<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/NCT02214342</url>
  </required_header>
  <id_info>
    <org_study_id>1401199972</org_study_id>
    <nct_id>NCT02214342</nct_id>
  </id_info>
  <brief_title>Virtual Reality Based Balance Training in People With Mild Cognitive Impairment</brief_title>
  <official_title>Virtual Reality Based Balance Training in People With Mild Cognitive Impairment: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Arizona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Banner Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Arizona</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the present study is to evaluate an innovative virtual reality-based balance&#xD;
      training intervention for improving clinically relevant motor performances (balance and gait)&#xD;
      in people with mild cognitive impairment.&#xD;
&#xD;
      The investigators hypothesize that the virtual reality-based balance training intervention&#xD;
      will improve balance and gait performances in people with mild cognitive impairment compared&#xD;
      to a control group receiving usual care only.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">September 2014</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postural Balance</measure>
    <time_frame>4 weeks</time_frame>
    <description>Postural Balance during quiet standing for 30 seconds will be assessed using validated wearable sensor technology (BalanSens™)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gait performance</measure>
    <time_frame>4 weeks</time_frame>
    <description>Gait performance will be measured using validated wearable sensor technology (LEGSys™)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive status</measure>
    <time_frame>4 weeks</time_frame>
    <description>Changes in cognitive status will be measured by the Trail Making Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear of falling</measure>
    <time_frame>4 weeks</time_frame>
    <description>Fear of falling will be measured by the Falls Efficacy scale international (short form)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>User experience</measure>
    <time_frame>4 weeks</time_frame>
    <description>User experience will be measured using a standardized questionaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive signs</measure>
    <time_frame>4 weeks</time_frame>
    <description>Depressive signs will be measured using the Center for Epidemiologic Studies Depression Scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Distorted; Balance</condition>
  <condition>Motor Deficit</condition>
  <condition>Cognitive Deficit</condition>
  <arm_group>
    <arm_group_label>Balance Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Balance training will be conducted individually two times per week for 4 weeks. Each training session will include virtual reality tasks such as &quot;ankle reaching&quot; and &quot;obstacle crossing&quot; using a virtual obstacle shown on a computer screen. Each session will last 30 - 45 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will keep their normal activity without receiving any intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Balance Training</intervention_name>
    <description>Experimental: Balance Training Balance training will be conducted individually two times per week for 4 weeks. Each training session will include virtual reality tasks such as &quot;ankle reaching&quot; and &quot;obstacle crossing&quot; using a virtual obstacle shown on a computer screen. Each session will last 30 - 45 minutes.</description>
    <arm_group_label>Balance Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of Mild Cognitive Impairment&#xD;
&#xD;
          -  willingness to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe neurologic, cardiovascular, metabolic, or psychiatric disorders&#xD;
&#xD;
          -  severe visual impairment&#xD;
&#xD;
          -  severe cognitive impairment&#xD;
&#xD;
          -  dementia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bijan Najafi, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Arizona</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Banner Sun Health Research Institute</name>
      <address>
        <city>Sun City</city>
        <state>Arizona</state>
        <zip>85351</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>December 15, 2014</last_update_submitted>
  <last_update_submitted_qc>December 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</mesh_term>
    <mesh_term>Cognition Disorders</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/NCT02214342
org study id: 1401199972
nct id: NCT02214342
lead sponsor: 
collaborator: 
has dmc: No
The aim of the present study is to evaluate an innovative virtual reality-based balance
      training intervention for improving clinically relevant motor performances (balance and gait)
      in people with mild cognitive impairment.

      The investigators hypothesize that the virtual reality-based balance training intervention
      will improve balance and gait performances in people with mild cognitive impairment compared
      to a control group receiving usual care only.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Postural Balance
time frame: 4 weeks
description: Postural Balance during quiet standing for 30 seconds will be assessed using validated wearable sensor technology (BalanSens™)
measure: Gait performance
time frame: 4 weeks
description: Gait performance will be measured using validated wearable sensor technology (LEGSys™)
measure: Cognitive status
time frame: 4 weeks
description: Changes in cognitive status will be measured by the Trail Making Test
measure: Fear of falling
time frame: 4 weeks
description: Fear of falling will be measured by the Falls Efficacy scale international (short form)
measure: User experience
time frame: 4 weeks
description: User experience will be measured using a standardized questionaire
measure: Depressive signs
time frame: 4 weeks
description: Depressive signs will be measured using the Center for Epidemiologic Studies Depression Scale
arm group label: Balance Training
arm group type: Experimental
description: Balance training will be conducted individually two times per week for 4 weeks. Each training session will include virtual reality tasks such as "ankle reaching" and "obstacle crossing" using a virtual obstacle shown on a computer screen. Each session will last 30 - 45 minutes.
arm group label: Control
arm group type: No Intervention
description: The control group will keep their normal activity without receiving any intervention.
intervention type: Other
intervention name: Balance Training
description: Experimental: Balance Training Balance training will be conducted individually two times per week for 4 weeks. Each training session will include virtual reality tasks such as "ankle reaching" and "obstacle crossing" using a virtual obstacle shown on a computer screen. Each session will last 30 - 45 minutes.
arm group label: Balance Training
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Bijan Najafi, PhD
role: Principal Investigator
affiliation: University of Arizona
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cognitive Dysfunction
mesh term: Cognition Disorders