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/NCT06027762</url>
    </required_header>
    <id_info>
      <org_study_id>2021-A02409-32</org_study_id>
      <nct_id>NCT06027762</nct_id>
    </id_info>
    <brief_title>Assessment of vGRF Measurement During Walking With Feetme® Insoles in Healthy Adults</brief_title>
    <acronym>FeetMe-GRF</acronym>
    <official_title>Assessment of Vertical Ground Reaction Force Measurement During Walking With Feetme® Insoles in Healthy Adults</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>FeetMe</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Hopitaux de Saint-Maurice</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>FeetMe</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 objective of the present study is to demonstrate the validity and reliability of vGRF and&#xD;
        other gait parameters measurement in healthy adults while walking with FeetMe® insoles&#xD;
        compared to force plates (AMTI BP400600) and video motion capture system (Vicon NEXUS and&#xD;
        MX-T40) .&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 1, 2022</start_date>
    <completion_date type="Actual">November 30, 2022</completion_date>
    <primary_completion_date type="Actual">November 30, 2022</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>1 Day</target_duration>
    <primary_outcome>
      <measure>precision of measurement of 'maximum weight acceptance' and 'push-off' peaks in healthy adults by FeetMe® insoles</measure>
      <time_frame>between February 2022 and November 2022</time_frame>
      <description>The primary objective of this clinical trial is to quantify precision of measurement of two peaks of vGRF, peaks that correspond to 'maximum weight acceptance' and 'push-off', also called 'heelmax load' and 'toemax load' for healthy adults by FeetMe® insoles compared with Vicon and force plates during a free walk test.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">37</enrollment>
    <condition>Healthy Volunteers</condition>
    <arm_group>
      <arm_group_label>Single-Groupe</arm_group_label>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Healthy Adults between 18 and 85 years old without gait pathologies&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria.&#xD;
  &#xD;
          Volunteers with following criteria satisfied:&#xD;
  &#xD;
            -  Between the ages of 18 and 80.&#xD;
  &#xD;
            -  Shoe size between 35 to 46.&#xD;
  &#xD;
            -  Body weight from 40kg to 120kg.&#xD;
  &#xD;
            -  Able to walk for 30 mins without assistance.&#xD;
  &#xD;
            -  Comfortable with using a smartphone.&#xD;
  &#xD;
          Non-inclusion Criteria.&#xD;
  &#xD;
          A volunteer will not be included if one of the following conditions is met:&#xD;
  &#xD;
            -  cognitive or behavioral problems limiting communication or participation in the study&#xD;
  &#xD;
            -  deprivation of liberty by a legal or administrative decision&#xD;
  &#xD;
            -  adults subject to a legal protection measure or unable to express their consent&#xD;
  &#xD;
            -  pregnant, parturient and nursing mothers&#xD;
  &#xD;
            -  people admitted to a health or social establishment for purposes other than research&#xD;
  &#xD;
            -  Past or planned surgery with the possibility of impacting walking in the past 3 months&#xD;
               or which had an impact on walking: orthopedic surgery, trauma to the lower limbs and&#xD;
               spine, urological or gynecological surgery, brain and spinal cord surgery .&#xD;
  &#xD;
            -  Chronic disease affecting walking: Rheumatological, orthopedic, painful, neurological&#xD;
               pathology.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Hopitaux Saint-Maurice</name>
        <address>
          <city>Saint-Maurice</city>
          <state>Ile-de-France</state>
          <zip>94410</zip>
          <country>France</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>legal reasons</ipd_description>
    </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/NCT06027762
  org study id: 2021-A02409-32
  nct id: NCT06027762
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The objective of the present study is to demonstrate the validity and reliability of vGRF and
        other gait parameters measurement in healthy adults while walking with FeetMe® insoles
        compared to force plates (AMTI BP400600) and video motion capture system (Vicon NEXUS and
        MX-T40) .
  observational model: Cohort
  time perspective: Prospective
  measure: precision of measurement of 'maximum weight acceptance' and 'push-off' peaks in healthy adults by FeetMe® insoles
  time frame: between February 2022 and November 2022
  description: The primary objective of this clinical trial is to quantify precision of measurement of two peaks of vGRF, peaks that correspond to 'maximum weight acceptance' and 'push-off', also called 'heelmax load' and 'toemax load' for healthy adults by FeetMe® insoles compared with Vicon and force plates during a free walk test.
  arm group label: Single-Groupe
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: France
  responsible party type: Sponsor
  sharing ipd: No
  ipd description: legal reasons