Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04426929 |
| Other study ID # |
bmenek |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 15, 2020 |
| Est. completion date |
October 12, 2021 |
Study information
| Verified date |
October 2021 |
| Source |
Istanbul Medipol University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Rotator Cuff muscles are injured due to frequent use, repeated subacromial loadings and
circulatory failure, traction, compression, contusion, subacromial abrasion, inflammation,
injection and age-related degeneration, causing Rotator Cuff ruptures.Rotator Cuff treatment
strategies vary according to the stage of the disease. While conservative treatment is
preferred in Stage 1 and Stage 2 of Rotator Cuff injuries, surgical approaches are performed
in stage 3. The most common conservative methods used in its treatment are corticosteroid
injections, nonsteroidal anti-inflammatory drugs and physiotherapy methods. When the
literature is examined, there is no consensus about physiotherapy methods among conservative
treatment approaches. It is stated in the literature that there is no standard exercise
protocol for Rotator Cuff rehabilitation and specific exercise programs are needed. In
addition, the virtual reality treatment approach, the most common example of the use of
technology in rehabilitation, has begun to take part in rehabilitation studies. The aim of
the project is to examine the effectiveness of video-based game exercise therapy in
individuals with Rotator Cuff rupture, to develop a new exercise protocol with closed kinetic
chain exercises and to investigate the most effective treatment method for Rotator Cuff
ruptures.
Description:
INTRODUCTION: Rotator Cuff muscles are injured due to frequent use, repeated subacromial
loadings and circulatory failure, traction, compression, contusion, subacromial abrasion,
inflammation, injection and age-related degeneration, causing Rotator Cuff ruptures. The
prevalence of rotator Cuff ruptures increases with age, it usually starts at the age of 40,
and its incidence increases by 54% at 60, and 60-80% at 80. Rotator Cuff treatment strategies
vary according to the stage of the disease. While conservative treatment is preferred in
Stage 1 and Stage 2 of Rotator Cuff injuries, surgical approaches are performed in stage 3.
The most common conservative methods used in its treatment are corticosteroid injections,
nonsteroidal anti-inflammatory drugs and physiotherapy methods. When the literature is
examined, there is no consensus about physiotherapy methods among conservative treatment
approaches. It is stated in the literature that there is no standard exercise protocol for
Rotator Cuff rehabilitation and specific exercise programs are needed. In recent years,
closed kinetic chain exercises have become the preferred exercises for the rehabilitation of
musculoskeletal system problems. In the clinic, these exercises are preferred because they
put less stress on the healing tissue, which is more functional and safe. In the literature,
the study involving closed kinetic chain exercises related to Rotator Cuff ruptures is very
few, and there is no structured exercise protocol in this regard. In addition, the virtual
reality treatment approach, the most common example of the use of technology in
rehabilitation, has begun to take part in rehabilitation studies.
AIM: The aim of the project is to examine the effectiveness of video-based game exercise
therapy in individuals with Rotator Cuff rupture, to develop a new exercise protocol with
closed kinetic chain exercises and to investigate the most effective treatment method for
Rotator Cuff ruptures.
METHOD: The project will include 45 Rotator Cuff partial ruptures in accordance with the
inclusion criteria in the Physiotherapy and Rehabilitation Policlinic in Esenler Medipol
University Hospital. Individuals who have been diagnosed with Rotator Cuff partial rupture
between the ages of 18-60, who do not have a professional sports history, who have had pain
for more than 4 weeks, and have not undergone any shoulder surgery will be included in our
project. Individuals with symptomatic neurological findings of cervical origin, having an
additional orthopedic problem on the shoulder, having mental problems, and individuals with
neurological, vascular, cardiac problems that limit function will not be included in our
project. Pain with Visual Analog Scale, pain threshold with algometer, Functionality with
Arm, Shoulder and Hand Problems Survey, quality of life with Life Quality Scale with Rotator
Cuff Patients, normal range of motion and proprioception with Fizyosoft applications,
shoulder aproximation force with Fizyosoft balance system will be evaluated in all
participants before and after treatment. Individuals participating in our project will be
randomly divided into 3 groups. Electrotherapy program will be applied to all individuals.
conventional exercise therapy will be applied to the first group. An exercise program
consisting of 3 phases that runs from simple to difficult and includes closed kinetic chain
exercises and proprioceptive exercises will be implemented in second group. Video group
exercise program will be applied to the third group. By comparing the groups at the end of
the treatment, it is aimed to find the most effective treatment method for individuals with
Rotator Cuff rupture.
