<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/NCT03764332</url>
  </required_header>
  <id_info>
    <org_study_id>1402201803718</org_study_id>
    <nct_id>NCT03764332</nct_id>
  </id_info>
  <brief_title>Evaluation of the Static Stability of Footwear</brief_title>
  <acronym>EEECS</acronym>
  <official_title>Evaluation of the Static Stability of Footwear: A Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>JOSE MANUEL SANCHEZ SAEZ</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade da Coruña</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>
      Introduction: Postural control is a crucial factor for maintaining balance while standing and&#xD;
      walking. The shoe has a role to play in postural stability.&#xD;
&#xD;
      Objectives: To evaluate the static balance of subjects when barefoot and when using three&#xD;
      types of footwear with their eyes closed or open.&#xD;
&#xD;
      Material and methods:&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Each participant was asked to focus on a white mark 2 cm in diameter, positioned on a screen&#xD;
      2 m in front of them at eye level. This was done to standardize the data collection and&#xD;
      minimize any variation in postural stability caused by changes in the visual field. Each&#xD;
      participant was asked to remain in this position for a period of 30 seconds, while the data&#xD;
      was collected. Three repetitions were made for each condition to obtain an average value. The&#xD;
      condition on footwear and open / closed eyes was randomized to reduce the learning effect. On&#xD;
      the other hand to reduce fatigue, each participant was allowed to rest for 5 minutes between&#xD;
      shoe changes.&#xD;
&#xD;
      The size of the sample was calculated with the software of the Clinical Epidemiology and&#xD;
      Biostatistics Unit. Complexo Hospitalario Universitario de A Coruña. University of A Coruña&#xD;
      (www.fisterra.com). The estimated sample size estimated was calculated to be at least 16&#xD;
      subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 7, 2018</start_date>
  <completion_date type="Actual">January 4, 2019</completion_date>
  <primary_completion_date type="Actual">December 30, 2018</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Stroke length</measure>
    <time_frame>30 seconds</time_frame>
    <description>Length traveled by the pressure center (CoP), forming a line called oscillatory ball. In mm. The Podoprint pressure platform was used as a measuring device.&#xD;
Quantitative variable</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stroke surface</measure>
    <time_frame>30 seconds</time_frame>
    <description>Area of the smallest ellipse able to encompass the oscillating ball. In mm. The Podoprint pressure platform was used as a measuring device.&#xD;
Quantitative variable</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Relationship between Length / surface</measure>
    <time_frame>30 seconds</time_frame>
    <description>Value resulting from the relationship between the two previous measures. The Podoprint pressure platform was used as a measuring device.&#xD;
Quantitative variable</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Average swing speed</measure>
    <time_frame>30 seconds</time_frame>
    <description>Average speed that reaches the displacement of the center of pressures. The Podoprint pressure platform was used as a measuring device.&#xD;
Quantitative variable</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lateral velocity</measure>
    <time_frame>30 seconds</time_frame>
    <description>Average speed of oscillation in its axis of ordinates. The Podoprint pressure platform was used as a measuring device. Quantitative variable</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Forward speed</measure>
    <time_frame>30 seconds</time_frame>
    <description>Average oscillation speed on its abscissa axis. The Podoprint pressure platform was used as a measuring device. Quantitative variable</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Average displacement in the X axis</measure>
    <time_frame>30 seconds</time_frame>
    <description>Average of the displacements made by the center of pressures in the axis of ordinates. The Podoprint pressure platform was used as a measuring device.&#xD;
Quantitative variable</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Average displacement on the Y axis</measure>
    <time_frame>30 seconds</time_frame>
    <description>Average of the displacements made by the center of pressures on the abscissa axis. The Podoprint pressure platform was used as a measuring device.&#xD;
Quantitative variable</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Postural; Strain</condition>
  <arm_group>
    <arm_group_label>Stabilometry</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The Podoprint pressure platform was used as a measuring device. The Podoprint platform is a low profile floor platform consisting of 1.4 sensors / cm2 with a sampling frequency of 40Hz.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Stabilometry</intervention_name>
    <description>To evaluate the static balance of subjects when barefoot and when using three types of footwear with their eyes closed or open.</description>
    <arm_group_label>Stabilometry</arm_group_label>
    <other_name>Eyes open and eyes closed</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Acceptance and signature of informed consent.&#xD;
&#xD;
          -  Persons aged between 25-35 years.&#xD;
&#xD;
          -  People with a weight between 40 and 95kg.&#xD;
&#xD;
          -  People with a height between 1.50 and 1.90m&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  People with surgical history of lower limbs.&#xD;
&#xD;
          -  People with systemic pathology / algia that can alter the physiological static&#xD;
             pattern.&#xD;
&#xD;
          -  Congenital deformities or acquired in childhood.&#xD;
&#xD;
          -  If after a complete exploration in decubitus, sitting, static standing and gait&#xD;
             dynamics, any anomaly that could negatively influence the acquisition of data for the&#xD;
             study was detected.&#xD;
&#xD;
          -  Patients who do not accept or sign the informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jose Sanchez Saez, Podólogo</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade da Coruña</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clínica López del Amo</name>
      <address>
        <city>Murcia</city>
        <zip>30008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 2, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>January 4, 2019</last_update_submitted>
  <last_update_submitted_qc>January 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Universidade da Coruña</investigator_affiliation>
    <investigator_full_name>JOSE MANUEL SANCHEZ SAEZ</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Footwear</keyword>
  <keyword>Barefoot</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03764332
org study id: 1402201803718
nct id: NCT03764332
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Introduction: Postural control is a crucial factor for maintaining balance while standing and
      walking. The shoe has a role to play in postural stability.

      Objectives: To evaluate the static balance of subjects when barefoot and when using three
      types of footwear with their eyes closed or open.

      Material and methods:
Each participant was asked to focus on a white mark 2 cm in diameter, positioned on a screen
      2 m in front of them at eye level. This was done to standardize the data collection and
      minimize any variation in postural stability caused by changes in the visual field. Each
      participant was asked to remain in this position for a period of 30 seconds, while the data
      was collected. Three repetitions were made for each condition to obtain an average value. The
      condition on footwear and open / closed eyes was randomized to reduce the learning effect. On
      the other hand to reduce fatigue, each participant was allowed to rest for 5 minutes between
      shoe changes.

      The size of the sample was calculated with the software of the Clinical Epidemiology and
      Biostatistics Unit. Complexo Hospitalario Universitario de A Coruña. University of A Coruña
      (www.fisterra.com). The estimated sample size estimated was calculated to be at least 16
      subjects.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Stroke length
time frame: 30 seconds
description: Length traveled by the pressure center (CoP), forming a line called oscillatory ball. In mm. The Podoprint pressure platform was used as a measuring device.
Quantitative variable
measure: Stroke surface
time frame: 30 seconds
description: Area of the smallest ellipse able to encompass the oscillating ball. In mm. The Podoprint pressure platform was used as a measuring device.
Quantitative variable
measure: Relationship between Length / surface
time frame: 30 seconds
description: Value resulting from the relationship between the two previous measures. The Podoprint pressure platform was used as a measuring device.
Quantitative variable
measure: Average swing speed
time frame: 30 seconds
description: Average speed that reaches the displacement of the center of pressures. The Podoprint pressure platform was used as a measuring device.
Quantitative variable
measure: Lateral velocity
time frame: 30 seconds
description: Average speed of oscillation in its axis of ordinates. The Podoprint pressure platform was used as a measuring device. Quantitative variable
measure: Forward speed
time frame: 30 seconds
description: Average oscillation speed on its abscissa axis. The Podoprint pressure platform was used as a measuring device. Quantitative variable
measure: Average displacement in the X axis
time frame: 30 seconds
description: Average of the displacements made by the center of pressures in the axis of ordinates. The Podoprint pressure platform was used as a measuring device.
Quantitative variable
measure: Average displacement on the Y axis
time frame: 30 seconds
description: Average of the displacements made by the center of pressures on the abscissa axis. The Podoprint pressure platform was used as a measuring device.
Quantitative variable
arm group label: Stabilometry
arm group type: Other
description: The Podoprint pressure platform was used as a measuring device. The Podoprint platform is a low profile floor platform consisting of 1.4 sensors / cm2 with a sampling frequency of 40Hz.
intervention type: Device
intervention name: Stabilometry
description: To evaluate the static balance of subjects when barefoot and when using three types of footwear with their eyes closed or open.
arm group label: Stabilometry
other name: Eyes open and eyes closed
criteria: 
gender: All
minimum age: 25 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jose Sanchez Saez, Podólogo
role: Principal Investigator
affiliation: Universidade da Coruña
facility: 
country: Spain
responsible party type: Sponsor-Investigator
investigator affiliation: Universidade da Coruña
investigator full name: JOSE MANUEL SANCHEZ SAEZ
investigator title: Principal investigator
sharing ipd: No