Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-26 @ 3:44 AM
Study NCT ID:
NCT01979718
Status:
COMPLETED
Last Update Posted:
2016-06-16
First Post:
2013-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Post-operative Analgesia of the Virtual Reality Using a Mirror Therapy After Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020370', 'term': 'Osteoarthritis, Knee'}, {'id': 'D059226', 'term': 'Nociceptive Pain'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-15', 'studyFirstSubmitDate': '2013-11-03', 'studyFirstSubmitQcDate': '2013-11-03', 'lastUpdatePostDateStruct': {'date': '2016-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6 minute walk test', 'timeFrame': 'shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention', 'description': 'The distance walked at a self-selected speed along a 40 cm corridor in 6 min. The distance was measured in meters, and more the meters better the result. A walking aid was used if needed.'}], 'secondaryOutcomes': [{'measure': 'Visual analogue scale (VAS) while resting', 'timeFrame': 'shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention', 'description': 'checking the VAS while resting'}, {'measure': 'Visual analogue scale (VAS) while moving', 'timeFrame': 'shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention', 'description': 'checking the VAS while resting'}, {'measure': 'Active ROM of flexion and extension on the knee', 'timeFrame': 'shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention'}, {'measure': 'Tridol consumption per week', 'timeFrame': 'after the 1st and 2nd session (5 days) intervention'}, {'measure': 'WOMAC index', 'timeFrame': 'shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention'}, {'measure': 'Graded ambulation distances', 'timeFrame': 'shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention', 'description': 'Grade 1: able to ambulate ≤5 feet Grade 2: able to ambulate \\>5 feet but \\<10 feet Grade 3: able to ambulate \\>10 feet but \\<30 feet Grade 4: able to ambulate ≥30 feet'}, {'measure': 'Timed-stands test', 'timeFrame': 'shortly after the 1st and 2nd session (5 days) intervention, and after 6 weeks after intervention', 'description': 'The patients were asked to rise from and sit down on a chair with a height of 45 cm, 10 times and as quickly as possible, without using the armrests. The time spent was recorded.'}, {'measure': 'Side effects', 'timeFrame': 'after the 1st and 2nd session (5 days) intervention'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Osteoarthritis, Knee', 'Nociceptive Pain', 'Virtual Reality']}, 'descriptionModule': {'briefSummary': 'It was well known that the mirror therapy could decrease pain of upper-limb amputated patients.\n\nThe mirror therapy is known to make a plastic change some parts of the brain perceiving the painful body part and modulating its signal by feedback of visual information mirrored with the corresponding contra-lateral normal parts.\n\nIn this study, post-operative analgesic efficiency of the virtual reality using a mirror therapy after total knee arthroplasty will be evaluated.\n\nThis clinical trial will be performed in the form of prospective, single-blind (i.e. assessor-blind), parallel group, randomized (allocation ratio 1:1), single cohort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who were transferred to RM after unilateral TKA\n\nExclusion Criteria:\n\n* patients cannot freely move the contralat. leg d/t neurologic or musculoskeletal problems\n* patients are not enough clear to indicate VAS\n* patients cannot look at the virtual reality monitor d/t visual problem\n* refusal of the participation'}, 'identificationModule': {'nctId': 'NCT01979718', 'briefTitle': 'The Post-operative Analgesia of the Virtual Reality Using a Mirror Therapy After Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Ulsan University Hospital'}, 'officialTitle': 'The Post-operative Analgesia of the Virtual Reality Using a Mirror Therapy After Total Knee Arthroplasty: Prospective, Single-blind, Parallel Group, Randomized, Single Cohort Clinical Trial of Efficacy', 'orgStudyIdInfo': {'id': 'chhwang3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Full term intervention', 'description': '* random selection\n* composed of the daily standard physical treatment and 1 session per one day over two weeks with a break on Saturday and Sunday (1 session is consisted of 50 repetitions of voluntary simultaneous flexion and extension of the both knees, taking a look at the mirrored virtual reality simulating the surgeried knee.', 'interventionNames': ['Device: Mirrored Virtual reality']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Half term intervention', 'description': '* random selection\n* composed of the daily standard physical treatment over two weeks and 1 session per one day over one weeks with a break on Saturday and Sunday (1 session is consisted of 50 repetitions of voluntary simultaneous flexion and extension of the both knees, taking a look at the mirrored virtual reality stimmulating the surgeried knee )', 'interventionNames': ['Device: Mirrored Virtual reality']}], 'interventions': [{'name': 'Mirrored Virtual reality', 'type': 'DEVICE', 'description': 'Patients are required to look at the images of both lower extremities ranged from the perineal area to the foot. Virtual reality system records in real-time method both lower extremities. Following the validity assessement mirrored image of the surgeried lower extremity is re-formed using the virtusal reality system flipping the image of lower extremity not-surgeried and being calibration for the symmetricity.', 'armGroupLabels': ['Full term intervention', 'Half term intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '682-714', 'city': 'Ulsan', 'country': 'South Korea', 'facility': 'Ulsan University Hospital', 'geoPoint': {'lat': 35.53722, 'lon': 129.31667}}], 'overallOfficials': [{'name': 'Chang Ho Hwang, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ulsan University Hospital'}, {'name': 'Sung Do Cho, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ulsan University Hospital'}, {'name': 'Youngjoon Chee, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Biomedical Engineering, University of Ulsan'}, {'name': 'Kyo-In Koo, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Biomedical Engineering, University of Ulsan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ulsan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Chang Ho Hwang', 'investigatorAffiliation': 'Ulsan University Hospital'}}}}