Comparing Two Different Rehabilitation Protochols on Patients With Rotator Cuff Repair

Sponsor

Hacettepe University (Other)

Overall Status

Completed

CT.gov ID

NCT03533088

Collaborator

(none)

Enrollment

Location

Arms

19.1

Actual Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rotator Cuff Tear	Other: Hospitalized rehabilitation Other: Home-based rehabilitation	N/A

Detailed Description

Study Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomised control trialRandomised control trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparing Two Different Rehabilitation Protochols on Patients With Rotator Cuff Repair

Actual Study Start Date :

Jul 15, 2019

Actual Primary Completion Date :

Sep 30, 2020

Actual Study Completion Date :

Feb 15, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

scapular kinematics [6 months]
3-Dimensional scapular kinematics will be assessed

Secondary Outcome Measures

gleno-humeral range of motion [6 months]
patients' shoulder range of motions will be assessed

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hacettepe Univercity, Faculty of Physical Theraphy and Rehablitation	Altındağ	Ankara	Turkey	06600

Sponsors and Collaborators

Hacettepe University

Investigators

Study Chair: Taha Yıdız, Msc, İnvestigator

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Irem Duzgun, Doç. Dr. İrem Düzgün, Hacettepe University

ClinicalTrials.gov Identifier:

NCT03533088

Other Study ID Numbers:

1233412334

First Posted:

May 22, 2018

Last Update Posted:

Aug 25, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Irem Duzgun, Doç. Dr. İrem Düzgün, Hacettepe University

shoulder

rotator cuff

exercise

Additional relevant MeSH terms:

Rotator Cuff Injuries

Study Results

No Results Posted as of Aug 25, 2021