<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/NCT03827746</url>
  </required_header>
  <id_info>
    <org_study_id>09.2017.226</org_study_id>
    <nct_id>NCT03827746</nct_id>
  </id_info>
  <brief_title>The Effect of Kinesiophobia on Physical Activity, Balance and Falling in Parkinson's Disease Patients</brief_title>
  <official_title>The Effect of Kinesiophobia on Physical Activity, Balance and Falling in Parkinson's Disease Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul Kültür University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Marmara University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Istanbul University - Cerrahpasa (IUC)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Istanbul Kültür 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 kinesiophobia; defined as irrational fear of movement, which may occur after painful&#xD;
      injury and reduce physical activity. It develops the idea that movement in individuals will&#xD;
      cause re-injury and cause additional pain to existing pain. Studies have shown that this&#xD;
      situation leads to a decrease in physical fitness, avoidance of activity, decrease in quality&#xD;
      of life and even depression in the long term. It is known that functional problems such as&#xD;
      balance problems and decrease in physical activity level occur in patients with Parkinson's&#xD;
      disease. However, in the literature, there is no study investigating the presence of&#xD;
      kinesiophobia in patients with Parkinson's disease. Therefore, the aims of our study were to&#xD;
      1) determine the presence / absence of kinesiophobia in patients with Parkinson's disease 2)&#xD;
      determine the relationship between kinesiophobia and falling, balance, physical activity&#xD;
      level in the presence of kinesiophobia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2018</start_date>
  <completion_date type="Actual">October 1, 2019</completion_date>
  <primary_completion_date type="Actual">April 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Tampa Kinesiophobia Scale (TSK)</measure>
    <time_frame>10 minutes</time_frame>
    <description>It is a 17-item self report checklist using a 4-point Likert scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Berg-Balance Test</measure>
    <time_frame>15-20 minutes</time_frame>
    <description>14-item scale designed to measure balance of the older adult in a clinical setting. Scoring: A five-point ordinal scale, ranging from 0-4. &quot;0&quot; indicates the lowest level of function and &quot;4&quot; the highest level of function. Total Score = 56 41-56 = low fall risk 21-40 = medium fall risk 0 -20 = high fall risk</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Falls Efficacy Scale</measure>
    <time_frame>5-7 minutes</time_frame>
    <description>It is a 10 item scale where each item is rated on a scale of 1-10. A score of 10 signifies no confidence in these activities; a score of 1 indicates confidence. Out of a total score of 100, a score of 70 or above indicates the individual has a fear of falling.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>International Physical Activity Questionnaire - Short form</measure>
    <time_frame>5-10 minutes</time_frame>
    <description>This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting. Walking = 3.3 METs Moderate Intensity = 4.0 METs Vigorous Intensity = 8.0 METs Total MET-minutes/week = Walk (METs*min*days) + Mod (METs*min*days) + Vig (METs*min*days)&#xD;
1. Low: • No activity is reported OR • Some activity is reported but not enough to meet Categories 2 or 3. 2. Moderate: • 3 or more days of vigorous activity of at least 20 minutes per day OR • 5 or more days of moderate-intensity activity and/or walking of at least 30 minutes per day OR • 5 or more days of any combination of walking, moderate-intensity or vigorousintensity activities achieving a minimum of at least 600 MET-minutes/week. 3. High: • Vigorous-intensity activity on at least 3 days and accumulating at least 1500 MET-minutes/week OR • 7 or more days of any combination of walki</description>
  </primary_outcome>
  <enrollment type="Actual">60</enrollment>
  <condition>Parkinson Disease</condition>
  <condition>Kinesiophobia</condition>
  <condition>Physical Activity</condition>
  <condition>Balance</condition>
  <condition>Falling</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Tampa Kinesiophobia Scale, Berg-Balance Test, International Physical Activity Questionnaire-Short Form, Falls Efficacy Scale</intervention_name>
    <description>Tampa Kinesiophobia Scale: The TSK is a 17-item self report checklist using a 4-point Likert scale that was developed as a measure of fear of movement or (re)injury.&#xD;
Berg-Balance Test: 14-item scale designed to measure balance of the older adult in a clinical setting.&#xD;
International Physical Activity Questionnaire-Short Form: This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting.&#xD;
Falls Efficacy Scale: A 16- item self-administered questionnaire designed to assess fear of falling in mainly older population</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The population of the study consisted of patients with Parkinson's disease who were in 1-3&#xD;
        stages according to Hoehn-Yahr Scale.&#xD;
&#xD;
        The sample consisted of 60 patients who applied to Istanbul University Cerrahpaşa Medical&#xD;
        Faculty Neurology Department Movement Disorders Unit, complied with the inclusion criteria,&#xD;
        read the information form and signed an informed consent form.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being diagnosed with Parkinson's disease according to the criteria of United Kingdom&#xD;
             Brain Bank and diagnosed as Parkinson's disease by neurologist&#xD;
&#xD;
          -  According to Hoehn-Yahr scale 1-3&#xD;
&#xD;
          -  Mini-Mental Test score 24 and above&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Another disease that will prevent walking&#xD;
&#xD;
          -  Visual impairment and vestibular dysfunction&#xD;
&#xD;
          -  Cognitive impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Marmara University</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>February 16, 2021</last_update_submitted>
  <last_update_submitted_qc>February 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul Kültür University</investigator_affiliation>
    <investigator_full_name>Gamze Ertürk</investigator_full_name>
    <investigator_title>Research assistant</investigator_title>
  </responsible_party>
  <keyword>Parkinson's Disease, Kinesiophobia, Physical Activity, Balance, Falling</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Kinesiophobia</mesh_term>
  </condition_browse>
  <!-- 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/NCT03827746
org study id: 09.2017.226
nct id: NCT03827746
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The kinesiophobia; defined as irrational fear of movement, which may occur after painful
      injury and reduce physical activity. It develops the idea that movement in individuals will
      cause re-injury and cause additional pain to existing pain. Studies have shown that this
      situation leads to a decrease in physical fitness, avoidance of activity, decrease in quality
      of life and even depression in the long term. It is known that functional problems such as
      balance problems and decrease in physical activity level occur in patients with Parkinson's
      disease. However, in the literature, there is no study investigating the presence of
      kinesiophobia in patients with Parkinson's disease. Therefore, the aims of our study were to
      1) determine the presence / absence of kinesiophobia in patients with Parkinson's disease 2)
      determine the relationship between kinesiophobia and falling, balance, physical activity
      level in the presence of kinesiophobia.
observational model: Case-Only
time perspective: Prospective
measure: Tampa Kinesiophobia Scale (TSK)
time frame: 10 minutes
description: It is a 17-item self report checklist using a 4-point Likert scale
measure: Berg-Balance Test
time frame: 15-20 minutes
description: 14-item scale designed to measure balance of the older adult in a clinical setting. Scoring: A five-point ordinal scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function. Total Score = 56 41-56 = low fall risk 21-40 = medium fall risk 0 -20 = high fall risk
measure: Falls Efficacy Scale
time frame: 5-7 minutes
description: It is a 10 item scale where each item is rated on a scale of 1-10. A score of 10 signifies no confidence in these activities; a score of 1 indicates confidence. Out of a total score of 100, a score of 70 or above indicates the individual has a fear of falling.
measure: International Physical Activity Questionnaire - Short form
time frame: 5-10 minutes
description: This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting. Walking = 3.3 METs Moderate Intensity = 4.0 METs Vigorous Intensity = 8.0 METs Total MET-minutes/week = Walk (METs*min*days) + Mod (METs*min*days) + Vig (METs*min*days)
1. Low: • No activity is reported OR • Some activity is reported but not enough to meet Categories 2 or 3. 2. Moderate: • 3 or more days of vigorous activity of at least 20 minutes per day OR • 5 or more days of moderate-intensity activity and/or walking of at least 30 minutes per day OR • 5 or more days of any combination of walking, moderate-intensity or vigorousintensity activities achieving a minimum of at least 600 MET-minutes/week. 3. High: • Vigorous-intensity activity on at least 3 days and accumulating at least 1500 MET-minutes/week OR • 7 or more days of any combination of walki
intervention type: Other
intervention name: Tampa Kinesiophobia Scale, Berg-Balance Test, International Physical Activity Questionnaire-Short Form, Falls Efficacy Scale
description: Tampa Kinesiophobia Scale: The TSK is a 17-item self report checklist using a 4-point Likert scale that was developed as a measure of fear of movement or (re)injury.
Berg-Balance Test: 14-item scale designed to measure balance of the older adult in a clinical setting.
International Physical Activity Questionnaire-Short Form: This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting.
Falls Efficacy Scale: A 16- item self-administered questionnaire designed to assess fear of falling in mainly older population
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Istanbul Kültür University
investigator full name: Gamze Ertürk
investigator title: Research assistant
mesh term: Parkinson Disease
mesh term: Kinesiophobia