AzTrials
AzTrials

Rotator Cuff InjuriesExerciseNCT04426929

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

A study testing Conventional exercise therapy, Closed Chain Exercise Group and Video Based Exercise Group in people with Rotator Cuff Injuries, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Rotator Cuff Injuries
What is being tested?
Conventional exercise therapy, Closed Chain Exercise Group and Video Based Exercise Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Jun 2020to 12 Oct 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul Medipol University

    Istanbul, 34820

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of 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.

Read the 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.

Being tested
Conventional exercise therapy, Closed Chain Exercise Group, Video Based Exercise Group
Keywords
Virtual Reality, Exercise, Rotator Cuff Injury
Medical subject headings
Rotator Cuff Injuries, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conventional exercise therapyOther

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

  • Closed Chain Exercise GroupOther

    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 GroupOther

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

Study groups in NCT04426929
Study groupRoleWhat they receive
Conventional GroupExperimentalElectrotherapy program will be applied to all individuals. conventional exercise therapy will be applied to this group.
Receives: Other: Conventional exercise therapy
Closed Chain Exercise GroupExperimentalAn 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.
Receives: Other: Closed Chain Exercise Group
Video Based Exercise GroupExperimentalVideo based exercise program will be applied to the this group.
Receives: Other: Video Based Exercise Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. VAS

    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.

    Measured: 5 minutes

  2. pain threshold

    with algometer

    Measured: 5 minutes

  3. Normal range of motion and proprioception

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

    Measured: 10 minutes

  4. Shoulder aproximation force

    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.

    Measured: 10 minutes

Secondary outcomes (2)
  1. Functionality

    Arm, Shoulder and Hand Problems Survey

    Measured: 5 minutes

  2. Rotator Cuff Quality of life Scale

    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.

    Measured: 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2020
  2. Study start15 Jun 2020
  3. Primary completion18 Aug 2021
  4. Study completion12 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04426929
Sponsor's protocol ID
bmenek
Acronym
Exercise
Status last verified
Oct 2021
First submitted
9 Jun 2020
Last updated
21 Oct 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: I will publish my manuscript about this study, so researchers can access my individual participant data with this way.

Publications

  • 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.

    PubMed 28446376

Questions about this trial

What is this clinical trial studying?

A study testing Conventional exercise therapy, Closed Chain Exercise Group and Video Based Exercise Group in people with Rotator Cuff Injuries, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VAS (time frame: 5 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04426929, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2021; AzTrials last refreshed its copy on 2 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in