xml: <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/NCT06024551</url>
    </required_header>
    <id_info>
      <org_study_id>TR35TR</org_study_id>
      <nct_id>NCT06024551</nct_id>
    </id_info>
    <brief_title>Investigation of the Efficacy of Telerehabilitation in Patients With Rotator Cuff Tendinopathy</brief_title>
    <official_title>Investigation of the Efficacy of Telerehabilitation in Patients With Rotator Cuff Tendinopathy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Izmir Democracy University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Izmir Democracy University</source>
    <oversight_info>
      <has_dmc>No</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>
        The goal of this study is to investigate the effect of telerehabilitation in patients with&#xD;
        rotator cuff tendinopathy. The main questions it aims to answer are:&#xD;
  &#xD;
          -  Is telerehabilitation effective in improving the functional status of patients with&#xD;
             rotator cuff tendinopathy?&#xD;
  &#xD;
          -  Is telerehabilitation effective in reducing the pain of rotator cuff patients?&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Patients between the ages of 18-65 who were diagnosed with rotator cuff tendinopathy will be&#xD;
        included in the study. Patients will be divided into two groups. Patients in group 1 will be&#xD;
        given a home exercise program. Then, the patients will be called 3 times a week and it will&#xD;
        be evaluated whether they do their exercises regularly and whether they do it correctly. At&#xD;
        the end of the first month, the patients will be evaluated again for functionality and pain.&#xD;
  &#xD;
        The patients in group 2 will be given a home exercise program and at the end of the first&#xD;
        month, the patients will be evaluated again in terms of functionality and pain.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 4, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 4, 2023</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>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Western Ontario Rotator Cuff Index</measure>
      <time_frame>one month</time_frame>
      <description>Western Ontario Rotator Cuff Index is a disease-specific quality of life questionnaire, evaluating the change in symptoms and functional ability, specific to a Rotator Cuff tendinopathy. Raw scores range from 0 to 2100 with a higher score indicating decreased quality of life.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Simple Shoulder Test</measure>
      <time_frame>one month</time_frame>
      <description>A questionnaire about the function of the involved shoulder. Overall scored is calculated by number of yes/number of completed items. Minimum score is 0 %and maximum is 100 %. Higher scores indicate better function.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Range of motion</measure>
      <time_frame>one month</time_frame>
      <description>shoulder range of motion will be measured.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Rotator Cuff Injuries</condition>
    <condition>Rotator Cuff Tendinitis</condition>
    <arm_group>
      <arm_group_label>Intervention Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients who receive telerehabilitation</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Patients who receive home exercise program</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Telerehabilitation</intervention_name>
      <description>Patients in this arm will be given telerehabilitation three times a week, for four weeks.</description>
      <arm_group_label>Intervention Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>home exercise program</intervention_name>
      <description>Patients in this arm will receive home exercise program for four weeks</description>
      <arm_group_label>Control Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of Rotator cuff tendinopathy&#xD;
  &#xD;
            -  Being able to do the prescribed exercises&#xD;
  &#xD;
            -  Having an access to internet and having a computer or smart phone for&#xD;
               telerehabilitation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with a neurological disease that may affect the effectiveness of exercise&#xD;
  &#xD;
            -  History of fracture in shoulder region&#xD;
  &#xD;
            -  History of surgery in shoulder region&#xD;
  &#xD;
            -  Patients with a psychiatric disorder&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ferruh Taşpınar</last_name>
      <role>Study Director</role>
      <affiliation>Izmir Democracy University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Onur Engin</last_name>
      <phone>00905367915466</phone>
      <email>oengin04@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Izmir Democracy University</name>
        <address>
          <city>İzmir</city>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Onur Engin</last_name>
        <phone>00905367915466</phone>
        <email>oengin04@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>April 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Izmir Democracy University</investigator_affiliation>
      <investigator_full_name>Ferruh Taşpınar</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>rotator cuff tendinopathy</keyword>
    <keyword>telerehabilitation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Tendinopathy</mesh_term>
      <mesh_term>Rotator Cuff Injuries</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06024551
  org study id: TR35TR
  nct id: NCT06024551
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this study is to investigate the effect of telerehabilitation in patients with
        rotator cuff tendinopathy. The main questions it aims to answer are:
  
          -  Is telerehabilitation effective in improving the functional status of patients with
             rotator cuff tendinopathy?
  
          -  Is telerehabilitation effective in reducing the pain of rotator cuff patients?
  Patients between the ages of 18-65 who were diagnosed with rotator cuff tendinopathy will be
        included in the study. Patients will be divided into two groups. Patients in group 1 will be
        given a home exercise program. Then, the patients will be called 3 times a week and it will
        be evaluated whether they do their exercises regularly and whether they do it correctly. At
        the end of the first month, the patients will be evaluated again for functionality and pain.
  
        The patients in group 2 will be given a home exercise program and at the end of the first
        month, the patients will be evaluated again in terms of functionality and pain.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Western Ontario Rotator Cuff Index
  time frame: one month
  description: Western Ontario Rotator Cuff Index is a disease-specific quality of life questionnaire, evaluating the change in symptoms and functional ability, specific to a Rotator Cuff tendinopathy. Raw scores range from 0 to 2100 with a higher score indicating decreased quality of life.
  measure: Simple Shoulder Test
  time frame: one month
  description: A questionnaire about the function of the involved shoulder. Overall scored is calculated by number of yes/number of completed items. Minimum score is 0 %and maximum is 100 %. Higher scores indicate better function.
  measure: Range of motion
  time frame: one month
  description: shoulder range of motion will be measured.
  arm group label: Intervention Group
  arm group type: Experimental
  description: Patients who receive telerehabilitation
  arm group label: Control Group
  arm group type: Other
  description: Patients who receive home exercise program
  intervention type: Other
  intervention name: Telerehabilitation
  description: Patients in this arm will be given telerehabilitation three times a week, for four weeks.
  arm group label: Intervention Group
  intervention type: Other
  intervention name: home exercise program
  description: Patients in this arm will receive home exercise program for four weeks
  arm group label: Control Group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Ferruh Taşpınar
  role: Study Director
  affiliation: Izmir Democracy University
  last name: Onur Engin
  phone: 00905367915466
  email: oengin04@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Izmir Democracy University
  investigator full name: Ferruh Taşpınar
  investigator title: Associate Professor
  mesh term: Tendinopathy
  mesh term: Rotator Cuff Injuries