- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03511469
Kontralateral Training in Patients With Bankart Lesion
Effects of Kontralateral Training in Patients With Bankart Lesion
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 .
The 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).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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 .
The 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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ankara
-
Altındağ, Ankara, Turkey, 06600
- Hacettepe Univercity, Faculty of Physical Theraphy and Rehablitation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Having isolated arthroskopic bankart surgery
- Having <3 dislocation number
- Accepting to participate in the study
- Having rehabilitation in our clinic
Exclusion Criteria:
- Revision surgery
- Additional problem like bony bankart or laterjet surgery
- Having > 3 disloccation before surgery
- Refusing to participate in the study
- Not participating to the exercise program more then twice
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Control Group
Patients in this group will only received standardized rehabilitation protochol after Bankart surgery
|
Control Group: Standart rehabilitation
|
EXPERIMENTAL: Isokinetic Group
Patients in this group will receive concentric training for rotator cuff muscles with isokinetic device in addition the the standart rehabilitation protocol.
|
Concentric group: Standart rehabilitation + isokinetic training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
İsokinetic assessment
Time Frame: six months
|
Muscle strenhgt assesment on isokinetic dynamometer
|
six months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Funtional assesment
Time Frame: siz monyhs
|
Sport-spesific Functional tests
|
siz monyhs
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Irem Duzgun, Prof., Director of the study
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BK 1233412
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Strenght of Rotator Cuff Muscles
-
Bezmialem Vakif UniversityNot yet recruitingRotator Cuff Tears | Partial Tear of Rotator CuffTurkey
-
Xiros LtdNot yet recruitingRotator Cuff Tear | Rotator Cuff Injuries | Rotator Cuff Tears | Rotator Cuff Tears of the Shoulder
-
St. Antonius HospitalCompletedDisorder of Rotator Cuff | Other Instability, Shoulder | Rotator Cuff LesionNetherlands
-
Ivan WongCompletedRotator Cuff Injury | Full Thickness Rotator Cuff Tear | Rotator Cuff Syndrome | Disorder of Rotator Cuff | Skin Graft (Allograft) (Autograft) FailureCanada
-
University of Alabama at BirminghamTerminatedPartial Tear of Rotator Cuff | Tendinopathy of Rotator CuffUnited States
-
Hospital Universitario La Pazspanish society of orthopedics and traumatologyCompletedRotator Cuff Tears of the ShoulderSpain
-
University of UtahEnrolling by invitationStudying the Genetic Relationship of Rotator Cuff TearsUnited States
-
Northern Orthopaedic Division, DenmarkCompletedFull Thickness Rotator Cuff TearDenmark
-
Duke UniversityRecruitingRotator Cuff Injuries | Shoulder Injuries | Shoulder Pain | Rotator Cuff Repair | Rotator Cuff Tears | Shoulder Surgery | Shoulder Arthritis | Shoulder Disease | Rotator Cuff Arthropathy of Left Shoulder | Rotator Cuff Arthropathy of Right ShoulderUnited States
-
Anesiva, Inc.TerminatedRotator Cuff Repair of the ShoulderKorea, Republic of
Clinical Trials on Control Group
-
Tasly Pharmaceutical Group Co., LtdCompleted
-
Henan Cancer HospitalRecruitingChemotherapy | Immune Checkpoint Inhibitor | Locally Advanced Gastric CarcinomaChina
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI); National Institutes of Health (NIH)Completed
-
International University of La RiojaRecruiting
-
Romanian Society of Anesthesia and Intensive CareUniversity of Medicine and Pharmacy "Victor Babes" Timisoara; Timişoara County...Completed
-
The University of Hong Konghong Kong Cancer FundCompletedBreast Cancer | Yoga Therapy | Shoulder Joint Motion | Scar Contracture
-
University of PernambucoUnknown
-
Yonsei UniversityUnknownAdvanced Gastric Cancer | Neoadjuvant Chemotherapy | Palliative ChemotherapyKorea, Republic of
-
Physicians Committee for Responsible MedicineMetropolitan Police Department of Washington, D.C.SuspendedDiabetes Mellitus, Type 2 | Overweight | Blood PressureUnited States
-
Istanbul University - Cerrahpasa (IUC)Active, not recruiting