<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/NCT02263560</url>
  </required_header>
  <id_info>
    <org_study_id>UFribourg</org_study_id>
    <nct_id>NCT02263560</nct_id>
  </id_info>
  <brief_title>Supraspinal Contributions to the Control of Human Locomotion: Clinical and Fundamental Aspects</brief_title>
  <acronym>SUPLOCO</acronym>
  <official_title>Supraspinal Contributions to the Control of Human Locomotion: Clinical and Fundamental Aspects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Fribourg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dr Titus Bihl, Hopital Cantonal Fribourgeois</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Fribourg</source>
  <brief_summary>
    <textblock>
      Many neurological patients express enhanced deficits while walking in a dark room (or during&#xD;
      the night): the supraspinal structures involved in this navigational deficit have not been&#xD;
      identified yet. In this project, the investigators will study post-stroke gaits of human&#xD;
      patients and compare them to those of a control population during a goal-oriented task&#xD;
      performed in different visual conditions.&#xD;
&#xD;
      The investigators want to test the hypothesis that during simple goal-oriented locomotor&#xD;
      tasks, only patients with specific (e.g. medio or infero- temporal) lesions will express&#xD;
      navigational deficits.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">January 2015</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>Other</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Walking stability indices of post-stroke patients</measure>
    <time_frame>1 hour and 30 minutes (including pre-tests, instructions delivery...).</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Spatial accuracy of walking trajectories in post-stroke patients</measure>
    <time_frame>1 hour and 30 minutes (including pre-tests, instructions delivery...).</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>Post-stroke Gait Assessments</condition>
  <arm_group>
    <arm_group_label>Post-stroke patients</arm_group_label>
    <description>Patients who experienced stroke and who already recover gait abilities.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control population</arm_group_label>
    <description>Participants matching the criterion (age and gender) of the patients' group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Kinematic measurements</intervention_name>
    <arm_group_label>Control population</arm_group_label>
    <arm_group_label>Post-stroke patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The selected patients will be described by following parameters:&#xD;
&#xD;
          -  Parameters in relation to the person: age, gender.&#xD;
&#xD;
          -  Parameters in relation to the pathology: NIHSS, exact localisation, time since start&#xD;
             of the symptoms, FIM (functional independence measure) visual field (ophthalmological&#xD;
             examen), visual acuity (ophtalmological examen), visual neglect (Bells Cancellation&#xD;
             Task), visuo-spatial short term working memory (Corsi span), visual motor integration&#xD;
             (3-D cub subtest MoCA)&#xD;
&#xD;
          -  Parameters in relation to hospital stay: length of stay.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria (for matching controls):&#xD;
&#xD;
          -  Adult male and female subjects (18--&gt;85 years old)&#xD;
&#xD;
        Exclusion Criteria (for matching controls):&#xD;
&#xD;
          -  Persons with history of an acquired or congenital neurological disorder, e.g. stroke,&#xD;
             multiple sclerosis, Parkinson disease, increased intracranial pressure, etc.;&#xD;
&#xD;
          -  Persons injured at the time of the experiments (fractures,…);&#xD;
&#xD;
          -  Persons having reported repetitive spatial troubles/disorders;&#xD;
&#xD;
          -  Persons with eye disorders and non-corrected vision problems;&#xD;
&#xD;
          -  Pregnant women.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University (UNIFR) and Hospital of Fribourg (HFR)</name>
      <address>
        <city>Fribourg</city>
        <zip>1700</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 6, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>October 24, 2017</last_update_submitted>
  <last_update_submitted_qc>October 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Fribourg</investigator_affiliation>
    <investigator_full_name>Halim HICHEUR</investigator_full_name>
    <investigator_title>Lecturer (PhD)</investigator_title>
  </responsible_party>
  <!-- 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/NCT02263560
org study id: UFribourg
nct id: NCT02263560
lead sponsor: 
collaborator: 
Many neurological patients express enhanced deficits while walking in a dark room (or during
      the night): the supraspinal structures involved in this navigational deficit have not been
      identified yet. In this project, the investigators will study post-stroke gaits of human
      patients and compare them to those of a control population during a goal-oriented task
      performed in different visual conditions.

      The investigators want to test the hypothesis that during simple goal-oriented locomotor
      tasks, only patients with specific (e.g. medio or infero- temporal) lesions will express
      navigational deficits.
observational model: Cohort
time perspective: Other
measure: Walking stability indices of post-stroke patients
time frame: 1 hour and 30 minutes (including pre-tests, instructions delivery...).
measure: Spatial accuracy of walking trajectories in post-stroke patients
time frame: 1 hour and 30 minutes (including pre-tests, instructions delivery...).
arm group label: Post-stroke patients
description: Patients who experienced stroke and who already recover gait abilities.
arm group label: Control population
description: Participants matching the criterion (age and gender) of the patients' group.
intervention type: Behavioral
intervention name: Kinematic measurements
arm group label: Control population
arm group label: Post-stroke patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: University of Fribourg
investigator full name: Halim HICHEUR
investigator title: Lecturer (PhD)