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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03511469
Other study ID # BK 1233412
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 10, 2019
Est. completion date April 1, 2021

Study information

Verified date May 2021
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


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).


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date April 1, 2021
Est. primary completion date November 15, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Control Group
Control Group: Standart rehabilitation
Isokinetic Group
Concentric group: Standart rehabilitation + isokinetic training

Locations

Country Name City State
Turkey Hacettepe Univercity, Faculty of Physical Theraphy and Rehablitation Altindag Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Isokinetic assessment Muscle strenhgt assesment on isokinetic dynamometer six months
Secondary Funtional assesment Sport-spesific Functional tests siz monyhs