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Comparing Two Different Rehabilitation Protochols on Patients With Rotator Cuff Repair

Primary Purpose

Rotator Cuff Tear

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Hospitalized rehabilitation
Home-based rehabilitation
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tear focused on measuring shoulder, rotator cuff, exercise

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hacettepe Univercity, Faculty of Physical Theraphy and Rehablitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Hospitalized rehabilitation

Home-based rehabilitation

Arm Description

Patients in this group will recieve rehabilitation program twice in a week at our clinic after the surgical procedure until post-operative 12 weeks.

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.

Outcomes

Primary Outcome Measures

scapular kinematics
3-Dimensional scapular kinematics will be assessed

Secondary Outcome Measures

gleno-humeral range of motion
patients' shoulder range of motions will be assessed

Full Information

First Posted
May 10, 2018
Last Updated
August 24, 2021
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT03533088
Brief Title
Comparing Two Different Rehabilitation Protochols on Patients With Rotator Cuff Repair
Official Title
Comparing Two Different Rehabilitation Protochols on Patients With Rotator Cuff Repair
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
July 15, 2019 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
February 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tear
Keywords
shoulder, rotator cuff, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised control trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hospitalized rehabilitation
Arm Type
Experimental
Arm Description
Patients in this group will recieve rehabilitation program twice in a week at our clinic after the surgical procedure until post-operative 12 weeks.
Arm Title
Home-based rehabilitation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Hospitalized rehabilitation
Intervention Description
Patients will recive a rehabilitation prgram at the clinic twice in a week until the post-operative 12. weeks
Intervention Type
Other
Intervention Name(s)
Home-based rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
scapular kinematics
Description
3-Dimensional scapular kinematics will be assessed
Time Frame
6 months
Secondary Outcome Measure Information:
Title
gleno-humeral range of motion
Description
patients' shoulder range of motions will be assessed
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taha Yıdız, Msc
Organizational Affiliation
İnvestigator
Official's Role
Study Chair
Facility Information:
Facility Name
Hacettepe Univercity, Faculty of Physical Theraphy and Rehablitation
City
Altındağ
State/Province
Ankara
ZIP/Postal Code
06600
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25797067
Citation
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.
Results Reference
result
PubMed Identifier
26510584
Citation
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.
Results Reference
result

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Comparing Two Different Rehabilitation Protochols on Patients With Rotator Cuff Repair

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