<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/NCT02231827</url>
  </required_header>
  <id_info>
    <org_study_id>2014/058/HP</org_study_id>
    <nct_id>NCT02231827</nct_id>
  </id_info>
  <brief_title>Balance Control During Gait</brief_title>
  <acronym>FREINAGE3D</acronym>
  <official_title>A Study of the Balance Control During Gait : Comparison of Data Acquisition Between Force Plate and 3D Optoelectronic Gait Analysis System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Rouen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Rouen</source>
  <brief_summary>
    <textblock>
      Gait and balance disorders are important public health problem necessitating studies to try&#xD;
      to prevent falls. Many studies have dealt with spatiotemporal gait parameters or balance&#xD;
      during quiet standing (posturography). Nevertheless, falls occurred predominantly during&#xD;
      gait, and rarely during quiet standing. We have developed a tool to measure balance during&#xD;
      gait : the braking of the center of mass (CM), a biomechanical parameter obtained from the&#xD;
      vertical velocity of the CM recorded with a force plate.&#xD;
&#xD;
      In previous studies, we have shown that the braking of the CM was a physiological and a&#xD;
      active mechanism, reflecting balance during gait. Unfortunately, the braking of the CM&#xD;
      measured on a force plate provide an important intra-individual variability.&#xD;
&#xD;
      The 3D optoelectronic gait analysis system (VICON) also provide an estimation of the CM. The&#xD;
      primary goal of this study is to compare intra-individual variability of the braking of the&#xD;
      CM determined by a force plate or the 3D optoelectronic gait analysis system (VICON) in&#xD;
      healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Braking of the center of mass index during gait initiation</measure>
    <time_frame>1 day</time_frame>
    <description>Braking of the center of mass (CM), a biomechanical parameter obtained from the vertical velocity of the CM, determined by a force plate or a 3D optoelectronic gait analysis system (VICON).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Braking of the center of mass index during locomotion</measure>
    <time_frame>1 day</time_frame>
    <description>Braking of the center of mass (CM), a biomechanical parameter obtained from the vertical velocity of the CM, determined by a 3D optoelectronic gait analysis system (VICON).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Gait analysis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Gait analysis</intervention_name>
    <description>Subjects, barefoot and standing upright and motionless on a force plate, were instructed to walk for 10 m following a beep delivered by the experimenter. Two experimental conditions were tested: (i) the 'natural' gait condition where subjects walked normally and (ii) the 'fast' gait condition where subjects walked as fast as they could, taking large steps. Each subject performed 10 trials in each condition.</description>
    <arm_group_label>Gait analysis</arm_group_label>
    <other_name>- Force plate</other_name>
    <other_name>- 3D optoelectronic gait analysis system (VICON)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy subjects&#xD;
&#xD;
          -  Between 20 and 40 years old&#xD;
&#xD;
          -  Effective contraception for women of childbearing age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neurological, vestibular, rheumatologic, orthopaedic disorders, which could influence&#xD;
             gait and balance.&#xD;
&#xD;
          -  Known spinal deformity&#xD;
&#xD;
          -  Severe visual impairment : visual acuity less than 6/10&#xD;
&#xD;
          -  Inability to stand and walk without assistance 15 meters&#xD;
&#xD;
          -  Subjects without social security&#xD;
&#xD;
          -  Subjects involved in another biomedical trial during this study&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nathalie CHASTAN, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rouen University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rouen University Hospital</name>
      <address>
        <city>Rouen</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>September 1, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <last_update_submitted>September 14, 2015</last_update_submitted>
  <last_update_submitted_qc>September 14, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 15, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>subjects</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/NCT02231827
org study id: 2014/058/HP
nct id: NCT02231827
lead sponsor: 
Gait and balance disorders are important public health problem necessitating studies to try
      to prevent falls. Many studies have dealt with spatiotemporal gait parameters or balance
      during quiet standing (posturography). Nevertheless, falls occurred predominantly during
      gait, and rarely during quiet standing. We have developed a tool to measure balance during
      gait : the braking of the center of mass (CM), a biomechanical parameter obtained from the
      vertical velocity of the CM recorded with a force plate.

      In previous studies, we have shown that the braking of the CM was a physiological and a
      active mechanism, reflecting balance during gait. Unfortunately, the braking of the CM
      measured on a force plate provide an important intra-individual variability.

      The 3D optoelectronic gait analysis system (VICON) also provide an estimation of the CM. The
      primary goal of this study is to compare intra-individual variability of the braking of the
      CM determined by a force plate or the 3D optoelectronic gait analysis system (VICON) in
      healthy subjects.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Braking of the center of mass index during gait initiation
time frame: 1 day
description: Braking of the center of mass (CM), a biomechanical parameter obtained from the vertical velocity of the CM, determined by a force plate or a 3D optoelectronic gait analysis system (VICON).
measure: Braking of the center of mass index during locomotion
time frame: 1 day
description: Braking of the center of mass (CM), a biomechanical parameter obtained from the vertical velocity of the CM, determined by a 3D optoelectronic gait analysis system (VICON).
arm group label: Gait analysis
arm group type: Experimental
intervention type: Other
intervention name: Gait analysis
description: Subjects, barefoot and standing upright and motionless on a force plate, were instructed to walk for 10 m following a beep delivered by the experimenter. Two experimental conditions were tested: (i) the 'natural' gait condition where subjects walked normally and (ii) the 'fast' gait condition where subjects walked as fast as they could, taking large steps. Each subject performed 10 trials in each condition.
arm group label: Gait analysis
other name: - Force plate
other name: - 3D optoelectronic gait analysis system (VICON)
criteria: 
gender: All
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nathalie CHASTAN, MD
role: Principal Investigator
affiliation: Rouen University Hospital
facility: 
country: France
responsible party type: Sponsor