Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-03-01 @ 10:11 AM
Study NCT ID:
NCT02748759
Status:
COMPLETED
Last Update Posted:
2016-04-22
First Post:
2016-04-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Mobilization of Knee Joint After ACL Surgery. Continuous Passive Motion Versus Manual Passive Mobilization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-20', 'studyFirstSubmitDate': '2016-04-15', 'studyFirstSubmitQcDate': '2016-04-20', 'lastUpdatePostDateStruct': {'date': '2016-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knee Range of Motion (ROM) angle', 'timeFrame': 'Fifteen hours after surgery', 'description': 'Maximum knee flexion angle minus the maximum knee extension angle obtained from 15 repetitions of flexo-extension. Measurements were obtained by CPM device and an external goniometer'}, {'measure': 'Knee maximum flexion', 'timeFrame': 'Fifteen hours after surgery', 'description': 'Maximum knee flexion obtained form 15 repetitions of flexo-extensión. Measurements were obtained by CPM device and an external goniometer'}, {'measure': 'Knee maximum extension', 'timeFrame': 'Fifteen hours after surgery', 'description': 'Maximum knee extension obtained form 15 repetitions of flexo-extensión. Measurements were obtained by CPM device and an external goniometer'}], 'secondaryOutcomes': [{'measure': 'Pain', 'timeFrame': 'Fifteen hours after surgery', 'description': 'Pain reported by the patient according to Visual Analogic Scale'}, {'measure': 'Fluid volumen drained (ml)', 'timeFrame': 'Fifteen hours after surgery', 'description': 'Fluid volume drained during procedure (ml)'}, {'measure': 'Time (seconds)', 'timeFrame': 'Fifteen hours after surgery', 'description': 'Overall time spent in manual mobilization and CPM mobilization'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Continous Passive Motion', 'Manual Physical Therapy', 'Range of Motion, Articular', 'Anterior Cruciate Ligament Reconstruction', 'Rehabilitation', 'Kaltenborn Manual Therapy'], 'conditions': ['Anterior Cruciate Ligament Reconstruction']}, 'descriptionModule': {'briefSummary': 'Anterior Cruciate Ligament (ACL) injuries by trauma are a prevalent pathology. In the USA, about 200.000 injuries are estimated per year, half of which implicate a total rupture of the ligament. Data indicates that the number of ACL injuries is increasing in young athletes and presents a common problem, especially people playing agility sports.\n\nOne of the most widely used methods for the post-surgical mobilization after ACL is the use of Continuous Passive Motion (CPM) devices. These machines are meant to drain residual fluid from the articulation and maintain the mobility of the joint and muscles in the knee. Even though studies show that, an early mobilization after surgery is beneficial to the rehabilitation of the knee joint, recent studies are questioning the efficiency of the CPM when compared with the goal of application. While literature suggests that efficacy of CPM are related with the magnitude of knee flexion and the Range of Motion (ROM) achieved some studies show that the range of motion measured by the CPM is considerably less than the actual ROM.\n\nAs other therapy that provides an effective mobilization of the knee joint, the Specific Manual Physical Therapy method (Kaltenborn method) takes in account the physiological combination of rotation and gliding of the two joint surfaces. This technique mobilizes the femorotibial joint by controlling the tibial plateau anteroposterior during flexion and posteroanterior during extension of the knee. Therefore, in the past 30 years there are not studies comparing ROM measurements obtained with CPM and manual physical therapy methods.\n\nIt is hypothesized that the benefits of the early passive mobilization after ACL reconstructive surgery are diminished by the limited efficacy of currently used CPM devices. The aim of our study was to determine the range of motion achieved with the passive mobilization using a CPM device compared with a manual method (Kaltenborn method) and to assess that ROM measurements provided by the CPM correlates the real ROM.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Rupture of Anterior cruciate ligament\n* Ligamentoplasty with partial meniscectomy when necessary using arthroscopy technique\n\nExclusion Criteria:\n\n* Patients operated after three weeks post-injury because of greater risk of arthrofibrosis\n* Patients who had medical complications during surgery\n* Patients unable to understand the study protocol and those unwilling to give informed consent'}, 'identificationModule': {'nctId': 'NCT02748759', 'briefTitle': 'Early Mobilization of Knee Joint After ACL Surgery. Continuous Passive Motion Versus Manual Passive Mobilization', 'organization': {'class': 'OTHER', 'fullName': 'Althaia Xarxa Assistencial Universitària de Manresa'}, 'officialTitle': 'Early Mobilization of Knee Joint After ACL Reconstructive Surgery Comparing Continuous Passive Motion Versus Manual Passive Mobilization', 'orgStudyIdInfo': {'id': 'CEIC 13/106'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'EXP 1: Manual mobilization / CPM', 'description': 'Patients were subjected to a manual mobilization using the Kaltenborn approach, in which 15 tibiofemoral glides were applied by a physiotherapist. After a pause of 5 minutes, the patient was collocated in a commercially available CPM device (Kinetec Advanced Prima) and received 15 repetitions of flexo-extension.', 'interventionNames': ['Device: CPM', 'Other: Manual mobilization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EXP 2: CPM / Manual mobilization', 'description': 'Patients were collocated in a commercially available CPM device (Kinetec Advanced Prima) and received 15 repetitions of flexo-extension. After a pause of 5 minutes, patients were subjected to a manual mobilization using the Kaltenborn approach, in which 15 tibiofemoral glides were applied by a physiotherapist.', 'interventionNames': ['Device: CPM', 'Other: Manual mobilization']}], 'interventions': [{'name': 'CPM', 'type': 'DEVICE', 'description': '15 repetitions of flexo-extensión with a commercially available CPM device (Kinetec Advanced Prima)', 'armGroupLabels': ['EXP 1: Manual mobilization / CPM', 'EXP 2: CPM / Manual mobilization']}, {'name': 'Manual mobilization', 'type': 'OTHER', 'description': 'Manual mobilization using the Kaltenborn approach, in which 15 tibiofemoral glides were applied by a physiotherapist', 'armGroupLabels': ['EXP 1: Manual mobilization / CPM', 'EXP 2: CPM / Manual mobilization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08243', 'city': 'Manresa', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Althaia Xarxa Assistencial Universitària de Manresa', 'geoPoint': {'lat': 41.72815, 'lon': 1.82399}}], 'overallOfficials': [{'name': 'Jesús Montesinos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Althaia Xarxa Assistencial de Manresa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jesús Montesinos Muñoz', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundació Eurecat', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Jesús Montesinos Muñoz', 'investigatorAffiliation': 'Althaia Xarxa Assistencial Universitària de Manresa'}}}}