<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/NCT03816085</url>
  </required_header>
  <id_info>
    <org_study_id>ETK00-2018-0239</org_study_id>
    <nct_id>NCT03816085</nct_id>
  </id_info>
  <brief_title>Shoes on Balance, Muscular Endurance and Functional Skills</brief_title>
  <official_title>The Effects of Shoes With Different Heel Heights on Balance, Muscular Endurance and Functional Skills</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eastern Mediterranean University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eastern Mediterranean University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In daily life, stiletto heeled shoes which are popularly preferred by women have different&#xD;
      heel heights. This study aims to investigate the effects of these differences on balance,&#xD;
      muscular endurance and functional skills. Heel heights were chosen as 4 and 10 cm. Other&#xD;
      features of shoes (stiletto type/colour etc.) will be same. The tests will be randomly done&#xD;
      barefoot, 10 cm, and 4cm shoes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The evaluations will include Functional Forward Reach Test for dynamic balance and Single Leg&#xD;
      Standing for static balance, heel raising and squat-up test for muscular endurance of plantar&#xD;
      flexor and quadriceps muscles, ascending stairs for functional skills.&#xD;
&#xD;
      Measuring distance will be used for Functional reach test and timing will be used for single&#xD;
      leg standing test. Timing and repetition number will be used for muscular endurance tests.&#xD;
      Timing will be used to climb up 10 stairs with and without heel contact.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 15, 2018</start_date>
  <completion_date type="Actual">March 10, 2019</completion_date>
  <primary_completion_date type="Actual">February 15, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Functional Skill</measure>
    <time_frame>at baseline</time_frame>
    <description>The case will be asked to climb up 10 stairs as fast as possible. Time (in seconds) will be recorded for climbing up with and without heel contact.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Single Leg Standing</measure>
    <time_frame>at baseline</time_frame>
    <description>The case will be asked to stand on dominant leg. If the raised leg touches anything around (other limb, floor) or in condition of hopping/splashing, time will be stopped. Time (seconds) will be recorded.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Repetition number of heel raising</measure>
    <time_frame>at baseline</time_frame>
    <description>Before the test, the case will be asked to stretch plantar flexor muscles. Then the case will be asked to raise the heels unilaterally. The repetition number will be written until the case cannot do the full movement.</description>
  </other_outcome>
  <other_outcome>
    <measure>Repetition number of squating</measure>
    <time_frame>at baseline</time_frame>
    <description>Before the test, the case will be asked to stretch quadriceps muscle with flexing the knee. Then the case will be asked to squat continuously. The repetition number will be written until the case cannot do the full movement.</description>
  </other_outcome>
  <other_outcome>
    <measure>Duration of heel raising</measure>
    <time_frame>at baseline</time_frame>
    <description>Before the test, the case will be asked to stretch plantar flexor muscles. Then the case will be asked to raise the heels unilaterally. The time (in seconds) will be written until the case cannot do the full movement.</description>
  </other_outcome>
  <other_outcome>
    <measure>Duration of squating</measure>
    <time_frame>Before the test, the case will be asked to stretch quadriceps muscle with flexing the knee. Then the case will be asked to squat continuously. The repetition number will be written until the case cannot do the full movement.</time_frame>
    <description>Before the test, the case will be asked to stretch quadriceps muscle with flexing the knee. Then the case will be asked to squat continuously. The time (in seconds) will be written until the case cannot do the full movement.</description>
  </other_outcome>
  <other_outcome>
    <measure>Functional Forward Reach Test</measure>
    <time_frame>Before the test, the case will be asked to stretch quadriceps muscle with flexing the knee. Then the case will be asked to squat continuously. The repetition number will be written until the case cannot do the full movement.</time_frame>
    <description>Before the test, the case will be asked to stretch quadriceps muscle with flexing the knee. Then the case will be asked to squat continuously. The repetition number will be written until the case cannot do the full movement.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Shoe with 4 cm heel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Shoes with 4 cm heel will be applied to women. Tests to measure balance, muscular endurance and function will be done while they wear this shoe.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Shoe with 10 cm heel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Shoes with 10 cm heel will be applied to women. Tests to measure balance, muscular endurance and function will be done while they wear this shoe.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Without shoes</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Women will be included in the tests to measure balance, muscular endurance and function without shoes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Shoes</intervention_name>
    <description>Shoes with different heel heights</description>
    <arm_group_label>Shoe with 10 cm heel</arm_group_label>
    <arm_group_label>Shoe with 4 cm heel</arm_group_label>
    <other_name>Women wearing shoes</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  the shoe number will be 37&#xD;
&#xD;
          -  women who do not regularly wear high heeled shoes&#xD;
&#xD;
          -  women who are familiar with stiletto heeled shoes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any pain which prevents to participate in tests&#xD;
&#xD;
          -  women with cardiovascular disease, metabolic disease, blood pressure disorders,&#xD;
             diabetes diseases, neuromuscular diseases.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Heeled shoes are used among women.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ZEHRA GÜÇHAN TOPCU</last_name>
    <role>Principal Investigator</role>
    <affiliation>Eastern Mediterranean University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zehra Güçhan Topcu</name>
      <address>
        <city>Famagusta</city>
        <zip>99628</zip>
        <country>Cyprus</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Cyprus</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 21, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>January 7, 2020</last_update_submitted>
  <last_update_submitted_qc>January 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>women</keyword>
  <keyword>shoes</keyword>
  <keyword>balance</keyword>
  <keyword>muscles</keyword>
  <!-- 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/NCT03816085
org study id: ETK00-2018-0239
nct id: NCT03816085
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
In daily life, stiletto heeled shoes which are popularly preferred by women have different
      heel heights. This study aims to investigate the effects of these differences on balance,
      muscular endurance and functional skills. Heel heights were chosen as 4 and 10 cm. Other
      features of shoes (stiletto type/colour etc.) will be same. The tests will be randomly done
      barefoot, 10 cm, and 4cm shoes.
The evaluations will include Functional Forward Reach Test for dynamic balance and Single Leg
      Standing for static balance, heel raising and squat-up test for muscular endurance of plantar
      flexor and quadriceps muscles, ascending stairs for functional skills.

      Measuring distance will be used for Functional reach test and timing will be used for single
      leg standing test. Timing and repetition number will be used for muscular endurance tests.
      Timing will be used to climb up 10 stairs with and without heel contact.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Functional Skill
time frame: at baseline
description: The case will be asked to climb up 10 stairs as fast as possible. Time (in seconds) will be recorded for climbing up with and without heel contact.
measure: Single Leg Standing
time frame: at baseline
description: The case will be asked to stand on dominant leg. If the raised leg touches anything around (other limb, floor) or in condition of hopping/splashing, time will be stopped. Time (seconds) will be recorded.
measure: Repetition number of heel raising
time frame: at baseline
description: Before the test, the case will be asked to stretch plantar flexor muscles. Then the case will be asked to raise the heels unilaterally. The repetition number will be written until the case cannot do the full movement.
measure: Repetition number of squating
time frame: at baseline
description: Before the test, the case will be asked to stretch quadriceps muscle with flexing the knee. Then the case will be asked to squat continuously. The repetition number will be written until the case cannot do the full movement.
measure: Duration of heel raising
time frame: at baseline
description: Before the test, the case will be asked to stretch plantar flexor muscles. Then the case will be asked to raise the heels unilaterally. The time (in seconds) will be written until the case cannot do the full movement.
measure: Duration of squating
time frame: Before the test, the case will be asked to stretch quadriceps muscle with flexing the knee. Then the case will be asked to squat continuously. The repetition number will be written until the case cannot do the full movement.
description: Before the test, the case will be asked to stretch quadriceps muscle with flexing the knee. Then the case will be asked to squat continuously. The time (in seconds) will be written until the case cannot do the full movement.
measure: Functional Forward Reach Test
time frame: Before the test, the case will be asked to stretch quadriceps muscle with flexing the knee. Then the case will be asked to squat continuously. The repetition number will be written until the case cannot do the full movement.
description: Before the test, the case will be asked to stretch quadriceps muscle with flexing the knee. Then the case will be asked to squat continuously. The repetition number will be written until the case cannot do the full movement.
arm group label: Shoe with 4 cm heel
arm group type: Experimental
description: Shoes with 4 cm heel will be applied to women. Tests to measure balance, muscular endurance and function will be done while they wear this shoe.
arm group label: Shoe with 10 cm heel
arm group type: Experimental
description: Shoes with 10 cm heel will be applied to women. Tests to measure balance, muscular endurance and function will be done while they wear this shoe.
arm group label: Without shoes
arm group type: No Intervention
description: Women will be included in the tests to measure balance, muscular endurance and function without shoes.
intervention type: Other
intervention name: Shoes
description: Shoes with different heel heights
arm group label: Shoe with 10 cm heel
arm group label: Shoe with 4 cm heel
other name: Women wearing shoes
criteria: 
gender: Female
gender based: Yes
gender description: Heeled shoes are used among women.
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: ZEHRA GÜÇHAN TOPCU
role: Principal Investigator
affiliation: Eastern Mediterranean University
facility: 
country: Cyprus
responsible party type: Sponsor