NCT03533088

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

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

May 10, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 22, 2018

Completed
1.1 years until next milestone

Study Start

First participant enrolled

July 15, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2021

Completed
Last Updated

August 25, 2021

Status Verified

August 1, 2021

Enrollment Period

1.2 years

First QC Date

May 10, 2018

Last Update Submit

August 24, 2021

Conditions

Keywords

shoulderrotator cuffexercise

Outcome Measures

Primary Outcomes (1)

  • scapular kinematics

    3-Dimensional scapular kinematics will be assessed

    6 months

Secondary Outcomes (1)

  • gleno-humeral range of motion

    6 months

Study Arms (2)

Hospitalized rehabilitation

EXPERIMENTAL

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

Home-based rehabilitation

EXPERIMENTAL

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

Interventions

Patients will recive a rehabilitation prgram at the clinic twice in a week until the post-operative 12. weeks

Hospitalized 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.

Home-based rehabilitation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

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)

  • Gallagher BP, Bishop ME, Tjoumakaris FP, Freedman KB. Early versus delayed rehabilitation following arthroscopic rotator cuff repair: A systematic review. Phys Sportsmed. 2015 May;43(2):178-87. doi: 10.1080/00913847.2015.1025683. Epub 2015 Mar 22.

  • Thomson S, Jukes C, Lewis J. Rehabilitation following surgical repair of the rotator cuff: a systematic review. Physiotherapy. 2016 Mar;102(1):20-8. doi: 10.1016/j.physio.2015.08.003. Epub 2015 Sep 8.

MeSH Terms

Conditions

Rotator Cuff InjuriesMotor Activity

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon InjuriesBehavior

Study Officials

  • Taha Yıdız, Msc

    İnvestigator

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised control trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doç. Dr. İrem Düzgün

Study Record Dates

First Submitted

May 10, 2018

First Posted

May 22, 2018

Study Start

July 15, 2019

Primary Completion

September 30, 2020

Study Completion

February 15, 2021

Last Updated

August 25, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations