<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/NCT03800771</url>
  </required_header>
  <id_info>
    <org_study_id>2018-A01109-46</org_study_id>
    <nct_id>NCT03800771</nct_id>
  </id_info>
  <brief_title>DOuble tasK Test On ergometeR - Basic Research on Acceptability and Use</brief_title>
  <acronym>DOKTORBRAU</acronym>
  <official_title>DOuble tasK Test On ergometeR - Basic Research on Acceptability and Use</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Angers</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Angers</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 goal of the study is to show the concordance between the dual-task test achieved usually&#xD;
      on an electronic treadmill and the dual-task test achieved with a cyclo-ergometer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Usually, dual task tests are only achieved on electronic treadmills. Patients who are coming&#xD;
      to perform these tests are mainly subjects with various levels of cognitive disorders and&#xD;
      with a high risk of fall because of potential motor and cognitive disorders.&#xD;
&#xD;
      The investigator will select patients referred for double task walking tests. After the&#xD;
      walking test, investigator will perform dual-task tests with a new bicycle device &quot;Cycléo&#xD;
      BRAU&quot; which allows the patients to achieve mental tasks while cycling. The aim of using a&#xD;
      bicycle is to limit the risk of falls compared to the treadmill or walking task. The &quot;Cycléo&#xD;
      BRAU&quot; device is equiped with a video projector which projects an environment of virtual&#xD;
      reality. It allows cycling without resistence and thus is not based on any incremental&#xD;
      worload. The mental tasks on bicycle will be of increasing difficulty and parameters such as&#xD;
      cycling speed will be recorded. Loss of speed regularity will be considered as an abnormal&#xD;
      response. The task for which cycling is stopped will be recorded and compared to the results&#xD;
      of the usual walking test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 28, 2019</start_date>
  <completion_date type="Actual">May 17, 2022</completion_date>
  <primary_completion_date type="Actual">May 17, 2021</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>
    <intervention_model_description>Patients are inhomogeneous in term of cognitive and physical function. The aim is to test faisability and security thus investigator will include a relatively large amount of patients.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Speed</measure>
    <time_frame>12 months</time_frame>
    <description>Evaluate the concordance of the speed during the tests on treadmill and on cyclo-ergometer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Speed variability</measure>
    <time_frame>12 months</time_frame>
    <description>Evaluate the concordance the speed variability during the tests on treadmill and on cyclo-ergometer.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Elderly Patients</condition>
  <arm_group>
    <arm_group_label>Practice dual-task tests</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The study consists to practice these dual-task tests with a new device which name is &quot;Cycléo BRAU&quot; that allows to the patients to achieve carefully an attentional task: cycle. Results will be compared tothe results obsvered during the routine GAITRITE analysis ( a validated tool for elderly patients and gait analysis).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cycléo BRAU</intervention_name>
    <description>Practice dual-task tests.</description>
    <arm_group_label>Practice dual-task tests</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>GAITRITE®</intervention_name>
    <description>Routine practice dual-task tests.</description>
    <arm_group_label>Practice dual-task tests</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 60 years old&#xD;
&#xD;
          -  Patient with a near visual acuity upper or equal to 2/10&#xD;
&#xD;
          -  Patient with a score of MMSE upper than 10&#xD;
&#xD;
          -  Patient able to walk on a treadmill for 15 meters on straight line without help&#xD;
&#xD;
          -  Patient covered by the French health insurance&#xD;
&#xD;
          -  Patient (or support person or legal representative) able to understand the protocol&#xD;
&#xD;
          -  Patient (or support person or legal representative) agrees to be involve in the&#xD;
             protocol and sign the consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient has a wash-out period for another clinical trial&#xD;
&#xD;
          -  Patient with a medical contraindication to practice bicycle&#xD;
&#xD;
          -  Patient with locomotor disorders preexisting, whatever the reason&#xD;
&#xD;
          -  Patient needing extern help to walk like a walking frame, rollator or tricycle&#xD;
&#xD;
          -  Patient with a medical or surgical disease acute from less of 3 months&#xD;
&#xD;
          -  Patient with cerebrovascular accident history or any other cerebro-medullary diseases&#xD;
             with sensorimotor consequences&#xD;
&#xD;
          -  Patient with severe depression (Geriatric Depression Scale 15 items upper than 10)&#xD;
&#xD;
          -  Patient with a low proficiency of French (oral or written)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pierre ABRAHAM, MD; PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital in Angers</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Angers</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>June 23, 2022</last_update_submitted>
  <last_update_submitted_qc>June 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>geriatric</keyword>
  <keyword>dual-task</keyword>
  <keyword>ergometer</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03800771
org study id: 2018-A01109-46
nct id: NCT03800771
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of the study is to show the concordance between the dual-task test achieved usually
      on an electronic treadmill and the dual-task test achieved with a cyclo-ergometer.
Usually, dual task tests are only achieved on electronic treadmills. Patients who are coming
      to perform these tests are mainly subjects with various levels of cognitive disorders and
      with a high risk of fall because of potential motor and cognitive disorders.

      The investigator will select patients referred for double task walking tests. After the
      walking test, investigator will perform dual-task tests with a new bicycle device "Cycléo
      BRAU" which allows the patients to achieve mental tasks while cycling. The aim of using a
      bicycle is to limit the risk of falls compared to the treadmill or walking task. The "Cycléo
      BRAU" device is equiped with a video projector which projects an environment of virtual
      reality. It allows cycling without resistence and thus is not based on any incremental
      worload. The mental tasks on bicycle will be of increasing difficulty and parameters such as
      cycling speed will be recorded. Loss of speed regularity will be considered as an abnormal
      response. The task for which cycling is stopped will be recorded and compared to the results
      of the usual walking test.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Patients are inhomogeneous in term of cognitive and physical function. The aim is to test faisability and security thus investigator will include a relatively large amount of patients.
primary purpose: Other
masking: None (Open Label)
measure: Speed
time frame: 12 months
description: Evaluate the concordance of the speed during the tests on treadmill and on cyclo-ergometer.
measure: Speed variability
time frame: 12 months
description: Evaluate the concordance the speed variability during the tests on treadmill and on cyclo-ergometer.
arm group label: Practice dual-task tests
arm group type: Experimental
description: The study consists to practice these dual-task tests with a new device which name is "Cycléo BRAU" that allows to the patients to achieve carefully an attentional task: cycle. Results will be compared tothe results obsvered during the routine GAITRITE analysis ( a validated tool for elderly patients and gait analysis).
intervention type: Device
intervention name: Cycléo BRAU
description: Practice dual-task tests.
arm group label: Practice dual-task tests
intervention type: Device
intervention name: GAITRITE®
description: Routine practice dual-task tests.
arm group label: Practice dual-task tests
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Pierre ABRAHAM, MD; PhD
role: Principal Investigator
affiliation: University Hospital in Angers
facility: 
country: France
responsible party type: Sponsor
sharing ipd: Undecided