<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/NCT03227601</url>
  </required_header>
  <id_info>
    <org_study_id>1808</org_study_id>
    <nct_id>NCT03227601</nct_id>
  </id_info>
  <brief_title>Effect of a Posture Adapter for 12 to 24-month Children With Zyka Virus Syndrome</brief_title>
  <official_title>Effect of a Posture Adapter Use on Body Alignment in Standing Position on Children Between 12 and 24 Months Old With Zyka Virys Congenital Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal de Pernambuco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal de Pernambuco</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Congenital Zika virus syndrome (SCZv) has been gaining attention in studies due to changes in&#xD;
      the central nervous system and in the motor development of children. These changes resulted&#xD;
      in an unexpected picture and without future predictability, with the appearance of several&#xD;
      functional impairments and also on orthostatic posture. In this context, the protocol of&#xD;
      orthostatism proposed here is a 10-week program of the use of a postural adjuster, the&#xD;
      standing frame, made of its own with alternative material to the commercial models&#xD;
      (cardboard). The use of low cost materials allows these devices to be made in the desired&#xD;
      size without cost high, individually adapted, easy to be transported as it is light and can&#xD;
      still be colored. It is an equipment that offers the opportunity to experience the&#xD;
      orthostatic posture and mainly benefits children with little economic resources that enable&#xD;
      the acquisition of traditional devices made of iron or wood and even imported equipment. The&#xD;
      postural adjuster allows physical and sensorial opportunity, being an auxiliary resource in&#xD;
      standing positioning, feasible for home use, besides being useful for performing functional&#xD;
      activities. Thus, the objective will be to analyze the repercussions of the use of the&#xD;
      standing frame on body alignment, muscle tone, gross motor function and gastrointestinal&#xD;
      functions of children with SCZv. An uncontrolled intervention study will be conducted with&#xD;
      children between 12 and 24 months of age, who will undergo an evaluation before use and after&#xD;
      the use of the adjunct along with the proposed orthostatism protocol. The postural alignment&#xD;
      will be evaluated through photogrammetry and the evaluation of muscle tone will be performed&#xD;
      through the modified Tardieu scale. The Gross Motor Function Measure (GMFM) scale will be&#xD;
      used to assess the gross motor function of the children involved in the study. Questionnaires&#xD;
      will be applied for the collection of maternal socio-demographic data, the child's data, the&#xD;
      type and time of therapy that the child already participates, and the gastrointestinal&#xD;
      functions. Evaluations will occur in four moments: initial / before use, on the first day of&#xD;
      placement in the adjuster, after the first month after use and after the second month of use.&#xD;
      For statistical analysis, the Shapiro Wilk Test will be applied to evaluate the normality of&#xD;
      the data, and the Friedman or ANOVA tests for repeated samples, to analyze intra-group time&#xD;
      factor for the dependent variables of each individual.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 20, 2017</start_date>
  <completion_date type="Anticipated">August 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">October 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Body Alignment</measure>
    <time_frame>two-month period</time_frame>
    <description>Position or attitude of the body, the Arrangement of the parts of the body for a specific activity, or a Characteristic way of someone sustaining your body</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Motor function</measure>
    <time_frame>two-month period</time_frame>
    <description>Ability to carry out human development stages</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastrointestinal function</measure>
    <time_frame>two-month period</time_frame>
    <description>intestinal motility</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Muscular tonus</measure>
    <time_frame>two-month period</time_frame>
    <description>basal level of muscle contraction</description>
  </secondary_outcome>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Zika Virus</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>posture adapter</intervention_name>
    <description>continued use of the device at home for 2 months after instructions of how to do it</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  children between 12 and 24 months old;&#xD;
&#xD;
          -  children with confirmed zika virus infection diagnosis;&#xD;
&#xD;
          -  children with STORCH + for zika virus (blood test)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  children with no medication for controlling zika virus infection symptoms;&#xD;
&#xD;
          -  children with musculoskeletal disorders or limitation to standing position&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Months</minimum_age>
    <maximum_age>24 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Labibe Mara Pinel Frederico</last_name>
    <phone>8191165364</phone>
    <email>labibep@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Universidade Federal de Pernambuco</name>
      <address>
        <city>Recife</city>
        <state>Pernambuco</state>
        <zip>50.740-545</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Labibe Mara Pinel Frederico</last_name>
      <phone>+5581991165364</phone>
      <email>labibep@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Karla Monica Ferraz Lambertz</last_name>
      <phone>+558199994-1064</phone>
      <email>karla_monica@hotmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>July 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>July 20, 2017</last_update_submitted>
  <last_update_submitted_qc>July 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal de Pernambuco</investigator_affiliation>
    <investigator_full_name>Labibe Mara Pinel Frederico</investigator_full_name>
    <investigator_title>master's student</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Zika Virus Infection</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/NCT03227601
org study id: 1808
nct id: NCT03227601
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Congenital Zika virus syndrome (SCZv) has been gaining attention in studies due to changes in
      the central nervous system and in the motor development of children. These changes resulted
      in an unexpected picture and without future predictability, with the appearance of several
      functional impairments and also on orthostatic posture. In this context, the protocol of
      orthostatism proposed here is a 10-week program of the use of a postural adjuster, the
      standing frame, made of its own with alternative material to the commercial models
      (cardboard). The use of low cost materials allows these devices to be made in the desired
      size without cost high, individually adapted, easy to be transported as it is light and can
      still be colored. It is an equipment that offers the opportunity to experience the
      orthostatic posture and mainly benefits children with little economic resources that enable
      the acquisition of traditional devices made of iron or wood and even imported equipment. The
      postural adjuster allows physical and sensorial opportunity, being an auxiliary resource in
      standing positioning, feasible for home use, besides being useful for performing functional
      activities. Thus, the objective will be to analyze the repercussions of the use of the
      standing frame on body alignment, muscle tone, gross motor function and gastrointestinal
      functions of children with SCZv. An uncontrolled intervention study will be conducted with
      children between 12 and 24 months of age, who will undergo an evaluation before use and after
      the use of the adjunct along with the proposed orthostatism protocol. The postural alignment
      will be evaluated through photogrammetry and the evaluation of muscle tone will be performed
      through the modified Tardieu scale. The Gross Motor Function Measure (GMFM) scale will be
      used to assess the gross motor function of the children involved in the study. Questionnaires
      will be applied for the collection of maternal socio-demographic data, the child's data, the
      type and time of therapy that the child already participates, and the gastrointestinal
      functions. Evaluations will occur in four moments: initial / before use, on the first day of
      placement in the adjuster, after the first month after use and after the second month of use.
      For statistical analysis, the Shapiro Wilk Test will be applied to evaluate the normality of
      the data, and the Friedman or ANOVA tests for repeated samples, to analyze intra-group time
      factor for the dependent variables of each individual.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Body Alignment
time frame: two-month period
description: Position or attitude of the body, the Arrangement of the parts of the body for a specific activity, or a Characteristic way of someone sustaining your body
measure: Motor function
time frame: two-month period
description: Ability to carry out human development stages
measure: Gastrointestinal function
time frame: two-month period
description: intestinal motility
measure: Muscular tonus
time frame: two-month period
description: basal level of muscle contraction
intervention type: Device
intervention name: posture adapter
description: continued use of the device at home for 2 months after instructions of how to do it
criteria: 
gender: All
minimum age: 12 Months
maximum age: 24 Months
healthy volunteers: No
last name: Labibe Mara Pinel Frederico
phone: 8191165364
email: labibep@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal de Pernambuco
investigator full name: Labibe Mara Pinel Frederico
investigator title: master's student
mesh term: Zika Virus Infection