<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/NCT03756142</url>
  </required_header>
  <id_info>
    <org_study_id>RC-P0067</org_study_id>
    <nct_id>NCT03756142</nct_id>
  </id_info>
  <brief_title>Biomechanical Characterization of the Locomotion in Multiple Sclerosis Patients</brief_title>
  <acronym>WALKING-SEP</acronym>
  <official_title>Biomechanical Characterization of the Locomotion in Multiple Sclerosis Patients : Determination of Indicators of the Premature Degradation of the Orthostatic Posture, Gait Initiation and Walking</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lille Catholic University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Laboratoire d'Automatique, de Mécanique et d'Informatique Industrielles et Humaines</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Lille Catholic 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>
      Multiple sclerosis (MS) is an inflammatory chronic disease of the central nervous system.&#xD;
      Patients are suffering from balance and gait impairments at the early stage of the disease.&#xD;
&#xD;
      85 % of the MS patients report gait disorders, which impact their autonomy and their quality&#xD;
      of life and increase the risk of fall.&#xD;
&#xD;
      The three-dimensional analysis of the walking by a motion capture system associated with&#xD;
      force platforms allows the quantification of the complex walking disorders, to look for the&#xD;
      cause, as well as side effects such as compensation strategies.&#xD;
&#xD;
      According to the 2006 report of the French National Authority for Health, the 3D analysis of&#xD;
      walking is essential in chronic pathologies to evaluate and quantify gait disorders. This&#xD;
      analysis allows the functional follow-up of the patients throughout their rehabilitation.&#xD;
      Some studies, on a small and heterogeneous population of MS patients, showed changes during&#xD;
      the walking concerning spatiotemporal, kinematic, dynamic parameters and muscular activation&#xD;
      of lower limbs at early stages of the disease. Only two studies evaluate the joint power&#xD;
      during walking in MS patients. However, these studies have some limits.&#xD;
&#xD;
      The 3D analysis of the walking proposed in this study would allow the biomechanical&#xD;
      characterization of the gait impairments of MS patients through tasks such as walking, gait&#xD;
      initiation and orthostatic posture. This methodology would contribute to adapt treatments and&#xD;
      the rehabilitation care, at an early stage of the disease.&#xD;
&#xD;
      From a functional point of view, the gait initiation is an interesting dynamic task to be&#xD;
      evaluated. Indeed, it represents the transition between the upright posture and the&#xD;
      stabilized walking. Throughout this complex task, a stereotypical motor program is set up&#xD;
      during a first phase of anticipatory postural adjustments, which allows the creation of&#xD;
      dynamic conditions essential for the execution of the first step. The gait initiation is&#xD;
      little documented for MS patients despite the risk of fall clinically highlighted. The&#xD;
      articular power during the gait initiation was never estimated in MS patients. On the other&#xD;
      hand, there is no study establishing correlations between the Expanded Disability Status&#xD;
      Scale functional features and the impairments of the gait initiation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 6, 2018</start_date>
  <completion_date type="Anticipated">November 5, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 5, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Kinematics of lower limbs articulations</measure>
    <time_frame>at inclusion</time_frame>
    <description>Kinematics of lower limbs will be performed by a motion analysis system. The analysis will be carried out with 4 infrared cameras, 2 force platforms, an electromyographic recording system, a computer system for signal analysis and data management. The optoelectronic system used is the 3D Vicon® system, which is based on passive stereovision. motive tasks (orthostatic posture, walking initiation, and the walking).</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Multiple sclerosis patients</arm_group_label>
    <description>Analysis of orthostatic posture, initiation of walking and walking in MS patients with an EDSS between 0 and 4 (included) by a motion analysis system</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <description>Analysis of orthostatic posture, initiation of walking and walking in a group of healthy volunteers</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Motion Analysis</intervention_name>
    <description>Analysis of orthostatic posture, initiation of walking and walking by a motion analysis system</description>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <arm_group_label>Multiple sclerosis patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with an early-stage of MS (cases) versus healthy controls who do not have MS.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria for MS patients :&#xD;
&#xD;
          -  EDSS &lt; 4.5&#xD;
&#xD;
          -  Stable disease for at least 6 weeks&#xD;
&#xD;
          -  No injection of botulinum toxin in the past 4 months&#xD;
&#xD;
        no specific inclusion criteria for healthy volunteers&#xD;
&#xD;
        Exclusion Criteria for MS patients :&#xD;
&#xD;
          -  Neurological disease other than MS&#xD;
&#xD;
          -  Disabling pathologies of the locomotor apparatus&#xD;
&#xD;
          -  Non-stabilized Respiratory, Cardiovascular disease&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
          -  Patient with cognitive impairment&#xD;
&#xD;
          -  Recent modification of MS treatment (&lt;3 months)&#xD;
&#xD;
        Exclusion Criteria for Healthy Volunteers :&#xD;
&#xD;
          -  Neurological disease&#xD;
&#xD;
          -  Rheumatological disease&#xD;
&#xD;
          -  Sprain of the lower limbs in the last 3 months&#xD;
&#xD;
          -  Fracture of the lower limbs in the last year&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Caroline Massot, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>GHICL</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Amélie Lansiaux, MD, PhD</last_name>
    <phone>3 20 22 52 69</phone>
    <phone_ext>0033</phone_ext>
    <email>lansiaux.amelie@ghicl.net</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jean-Jacques Vitagliano, PhD</last_name>
    <phone>3 20 22 57 51</phone>
    <phone_ext>0033</phone_ext>
    <email>vitagliano.jean-jacques@ghicl.net</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hôpital Saint-Philibert</name>
      <address>
        <city>Lomme</city>
        <zip>59000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Caroline Massot, MD</last_name>
    </contact>
    <investigator>
      <last_name>Caroline Massot, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Cécile Donzé, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>November 26, 2018</last_update_submitted>
  <last_update_submitted_qc>November 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>3D analysis</keyword>
  <keyword>Biomarkers</keyword>
  <keyword>Rehabilition</keyword>
  <keyword>Locomotion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <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/NCT03756142
org study id: RC-P0067
nct id: NCT03756142
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Multiple sclerosis (MS) is an inflammatory chronic disease of the central nervous system.
      Patients are suffering from balance and gait impairments at the early stage of the disease.

      85 % of the MS patients report gait disorders, which impact their autonomy and their quality
      of life and increase the risk of fall.

      The three-dimensional analysis of the walking by a motion capture system associated with
      force platforms allows the quantification of the complex walking disorders, to look for the
      cause, as well as side effects such as compensation strategies.

      According to the 2006 report of the French National Authority for Health, the 3D analysis of
      walking is essential in chronic pathologies to evaluate and quantify gait disorders. This
      analysis allows the functional follow-up of the patients throughout their rehabilitation.
      Some studies, on a small and heterogeneous population of MS patients, showed changes during
      the walking concerning spatiotemporal, kinematic, dynamic parameters and muscular activation
      of lower limbs at early stages of the disease. Only two studies evaluate the joint power
      during walking in MS patients. However, these studies have some limits.

      The 3D analysis of the walking proposed in this study would allow the biomechanical
      characterization of the gait impairments of MS patients through tasks such as walking, gait
      initiation and orthostatic posture. This methodology would contribute to adapt treatments and
      the rehabilitation care, at an early stage of the disease.

      From a functional point of view, the gait initiation is an interesting dynamic task to be
      evaluated. Indeed, it represents the transition between the upright posture and the
      stabilized walking. Throughout this complex task, a stereotypical motor program is set up
      during a first phase of anticipatory postural adjustments, which allows the creation of
      dynamic conditions essential for the execution of the first step. The gait initiation is
      little documented for MS patients despite the risk of fall clinically highlighted. The
      articular power during the gait initiation was never estimated in MS patients. On the other
      hand, there is no study establishing correlations between the Expanded Disability Status
      Scale functional features and the impairments of the gait initiation.
observational model: Case-Control
time perspective: Prospective
measure: Kinematics of lower limbs articulations
time frame: at inclusion
description: Kinematics of lower limbs will be performed by a motion analysis system. The analysis will be carried out with 4 infrared cameras, 2 force platforms, an electromyographic recording system, a computer system for signal analysis and data management. The optoelectronic system used is the 3D Vicon® system, which is based on passive stereovision. motive tasks (orthostatic posture, walking initiation, and the walking).
arm group label: Multiple sclerosis patients
description: Analysis of orthostatic posture, initiation of walking and walking in MS patients with an EDSS between 0 and 4 (included) by a motion analysis system
arm group label: Healthy volunteers
description: Analysis of orthostatic posture, initiation of walking and walking in a group of healthy volunteers
intervention type: Diagnostic Test
intervention name: Motion Analysis
description: Analysis of orthostatic posture, initiation of walking and walking by a motion analysis system
arm group label: Healthy volunteers
arm group label: Multiple sclerosis patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Caroline Massot, MD
role: Principal Investigator
affiliation: GHICL
last name: Amélie Lansiaux, MD, PhD
phone: 3 20 22 52 69
phone ext: 0033
email: lansiaux.amelie@ghicl.net
last name: Jean-Jacques Vitagliano, PhD
phone: 3 20 22 57 51
phone ext: 0033
email: vitagliano.jean-jacques@ghicl.net
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Sclerosis
sharing ipd: No