Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:10 AM
Study NCT ID:
NCT07417033
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-02-18
First Post:
2026-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
From Perception to Performance: A Comprehensive Evaluation in Knee Osteoarthritis.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-10', 'studyFirstSubmitDate': '2026-02-03', 'studyFirstSubmitQcDate': '2026-02-10', 'lastUpdatePostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective Evaluation of the Knee Function 1', 'timeFrame': 'All tests will be performed at baseline.', 'description': 'Knee joint function will be evaluated using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Total score ranges from 0 to 96. Higher scores indicate worse pain and functional limitation..'}, {'measure': 'Subjective Evaluation of the Knee Function 2', 'timeFrame': 'All tests will be performed at baseline.', 'description': 'Knee joint function will be evaluated using the Lequesne Algofunctional Knee Index. The index ranges from 0 to 24 points. Higher scores indicate greater pain and functional disability. The scale evaluates pain, maximum walking distance, and activities of daily living. A higher total score reflects a worse clinical condition.'}, {'measure': 'Subjective Evaluation of the Knee Function 3', 'timeFrame': 'All tests will be performed at baseline.', 'description': 'Knee joint function will be evaluated using the Lysholm Knee Score.The score ranges from 0 to 100 points. Higher scores indicate better knee function and fewer symptoms. The scale assesses limp, support, locking, instability, pain, swelling, stair climbing, and squatting ability.'}, {'measure': 'Objective Evaluation of the Knee Function 1', 'timeFrame': 'All tests will be performed at baseline.', 'description': "Knee joint function will be evaluated using the 2-minute walk test. The test measures the maximum distance walked in two minutes, expressed in meters. A greater walking distance indicates better functional exercise capacity and mobility. There is no fixed maximum score, as results depend on the individual's performance."}, {'measure': 'Objective Evaluation of the Knee Function 2', 'timeFrame': 'All tests will be performed at baseline.', 'description': 'Knee joint function will be evaluated using the 30-second sit-to-stand test which is one of the objective measures.The test measures the number of full stands completed from a seated position in 30 seconds. Results are expressed as repetition count. A higher number of repetitions indicates better lower-extremity strength and functional mobility. There is no fixed maximum score, as performance depends on the individual.'}, {'measure': 'Objective Evaluation of the Knee Function 3', 'timeFrame': 'All tests will be performed at baseline.', 'description': 'Knee joint function will be evaluated using the 9-step stair test.which is one of the objective measures.The test measures the time required to ascend and/or descend a flight of nine stairs, expressed in seconds. A shorter completion time indicates better functional mobility, balance, and lower-extremity performance. There is no fixed minimum or maximum score, as results depend on individual performance.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Knee OA specific functional outcome measures'], 'conditions': ['Osteoarthritis', 'Pain', 'Function', 'Knee Joint Arthritis']}, 'descriptionModule': {'briefSummary': 'Knee Osteoarthritis (KOA) is commonly characterized by joint pain, swelling, stiffness, and a reduction in range of motion. These symptoms significantly affect daily activities and overall quality of life. A decrease in physical activity levels may further contribute to the deterioration of joint function over time. Physiotherapy assessment plays a critical role in the management of KOA. Such assessment enables a comprehensive evaluation of parameters including pain intensity, joint range of motion, muscle strength, flexibility, functional status, and quality of life. The use of both subjective and objective assessment methods is essential for developing individualized and effective treatment plans.', 'detailedDescription': 'Osteoarthritis-specific outcome measures such as the KOOS, WOMAC, and the Lequesne Algofunctional Osteoarthritis Index include subscales that question pain and physical function, thereby enabling the subjective assessment of pain. Among these instruments, the KOOS specifically allows the evaluation of sports and recreational activities as well as quality of life, WOMAC provides assessment of joint stiffness, and the Lequesne Algofunctional Osteoarthritis Index evaluates walking distance. Objectively, algometric measurements enable the determination of pain sensitivity. In addition, muscle strength can be assessed using a hand dynamometer and isokinetic devices; joint proprioception can be evaluated with inclinometers and isokinetic systems; and flexibility can be measured through standardized flexibility tests. Among objective functional test methods, the 30-second sit-to-stand test provides information regarding lower extremity strength, whereas the Timed Up and Go test is another objective tool used to assess lower extremity function and balance. For the objective evaluation of walking capacity, tests such as the 2-minute walk test, 6-minute walk test, and 20- and 40-meter walk tests may be employed. Within the scope of our study, knee joint function will be evaluated using the subjective measures WOMAC, the Lequesne Algofunctional Knee Index, and the Lysholm Knee Score, as well as the objective measures including the 2-minute walk test, the 30-second sit-to-stand test, and the 9-step stair test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants diagnosed with Knee Osteoarthritis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of knee osteoarthritis at Kellgren-Lawrence Grade 2-3,\n* Age between 45 and 75 years,\n* A history of chronic knee pain lasting at least 6 months,\n* Absence of other diagnosed pathologies that could cause knee joint pain,\n* Willingness to participate in the study.\n\nExclusion Criteria:\n\n* Body mass index greater than 35 kg/m²,\n* A Lysholm Knee Score above 84,\n* A history of physiotherapy treatment or intra-articular injection within the previous 6 months,\n* A history of knee joint surgery,\n* The presence of a cardiorespiratory condition that would prevent the performance of functional tests,\n* The presence of a neuropsychiatric disorder that would interfere with the ability to follow instructions.'}, 'identificationModule': {'nctId': 'NCT07417033', 'briefTitle': 'From Perception to Performance: A Comprehensive Evaluation in Knee Osteoarthritis.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Lokman Hekim University'}, 'officialTitle': 'Understanding Function in Knee Osteoarthritis: Subjective and Objective Perspectives', 'orgStudyIdInfo': {'id': 'LHU-FTR-ZSBD-05'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Knee Osteoarthritis', 'description': 'Objective and Subjective Knee Evaluation Methods'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Lokman Hekim University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lokman Hekim University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assist. Prof.', 'investigatorFullName': 'Seda BAKTIR', 'investigatorAffiliation': 'Lokman Hekim University'}}}}