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/NCT05993624</url>
    </required_header>
    <id_info>
      <org_study_id>ELMİRAHASRET</org_study_id>
      <nct_id>NCT05993624</nct_id>
    </id_info>
    <brief_title>The Effect of Exergame Games on Geriatric Individuals With Kinesiophobia</brief_title>
    <official_title>The Effect of Exergame Games on Kinesiophobia, Balance, Lower Extremity Muscle Strength, Depression and Cognitive Function in Geriatric Individuals With Kinesiophobia</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>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 study included 15 geriatric individuals over the age of 65 staying in Kızılay Zeynep&#xD;
        Nedim Oyvar Nursing Home and Elderly Nursing Home. Participants in the study were&#xD;
        rehabilitated by playing exergame games with Xbox 360 KinectTM for 30 minutes once a week for&#xD;
        8 weeks. Before starting the application, the participants were given a demographic&#xD;
        information form, Tampa kinesiophobia scale for kinesiophobia, Nintendo Wii balance platform&#xD;
        and basic balance game for balance measurement, geriatric depression scale-short form for&#xD;
        depression, cognitive functions, and mini-mental state test for the lower extremities.&#xD;
        functional strength and risk of falling. The shuttle test was applied 5 times. These tests&#xD;
        will be repeated at the end of 8 sessions and before and after values were measured. As a&#xD;
        result of the analysis, the effects of Xbox 360 KinectTM games on kinesiophobia, balance,&#xD;
        lower extremity muscle strength, depression, and cognitive functions in geriatric individuals&#xD;
        with kinesiophobia were investigated.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        15 geriatric individuals over 65 years old living in Kızılay Zeynep Nedim Oyvar Nursing Home&#xD;
        and Elderly Care Center were included in the study. The ethics committee of Istanbul Gedik&#xD;
        University Ethics Committee, dated 17/01/2023 and numbered&#xD;
        E-56365223-050.01.04-2023.137548.27-433, was accepted. A consent form was signed by geriatric&#xD;
        individuals who met the conditions of this study. Participants participating in the study&#xD;
        played 30 minutes of exergame games once a week for 8 weeks and rehabilitation was applied.&#xD;
        Before starting the application, participants were given a demographic information form,&#xD;
        Tampa kinesiophobia scale for kinesiophobia, BeCure balance assessment system for balance&#xD;
        measurement, geriatric depression scale-short form for depression, mini-mental state test for&#xD;
        cognitive functions, and lower extremity functional strength and risk of falling 5 times.&#xD;
        lift test was applied. These tests were repeated at the end of 8 sessions and before and&#xD;
        after values were measured.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 17, 2023</start_date>
    <completion_date type="Actual">June 17, 2023</completion_date>
    <primary_completion_date type="Actual">April 5, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Tampa Kinesiophobia Scale (TKS)</measure>
      <time_frame>8 weeks</time_frame>
      <description>It measures fear of movement and fear of re-injury. It was used to evaluate the development of fear of movement after treatment. A 4-point Likert scoring (1= I strongly disagree, 4= I totally agree) is used in the scale. After reversing items 4, 8, 12 and 16, a total score is calculated. The person gets a total score between 17-68. A high score on the scale indicates that kinesiophobia is also high.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>BeCure Balance Evaluation System</measure>
      <time_frame>8 weeks</time_frame>
      <description>The BeCure Balance Assessment System protocol used in this study; It was planned to determine the amount of change in the center of gravity in the x and y axes and the position of the body center of gravity during standing balance on the board for 15 seconds with eyes open, with images.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Geriatric Depression Scale- Short Form</measure>
      <time_frame>8 weeks</time_frame>
      <description>It consists of 15 questions questioning the mood in the last week. This short form consists of 15 questions questioning the mood of the patient. The answers are given according to the feelings in the last week; The answers are &quot;yes&quot; or &quot;no&quot;, just like in the long form, and 1 point is given for &quot;yes&quot; or &quot;no&quot; answers depending on the question. A score of 0-4 indicates no depression, 5-8 indicates mild depression, 9-11 indicates moderate depression, and a score of 12-15 indicates severe depression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mini Mental State Test</measure>
      <time_frame>8 weeks</time_frame>
      <description>Cognitive testing of the elderly, especially the elderly with delirium and/or dementia.A minimum of 0 and a maximum of 30 points can be obtained from this test. It is thought that the higher the score, the worse the mental state of the individual.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>5 Times Sit Up Test</measure>
      <time_frame>8 weeks</time_frame>
      <description>It is a test used to evaluate the functional strength, balance and fall risk of the lower extremities.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">15</enrollment>
    <condition>Geriatric</condition>
    <condition>Kinesiophobia</condition>
    <arm_group>
      <arm_group_label>Rehabilitation Group</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Participants in the study played 30-minute exergame games once a week for 8 weeks and rehabilitation was applied. Before starting the application, the participants were given a demographic information form, Tampa kinesiophobia scale for kinesiophobia, BeCure balance assessment system for balance measurement, geriatric depression scale-short form for depression, mini-mental state test for cognitive functions, and lower extremity functional strength. and 5 times the risk of falling. lifting test was performed. These tests were repeated at the end of 8 sessions and before and after values were measured.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>virtual reality</intervention_name>
      <description>The BeCure Balance Assessment System protocol used in this study; It was planned to determine the amount of change in the center of gravity in the x and y axes and the position of the center of gravity of the body with images during standing and balancing for 15 seconds on the board with eyes open. In order to support the balanced development of the participants with the Becure system; Balance surfing, balance adventure, balance bowling and traffic games were played. uBall, gates, smartclean and SmartBubblePop games with Kinect for the upper extremity; KneeUp game was played on the lower extremity.</description>
      <arm_group_label>Rehabilitation Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Getting 38 or higher on the Tampa Kinesiophobia Scale&#xD;
  &#xD;
            -  Getting a Mini Mental State Test Score of 20 and above&#xD;
  &#xD;
            -  Being physically competent to apply the scales to be used&#xD;
  &#xD;
            -  Being 65 years or older&#xD;
  &#xD;
            -  Volunteering to work&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Having a mental and psychiatric problem diagnosed by a physician&#xD;
  &#xD;
            -  Having a serious neurological and orthopedic problem diagnosed by a physician&#xD;
  &#xD;
            -  Having serious hearing and vision problems&#xD;
  &#xD;
            -  Having uncontrolled diabetes and hypertension&#xD;
  &#xD;
            -  Using a walking device other than a cane (crutches, walkers, etc.)&#xD;
  &#xD;
            -  Drug use that increases the risk of falling (to be determined by the information&#xD;
               obtained from nurses and physiotherapists working in nursing homes)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ebru SEVER, Lecturer</last_name>
      <role>Study Director</role>
      <affiliation>Department of Physiotherapy &amp; Rehabilitation</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Kızılay Zeynep Nedim Oyvar Nursing Home and Elderly Care Center</name>
        <address>
          <city>Kartal</city>
          <zip>34860</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Istanbul Medipol University Hospital</investigator_affiliation>
      <investigator_full_name>Ebru Sever</investigator_full_name>
      <investigator_title>PhD, PT</investigator_title>
    </responsible_party>
    <keyword>geriatrics</keyword>
    <keyword>kinesiophobia</keyword>
    <keyword>virtual reality</keyword>
    <keyword>video based game</keyword>
    <keyword>Xbox 360 KinectTM</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Kinesiophobia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05993624
  org study id: ELMİRAHASRET
  nct id: NCT05993624
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study included 15 geriatric individuals over the age of 65 staying in Kızılay Zeynep
        Nedim Oyvar Nursing Home and Elderly Nursing Home. Participants in the study were
        rehabilitated by playing exergame games with Xbox 360 KinectTM for 30 minutes once a week for
        8 weeks. Before starting the application, the participants were given a demographic
        information form, Tampa kinesiophobia scale for kinesiophobia, Nintendo Wii balance platform
        and basic balance game for balance measurement, geriatric depression scale-short form for
        depression, cognitive functions, and mini-mental state test for the lower extremities.
        functional strength and risk of falling. The shuttle test was applied 5 times. These tests
        will be repeated at the end of 8 sessions and before and after values were measured. As a
        result of the analysis, the effects of Xbox 360 KinectTM games on kinesiophobia, balance,
        lower extremity muscle strength, depression, and cognitive functions in geriatric individuals
        with kinesiophobia were investigated.
  15 geriatric individuals over 65 years old living in Kızılay Zeynep Nedim Oyvar Nursing Home
        and Elderly Care Center were included in the study. The ethics committee of Istanbul Gedik
        University Ethics Committee, dated 17/01/2023 and numbered
        E-56365223-050.01.04-2023.137548.27-433, was accepted. A consent form was signed by geriatric
        individuals who met the conditions of this study. Participants participating in the study
        played 30 minutes of exergame games once a week for 8 weeks and rehabilitation was applied.
        Before starting the application, participants were given a demographic information form,
        Tampa kinesiophobia scale for kinesiophobia, BeCure balance assessment system for balance
        measurement, geriatric depression scale-short form for depression, mini-mental state test for
        cognitive functions, and lower extremity functional strength and risk of falling 5 times.
        lift test was applied. These tests were repeated at the end of 8 sessions and before and
        after values were measured.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Tampa Kinesiophobia Scale (TKS)
  time frame: 8 weeks
  description: It measures fear of movement and fear of re-injury. It was used to evaluate the development of fear of movement after treatment. A 4-point Likert scoring (1= I strongly disagree, 4= I totally agree) is used in the scale. After reversing items 4, 8, 12 and 16, a total score is calculated. The person gets a total score between 17-68. A high score on the scale indicates that kinesiophobia is also high.
  measure: BeCure Balance Evaluation System
  time frame: 8 weeks
  description: The BeCure Balance Assessment System protocol used in this study; It was planned to determine the amount of change in the center of gravity in the x and y axes and the position of the body center of gravity during standing balance on the board for 15 seconds with eyes open, with images.
  measure: Geriatric Depression Scale- Short Form
  time frame: 8 weeks
  description: It consists of 15 questions questioning the mood in the last week. This short form consists of 15 questions questioning the mood of the patient. The answers are given according to the feelings in the last week; The answers are "yes" or "no", just like in the long form, and 1 point is given for "yes" or "no" answers depending on the question. A score of 0-4 indicates no depression, 5-8 indicates mild depression, 9-11 indicates moderate depression, and a score of 12-15 indicates severe depression.
  measure: Mini Mental State Test
  time frame: 8 weeks
  description: Cognitive testing of the elderly, especially the elderly with delirium and/or dementia.A minimum of 0 and a maximum of 30 points can be obtained from this test. It is thought that the higher the score, the worse the mental state of the individual.
  measure: 5 Times Sit Up Test
  time frame: 8 weeks
  description: It is a test used to evaluate the functional strength, balance and fall risk of the lower extremities.
  arm group label: Rehabilitation Group
  arm group type: Other
  description: Participants in the study played 30-minute exergame games once a week for 8 weeks and rehabilitation was applied. Before starting the application, the participants were given a demographic information form, Tampa kinesiophobia scale for kinesiophobia, BeCure balance assessment system for balance measurement, geriatric depression scale-short form for depression, mini-mental state test for cognitive functions, and lower extremity functional strength. and 5 times the risk of falling. lifting test was performed. These tests were repeated at the end of 8 sessions and before and after values were measured.
  intervention type: Device
  intervention name: virtual reality
  description: The BeCure Balance Assessment System protocol used in this study; It was planned to determine the amount of change in the center of gravity in the x and y axes and the position of the center of gravity of the body with images during standing and balancing for 15 seconds on the board with eyes open. In order to support the balanced development of the participants with the Becure system; Balance surfing, balance adventure, balance bowling and traffic games were played. uBall, gates, smartclean and SmartBubblePop games with Kinect for the upper extremity; KneeUp game was played on the lower extremity.
  arm group label: Rehabilitation Group
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ebru SEVER, Lecturer
  role: Study Director
  affiliation: Department of Physiotherapy & Rehabilitation
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Istanbul Medipol University Hospital
  investigator full name: Ebru Sever
  investigator title: PhD, PT
  mesh term: Kinesiophobia
  sharing ipd: No