Effectiveness of Structured Closed Kinetic Chain and Video Based Game Exercise Program in Rotator Cuff Lesion

NCT ID: NCT04426929

Last Updated: 2021-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-15

Study Completion Date

2021-10-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rotator Cuff Injuries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Conventional Group

Electrotherapy program will be applied to all individuals. conventional exercise therapy will be applied to this group.

Group Type EXPERIMENTAL

Conventional exercise therapy

Intervention Type OTHER

Coldpack, TENS, Ultrasound agents and conventional exercise therapy (codman, wand, isometric exercise) will be applied.

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.

Group Type EXPERIMENTAL

Closed Chain Exercise Group

Intervention Type OTHER

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.

Video Based Exercise Group

Video based exercise program will be applied to the this group.

Group Type EXPERIMENTAL

Video Based Exercise Group

Intervention Type OTHER

Closed chain exercises based on video games will be applied. These exercises also include proprioceptive exercises.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Conventional exercise therapy

Coldpack, TENS, Ultrasound agents and conventional exercise therapy (codman, wand, isometric exercise) will be applied.

Intervention Type OTHER

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.

Intervention Type OTHER

Video Based Exercise Group

Closed chain exercises based on video games will be applied. These exercises also include proprioceptive exercises.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istanbul Medipol University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

burak menek

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istanbul Medipol University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Pekyavas NO, Ergun N. Comparison of virtual reality exergaming and home exercise programs in patients with subacromial impingement syndrome and scapular dyskinesis: Short term effect. Acta Orthop Traumatol Turc. 2017 May;51(3):238-242. doi: 10.1016/j.aott.2017.03.008. Epub 2017 Apr 24.

Reference Type RESULT
PMID: 28446376 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

bmenek

Identifier Type: -

Identifier Source: org_study_id