Comparing Two Different Rehabilitation Protochols on Patients With Rotator Cuff Repair

August 24, 2021 updated by: Irem Duzgun, Hacettepe University
Rotator cuff (RC) repair is one of the most common treatment approch to relief the pain and improve the shoulder function on patients with rotator cuff rupture. Despite the improved surgical techniques and decreased failure rate, there are still complications after the surgey like shoulder persistant shoulder pain, stiffness even re-tear. Therefore, rehabilitation after the RC repair procedure is crucial for the success of the treatment. However, there is no concencus between the post-operative rehabilitation protochol. The aim of this study is to compare two different rehabilitation protochols on patients with RC repair.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Rotator cuff (RC) repair is one of the most common treatment approch to relief the pain and improve the shoulder function on patients with rotator cuff rupture. Despite the improved surgical techniques and decreased failure rate, there are still complications after the surgey like shoulder persistant shoulder pain, stiffness even re-tear. Therefore, rehabilitation after the RC repair procedure is crucial for the success of the treatment. However, there is no concencus between the post-operative rehabilitation protochol. The aim of this study is to compare two different rehabilitation protochols in terms of shoulder range of motion, self-reported shoulder function and pain on patients with RC repair.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Ankara
      • Altındağ, Ankara, Turkey, 06600
        • Hacettepe Univercity, Faculty of Physical Theraphy and Rehablitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Having a Rotator Cuff repair surgery
  • Having post-op rehabilitation program at our clinic until post-op 3 months
  • No previous surgery in the shoulder joint

Exclusion Criteria:

  • Additional pathology other then RC tear
  • Refusing to participate to the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hospitalized rehabilitation
Patients in this group will recieve rehabilitation program twice in a week at our clinic after the surgical procedure until post-operative 12 weeks.
Other: Hospitalized rehabilitation
Patients will recive a rehabilitation prgram at the clinic twice in a week until the post-operative 12. weeks
Experimental: Home-based rehabilitation
Patients in his groups will performed home-based rehabilitation in the early stages of the post-op period. They will com to our clinic once in a two weeks and the recieve the exercise program to perform at home until the 6. weeks of the post-operative period. After the 6. week they will come to our clinic once in a week until the post-operative 12. week.
Other: Home-based rehabilitation
Patients will recive a home program once in a two weeks until the 6. weeks of post-operative period. Then will start to recieve a rehabilitation program ar the clinic once in a week auntil the 12. week of the post-operative period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
scapular kinematics
Time Frame: 6 months
3-Dimensional scapular kinematics will be assessed
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gleno-humeral range of motion
Time Frame: 6 months
patients' shoulder range of motions will be assessed
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Investigators

  • Study Chair: Taha Yıdız, Msc, Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2019

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

February 15, 2021

Study Registration Dates

First Submitted

May 10, 2018

First Submitted That Met QC Criteria

May 10, 2018

First Posted (Actual)

May 22, 2018

Study Record Updates

Last Update Posted (Actual)

August 25, 2021

Last Update Submitted That Met QC Criteria

August 24, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1233412334

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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