<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/NCT02994199</url>
  </required_header>
  <id_info>
    <org_study_id>F150909002</org_study_id>
    <nct_id>NCT02994199</nct_id>
  </id_info>
  <brief_title>Use of Adapted Controllers for Active Video Gaming in People With Physical Disabilities</brief_title>
  <official_title>Use of Adapted Controllers for Active Video Gaming (Interactive Exercise and Recreation Technologies and Exercise Physiology Benefiting People With Disabilities)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Disability, Independent Living, and Rehabilitation Research</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alabama at Birmingham</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 purpose of this study is to compare the effectiveness of off-the-shelf (OTS) and adapted&#xD;
      game controllers on quality of game play, enjoyment, and energy expenditure during active&#xD;
      video gaming in persons with mobility impairments. The controllers to be evaluated include&#xD;
      off-the-shelf and adapted gaming mats and off-the-shelf and adapted Wii Fit balance boards.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Previous studies have shown that individuals with disabilities have lower levels of physical&#xD;
      activity and fitness and higher levels of obesity compared to their non-disabled peers.&#xD;
      Research has also shown that engaging this population in physical activity can be extremely&#xD;
      challenging due to physical impairments associated with their disability, as well as fewer&#xD;
      opportunities to participate.&#xD;
&#xD;
      Active video games (AVG), also known as exergames, are a category of video games that require&#xD;
      much more body motion for successful play than the traditional pushbutton or joystick&#xD;
      actions. The recent introduction of motion controlled AVGs allow a much greater variety of&#xD;
      physical activity to be part of play. These games hold promise for promoting higher levels of&#xD;
      energy expenditure, weight management and fitness. However, many current AVGs are&#xD;
      inaccessible or offer limited play options for individuals who are unable to stand, have&#xD;
      balance issues, poor motor control, or cannot use their lower body to perform game&#xD;
      activities. Making AVGs accessible to people with disabilities offers an innovative approach&#xD;
      to overcoming various barriers to participation in beneficial physical activity.&#xD;
&#xD;
      A recent publication by Dr. Rimmer in the Physical Medicine and Rehabilitation journal&#xD;
      examining the use of AVGs as a means to increase energy expenditure in non-ambulatory young&#xD;
      adults with disabilities suggested that clinically significant increases in energy&#xD;
      expenditure could be achieved with AVGs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2016</start_date>
  <completion_date type="Actual">December 2021</completion_date>
  <primary_completion_date type="Actual">September 2016</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>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Energy expenditure (ml/kg/min)</measure>
    <time_frame>Visit 1: baseline measurement at rest</time_frame>
    <description>Measured using a portable metabolic system</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Energy expenditure (ml/kg/min)</measure>
    <time_frame>Visit 2: during game play</time_frame>
    <description>Measured using a portable metabolic system</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Energy expenditure (ml/kg/min)</measure>
    <time_frame>Visit 3: during game play</time_frame>
    <description>Measured using a portable metabolic system</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Enjoyment</measure>
    <time_frame>Visit 2: following first game set</time_frame>
    <description>Participants will complete the Physical Activity Enjoyment Scale (PACES)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Enjoyment</measure>
    <time_frame>Visit 2: following second game set</time_frame>
    <description>Participants will complete the Physical Activity Enjoyment Scale (PACES)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Enjoyment</measure>
    <time_frame>Visit 3: following first game set</time_frame>
    <description>Participants will complete the Physical Activity Enjoyment Scale (PACES)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Enjoyment</measure>
    <time_frame>Visit 3: following second game set</time_frame>
    <description>Participants will complete the Physical Activity Enjoyment Scale (PACES)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of game play</measure>
    <time_frame>Visit 2: following first game set</time_frame>
    <description>Subjective evaluation by the tester: degree of general game manipulation in comparison to able-bodied gamer; Likert scale 0 (unable) to 5 (excellent)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of game play</measure>
    <time_frame>Visit 2: following second game set</time_frame>
    <description>Subjective evaluation by the tester: degree of general game manipulation in comparison to able-bodied gamer; Likert scale 0 (unable) to 5 (excellent)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of game play</measure>
    <time_frame>Visit 3: following first game set</time_frame>
    <description>Subjective evaluation by the tester: degree of general game manipulation in comparison to able-bodied gamer; Likert scale 0 (unable) to 5 (excellent)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of game play</measure>
    <time_frame>Visit 3: following second game set</time_frame>
    <description>Subjective evaluation by the tester: degree of general game manipulation in comparison to able-bodied gamer; Likert scale 0 (unable) to 5 (excellent)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Controller usability</measure>
    <time_frame>At the completion of Visit 2</time_frame>
    <description>Participants will complete the System Usability Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Controller usability</measure>
    <time_frame>At the completion of Visit 3</time_frame>
    <description>Participants will complete the System Usability Scale</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">105</enrollment>
  <condition>Physical Disability</condition>
  <arm_group>
    <arm_group_label>Active video gaming</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will engage in active video game play.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Active video gaming</intervention_name>
    <description>Participants will engage in active video game play using two off-the-shelf (OTS) and two adapted controllers using the Wii gaming console. Controllers are: OTS balance board, OTS gaming mat, Adapted balance board, Adapted gaming mat.</description>
    <arm_group_label>Active video gaming</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Potential participants must have a confirmed diagnosis of lower extremity mobility&#xD;
             disability (e.g., spina bifida, cerebral palsy, muscular dystrophy,1 year post spinal&#xD;
             cord injury, multiple sclerosis, stroke, or limb loss) with partial or full use of&#xD;
             upper extremities and use of an assistive device (manual wheelchair, walker, crutches,&#xD;
             or canes) for balance and/or mobility or should have gait deviation.&#xD;
&#xD;
          -  Participants must be between the ages of 10 and 60 yrs, and not weigh more than 350&#xD;
             pounds.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unstable cardiovascular conditions as identified by their physician.&#xD;
&#xD;
          -  Weight over 350 pounds&#xD;
&#xD;
          -  Visual impairment that interferes with playing video games&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sangeetha Padalabalanarayanan, MS</last_name>
    <role>Study Director</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <reference>
    <citation>Malone LA, Padalabalanarayanan S, McCroskey J, Thirumalai M. Assessment of Active Video Gaming Using Adapted Controllers by Individuals With Physical Disabilities: A Protocol. JMIR Res Protoc. 2017 Jun 16;6(6):e116. doi: 10.2196/resprot.7621.</citation>
    <PMID>28623186</PMID>
  </reference>
  <results_reference>
    <citation>Malone LA, Thirumalai M, Padalabalanarayanan S, Neal WN, Bowman S, Mehta T. Energy Expenditure and Enjoyment During Active Video Gaming Using an Adapted Wii Fit Balance Board in Adults with Physical Disabilities: Observational Study. JMIR Serious Games. 2019 Feb 1;7(1):e11326. doi: 10.2196/11326.</citation>
    <PMID>30707098</PMID>
  </results_reference>
  <results_reference>
    <citation>Thirumalai M, Kirkland WB, Misko SR, Padalabalanarayanan S, Malone LA. Adapting the Wii Fit Balance Board to Enable Active Video Game Play by Wheelchair Users: User-Centered Design and Usability Evaluation. JMIR Rehabil Assist Technol. 2018 Mar 6;5(1):e2. doi: 10.2196/rehab.8003.</citation>
    <PMID>29510972</PMID>
  </results_reference>
  <results_reference>
    <citation>Malone LA, Davlyatov GK, Padalabalanarayanan S, Thirumalai M. Active Video Gaming Using an Adapted Gaming Mat in Youth and Adults With Physical Disabilities: Observational Study. JMIR Serious Games. 2021 Aug 26;9(3):e30672. doi: 10.2196/30672.</citation>
    <PMID>34435962</PMID>
  </results_reference>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>January 31, 2022</last_update_submitted>
  <last_update_submitted_qc>January 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Laurie A Malone, PhD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Active video gaming</keyword>
  <keyword>Energy expenditure</keyword>
  <patient_data>
    <sharing_ipd>No</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/NCT02994199
org study id: F150909002
nct id: NCT02994199
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare the effectiveness of off-the-shelf (OTS) and adapted
      game controllers on quality of game play, enjoyment, and energy expenditure during active
      video gaming in persons with mobility impairments. The controllers to be evaluated include
      off-the-shelf and adapted gaming mats and off-the-shelf and adapted Wii Fit balance boards.
Previous studies have shown that individuals with disabilities have lower levels of physical
      activity and fitness and higher levels of obesity compared to their non-disabled peers.
      Research has also shown that engaging this population in physical activity can be extremely
      challenging due to physical impairments associated with their disability, as well as fewer
      opportunities to participate.

      Active video games (AVG), also known as exergames, are a category of video games that require
      much more body motion for successful play than the traditional pushbutton or joystick
      actions. The recent introduction of motion controlled AVGs allow a much greater variety of
      physical activity to be part of play. These games hold promise for promoting higher levels of
      energy expenditure, weight management and fitness. However, many current AVGs are
      inaccessible or offer limited play options for individuals who are unable to stand, have
      balance issues, poor motor control, or cannot use their lower body to perform game
      activities. Making AVGs accessible to people with disabilities offers an innovative approach
      to overcoming various barriers to participation in beneficial physical activity.

      A recent publication by Dr. Rimmer in the Physical Medicine and Rehabilitation journal
      examining the use of AVGs as a means to increase energy expenditure in non-ambulatory young
      adults with disabilities suggested that clinically significant increases in energy
      expenditure could be achieved with AVGs.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Energy expenditure (ml/kg/min)
time frame: Visit 1: baseline measurement at rest
description: Measured using a portable metabolic system
measure: Energy expenditure (ml/kg/min)
time frame: Visit 2: during game play
description: Measured using a portable metabolic system
measure: Energy expenditure (ml/kg/min)
time frame: Visit 3: during game play
description: Measured using a portable metabolic system
measure: Enjoyment
time frame: Visit 2: following first game set
description: Participants will complete the Physical Activity Enjoyment Scale (PACES)
measure: Enjoyment
time frame: Visit 2: following second game set
description: Participants will complete the Physical Activity Enjoyment Scale (PACES)
measure: Enjoyment
time frame: Visit 3: following first game set
description: Participants will complete the Physical Activity Enjoyment Scale (PACES)
measure: Enjoyment
time frame: Visit 3: following second game set
description: Participants will complete the Physical Activity Enjoyment Scale (PACES)
measure: Quality of game play
time frame: Visit 2: following first game set
description: Subjective evaluation by the tester: degree of general game manipulation in comparison to able-bodied gamer; Likert scale 0 (unable) to 5 (excellent)
measure: Quality of game play
time frame: Visit 2: following second game set
description: Subjective evaluation by the tester: degree of general game manipulation in comparison to able-bodied gamer; Likert scale 0 (unable) to 5 (excellent)
measure: Quality of game play
time frame: Visit 3: following first game set
description: Subjective evaluation by the tester: degree of general game manipulation in comparison to able-bodied gamer; Likert scale 0 (unable) to 5 (excellent)
measure: Quality of game play
time frame: Visit 3: following second game set
description: Subjective evaluation by the tester: degree of general game manipulation in comparison to able-bodied gamer; Likert scale 0 (unable) to 5 (excellent)
measure: Controller usability
time frame: At the completion of Visit 2
description: Participants will complete the System Usability Scale
measure: Controller usability
time frame: At the completion of Visit 3
description: Participants will complete the System Usability Scale
arm group label: Active video gaming
arm group type: Experimental
description: Participants will engage in active video game play.
intervention type: Other
intervention name: Active video gaming
description: Participants will engage in active video game play using two off-the-shelf (OTS) and two adapted controllers using the Wii gaming console. Controllers are: OTS balance board, OTS gaming mat, Adapted balance board, Adapted gaming mat.
arm group label: Active video gaming
criteria: 
gender: All
minimum age: 10 Years
maximum age: 60 Years
healthy volunteers: No
last name: Sangeetha Padalabalanarayanan, MS
role: Study Director
affiliation: University of Alabama at Birmingham
citation: Malone LA, Padalabalanarayanan S, McCroskey J, Thirumalai M. Assessment of Active Video Gaming Using Adapted Controllers by Individuals With Physical Disabilities: A Protocol. JMIR Res Protoc. 2017 Jun 16;6(6):e116. doi: 10.2196/resprot.7621.
PMID: 28623186
citation: Malone LA, Thirumalai M, Padalabalanarayanan S, Neal WN, Bowman S, Mehta T. Energy Expenditure and Enjoyment During Active Video Gaming Using an Adapted Wii Fit Balance Board in Adults with Physical Disabilities: Observational Study. JMIR Serious Games. 2019 Feb 1;7(1):e11326. doi: 10.2196/11326.
PMID: 30707098
citation: Thirumalai M, Kirkland WB, Misko SR, Padalabalanarayanan S, Malone LA. Adapting the Wii Fit Balance Board to Enable Active Video Game Play by Wheelchair Users: User-Centered Design and Usability Evaluation. JMIR Rehabil Assist Technol. 2018 Mar 6;5(1):e2. doi: 10.2196/rehab.8003.
PMID: 29510972
citation: Malone LA, Davlyatov GK, Padalabalanarayanan S, Thirumalai M. Active Video Gaming Using an Adapted Gaming Mat in Youth and Adults With Physical Disabilities: Observational Study. JMIR Serious Games. 2021 Aug 26;9(3):e30672. doi: 10.2196/30672.
PMID: 34435962
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Laurie A Malone, PhD
investigator title: Principal Investigator
sharing ipd: No