<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/NCT04402034</url>
  </required_header>
  <id_info>
    <org_study_id>03851012.7.0000.5390</org_study_id>
    <nct_id>NCT04402034</nct_id>
  </id_info>
  <brief_title>Telerehabilitation in Disabled People: Proposal for Practical Intervention With Virtual Reality</brief_title>
  <official_title>Telerehabilitation in Disabled People: Proposal for Practical Intervention With Virtual Reality</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</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>
      This is a cross-sectional study, that is going to be conducted during the quarantine, period&#xD;
      established by the state of São Paulo to reduce the transmission of COVID-19, between March&#xD;
      24 2020 and May 31 2020. Thus, the differential of this study is to use 100%&#xD;
      telerehabilitation, in which the rehabilitation team and participants only had telephone&#xD;
      contact, communication application (WhatsApp) and software interaction. 40 participants will&#xD;
      be included. Potential and interested volunteers will be assessed by a detailed screening&#xD;
      using the eligibility criteria and attended an initial selection for enrolment in the study.&#xD;
      It wiil be used a platform called MoveHero, available for free use in&#xD;
      https://movehero.com.br/. The individual needs access the internet, and once he gets online,&#xD;
      he had to create his own account, inserting his name, email and creating a password.&#xD;
      Considering that the platform presents different levels of difficulty, after the participant&#xD;
      is connected to the platform, the researcher directed the participant to the protocol bespoke&#xD;
      for each participant, playing 3 rounds of the game for 5 minutes each (total of 15 minutes).&#xD;
      During the intervention, it will be applied BORG scale in order to assess their perceived&#xD;
      effort.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Instrument In this study, it will be used a platform called MoveHero, available for free use&#xD;
      in https://movehero.com.br/. The individual needs access the internet, and once he gets&#xD;
      online, he had to create his own account, inserting his name, email and creating a password.&#xD;
      Considering that the platform presents different levels of difficulty, after the participant&#xD;
      is connected to the platform, the researcher directed the participant to the protocol&#xD;
      specially developed for cerebral palsy. MoveHero is considerate a timing coincident task and&#xD;
      present several spheres falling down on the computer screen, with a musical rhythm to&#xD;
      increase engagement. Thus, the participants will be positioned in front of a computer and&#xD;
      when the game started the webcam captures the participant movements and a representation of&#xD;
      the players appears on the computer screen as an avatar. The game goals are to intercept all&#xD;
      falling spheres using upper limb wave movements in the exact moment the spheres reached their&#xD;
      specific target in the bottom of computer screen. The game presented four columns with fixed&#xD;
      targets in parallel allocated in two height levels (e.g. two on the left - targets A and B;&#xD;
      two on the right - targets C and D). The game provides hit and miss feedback - if the&#xD;
      individual reaches the spheres correctly, the game presented a feedback with the spheres&#xD;
      changing the color for green (hit information). On the other hand, if the participant do not&#xD;
      touch the spheres properly, the spheres changing the color for red and the letter X appears&#xD;
      inside the target (miss information).&#xD;
&#xD;
      Software score During the game match (each game match lasts for 5 minutes) the participant&#xD;
      can follow the score determined by the number of spheres hit (i.e. the information from each&#xD;
      sphere hit appears in the bottom left side of the screen all the time) and at the end of each&#xD;
      game match the participant had feedback with their total score (when the game match finished&#xD;
      a total score appears in the middle of the computer screen). The game features 10 different&#xD;
      and progressive phases of difficulty, considering the number of balls falling. In this study,&#xD;
      all participants will start at the easiest phase (phase 1) and according to their own score,&#xD;
      the researcher should move forward to a more difficult phase. The progression in the phase&#xD;
      was established by the table below. Thus, each participant presents an individual&#xD;
      progression, considering their performance.&#xD;
&#xD;
      Assessments&#xD;
&#xD;
      To characterize the participants it will be used some scales that characterize each disease&#xD;
      and can be applied such as Pediatric Evaluation of Disability Inventory (PEDI) for children&#xD;
      and Quality of Life and specific scales for adults. As well as sociodemographic Information:&#xD;
      some questions will be asked, such as age, sex, income to understand the studied population.&#xD;
&#xD;
      To analyse the outcome Measures will be used: 1) Brunel Mood Scale (BRUMS) measures six&#xD;
      identifiable affective states (Tension, Depression, Anger, Vigor, Fatigue, and Confusion)&#xD;
      through a 24-item self-report inventory, with respondents rating a list of adjectives on a&#xD;
      5-point Likert scale ranging from 0 (not at all) to 4 (extremely), based on subjective&#xD;
      feelings. The instructions refer to how participants have been feeling in the past week,&#xD;
      including today. 2) BORG scale: is Rating of Perceived Exertion used to measure the&#xD;
      subjective intensity of effort. It is based on the sensations felt during exercise, such as&#xD;
      muscle fatigue, increased heart rate and increased breathing. 3) System Usability Scale&#xD;
      (SUS), was proposed by John Brooke in 1986 as the usability test tool. It is a simple scale&#xD;
      based on a questionnaire and has been widely adopted in product usability evaluations. The&#xD;
      statements cover a variety of aspects of system usability such as the need for support,&#xD;
      training, and complexity, and thus have a high level of face validity for measuring usability&#xD;
      of a system. The SUS instrument is generally used after the respondent has had an opportunity&#xD;
      to use the system being evaluated. This instrument is a highly robust and versatile tool for&#xD;
      usability professionals.&#xD;
&#xD;
      1.5 Procedure and Design&#xD;
&#xD;
      Contact and assessment scales&#xD;
&#xD;
      The parent's individuals (for children) or the individual itself will be contacted by phone&#xD;
      and asked to perform the task at home, they will be assisted by the researcher over the&#xD;
      phone, with a video call. Important to emphasized that all participants that need assistance,&#xD;
      will be assisted by their parents or their caregivers. First, they wiil receive a link with&#xD;
      research information and the assent and consent form to fill out and the inclusion criteria&#xD;
      will be checked by researcher. When they agree to participate, a link to access a questioner&#xD;
      will be sent with Brunel Mood Scale, BORG scale, PEDI and Sociodemographic Information. When&#xD;
      parents and participants finish those scales the gaming platform will be accessed and the&#xD;
      participant starts the protocol practice.&#xD;
&#xD;
      Practicing the task&#xD;
&#xD;
      Participants will perform the task individually in their own house with a family member&#xD;
      helping and giving support during all protocol. The researcher contacts the family member and&#xD;
      gives the following instructions using videocall (research interact with the family member&#xD;
      and the participant during all the protocol): 1) place the computer on a table and login to&#xD;
      the platform; 2) position the cell phone (to provide videocall) on the side of the computer&#xD;
      to receive instructions; 3) provide a comfortable sitting position in a chair (individual&#xD;
      should be positioned at a distance of approximately 1.5 m meters from the computer monitor)&#xD;
      and adjusted in height according to the needs of the individual (if applicable, participants&#xD;
      could use their own wheelchair); 4) after being seated and connected to the platform the&#xD;
      research will explain the task verbally for all participants and ask the family member to&#xD;
      play ones (demonstrations of how to perform the coincidence timing was given form the family&#xD;
      member during two minutes); 5) after demonstration, the family member should grab the mobile&#xD;
      phone (to have the opportunity to move the phone and show the participant performance to the&#xD;
      researcher during all the protocol) and 6) thus, the therapist (by video call) instructed the&#xD;
      participant to stay still and wait the first sphere appears on the screen. Once the first&#xD;
      sphere appears, the individual had to move his or her hand to either touch the sphere exactly&#xD;
      at the moment coinciding with the bottom target and the game should move on with different&#xD;
      spheres falling in the computer screen.&#xD;
&#xD;
      Protocol&#xD;
&#xD;
      As presented before the parent and participant should answer 4 assessments (Brunel Mood&#xD;
      Scale, BORG scale, PEDI and Demographic Information), and start to perform the first game&#xD;
      phase (phase 1), after 5 minutes playing the game the participant will answer the Borg scale&#xD;
      and researcher will analyze the game score (e.g. according to table 2 the participant should&#xD;
      repeat phase one or move forward for a more difficult phase); the participant started a&#xD;
      second practice and after 5 minutes answer the Borg scale (again- the participant should&#xD;
      repeat last phase or move forward for a more difficult phase); the participant started a&#xD;
      third and last practice and after 5 minutes had to answer the Borg scale and to finish the&#xD;
      protocol the BRUMS scale and the System Usability Scale (SUS).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 15, 2020</start_date>
  <completion_date type="Actual">October 21, 2020</completion_date>
  <primary_completion_date type="Actual">October 20, 2020</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Motor performance.</measure>
    <time_frame>1 day</time_frame>
    <description>The motor performance will be measured by the virtual game &quot;MoveHero&quot;, which gives data about accuracy, precision and directional trend of movement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Perceived Exertion.</measure>
    <time_frame>1 day.</time_frame>
    <description>The Perceived Exertion will me assessed by the Borg Rating of Perceived Exertion (RPE), based on a 6 to 20 rating scale, in which a rating of 6 perceiving &quot;no exertion at all&quot; to 20 perceiving a &quot;maximal exertion&quot; of effort.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Disability Physical</condition>
  <arm_group>
    <arm_group_label>Application of tele-rehabilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individuals that will perform the protocol of virtual reality intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Application of tele-rehabilitation</intervention_name>
    <description>Individuals that will perform the virtual reality intervention.</description>
    <arm_group_label>Application of tele-rehabilitation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  agreement to participate&#xD;
&#xD;
          -  clinical diagnosis of the disease&#xD;
&#xD;
          -  age ranging from 7 to 80 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  do not understand the tasks&#xD;
&#xD;
          -  motor difficulties that impede the completing of the virtual tasks&#xD;
&#xD;
          -  do not have technology devices to perform the virtual task (computer) or to contact&#xD;
             the researcher (cell phone or a second computer)&#xD;
&#xD;
          -  was precluded from completing the task due to some technological failure (such as&#xD;
             internet crash).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Carlos BM Monteiro, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Sao Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Escola de Artes,Ciencias e Humanidades da Universidade d Sao Paulo</name>
      <address>
        <city>Sao Paulo</city>
        <zip>03828-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>October 22, 2020</last_update_submitted>
  <last_update_submitted_qc>October 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Carlos Bandeira de Mello Monteiro</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Disability Physical</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/NCT04402034
org study id: 03851012.7.0000.5390
nct id: NCT04402034
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a cross-sectional study, that is going to be conducted during the quarantine, period
      established by the state of São Paulo to reduce the transmission of COVID-19, between March
      24 2020 and May 31 2020. Thus, the differential of this study is to use 100%
      telerehabilitation, in which the rehabilitation team and participants only had telephone
      contact, communication application (WhatsApp) and software interaction. 40 participants will
      be included. Potential and interested volunteers will be assessed by a detailed screening
      using the eligibility criteria and attended an initial selection for enrolment in the study.
      It wiil be used a platform called MoveHero, available for free use in
      https://movehero.com.br/. The individual needs access the internet, and once he gets online,
      he had to create his own account, inserting his name, email and creating a password.
      Considering that the platform presents different levels of difficulty, after the participant
      is connected to the platform, the researcher directed the participant to the protocol bespoke
      for each participant, playing 3 rounds of the game for 5 minutes each (total of 15 minutes).
      During the intervention, it will be applied BORG scale in order to assess their perceived
      effort.
Instrument In this study, it will be used a platform called MoveHero, available for free use
      in https://movehero.com.br/. The individual needs access the internet, and once he gets
      online, he had to create his own account, inserting his name, email and creating a password.
      Considering that the platform presents different levels of difficulty, after the participant
      is connected to the platform, the researcher directed the participant to the protocol
      specially developed for cerebral palsy. MoveHero is considerate a timing coincident task and
      present several spheres falling down on the computer screen, with a musical rhythm to
      increase engagement. Thus, the participants will be positioned in front of a computer and
      when the game started the webcam captures the participant movements and a representation of
      the players appears on the computer screen as an avatar. The game goals are to intercept all
      falling spheres using upper limb wave movements in the exact moment the spheres reached their
      specific target in the bottom of computer screen. The game presented four columns with fixed
      targets in parallel allocated in two height levels (e.g. two on the left - targets A and B;
      two on the right - targets C and D). The game provides hit and miss feedback - if the
      individual reaches the spheres correctly, the game presented a feedback with the spheres
      changing the color for green (hit information). On the other hand, if the participant do not
      touch the spheres properly, the spheres changing the color for red and the letter X appears
      inside the target (miss information).

      Software score During the game match (each game match lasts for 5 minutes) the participant
      can follow the score determined by the number of spheres hit (i.e. the information from each
      sphere hit appears in the bottom left side of the screen all the time) and at the end of each
      game match the participant had feedback with their total score (when the game match finished
      a total score appears in the middle of the computer screen). The game features 10 different
      and progressive phases of difficulty, considering the number of balls falling. In this study,
      all participants will start at the easiest phase (phase 1) and according to their own score,
      the researcher should move forward to a more difficult phase. The progression in the phase
      was established by the table below. Thus, each participant presents an individual
      progression, considering their performance.

      Assessments

      To characterize the participants it will be used some scales that characterize each disease
      and can be applied such as Pediatric Evaluation of Disability Inventory (PEDI) for children
      and Quality of Life and specific scales for adults. As well as sociodemographic Information:
      some questions will be asked, such as age, sex, income to understand the studied population.

      To analyse the outcome Measures will be used: 1) Brunel Mood Scale (BRUMS) measures six
      identifiable affective states (Tension, Depression, Anger, Vigor, Fatigue, and Confusion)
      through a 24-item self-report inventory, with respondents rating a list of adjectives on a
      5-point Likert scale ranging from 0 (not at all) to 4 (extremely), based on subjective
      feelings. The instructions refer to how participants have been feeling in the past week,
      including today. 2) BORG scale: is Rating of Perceived Exertion used to measure the
      subjective intensity of effort. It is based on the sensations felt during exercise, such as
      muscle fatigue, increased heart rate and increased breathing. 3) System Usability Scale
      (SUS), was proposed by John Brooke in 1986 as the usability test tool. It is a simple scale
      based on a questionnaire and has been widely adopted in product usability evaluations. The
      statements cover a variety of aspects of system usability such as the need for support,
      training, and complexity, and thus have a high level of face validity for measuring usability
      of a system. The SUS instrument is generally used after the respondent has had an opportunity
      to use the system being evaluated. This instrument is a highly robust and versatile tool for
      usability professionals.

      1.5 Procedure and Design

      Contact and assessment scales

      The parent's individuals (for children) or the individual itself will be contacted by phone
      and asked to perform the task at home, they will be assisted by the researcher over the
      phone, with a video call. Important to emphasized that all participants that need assistance,
      will be assisted by their parents or their caregivers. First, they wiil receive a link with
      research information and the assent and consent form to fill out and the inclusion criteria
      will be checked by researcher. When they agree to participate, a link to access a questioner
      will be sent with Brunel Mood Scale, BORG scale, PEDI and Sociodemographic Information. When
      parents and participants finish those scales the gaming platform will be accessed and the
      participant starts the protocol practice.

      Practicing the task

      Participants will perform the task individually in their own house with a family member
      helping and giving support during all protocol. The researcher contacts the family member and
      gives the following instructions using videocall (research interact with the family member
      and the participant during all the protocol): 1) place the computer on a table and login to
      the platform; 2) position the cell phone (to provide videocall) on the side of the computer
      to receive instructions; 3) provide a comfortable sitting position in a chair (individual
      should be positioned at a distance of approximately 1.5 m meters from the computer monitor)
      and adjusted in height according to the needs of the individual (if applicable, participants
      could use their own wheelchair); 4) after being seated and connected to the platform the
      research will explain the task verbally for all participants and ask the family member to
      play ones (demonstrations of how to perform the coincidence timing was given form the family
      member during two minutes); 5) after demonstration, the family member should grab the mobile
      phone (to have the opportunity to move the phone and show the participant performance to the
      researcher during all the protocol) and 6) thus, the therapist (by video call) instructed the
      participant to stay still and wait the first sphere appears on the screen. Once the first
      sphere appears, the individual had to move his or her hand to either touch the sphere exactly
      at the moment coinciding with the bottom target and the game should move on with different
      spheres falling in the computer screen.

      Protocol

      As presented before the parent and participant should answer 4 assessments (Brunel Mood
      Scale, BORG scale, PEDI and Demographic Information), and start to perform the first game
      phase (phase 1), after 5 minutes playing the game the participant will answer the Borg scale
      and researcher will analyze the game score (e.g. according to table 2 the participant should
      repeat phase one or move forward for a more difficult phase); the participant started a
      second practice and after 5 minutes answer the Borg scale (again- the participant should
      repeat last phase or move forward for a more difficult phase); the participant started a
      third and last practice and after 5 minutes had to answer the Borg scale and to finish the
      protocol the BRUMS scale and the System Usability Scale (SUS).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Motor performance.
time frame: 1 day
description: The motor performance will be measured by the virtual game "MoveHero", which gives data about accuracy, precision and directional trend of movement.
measure: Perceived Exertion.
time frame: 1 day.
description: The Perceived Exertion will me assessed by the Borg Rating of Perceived Exertion (RPE), based on a 6 to 20 rating scale, in which a rating of 6 perceiving "no exertion at all" to 20 perceiving a "maximal exertion" of effort.
arm group label: Application of tele-rehabilitation
arm group type: Experimental
description: Individuals that will perform the protocol of virtual reality intervention.
intervention type: Behavioral
intervention name: Application of tele-rehabilitation
description: Individuals that will perform the virtual reality intervention.
arm group label: Application of tele-rehabilitation
criteria: 
gender: All
minimum age: 7 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Carlos BM Monteiro, PhD
role: Principal Investigator
affiliation: University of Sao Paulo
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Carlos Bandeira de Mello Monteiro
investigator title: Associate Professor
sharing ipd: No