Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-01-13 @ 12:42 PM
Study NCT ID:
NCT03511469
Status:
COMPLETED
Last Update Posted:
2021-05-04
First Post:
2018-04-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Kontralateral Training in Patients With Bankart Lesion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': "All assesment will be conducted with another therapist who is not aware of patient's treatment groups"}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Control, Parallel Group Study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-03', 'studyFirstSubmitDate': '2018-04-18', 'studyFirstSubmitQcDate': '2018-04-18', 'lastUpdatePostDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'İsokinetic assessment', 'timeFrame': 'six months', 'description': 'Muscle strenhgt assesment on isokinetic dynamometer'}], 'secondaryOutcomes': [{'measure': 'Funtional assesment', 'timeFrame': 'siz monyhs', 'description': 'Sport-spesific Functional tests'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Kontralateral Education, Bankart, Rehabilitation, Shoulder,'], 'conditions': ['Strenght of Rotator Cuff Muscles']}, 'referencesModule': {'references': [{'pmid': '26078450', 'type': 'BACKGROUND', 'citation': 'Tjong VK, Devitt BM, Murnaghan ML, Ogilvie-Harris DJ, Theodoropoulos JS. A Qualitative Investigation of Return to Sport After Arthroscopic Bankart Repair: Beyond Stability. Am J Sports Med. 2015 Aug;43(8):2005-11. doi: 10.1177/0363546515590222. Epub 2015 Jun 15.'}, {'pmid': '28936703', 'type': 'BACKGROUND', 'citation': 'Manca A, Dragone D, Dvir Z, Deriu F. Cross-education of muscular strength following unilateral resistance training: a meta-analysis. Eur J Appl Physiol. 2017 Nov;117(11):2335-2354. doi: 10.1007/s00421-017-3720-z. Epub 2017 Sep 21.'}]}, 'descriptionModule': {'briefSummary': 'The rate of re-dislocation after arthroscopic bankart repair is up to 30%. The most important dynamic structure that prevents re-dislocation is the rotator cuff muscles. The aim of our study is to investigate the efficacy of contralateral training on patients with arthroscopic Bankart surgery. Patients with arthroscopic Bankart surgery will be included in the study. The patients will be randomly assigned into 3 groups and the first group will be the control group, the second group will be the concentric group and the third group will be the eccentric group. Standard rehabilitation program will be applied to all groups until 3 months after surgery. Between 2nd and 12nd weeks after surgery, concentric strengthening program will be applied to the rotator cuff muscles with isokinetic dynamometer to the 2nd group. In group 3, the eccentric strengthening program will be applied to the rotator sheath muscles with the same isokinetic dynamometer from the 2nd week until 12nd week .\n\nThe strength of the rotator sheath muscles will be measured in pre-op period, post-op week 12 and post-op month 6 with the isokinetic dynamometer in all patients. In addition, functional tests will be performed in pre-op period and post-op 6 months (Y balance test for upper extremity, Closed Kinetic Chain Upper Extremity Stability Test and Medicine Ball Throw Test).', 'detailedDescription': 'The return to sport after bankart surgery is very high. Yet, the rate of re-dislocation after arthroscopic bankart repair is up to 30%. The most important dynamic structure that prevents re-dislocation is the rotator cuff muscles. The aim of our study is to investigate the efficacy of contralateral training on patients with arthroscopic Bankart surgery. Patients with arthroscopic Bankart surgery will be included in the study. The patients will be randomly assigned into 3 groups and the first group will be the control group, the second group will be the concentric group and the third group will be the eccentric group. Standard rehabilitation program will be applied to all groups until 3 months after surgery. Between 2nd and 12nd weeks after surgery, concentric strengthening program will be applied to the rotator cuff muscles with isokinetic dynamometer to the 2nd group. In group 3, the eccentric strengthening program will be applied to the rotator sheath muscles with the same isokinetic dynamometer from the 2nd week until 12nd week .\n\nThe strength of the rotator sheath muscles will be measured in pre-op period, post-op week 12 and post-op month 6 with the isokinetic dynamometer in all patients. In addition, functional tests will be performed in pre-op period and post-op 6 months (Y balance test for upper extremity, Closed Kinetic Chain Upper Extremity Stability Test and Medicine Ball Throw Test).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having isolated arthroskopic bankart surgery\n* Having \\<3 dislocation number\n* Accepting to participate in the study\n* Having rehabilitation in our clinic\n\nExclusion Criteria:\n\n* Revision surgery\n* Additional problem like bony bankart or laterjet surgery\n* Having \\> 3 disloccation before surgery\n* Refusing to participate in the study\n* Not participating to the exercise program more then twice'}, 'identificationModule': {'nctId': 'NCT03511469', 'briefTitle': 'Kontralateral Training in Patients With Bankart Lesion', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Effects of Kontralateral Training in Patients With Bankart Lesion', 'orgStudyIdInfo': {'id': 'BK 1233412'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control Group', 'description': 'Patients in this group will only received standardized rehabilitation protochol after Bankart surgery', 'interventionNames': ['Other: Control Group']}, {'type': 'EXPERIMENTAL', 'label': 'Isokinetic Group', 'description': 'Patients in this group will receive concentric training for rotator cuff muscles with isokinetic device in addition the the standart rehabilitation protocol.', 'interventionNames': ['Other: Isokinetic Group']}], 'interventions': [{'name': 'Control Group', 'type': 'OTHER', 'description': 'Control Group: Standart rehabilitation', 'armGroupLabels': ['Control Group']}, {'name': 'Isokinetic Group', 'type': 'OTHER', 'description': 'Concentric group: Standart rehabilitation + isokinetic training', 'armGroupLabels': ['Isokinetic Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06600', 'city': 'Altındağ', 'state': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Hacettepe Univercity, Faculty of Physical Theraphy and Rehablitation', 'geoPoint': {'lat': 39.96673, 'lon': 32.92254}}], 'overallOfficials': [{'name': 'Irem Duzgun, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Director of the study'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Uzm. Fzt. Taha İbrahim Yıldız', 'investigatorFullName': 'Taha İbrahim Yıldız', 'investigatorAffiliation': 'Hacettepe University'}}}}