NCT03511469

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 27, 2018

Completed
1.1 years until next milestone

Study Start

First participant enrolled

June 10, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

May 4, 2021

Status Verified

May 1, 2021

Enrollment Period

1.4 years

First QC Date

April 18, 2018

Last Update Submit

May 3, 2021

Conditions

Strenght of Rotator Cuff Muscles

Keywords

Kontralateral Education, Bankart, Rehabilitation, Shoulder,

Outcome Measures

Primary Outcomes (1)

  • İsokinetic assessment

    Muscle strenhgt assesment on isokinetic dynamometer

    six months

Secondary Outcomes (1)

  • Funtional assesment

    siz monyhs

Study Arms (2)

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

Control GroupOTHER

Control Group: Standart rehabilitation

Control Group
Isokinetic GroupOTHER

Concentric group: Standart rehabilitation + isokinetic training

Isokinetic Group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Having isolated arthroskopic bankart surgery
  • Having \<3 dislocation number
  • Accepting to participate in the study
  • Having rehabilitation in our clinic

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe Univercity, Faculty of Physical Theraphy and Rehablitation

Altındağ, Ankara, 06600, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 26078450BACKGROUND

  • 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.

    PMID: 28936703BACKGROUND

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Irem Duzgun, Prof.

    Director of the study

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
All assesment will be conducted with another therapist who is not aware of patient's treatment groups
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Control, Parallel Group Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Uzm. Fzt. Taha İbrahim Yıldız

Study Record Dates

First Submitted

April 18, 2018

First Posted

April 27, 2018

Study Start

June 10, 2019

Primary Completion

November 15, 2020

Study Completion

April 1, 2021

Last Updated

May 4, 2021

Record last verified: 2021-05

Locations

TU(1)