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Investigation of the Efficacy of Telerehabilitation in Patients With Rotator Cuff Tendinopathy

Primary Purpose

Rotator Cuff Injuries, Rotator Cuff Tendinitis

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Telerehabilitation
home exercise program
Sponsored by
Izmir Democracy University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Injuries focused on measuring rotator cuff tendinopathy, telerehabilitation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of Rotator cuff tendinopathy Being able to do the prescribed exercises Having an access to internet and having a computer or smart phone for telerehabilitation Exclusion Criteria: Patients with a neurological disease that may affect the effectiveness of exercise History of fracture in shoulder region History of surgery in shoulder region Patients with a psychiatric disorder

Sites / Locations

  • Izmir Democracy UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention Group

Control Group

Arm Description

Patients who receive telerehabilitation

Patients who receive home exercise program

Outcomes

Primary Outcome Measures

Western Ontario Rotator Cuff Index
Western Ontario Rotator Cuff Index is a disease-specific quality of life questionnaire, evaluating the change in symptoms and functional ability, specific to a Rotator Cuff tendinopathy. Raw scores range from 0 to 2100 with a higher score indicating decreased quality of life.
Simple Shoulder Test
A questionnaire about the function of the involved shoulder. Overall scored is calculated by number of yes/number of completed items. Minimum score is 0 %and maximum is 100 %. Higher scores indicate better function.

Secondary Outcome Measures

Range of motion
shoulder range of motion will be measured.

Full Information

First Posted
April 4, 2023
Last Updated
August 29, 2023
Sponsor
Izmir Democracy University
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1. Study Identification

Unique Protocol Identification Number
NCT06024551
Brief Title
Investigation of the Efficacy of Telerehabilitation in Patients With Rotator Cuff Tendinopathy
Official Title
Investigation of the Efficacy of Telerehabilitation in Patients With Rotator Cuff Tendinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 4, 2023 (Actual)
Primary Completion Date
December 4, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Izmir Democracy 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
The goal of this study is to investigate the effect of telerehabilitation in patients with rotator cuff tendinopathy. The main questions it aims to answer are: Is telerehabilitation effective in improving the functional status of patients with rotator cuff tendinopathy? Is telerehabilitation effective in reducing the pain of rotator cuff patients?
Detailed Description
Patients between the ages of 18-65 who were diagnosed with rotator cuff tendinopathy will be included in the study. Patients will be divided into two groups. Patients in group 1 will be given a home exercise program. Then, the patients will be called 3 times a week and it will be evaluated whether they do their exercises regularly and whether they do it correctly. At the end of the first month, the patients will be evaluated again for functionality and pain. The patients in group 2 will be given a home exercise program and at the end of the first month, the patients will be evaluated again in terms of functionality and pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Injuries, Rotator Cuff Tendinitis
Keywords
rotator cuff tendinopathy, telerehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Patients who receive telerehabilitation
Arm Title
Control Group
Arm Type
Other
Arm Description
Patients who receive home exercise program
Intervention Type
Other
Intervention Name(s)
Telerehabilitation
Intervention Description
Patients in this arm will be given telerehabilitation three times a week, for four weeks.
Intervention Type
Other
Intervention Name(s)
home exercise program
Intervention Description
Patients in this arm will receive home exercise program for four weeks
Primary Outcome Measure Information:
Title
Western Ontario Rotator Cuff Index
Description
Western Ontario Rotator Cuff Index is a disease-specific quality of life questionnaire, evaluating the change in symptoms and functional ability, specific to a Rotator Cuff tendinopathy. Raw scores range from 0 to 2100 with a higher score indicating decreased quality of life.
Time Frame
one month
Title
Simple Shoulder Test
Description
A questionnaire about the function of the involved shoulder. Overall scored is calculated by number of yes/number of completed items. Minimum score is 0 %and maximum is 100 %. Higher scores indicate better function.
Time Frame
one month
Secondary Outcome Measure Information:
Title
Range of motion
Description
shoulder range of motion will be measured.
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Rotator cuff tendinopathy Being able to do the prescribed exercises Having an access to internet and having a computer or smart phone for telerehabilitation Exclusion Criteria: Patients with a neurological disease that may affect the effectiveness of exercise History of fracture in shoulder region History of surgery in shoulder region Patients with a psychiatric disorder
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Onur Engin
Phone
00905367915466
Email
oengin04@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ferruh Taşpınar
Organizational Affiliation
Izmir Democracy University
Official's Role
Study Director
Facility Information:
Facility Name
Izmir Democracy University
City
İzmir
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Onur Engin
Phone
00905367915466
Email
oengin04@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Investigation of the Efficacy of Telerehabilitation in Patients With Rotator Cuff Tendinopathy

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