Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-01-05 @ 2:09 AM
Study NCT ID:
NCT03900351
Status:
COMPLETED
Last Update Posted:
2019-06-14
First Post:
2019-04-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Virtual Reality Games on Knee Proprioception After Anterior Cruciate Ligament Reconstruction (ACLR)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D020886', 'term': 'Somatosensory Disorders'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'There are two group of subjects:\n\n1. Group A (study group).\n2. Group B:(Control group).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-06-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-13', 'studyFirstSubmitDate': '2019-04-01', 'studyFirstSubmitQcDate': '2019-04-01', 'lastUpdatePostDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'knee proprioception at 30 degrees', 'timeFrame': '3 minutes', 'description': 'Biodex Isokinetic Dynamometer will be used to measure knee proprioception.'}, {'measure': 'knee proprioception at 45 degrees', 'timeFrame': '3 minutes', 'description': 'Biodex Isokinetic Dynamometer will be used to measure knee proprioception.'}, {'measure': 'knee proprioception at 60 degrees', 'timeFrame': '3 minutes', 'description': 'Biodex Isokinetic Dynamometer will be used to measure knee proprioception'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Motor Activity', 'Proprioceptive Disorders', 'Balance; Distorted']}, 'descriptionModule': {'briefSummary': 'Influence of virtual reality games(Wii Fit) on knee proprioception after anterior cruciate ligament reconstruction (ACLR) will be measured in 30 postoperative patients. The age of participants will be ranged from 20 to 30 years old. Subjects will be randomly assigned to Group A is the study group and Group B is the control group.', 'detailedDescription': "Group A will receive the Wii fit protocol of virtual reality games, in addition to the regular exercise rehabilitation protocol, for 3 non-consecutive days per week, for 8 weeks , 40 minutes for each session. Group B will receive the regular exercise rehabilitation protocol only for 3 non-consecutive days per week for 8 weeks, 40 minutes for each session.\n\nA Universal Weight and Height Scale: will be used to measure the patient's BMI.\n\nBiodex Isokinetic Dynamometer: will be used to assess the knee proprioception of the affected operated leg at three target angles (30,45,and 60 degrees)."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. patients who will be in the early postoperative phase (week 2 after surgery)\n2. patients with BMI less than 25, and more than 20.\n\nExclusion Criteria:\n\n1. Patients with injury or operation accompanied by the ACLR as meniscectomy.\n2. Patients with any deformities affecting knee joint alignment as genu valgus, genu varus, or genu recurvatum.'}, 'identificationModule': {'nctId': 'NCT03900351', 'briefTitle': 'Influence of Virtual Reality Games on Knee Proprioception After Anterior Cruciate Ligament Reconstruction (ACLR)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University of Jazan'}, 'officialTitle': 'Influence of Virtual Reality Games on Knee Proprioception After Anterior Cruciate Ligament Reconstruction (ACLR)', 'orgStudyIdInfo': {'id': '2387594650'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A: Study group', 'description': 'They will receive the Wii fit protocol of virtual reality games for 40 minutes, 3 times per week, for 8 weeks, in addition to the regular exercise rehabilitation protocol according to the criterion of Adams et al. (2012).', 'interventionNames': ['Procedure: Wii fit protocol of virtual reality games', 'Procedure: Regular exercise rehabilitation protocol']}, {'type': 'EXPERIMENTAL', 'label': 'Group B: Control group', 'description': 'They will receive the regular exercise rehabilitation protocol only for 40 minutes, for 3 days per week, for 8 weeks.', 'interventionNames': ['Procedure: Regular exercise rehabilitation protocol']}], 'interventions': [{'name': 'Wii fit protocol of virtual reality games', 'type': 'PROCEDURE', 'description': 'the Wii fit session by standing on the Wii fit board with bare feet, hands on hips and both eyes open. Pretest on Wii fit was done to make the subject familiar with the board and tasks of weight shift .', 'armGroupLabels': ['Group A: Study group']}, {'name': 'Regular exercise rehabilitation protocol', 'type': 'PROCEDURE', 'description': 'It will be according to the criterion of Adams et al. (2012).', 'armGroupLabels': ['Group A: Study group', 'Group B: Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45142', 'city': 'Jizan', 'state': 'Jazan Region', 'country': 'Saudi Arabia', 'facility': 'Jazan University', 'geoPoint': {'lat': 16.88917, 'lon': 42.55111}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Jazan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal invsetigator', 'investigatorFullName': 'Mohammed Moustafa', 'investigatorAffiliation': 'University of Jazan'}}}}