<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04426929</url>
  </required_header>
  <id_info>
    <org_study_id>bmenek</org_study_id>
    <nct_id>NCT04426929</nct_id>
  </id_info>
  <brief_title>Effectiveness of Structured Closed Kinetic Chain and Video Based Game Exercise Program in Rotator Cuff Lesion</brief_title>
  <acronym>Exercise</acronym>
  <official_title>Investigation of Effectiveness of Structured Closed Kinetic Chain and Video Based Game Exercise Program in Rotator Cuff Lesion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul Medipol University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul Medipol University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rotator Cuff muscles are injured due to frequent use, repeated subacromial loadings and&#xD;
      circulatory failure, traction, compression, contusion, subacromial abrasion, inflammation,&#xD;
      injection and age-related degeneration, causing Rotator Cuff ruptures.Rotator Cuff treatment&#xD;
      strategies vary according to the stage of the disease. While conservative treatment is&#xD;
      preferred in Stage 1 and Stage 2 of Rotator Cuff injuries, surgical approaches are performed&#xD;
      in stage 3. The most common conservative methods used in its treatment are corticosteroid&#xD;
      injections, nonsteroidal anti-inflammatory drugs and physiotherapy methods. When the&#xD;
      literature is examined, there is no consensus about physiotherapy methods among conservative&#xD;
      treatment approaches. It is stated in the literature that there is no standard exercise&#xD;
      protocol for Rotator Cuff rehabilitation and specific exercise programs are needed. In&#xD;
      addition, the virtual reality treatment approach, the most common example of the use of&#xD;
      technology in rehabilitation, has begun to take part in rehabilitation studies. The aim of&#xD;
      the project is to examine the effectiveness of video-based game exercise therapy in&#xD;
      individuals with Rotator Cuff rupture, to develop a new exercise protocol with closed kinetic&#xD;
      chain exercises and to investigate the most effective treatment method for Rotator Cuff&#xD;
      ruptures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      INTRODUCTION: Rotator Cuff muscles are injured due to frequent use, repeated subacromial&#xD;
      loadings and circulatory failure, traction, compression, contusion, subacromial abrasion,&#xD;
      inflammation, injection and age-related degeneration, causing Rotator Cuff ruptures. The&#xD;
      prevalence of rotator Cuff ruptures increases with age, it usually starts at the age of 40,&#xD;
      and its incidence increases by 54% at 60, and 60-80% at 80. Rotator Cuff treatment strategies&#xD;
      vary according to the stage of the disease. While conservative treatment is preferred in&#xD;
      Stage 1 and Stage 2 of Rotator Cuff injuries, surgical approaches are performed in stage 3.&#xD;
      The most common conservative methods used in its treatment are corticosteroid injections,&#xD;
      nonsteroidal anti-inflammatory drugs and physiotherapy methods. When the literature is&#xD;
      examined, there is no consensus about physiotherapy methods among conservative treatment&#xD;
      approaches. It is stated in the literature that there is no standard exercise protocol for&#xD;
      Rotator Cuff rehabilitation and specific exercise programs are needed. In recent years,&#xD;
      closed kinetic chain exercises have become the preferred exercises for the rehabilitation of&#xD;
      musculoskeletal system problems. In the clinic, these exercises are preferred because they&#xD;
      put less stress on the healing tissue, which is more functional and safe. In the literature,&#xD;
      the study involving closed kinetic chain exercises related to Rotator Cuff ruptures is very&#xD;
      few, and there is no structured exercise protocol in this regard. In addition, the virtual&#xD;
      reality treatment approach, the most common example of the use of technology in&#xD;
      rehabilitation, has begun to take part in rehabilitation studies.&#xD;
&#xD;
      AIM: The aim of the project is to examine the effectiveness of video-based game exercise&#xD;
      therapy in individuals with Rotator Cuff rupture, to develop a new exercise protocol with&#xD;
      closed kinetic chain exercises and to investigate the most effective treatment method for&#xD;
      Rotator Cuff ruptures.&#xD;
&#xD;
      METHOD: The project will include 45 Rotator Cuff partial ruptures in accordance with the&#xD;
      inclusion criteria in the Physiotherapy and Rehabilitation Policlinic in Esenler Medipol&#xD;
      University Hospital. Individuals who have been diagnosed with Rotator Cuff partial rupture&#xD;
      between the ages of 18-60, who do not have a professional sports history, who have had pain&#xD;
      for more than 4 weeks, and have not undergone any shoulder surgery will be included in our&#xD;
      project. Individuals with symptomatic neurological findings of cervical origin, having an&#xD;
      additional orthopedic problem on the shoulder, having mental problems, and individuals with&#xD;
      neurological, vascular, cardiac problems that limit function will not be included in our&#xD;
      project. Pain with Visual Analog Scale, pain threshold with algometer, Functionality with&#xD;
      Arm, Shoulder and Hand Problems Survey, quality of life with Life Quality Scale with Rotator&#xD;
      Cuff Patients, normal range of motion and proprioception with Fizyosoft applications,&#xD;
      shoulder aproximation force with Fizyosoft balance system will be evaluated in all&#xD;
      participants before and after treatment. Individuals participating in our project will be&#xD;
      randomly divided into 3 groups. Electrotherapy program will be applied to all individuals.&#xD;
      conventional exercise therapy will be applied to the first group. An exercise program&#xD;
      consisting of 3 phases that runs from simple to difficult and includes closed kinetic chain&#xD;
      exercises and proprioceptive exercises will be implemented in second group. Video group&#xD;
      exercise program will be applied to the third group. By comparing the groups at the end of&#xD;
      the treatment, it is aimed to find the most effective treatment method for individuals with&#xD;
      Rotator Cuff rupture.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 15, 2020</start_date>
  <completion_date type="Actual">October 12, 2021</completion_date>
  <primary_completion_date type="Actual">August 18, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>VAS</measure>
    <time_frame>5 minutes</time_frame>
    <description>The score is determined by measuring the distance (mm) on the 10-cm line between the &quot;no pain&quot; anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>pain threshold</measure>
    <time_frame>5 minutes</time_frame>
    <description>with algometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Normal range of motion and proprioception</measure>
    <time_frame>10 minutes</time_frame>
    <description>Normal range of motion and proprioception can be measured with Fizyosoft applications.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Shoulder aproximation force</measure>
    <time_frame>10 minutes</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functionality</measure>
    <time_frame>5 minutes</time_frame>
    <description>Arm, Shoulder and Hand Problems Survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rotator Cuff Quality of life Scale</measure>
    <time_frame>10 minutes</time_frame>
    <description>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 &quot;not applicable&quot; 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.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Rotator Cuff Injuries</condition>
  <arm_group>
    <arm_group_label>Conventional Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Electrotherapy program will be applied to all individuals. conventional exercise therapy will be applied to this group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Closed Chain Exercise Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Video Based Exercise Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Video based exercise program will be applied to the this group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Conventional exercise therapy</intervention_name>
    <description>Coldpack, TENS, Ultrasound agents and conventional exercise therapy (codman, wand, isometric exercise) will be applied.</description>
    <arm_group_label>Conventional Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Closed Chain Exercise Group</intervention_name>
    <description>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.</description>
    <arm_group_label>Closed Chain Exercise Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Video Based Exercise Group</intervention_name>
    <description>Closed chain exercises based on video games will be applied. These exercises also include proprioceptive exercises.</description>
    <arm_group_label>Video Based Exercise Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals who have been diagnosed with Rotator Cuff partial rupture between the ages&#xD;
             of 18-60, who do not have a professional sports history, who have had pain for more&#xD;
             than 4 weeks, and have not undergone any shoulder surgery will be included&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals with symptomatic neurological findings of cervical origin, having an&#xD;
             additional orthopedic problem on the shoulder, having mental problems, and individuals&#xD;
             with neurological, vascular, cardiac problems that limit function will not be included&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Istanbul Medipol University</name>
      <address>
        <city>Istanbul</city>
        <zip>34820</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>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.</citation>
    <PMID>28446376</PMID>
  </results_reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>October 14, 2021</last_update_submitted>
  <last_update_submitted_qc>October 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul Medipol University Hospital</investigator_affiliation>
    <investigator_full_name>burak menek</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Virtual Reality</keyword>
  <keyword>Exercise</keyword>
  <keyword>Rotator Cuff Injury</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rotator Cuff Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>I will publish my manuscript about this study, so researchers can access my individual participant data with this way.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04426929
org study id: bmenek
nct id: NCT04426929
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: VAS
time frame: 5 minutes
description: 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.
measure: pain threshold
time frame: 5 minutes
description: with algometer
measure: Normal range of motion and proprioception
time frame: 10 minutes
description: Normal range of motion and proprioception can be measured with Fizyosoft applications.
measure: Shoulder aproximation force
time frame: 10 minutes
description: 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.
measure: Functionality
time frame: 5 minutes
description: Arm, Shoulder and Hand Problems Survey
measure: Rotator Cuff Quality of life Scale
time frame: 10 minutes
description: 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.
arm group label: Conventional Group
arm group type: Experimental
description: Electrotherapy program will be applied to all individuals. conventional exercise therapy will be applied to this group.
arm group label: Closed Chain Exercise Group
arm group type: Experimental
description: 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.
arm group label: Video Based Exercise Group
arm group type: Experimental
description: Video based exercise program will be applied to the this group.
intervention type: Other
intervention name: Conventional exercise therapy
description: Coldpack, TENS, Ultrasound agents and conventional exercise therapy (codman, wand, isometric exercise) will be applied.
arm group label: Conventional Group
intervention type: Other
intervention name: Closed Chain Exercise Group
description: 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.
arm group label: Closed Chain Exercise Group
intervention type: Other
intervention name: Video Based Exercise Group
description: Closed chain exercises based on video games will be applied. These exercises also include proprioceptive exercises.
arm group label: Video Based Exercise Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: Turkey
citation: 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.
PMID: 28446376
responsible party type: Principal Investigator
investigator affiliation: Istanbul Medipol University Hospital
investigator full name: burak menek
investigator title: Principal Investigator
mesh term: Rotator Cuff Injuries
sharing ipd: No
ipd description: I will publish my manuscript about this study, so researchers can access my individual participant data with this way.