Kontralateral Training in Patients With Bankart Lesion
Primary Purpose
Strenght of Rotator Cuff Muscles
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Control Group
Isokinetic Group
Sponsored by
About this trial
This is an interventional treatment trial for Strenght of Rotator Cuff Muscles focused on measuring Kontralateral Education, Bankart, Rehabilitation, Shoulder,
Eligibility Criteria
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
Sites / Locations
- Hacettepe Univercity, Faculty of Physical Theraphy and Rehablitation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Control Group
Isokinetic Group
Arm Description
Patients in this group will only received standardized rehabilitation protochol after Bankart surgery
Patients in this group will receive concentric training for rotator cuff muscles with isokinetic device in addition the the standart rehabilitation protocol.
Outcomes
Primary Outcome Measures
İsokinetic assessment
Muscle strenhgt assesment on isokinetic dynamometer
Secondary Outcome Measures
Funtional assesment
Sport-spesific Functional tests
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03511469
Brief Title
Kontralateral Training in Patients With Bankart Lesion
Official Title
Effects of Kontralateral Training in Patients With Bankart Lesion
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
June 10, 2019 (Actual)
Primary Completion Date
November 15, 2020 (Actual)
Study Completion Date
April 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Strenght of Rotator Cuff Muscles
Keywords
Kontralateral Education, Bankart, Rehabilitation, Shoulder,
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Control, Parallel Group Study
Masking
Outcomes Assessor
Masking Description
All assesment will be conducted with another therapist who is not aware of patient's treatment groups
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Experimental
Arm Description
Patients in this group will only received standardized rehabilitation protochol after Bankart surgery
Arm Title
Isokinetic Group
Arm Type
Experimental
Arm Description
Patients in this group will receive concentric training for rotator cuff muscles with isokinetic device in addition the the standart rehabilitation protocol.
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
Control Group: Standart rehabilitation
Intervention Type
Other
Intervention Name(s)
Isokinetic Group
Intervention Description
Concentric group: Standart rehabilitation + isokinetic training
Primary Outcome Measure Information:
Title
İsokinetic assessment
Description
Muscle strenhgt assesment on isokinetic dynamometer
Time Frame
six months
Secondary Outcome Measure Information:
Title
Funtional assesment
Description
Sport-spesific Functional tests
Time Frame
siz monyhs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Irem Duzgun, Prof.
Organizational Affiliation
Director of the study
Official's Role
Study Director
Facility Information:
Facility Name
Hacettepe Univercity, Faculty of Physical Theraphy and Rehablitation
City
Altındağ
State/Province
Ankara
ZIP/Postal Code
06600
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
26078450
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.
Results Reference
background
PubMed Identifier
28936703
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.
Results Reference
background
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Kontralateral Training in Patients With Bankart Lesion
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