Ignite Creation Date:
2025-12-24 @ 12:04 PM
Ignite Modification Date:
2026-02-22 @ 4:11 AM
Study NCT ID:
NCT03304561
Status:
COMPLETED
Last Update Posted:
2018-02-05
First Post:
2017-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Contralateral Limb Training on Functional Outcomes in Patients With ACL Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-31', 'studyFirstSubmitDate': '2017-10-04', 'studyFirstSubmitQcDate': '2017-10-04', 'lastUpdatePostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'quadriceps and hamstring muscle strenght', 'timeFrame': '6 month', 'description': 'quadriceps strength change during the first, second and sixth months of the rehabilitation proccess after ACL reconstruction surgery. the strength measurements will conducted on isokinetic dynamometer (isomed 2000)'}], 'secondaryOutcomes': [{'measure': 'functional outcomes', 'timeFrame': '6 month', 'description': 'one leg hop test, vertical jump test on the sixth month after surgery. the functional outcomes will be measured only at the sixth month after surgery.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['knee', 'rehabilitation', 'ACL', 'Contralateral training'], 'conditions': ['Anterior Cruciate Ligament Reconstruction']}, 'descriptionModule': {'briefSummary': 'Quadriceps and hamstring muscle strenghts have important role in returning to sport after ACL reconstruction and one of the main focus of rehabilitation is to improve strenght of these muscles. With the strenghtening of the contralateral limb (cross-over training) we aimed to improve the strenght of the quadriceps', 'detailedDescription': 'Returning to sport after ACL reconstruction is not at desired level among athletes. Quadriceps and hamstring muscle strenghts have important role in returning to sport after ACL reconstruction. Cross-over training is recomended during rehabilitation after ACL reconstrucion. Yet duration of the training, frequancy and type of exercise interention are not clear for the cross-over training. Ain of the study is to investigate the effects of cross-over training on muscle strenght'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* having surgery of ACL reconstruction on one side\n* having no problem at least six month on the nonsrgical side\n* recieving the rehabilitation programme at hacettepe university, physiotherapy department\n\nExclusion Criteria:\n\n* refusing to include to the study\n* having revision ACL surgery\n* addition of PCL or cartilage surgery addition to the ACL surgery\n* not participating to the rehabilidation program regularly over 3 month after sugery'}, 'identificationModule': {'nctId': 'NCT03304561', 'briefTitle': 'The Effect of Contralateral Limb Training on Functional Outcomes in Patients With ACL Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Contralateral Strength Training Effects on Functional Outcomes in Patients Who Had Undergone ACL Reconstruction: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '123456'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'traditional rehabilitation', 'description': 'patients in this groups is going to recieve traditional rehabilitation programme for 3 months after ACL recontsruction', 'interventionNames': ['Other: Traditional rehabilitation']}, {'type': 'EXPERIMENTAL', 'label': 'Cross-over training', 'description': 'patients in this programme is going to recieve isokinetic exercise programme targeting unilvolved limb during rehabilitation. for the first 4 weeks after ACL reconstruction traditional rehabiitation programme is going to applied to the subjects. after 4 weeks, isokinetic strenghtening programme at 60˚/second angular velocity, between 0-90 degree knee flexion until 3 months after ACL reconstructon', 'interventionNames': ['Other: Cross-over training']}], 'interventions': [{'name': 'Traditional rehabilitation', 'type': 'OTHER', 'otherNames': ['Standard post-operative ACL rehabilidation program'], 'description': 'traditional ACL rehabilitation program', 'armGroupLabels': ['traditional rehabilitation']}, {'name': 'Cross-over training', 'type': 'OTHER', 'description': 'Cross-over training addition to the traditional rehabilidation', 'armGroupLabels': ['Cross-over training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Sports Physiotherapy Unit', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'volga tunay, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'volgamel@yahoo.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Phd', 'investigatorFullName': 'GULCAN HARPUT', 'investigatorAffiliation': 'Hacettepe University'}}}}