Kontralateral Training in Patients With Bankart Lesion | NCT03511469

Studies
Kontralateral Training in Patients With Bankart Lesion

NCT03511469

Sponsor

Hacettepe University

Status

Completed

Last Update Posted

May 4, 2021Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Strenght of Rotator Cuff Muscles

Interventions

Control Group
Isokinetic Group

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 10, 2019Actual

Primary Completion Date

Nov 15, 2020Actual

Completion Date

Apr 1, 2021Actual

First Submitted Date

Apr 18, 2018

First Submission Date that Met QC Criteria

Apr 18, 2018

First Posted Date

Apr 27, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 3, 2021

Last Update Posted Date

May 4, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Taha İbrahim Yıldız, Uzm. Fzt. Taha İbrahim Yıldız, Hacettepe UniversityPrincipal Investigator

Lead Sponsor

Hacettepe UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 .

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control Group	Experimental	Patients in this group will only received standardized rehabilitation protochol after Bankart surgery	Other: Control Group
Isokinetic Group	Experimental	Patients in this group will receive concentric training for rotator cuff muscles with isokinetic device in addition the the standart rehabilitation protocol.	Other: Isokinetic Group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Control Group	Other	Control Group: Standart rehabilitation	Control Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
İsokinetic assessment	Muscle strenhgt assesment on isokinetic dynamometer	six months

Secondary Outcomes

Measure	Description	Time Frame
Funtional assesment	Sport-spesific Functional tests	siz monyhs

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Irem Duzgun, Prof.	Director of the study	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hacettepe Univercity, Faculty of Physical Theraphy and Rehablitation		Altındağ	Ankara	06600	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26078450	Background	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.
28936703	Background	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.

ID	Term
D015340	Epidemiologic Research Design
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D012107	Research Design