteoarthritis'], 'conditions': ['Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': '* To translate the Oxford knee score into Urdu language\n* To evaluate the reliability and validity of Urdu Version of Oxford knee score for accessing pain and physical function in patients with knee osteoarthritis.\n* To evaluate the correlation of Oxford knee score with Western Ontario McMaster universities osteoarthritis index and International Knee Documentation Committee', 'detailedDescription': 'The original English version of Oxford Knee Score will be translated and culturally adapted as per previous recommendation. In patients with knee osteoarthritis, Urdu Version of Oxford Knee Score will be distributed among 100 participants choose a convenience sampling technique based on pre-defined inclusion and exclusion criteria. To test reliability of inter/intra observer of ultimate final Urdu Version of Oxford Knee Score will be filled from patients on the equivalent day, by 2 different bystanders, and for inter observer valuation, with an interval of 30 minutes between the first and second application. Third assessment will be carried out after 7 days of the Observer -1, for intra-observer assessment. Data will be entered and analyzed Cronbach alpha value. Test-retest reliability will be assessed using an intra-class correlation coefficient. Urdu Version of Oxford Knee Score will be evaluated for content validity, construct validity, criterion validity and responsiveness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '35 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with knee Osteoarthritis were included from Pakistan', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed knee Osteoarthritis patients were included\n* Both male and female patients were included\n* Both unilateral and bilateral knee Osteoarthritis patients were included\n* Patients were included who fulfilled the American college of rheumatology criteria\n* Patients were included between the age of 35-80 Y old patients\n\nExclusion Criteria:\n\n* Patients with any heart problem were excluded\n* Patients with peripheral vascular injury were excluded'}, 'identificationModule': {'nctId': 'NCT05440461', 'briefTitle': 'Reliability and Validity Study of Urdu Version of Oxford Knee Score in Patients With Knee Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Analysis of Psychometric Properties and Cultural Adaptation of Urdu Version of Oxford Knee Score in Patients With Knee Osteoarthritis', 'orgStudyIdInfo': {'id': 'REC/FSD/0290'}}, 'contactsLocationsModule': {'locations': [{'zip': '38000', 'city': 'Faisalabad', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Ripah International University', 'geoPoint': {'lat': 31.41554, 'lon': 73.08969}}], 'overallOfficials': [{'name': 'Muhammad Kashif', 'role': 'STUDY_CHAIR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}