<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/NCT02990507</url>
  </required_header>
  <id_info>
    <org_study_id>123UAB</org_study_id>
    <nct_id>NCT02990507</nct_id>
  </id_info>
  <brief_title>Advanced Virtual Exercise Environment Device for Use by Persons With Physical Disabilities</brief_title>
  <acronym>AVEED</acronym>
  <official_title>Evaluation of an Advanced Virtual Exercise Environment Device (AVEED) for Use by Persons With Physical 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>
      An Advanced Virtual Exercise Environment Device (AVEED) has been developed that incorporates&#xD;
      arm and leg ergometers in conjunction with a virtual reality interface. The purpose of this&#xD;
      study is to examine participant perspectives regarding the virtual interface and exercise&#xD;
      device combination with regard to usability, comfort, safety, rating of perceived exertion,&#xD;
      and enjoyment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Individuals with physical disabilities show much lower rates of exercise participation than&#xD;
      their able-bodied peers (Boslaugh et al. 2006, Preventing Chronic Disease). Much of the&#xD;
      reason for the low rates of activity among this population come from the presence of&#xD;
      barriers. Lack of motivation, lack of transportation, lack of accessible facilities and&#xD;
      equipment, and cost are all factors that discourage exercise participation among those with&#xD;
      disabilities (Rimmer et al. 2008, JRRD; Barfield and Malone 2013, JRRD). Based on these&#xD;
      factors, there is a need for accessible enjoyable exercise options for people with physical&#xD;
      disabilities. The AVEED is comprised of an ergometer with foot and hand pedals, and a visual&#xD;
      display in front of the user that can show a variety of scenic pathways.&#xD;
&#xD;
      The AVEED builds on previous work that demonstrates the potential benefit of interactive&#xD;
      exercise for those with physical disabilities. The present study will establish the potential&#xD;
      of this device to provide an engaging moderate intensity exercise opportunity for persons&#xD;
      with disabilities.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 10, 2017</start_date>
  <completion_date type="Actual">May 19, 2017</completion_date>
  <primary_completion_date type="Actual">May 19, 2017</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>Participant feedback</measure>
    <time_frame>2 days (approximately 48 hours) after enrolling</time_frame>
    <description>Likert-style questions regarding ease of use, comfort, safety, and enjoyment related to using the device. Other questions will ask participants to compare the device with virtual interface to the device without the interface, as well as the likelihood of using their using the device if they had access to one.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Exercise intensity</measure>
    <time_frame>2 days (approximately 48 hours) after enrolling</time_frame>
    <description>Percent heart rate reserve (%HRR) is a measure of exercise intensity and is calculated as (HR - HRrest)/(HRmax - HRrest). Maximum HR can be estimated using the Karvonen formula which states HRmax = 220 - age. The participant's HR will be monitored in real time via a Bluetooth enabled device strapped to the chest. The goal is for the participant to input energy into the AVEED system and maintain a rate that produces a HRR of approximately 60%. Exercising at a rate of 60% of their age-predicted HRR, would establish them within the range of intensity for cardiovascular improvement. Verbal cues will be provided to ensure participants stay between 50-70% of HRR. If the participant is unable to sustain this intensity they will be allowed to rest for 1-2 minutes and then start again. Data recorded by the system will include continuous HR and energy output (watts).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body orientation</measure>
    <time_frame>2 days (approximately 48 hours) after enrolling</time_frame>
    <description>Video recordings will be used to assess how the participant's body is oriented in relation to the ergometer and their ease of use in rotating the cranks under the different conditions. the video will be scored using a 3 point likert scale: 1 being very poor body orientation to 3 being excellent orientation.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Physically Disabled</condition>
  <arm_group>
    <arm_group_label>AVEED</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AVEED is composed of arm and leg cranks that can be used independently or together with a virtual exercise environment (VEE). Participants rotate arm and/or leg cranks under 4 conditions for 5 min each with a 5 min rest between: 1) Arm rotation with VEE, while sitting or standing (AVEED: Arm rotation, video display); 2) Arm rotation without VEE, while sitting or standing (AVEED: Arm rotation, without video display); 3) Leg rotation with arm-energy input to assist the legs with VEE, while sitting (AVEED: Leg rotation, arm-energy input, video display); 4) Leg rotation with arm-energy input to assist the legs without VEE, while sitting (AVEED: Leg rotation, arm-energy input, without video display). VEE controlled with voice commands, leaning, or keyboard buttons.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>AVEED: Arm rotation, video display</intervention_name>
    <description>Participants rotate arm cranks for 5 minutes then rest for 5 minutes.</description>
    <arm_group_label>AVEED</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>AVEED: Arm rotation, without video display</intervention_name>
    <description>Participants rotate arm cranks for 5 minutes then rest for 5 minutes.</description>
    <arm_group_label>AVEED</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>AVEED: Leg rotation, arm-energy input, video display</intervention_name>
    <description>Participants rotate leg cranks for 5 minutes then rest for 5 minutes.</description>
    <arm_group_label>AVEED</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>AVEED: Leg rotation, arm-energy input, without video display</intervention_name>
    <description>Participants rotate leg cranks for 5 minutes then rest for 5 minutes.</description>
    <arm_group_label>AVEED</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Greater than 18 years old&#xD;
&#xD;
          -  Mobility impairment, able to push a manual wheelchair&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals without a disability&#xD;
&#xD;
          -  Individuals with vision loss that prevents them from seeing video elements on the&#xD;
             screen&#xD;
&#xD;
          -  Individuals with unstable cardiovascular conditions&#xD;
&#xD;
          -  Individuals unable to push a manual wheelchair&#xD;
&#xD;
          -  Individuals unable to understand study directions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</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>
  <location>
    <facility>
      <name>Univerisity of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>June 15, 2018</last_update_submitted>
  <last_update_submitted_qc>June 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2018</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>mobility impairment</keyword>
  <keyword>virtual environment</keyword>
  <keyword>exercise</keyword>
  <keyword>physical activity</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methyltestosterone</mesh_term>
    <mesh_term>Testosterone 17 beta-cypionate</mesh_term>
    <mesh_term>Testosterone</mesh_term>
    <mesh_term>Testosterone undecanoate</mesh_term>
    <mesh_term>Testosterone enanthate</mesh_term>
  </intervention_browse>
  <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/NCT02990507
org study id: 123UAB
nct id: NCT02990507
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
An Advanced Virtual Exercise Environment Device (AVEED) has been developed that incorporates
      arm and leg ergometers in conjunction with a virtual reality interface. The purpose of this
      study is to examine participant perspectives regarding the virtual interface and exercise
      device combination with regard to usability, comfort, safety, rating of perceived exertion,
      and enjoyment.
Individuals with physical disabilities show much lower rates of exercise participation than
      their able-bodied peers (Boslaugh et al. 2006, Preventing Chronic Disease). Much of the
      reason for the low rates of activity among this population come from the presence of
      barriers. Lack of motivation, lack of transportation, lack of accessible facilities and
      equipment, and cost are all factors that discourage exercise participation among those with
      disabilities (Rimmer et al. 2008, JRRD; Barfield and Malone 2013, JRRD). Based on these
      factors, there is a need for accessible enjoyable exercise options for people with physical
      disabilities. The AVEED is comprised of an ergometer with foot and hand pedals, and a visual
      display in front of the user that can show a variety of scenic pathways.

      The AVEED builds on previous work that demonstrates the potential benefit of interactive
      exercise for those with physical disabilities. The present study will establish the potential
      of this device to provide an engaging moderate intensity exercise opportunity for persons
      with disabilities.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Participant feedback
time frame: 2 days (approximately 48 hours) after enrolling
description: Likert-style questions regarding ease of use, comfort, safety, and enjoyment related to using the device. Other questions will ask participants to compare the device with virtual interface to the device without the interface, as well as the likelihood of using their using the device if they had access to one.
measure: Exercise intensity
time frame: 2 days (approximately 48 hours) after enrolling
description: Percent heart rate reserve (%HRR) is a measure of exercise intensity and is calculated as (HR - HRrest)/(HRmax - HRrest). Maximum HR can be estimated using the Karvonen formula which states HRmax = 220 - age. The participant's HR will be monitored in real time via a Bluetooth enabled device strapped to the chest. The goal is for the participant to input energy into the AVEED system and maintain a rate that produces a HRR of approximately 60%. Exercising at a rate of 60% of their age-predicted HRR, would establish them within the range of intensity for cardiovascular improvement. Verbal cues will be provided to ensure participants stay between 50-70% of HRR. If the participant is unable to sustain this intensity they will be allowed to rest for 1-2 minutes and then start again. Data recorded by the system will include continuous HR and energy output (watts).
measure: Body orientation
time frame: 2 days (approximately 48 hours) after enrolling
description: Video recordings will be used to assess how the participant's body is oriented in relation to the ergometer and their ease of use in rotating the cranks under the different conditions. the video will be scored using a 3 point likert scale: 1 being very poor body orientation to 3 being excellent orientation.
arm group label: AVEED
arm group type: Experimental
description: AVEED is composed of arm and leg cranks that can be used independently or together with a virtual exercise environment (VEE). Participants rotate arm and/or leg cranks under 4 conditions for 5 min each with a 5 min rest between: 1) Arm rotation with VEE, while sitting or standing (AVEED: Arm rotation, video display); 2) Arm rotation without VEE, while sitting or standing (AVEED: Arm rotation, without video display); 3) Leg rotation with arm-energy input to assist the legs with VEE, while sitting (AVEED: Leg rotation, arm-energy input, video display); 4) Leg rotation with arm-energy input to assist the legs without VEE, while sitting (AVEED: Leg rotation, arm-energy input, without video display). VEE controlled with voice commands, leaning, or keyboard buttons.
intervention type: Other
intervention name: AVEED: Arm rotation, video display
description: Participants rotate arm cranks for 5 minutes then rest for 5 minutes.
arm group label: AVEED
intervention type: Other
intervention name: AVEED: Arm rotation, without video display
description: Participants rotate arm cranks for 5 minutes then rest for 5 minutes.
arm group label: AVEED
intervention type: Other
intervention name: AVEED: Leg rotation, arm-energy input, video display
description: Participants rotate leg cranks for 5 minutes then rest for 5 minutes.
arm group label: AVEED
intervention type: Other
intervention name: AVEED: Leg rotation, arm-energy input, without video display
description: Participants rotate leg cranks for 5 minutes then rest for 5 minutes.
arm group label: AVEED
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sangeetha Padalabalanarayanan, MS
role: Study Director
affiliation: University of Alabama at Birmingham
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Laurie A Malone, PhD
investigator title: Principal Investigator
mesh term: Methyltestosterone
mesh term: Testosterone 17 beta-cypionate
mesh term: Testosterone
mesh term: Testosterone undecanoate
mesh term: Testosterone enanthate
sharing ipd: No