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Completed

NCT Number: NCT04426929

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University

Istanbul, 34820, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional exercise therapy

Other

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

Closed Chain Exercise Group

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

Other

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

Primary outcomes

  1. 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.

  2. pain threshold

    Time frame: 5 minutes

    with algometer

  3. Normal range of motion and proprioception

    Time frame: 10 minutes

    Normal range of motion and proprioception can be measured with Fizyosoft applications.

  4. Shoulder aproximation force

    Time frame: 10 minutes

    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.

Secondary outcomes

  1. Functionality

    Time frame: 5 minutes

    Arm, Shoulder and Hand Problems Survey

  2. Rotator Cuff Quality of life Scale

    Time frame: 10 minutes

    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.

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Official study title

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

Acronym: Exercise

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 11, 2020
Registry last updated
Oct 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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