<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/NCT01727687</url>
  </required_header>
  <id_info>
    <org_study_id>PDcrossroad</org_study_id>
    <nct_id>NCT01727687</nct_id>
  </id_info>
  <brief_title>Investigation of Road-crossing Safety Before and After Training Between Parkinson Disease Pedestrians and Older Pedestrians</brief_title>
  <official_title>An Investigation of Road Crossing Safety Before and After Training Between Parkinson Disease Pedestrians and Older Pedestrians</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      As society ages, a large amount of human factors related research has been carried out into&#xD;
      the subject of the safety of the elderly in their daily lives. However, most research focuses&#xD;
      on the general elderly population and there is a serious lack of research into elderly&#xD;
      sufferers of Parkinson's disease (PD), who receive a substantial amount of attention in&#xD;
      medical circles. In the investigators previous study, the investigators have found that&#xD;
      patient with PD had decreased ability to cross the road as compared to age/gender matched&#xD;
      control subjects. Hence, this research proposed several training programs to enhance the&#xD;
      safety of crossing road, including safe place finding，roadside search，time gap and perception&#xD;
      of other's intentions. The investigators will compare the parameters of crossing road ability&#xD;
      before and after training programs in patients with PD and control subjects.&#xD;
&#xD;
      The results of this research will clarify the correlation between medical scale test&#xD;
      indicators and movement safety for patients with PD. The effects of training programs will be&#xD;
      provided for further safety management and design concepts to improve the lives of this&#xD;
      disease group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>August 2011</start_date>
  <completion_date type="Anticipated">August 2013</completion_date>
  <primary_completion_date type="Anticipated">August 2013</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The parameters of cross road</measure>
    <time_frame>1 year</time_frame>
    <description>The main outcome variables were crossing time (CT), remaining time (RT), and safety margin (SM). The CT was the time taken by the subjects to cross the 3.5-m-wide road. The CT was measured at the normal walking pace and the fastest pace of each individual. Response time was measured in the simulated traffic situation and was defined as the time between starting the visual situation and the participant pressing the response button to decide to cross the road. The RT was the difference between the time gap (between the coming vehicle and the pedestrian) and the response time.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Parkinson's Disease</condition>
  <arm_group>
    <arm_group_label>Patients with Parkinson's disease</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Using simulated traffic scene system to help patients with Parkinson's disease improve crossing road behaviors.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>behavioral training for crossing road</intervention_name>
    <description>behavioral training programs for crossing road, such as verbal oral cues and simulated traffic scenes</description>
    <arm_group_label>Patients with Parkinson's disease</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with Parkinson's disease&#xD;
&#xD;
          -  Age between 18-80 years&#xD;
&#xD;
          -  Patients signed the consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with atypical parkinsonism&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chin-Hsien Lin, MD. PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>January 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 16, 2012</study_first_posted>
  <last_update_submitted>November 12, 2012</last_update_submitted>
  <last_update_submitted_qc>November 12, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 16, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>To asses the training effects on traffic safety between normal and patients with Parkinson's disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <!-- 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/NCT01727687
org study id: PDcrossroad
nct id: NCT01727687
lead sponsor: 
has dmc: Yes
As society ages, a large amount of human factors related research has been carried out into
      the subject of the safety of the elderly in their daily lives. However, most research focuses
      on the general elderly population and there is a serious lack of research into elderly
      sufferers of Parkinson's disease (PD), who receive a substantial amount of attention in
      medical circles. In the investigators previous study, the investigators have found that
      patient with PD had decreased ability to cross the road as compared to age/gender matched
      control subjects. Hence, this research proposed several training programs to enhance the
      safety of crossing road, including safe place finding，roadside search，time gap and perception
      of other's intentions. The investigators will compare the parameters of crossing road ability
      before and after training programs in patients with PD and control subjects.

      The results of this research will clarify the correlation between medical scale test
      indicators and movement safety for patients with PD. The effects of training programs will be
      provided for further safety management and design concepts to improve the lives of this
      disease group.
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: The parameters of cross road
time frame: 1 year
description: The main outcome variables were crossing time (CT), remaining time (RT), and safety margin (SM). The CT was the time taken by the subjects to cross the 3.5-m-wide road. The CT was measured at the normal walking pace and the fastest pace of each individual. Response time was measured in the simulated traffic situation and was defined as the time between starting the visual situation and the participant pressing the response button to decide to cross the road. The RT was the difference between the time gap (between the coming vehicle and the pedestrian) and the response time.
arm group label: Patients with Parkinson's disease
arm group type: Experimental
description: Using simulated traffic scene system to help patients with Parkinson's disease improve crossing road behaviors.
intervention type: Behavioral
intervention name: behavioral training for crossing road
description: behavioral training programs for crossing road, such as verbal oral cues and simulated traffic scenes
arm group label: Patients with Parkinson's disease
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Chin-Hsien Lin, MD. PhD
role: Principal Investigator
affiliation: National Taiwan University Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Parkinson Disease