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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
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

First Posted
April 18, 2018
Last Updated
May 3, 2021
Sponsor
Hacettepe University
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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
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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
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Kontralateral Training in Patients With Bankart Lesion

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