Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-03-01 @ 1:46 PM
Study NCT ID:
NCT03215160
Status:
COMPLETED
Last Update Posted:
2018-07-18
First Post:
2017-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Mobilization Exercises on Total Knee Arthroplasty Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-16', 'studyFirstSubmitDate': '2017-06-19', 'studyFirstSubmitQcDate': '2017-07-11', 'lastUpdatePostDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Satisfaction levels of the patients', 'timeFrame': 'At 2 months', 'description': 'Satisfaction levels of the patients with Global Rating of Change Score'}], 'primaryOutcomes': [{'measure': 'Change from Baseline Range of Motion Degree at 2 weeks', 'timeFrame': 'Baseline, Post-op 2 weeks, and Post-op 2 months', 'description': 'Passive knee flexion range of motion'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline Pain Degree at 2 weeks', 'timeFrame': 'Baseline, Post-op 2 weeks, and Post-op 2 months', 'description': 'Patient reported pain degree'}, {'measure': 'Function', 'timeFrame': 'Baseline, Post-op 2 weeks, and Post-op 2 months', 'description': 'Functional Performance tests'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mobilization', 'Manual Therapies', 'Exercise'], 'conditions': ['Total Knee Arthroplasty', 'Total Knee Replacement']}, 'referencesModule': {'references': [{'pmid': '24500904', 'type': 'BACKGROUND', 'citation': 'Harvey LA, Brosseau L, Herbert RD. Continuous passive motion following total knee arthroplasty in people with arthritis. Cochrane Database Syst Rev. 2014 Feb 6;2014(2):CD004260. doi: 10.1002/14651858.CD004260.pub3.'}, {'pmid': '24553908', 'type': 'BACKGROUND', 'citation': 'Cross M, Smith E, Hoy D, Nolte S, Ackerman I, Fransen M, Bridgett L, Williams S, Guillemin F, Hill CL, Laslett LL, Jones G, Cicuttini F, Osborne R, Vos T, Buchbinder R, Woolf A, March L. The global burden of hip and knee osteoarthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1323-30. doi: 10.1136/annrheumdis-2013-204763. Epub 2014 Feb 19.'}, {'pmid': '24387819', 'type': 'BACKGROUND', 'citation': 'Nelson AE, Allen KD, Golightly YM, Goode AP, Jordan JM. A systematic review of recommendations and guidelines for the management of osteoarthritis: The chronic osteoarthritis management initiative of the U.S. bone and joint initiative. Semin Arthritis Rheum. 2014 Jun;43(6):701-12. doi: 10.1016/j.semarthrit.2013.11.012. Epub 2013 Dec 4.'}, {'pmid': '24534535', 'type': 'BACKGROUND', 'citation': 'Jacobs CA, Christensen CP. Factors influencing patient satisfaction two to five years after primary total knee arthroplasty. J Arthroplasty. 2014 Jun;29(6):1189-91. doi: 10.1016/j.arth.2014.01.008. Epub 2014 Jan 21.'}, {'pmid': '20710093', 'type': 'BACKGROUND', 'citation': 'Bade MJ, Kohrt WM, Stevens-Lapsley JE. Outcomes before and after total knee arthroplasty compared to healthy adults. J Orthop Sports Phys Ther. 2010 Sep;40(9):559-67. doi: 10.2519/jospt.2010.3317.'}, {'pmid': '15685070', 'type': 'BACKGROUND', 'citation': 'Noble PC, Gordon MJ, Weiss JM, Reddix RN, Conditt MA, Mathis KB. Does total knee replacement restore normal knee function? Clin Orthop Relat Res. 2005 Feb;(431):157-65. doi: 10.1097/01.blo.0000150130.03519.fb.'}, {'pmid': '24602550', 'type': 'BACKGROUND', 'citation': 'Ebert JR, Munsie C, Joss B. Guidelines for the early restoration of active knee flexion after total knee arthroplasty: implications for rehabilitation and early intervention. Arch Phys Med Rehabil. 2014 Jun;95(6):1135-40. doi: 10.1016/j.apmr.2014.02.015. Epub 2014 Mar 3.'}, {'pmid': '21979411', 'type': 'BACKGROUND', 'citation': 'Bade MJ, Stevens-Lapsley JE. Early high-intensity rehabilitation following total knee arthroplasty improves outcomes. J Orthop Sports Phys Ther. 2011 Dec;41(12):932-41. doi: 10.2519/jospt.2011.3734. Epub 2011 Sep 30.'}, {'pmid': '33352007', 'type': 'DERIVED', 'citation': 'Karaborklu Argut S, Celik D, Kilicoglu OI. The Combination of Exercise and Manual Therapy Versus Exercise Alone in Total Knee Arthroplasty Rehabilitation: A Randomized Controlled Clinical Trial. PM R. 2021 Oct;13(10):1069-1078. doi: 10.1002/pmrj.12542. Epub 2021 Feb 3.'}]}, 'descriptionModule': {'briefSummary': 'There is no definite evidence about the most effective treatment approach in early-stage rehabilitation after total knee arthroplasty surgery. The purpose of this study is to investigate the effects of mobilization exercises applied with classical exercises on pain, joint range of motion, edema, function, quality of life and patient satisfaction in early stage rehabilitation after total knee arthroplasty surgery.', 'detailedDescription': 'There is no definite evidence about the most effective treatment approach in early-stage rehabilitation after total knee arthroplasty surgery. The purpose of this study is to investigate the effects of mobilization exercises applied with classical exercises on pain, joint range of motion, edema, function, quality of life and patient satisfaction in early stage rehabilitation after total knee arthroplasty surgery. Patients with bicompartmental total knee arthroplasty operation due to knee osteoarthritis will randomly assign to 2 groups. Patients in group 1 will treat with mobilization exercises in addition to classical exercises performed in the early post-op period; patients in group 2 will treat only with classical exercises.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with TKA surgery due to the diagnosis of knee OA\n* Between the ages of 50-75 years\n\nExclusion Criteria:\n\n* Revision TKA,\n* Previous unicompartmental arthroplasty or tibial osteotomy,\n* Hemophilia,\n* Rheumatic diseases,\n* Lower extremity fractures and tumors,\n* Neurological diseases leading to muscle weakness in the lower limbs,\n* Patients with emotional and cognitive problems'}, 'identificationModule': {'nctId': 'NCT03215160', 'briefTitle': 'Using Mobilization Exercises on Total Knee Arthroplasty Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Effectiveness of Mobilization Exercises on Total Knee Arthroplasty Rehabilitation', 'orgStudyIdInfo': {'id': '22595'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mobilization Exercise Group', 'description': 'Mobilization exercises in addition to classical exercises performed in the early post-op period', 'interventionNames': ['Behavioral: Exercises']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Classical Exercise Group', 'description': 'only classical exercises performed in the early post-op period', 'interventionNames': ['Behavioral: Exercises']}], 'interventions': [{'name': 'Exercises', 'type': 'BEHAVIORAL', 'description': 'mobilization exercises (Patellofemoral joint, Tibiofemoral joint, Soft tissue) and classical exercises performed in the early post-op period', 'armGroupLabels': ['Classical Exercise Group', 'Mobilization Exercise Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34740', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MSc Research Assistant', 'investigatorFullName': 'Sezen Karabörklü Argut', 'investigatorAffiliation': 'Istanbul University'}}}}