<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/NCT02235168</url>
  </required_header>
  <id_info>
    <org_study_id>6MWTElderly</org_study_id>
    <nct_id>NCT02235168</nct_id>
  </id_info>
  <brief_title>Effect of Rollator on Walking Distance in Elderly Patients</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cliniques universitaires Saint-Luc- Université Catholique de Louvain</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cliniques universitaires Saint-Luc- Université Catholique de Louvain</source>
  <brief_summary>
    <textblock>
      To evaluate the effect of a rollator on 6 Minute Walking Test (6MWT) in elderly people.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>six minute walking test</measure>
    <time_frame>6 minutes</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Healthy Elderly</condition>
  <arm_group>
    <arm_group_label>With rollator</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Six minutes walking test with rollator</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Without rolator</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Six minutes walking test without rollator</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>six minute walking test</intervention_name>
    <arm_group_label>With rollator</arm_group_label>
    <arm_group_label>Without rolator</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  elderly people (older than 60 years)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  respiratory diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cliniques universitaires Saint-Luc</name>
      <address>
        <city>Brussels</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>November 25, 2015</last_update_submitted>
  <last_update_submitted_qc>November 25, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 26, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cliniques universitaires Saint-Luc- Université Catholique de Louvain</investigator_affiliation>
    <investigator_full_name>G.Reychler</investigator_full_name>
    <investigator_title>Doctor in Physiotherapy</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/NCT02235168
org study id: 6MWTElderly
nct id: NCT02235168
lead sponsor: 
To evaluate the effect of a rollator on 6 Minute Walking Test (6MWT) in elderly people.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Single (Outcomes Assessor)
measure: six minute walking test
time frame: 6 minutes
arm group label: With rollator
arm group type: Experimental
description: Six minutes walking test with rollator
arm group label: Without rolator
arm group type: Active Comparator
description: Six minutes walking test without rollator
intervention type: Procedure
intervention name: six minute walking test
arm group label: With rollator
arm group label: Without rolator
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
investigator full name: G.Reychler
investigator title: Doctor in Physiotherapy