- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04426929
Effectiveness of Structured Closed Kinetic Chain and Video Based Game Exercise Program in Rotator Cuff Lesion (Exercise)
Investigation of Effectiveness of Structured Closed Kinetic Chain and Video Based Game Exercise Program in Rotator Cuff Lesion
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey, 34820
- Istanbul Medipol University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Conventional Group
Electrotherapy program will be applied to all individuals.
conventional exercise therapy will be applied to this group.
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Coldpack, TENS, Ultrasound agents and conventional exercise therapy (codman, wand, isometric exercise) will be applied.
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Experimental: Closed Chain Exercise 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 this group.
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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 this group.
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Experimental: Video Based Exercise Group
Video based exercise program will be applied to the this group.
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Closed chain exercises based on video games will be applied.
These exercises also include proprioceptive exercises.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VAS
Time Frame: 5 minutes
|
The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100.
A higher score indicates greater pain intensity.
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5 minutes
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pain threshold
Time Frame: 5 minutes
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with algometer
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5 minutes
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Normal range of motion and proprioception
Time Frame: 10 minutes
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Normal range of motion and proprioception can be measured with Fizyosoft applications.
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10 minutes
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Shoulder aproximation force
Time Frame: 10 minutes
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Shoulder aproximation force will be evaluated Fizyosoft balance system.
The patient's shoulder should be 0 and 90 degree of flexion position.
And then they give their force on the platform of the Fizyosoft system.
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10 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functionality
Time Frame: 5 minutes
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Arm, Shoulder and Hand Problems Survey
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5 minutes
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Rotator Cuff Quality of life Scale
Time Frame: 10 minutes
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The Rotator Cuff Quality of Life Index (RC-QOL) was developed to evaluate quality oflife in patients with rotator cuff disorders.The RC-QOL consisted of 34 questions and 5 subscales: (1) symp-toms and physical complaints (SYMPTOMS), 16 items; (2) work-related concerns (WORK), 4 items; (3) recreational activities, sportsparticipation, or competition concerns (SPORTS), 4 items; (4) life-style concerns (LIFESTYLE), 5 items; and (5) social and emotionalconcerns (SOCIAL), 5 items.
Respondents were given the optionof answering "not applicable" to 14 questions.
All questions werescored on a 100-mm visual analog scale from 0 to 100.
The qualityof life score was calculated by taking an average of items an-swered by respondents.
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10 minutes
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- bmenek
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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