<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/NCT02252874</url>
  </required_header>
  <id_info>
    <org_study_id>K-ZK 93</org_study_id>
    <nct_id>NCT02252874</nct_id>
  </id_info>
  <brief_title>Can Entertaining Action-video Games Enhance Dynamic Visual Function and Improve Balance? A Randomized Controlled Trial.</brief_title>
  <official_title>Can Entertaining Action-video Games Enhance Dynamic Visual Functions and Improve Balance? A Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hong Kong Polytechnic University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Waterloo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, Berkeley</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Hong Kong Polytechnic University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project is aimed to find out whether action video games can enhance dynamic visual&#xD;
      function and improve balance function in the community-dwelling older adults. It is also&#xD;
      aimed to examine the relationship between dynamic visions and balance functions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Balance control is an important component even in a very simple daily task like walking.&#xD;
      However, as we age, our physical and visual function would gradually deteriorate even in the&#xD;
      absence of health or eye problems. Improving elderly balance control through different&#xD;
      training is one way to prevent falls. In our project, we investigate the use of action video&#xD;
      games, which is easy-to-find and entertaining, as a visual function trainer to improve&#xD;
      balance of older adults.&#xD;
&#xD;
      We hypothesize that the training would show an improvement in both balance and dynamic&#xD;
      vision. Our primary hypothesis is that postural sway in static and dynamic balance measures&#xD;
      will improve after action video-game intervention. For secondary outcome measures, we&#xD;
      hypothesize that the training will improve dynamic visual function (as measured by dynamic&#xD;
      visual acuity and dynamic contrast sensitivity), and visual attention measures (as measured&#xD;
      by useful field of view, multiple object tracking and spatial attention).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">February 2017</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>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Static and dynamic postural sway on forced platform</measure>
    <time_frame>Change from baseline at week 8 and change from baseline at week 16</time_frame>
    <description>Static Balance - postural sway when standing on firm or foam surface.&#xD;
Dynamic Balance:&#xD;
Limits of stability (LOS)&#xD;
Sequential weight shifting test (SWS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Grating visual acuity at different moving speeds</measure>
    <time_frame>Change from baseline at week 8 and change from baseline at week 16</time_frame>
    <description>Dynamic visual function measure - Grating visual acuity is measured with different moving speeds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Useful Field of View (UFOV)</measure>
    <time_frame>Change from baseline at week 8 and change from baseline at week 16</time_frame>
    <description>One of the visual attention measures - Useful Field of View (UFOV)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multiple tracking objects (MOT)</measure>
    <time_frame>Change from baseline at week 8 and change from baseline at week 16</time_frame>
    <description>One of the visual attention measures - Multiple tracking objects (MOT)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">160</enrollment>
  <condition>Vision, Balance and Falls in Older Adults</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Receive leisure activities (e.g. reading, web-surfing, playing chess/ Mahjong) Twenty hours (2-3 sessions per week, 1.5 hours per session)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention Group 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Receive slow motion Nintendo Wii video games Twenty hours ( 2-3 sessions per week, 1.5 hours per session)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention Group 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Receive fast motion Nintendo Wii video games (e.g. shooting game) Twenty hours ( 2-3 sessions per week, 1.5 hours per session)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Slow-paced action video game</intervention_name>
    <description>20 hours slow-paced action video games</description>
    <arm_group_label>Intervention Group 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Fast-paced action video game</intervention_name>
    <description>20 hours fast-paced action video games</description>
    <arm_group_label>Intervention Group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>20 hours leisure activities</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ability to understand and speak Cantonese&#xD;
&#xD;
          -  No formal training or regular practice of balance function (e.g. Tai-chi)&#xD;
&#xD;
          -  Little and preferably no video-game experience&#xD;
&#xD;
          -  Best corrected distance acuity of 0.2 logMAR or better&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any diagnosed ocular diseases and ocular-motor abnormalities&#xD;
&#xD;
          -  Suffering form severe medical problems or self reported neurological or cognitive&#xD;
             disorders&#xD;
&#xD;
          -  Suffering from physical impairments or physical limitations restricting them from&#xD;
             training&#xD;
&#xD;
          -  Having self reported vestibular or cerebellar dysfunction, history of vertigo or&#xD;
             severe hearing loss&#xD;
&#xD;
          -  Suffering from crippling arthritis, or a recent fracture of lower limb&#xD;
&#xD;
          -  Planned major surgery during the trial&#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>
  <overall_official>
    <last_name>Allen MY Cheong, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Hong Kong Polytechnic University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Allen MY Cheong</name>
      <address>
        <city>Hong Kong</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 30, 2014</study_first_posted>
  <last_update_submitted>February 22, 2018</last_update_submitted>
  <last_update_submitted_qc>February 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hong Kong Polytechnic University</investigator_affiliation>
    <investigator_full_name>Allen MY Cheong</investigator_full_name>
    <investigator_title>Phd, Assistant Professor, School of Optometry</investigator_title>
  </responsible_party>
  <keyword>balance</keyword>
  <keyword>visual function</keyword>
  <keyword>community-dwelling older adults</keyword>
  <keyword>action video-game</keyword>
  <!-- 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/NCT02252874
org study id: K-ZK 93
nct id: NCT02252874
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This project is aimed to find out whether action video games can enhance dynamic visual
      function and improve balance function in the community-dwelling older adults. It is also
      aimed to examine the relationship between dynamic visions and balance functions.
Balance control is an important component even in a very simple daily task like walking.
      However, as we age, our physical and visual function would gradually deteriorate even in the
      absence of health or eye problems. Improving elderly balance control through different
      training is one way to prevent falls. In our project, we investigate the use of action video
      games, which is easy-to-find and entertaining, as a visual function trainer to improve
      balance of older adults.

      We hypothesize that the training would show an improvement in both balance and dynamic
      vision. Our primary hypothesis is that postural sway in static and dynamic balance measures
      will improve after action video-game intervention. For secondary outcome measures, we
      hypothesize that the training will improve dynamic visual function (as measured by dynamic
      visual acuity and dynamic contrast sensitivity), and visual attention measures (as measured
      by useful field of view, multiple object tracking and spatial attention).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Static and dynamic postural sway on forced platform
time frame: Change from baseline at week 8 and change from baseline at week 16
description: Static Balance - postural sway when standing on firm or foam surface.
Dynamic Balance:
Limits of stability (LOS)
Sequential weight shifting test (SWS)
measure: Grating visual acuity at different moving speeds
time frame: Change from baseline at week 8 and change from baseline at week 16
description: Dynamic visual function measure - Grating visual acuity is measured with different moving speeds
measure: Useful Field of View (UFOV)
time frame: Change from baseline at week 8 and change from baseline at week 16
description: One of the visual attention measures - Useful Field of View (UFOV)
measure: Multiple tracking objects (MOT)
time frame: Change from baseline at week 8 and change from baseline at week 16
description: One of the visual attention measures - Multiple tracking objects (MOT)
arm group label: Control Group
arm group type: Placebo Comparator
description: Receive leisure activities (e.g. reading, web-surfing, playing chess/ Mahjong) Twenty hours (2-3 sessions per week, 1.5 hours per session)
arm group label: Intervention Group 1
arm group type: Active Comparator
description: Receive slow motion Nintendo Wii video games Twenty hours ( 2-3 sessions per week, 1.5 hours per session)
arm group label: Intervention Group 2
arm group type: Active Comparator
description: Receive fast motion Nintendo Wii video games (e.g. shooting game) Twenty hours ( 2-3 sessions per week, 1.5 hours per session)
intervention type: Behavioral
intervention name: Slow-paced action video game
description: 20 hours slow-paced action video games
arm group label: Intervention Group 1
intervention type: Behavioral
intervention name: Fast-paced action video game
description: 20 hours fast-paced action video games
arm group label: Intervention Group 2
intervention type: Behavioral
intervention name: Control
description: 20 hours leisure activities
arm group label: Control Group
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Allen MY Cheong, PhD
role: Principal Investigator
affiliation: The Hong Kong Polytechnic University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: The Hong Kong Polytechnic University
investigator full name: Allen MY Cheong
investigator title: Phd, Assistant Professor, School of Optometry