<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/NCT02996643</url>
  </required_header>
  <id_info>
    <org_study_id>Pro000028133</org_study_id>
    <nct_id>NCT02996643</nct_id>
  </id_info>
  <brief_title>Ultrasound-Assisted Brace Casting for AIS</brief_title>
  <official_title>Determine the Optimum Applied Pressure for the Brace Treatment of Scoliosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alberta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alberta</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Adolescent Idiopathic Scoliosis (AIS) is a three-dimensional deformity of the spine&#xD;
      associated with vertebral rotation. Brace treatment is the most commonly used non-surgical&#xD;
      treatment. To obtain the best possible outcome, the best in-brace correction within the&#xD;
      patient's accepted tolerance must be provided. However, in the existing clinical practice,&#xD;
      the immediate in-brace correction cannot be measured during the design and fitting of the&#xD;
      brace because the correction is determined using a radiograph. This study is to evaluate the&#xD;
      effect of applying ultrasound to measure the stimulated in-brace correction during brace&#xD;
      casting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Adolescent Idiopathic Scoliosis (AIS) is a three-dimensional deformity of the&#xD;
      spine associated with vertebral rotation. Brace treatment is the most commonly used&#xD;
      non-surgical treatment. To obtain the best possible outcome, the best in-brace correction&#xD;
      within the patient's accepted tolerance must be provided. However, in the existing clinical&#xD;
      practice, the immediate in-brace correction cannot be measured during the design and fitting&#xD;
      of the brace because the correction is determined using a radiograph.&#xD;
&#xD;
      Objectives: The objective of this study is to use ultrasound method to determine the optimum&#xD;
      tolerable applied pressure level that can provide maximum in-brace correction.&#xD;
&#xD;
      Procedure:&#xD;
&#xD;
      Control Group: In the traditional method, each brace will be constructed using a plaster cast&#xD;
      of the patient's trunk. Before the plaster cast hardens, the subject will lie on a casting&#xD;
      board with multiple brace pads applied to correct the curve(s). The trim lines, pad&#xD;
      placement, and areas of relief are then determined by the orthotist and guided by the&#xD;
      curvature seen on the pre-brace PA spine radiograph.&#xD;
&#xD;
      Intervention Group: Before applying the plaster, subjects will lie on the custom designed&#xD;
      frame. Two ultrasound scans will be performed and the average Cobb value will be used as the&#xD;
      baseline. Multiple adjustable brace pads, each allowing for 6° of freedom and variable&#xD;
      forces, will be applied to the patients' body according to orthotist suggestion. The apical&#xD;
      brace pad that is used to control the major curve will be marked relative to the casting&#xD;
      board as the reference location. The major pressure pad will be moved up 1 inch, then down 1&#xD;
      inch relative to the reference location. The 1 inch increment corresponds to the casting&#xD;
      board, but finer adjustment is available. Two repeated ultrasound scans will be performed at&#xD;
      each pad location (total 3 locations), and the average in-brace Cobb values will be estimated&#xD;
      to determine optimum apical brace pad location. Next, pressure will be increased&#xD;
      incrementally up to the tolerance level of the subject; this will be done by inflating the&#xD;
      bladder at the apical brace pad. Another two ultrasound scans will then be performed to&#xD;
      confirm that the maximum in-brace Cobb value is obtained. The orthotist will use this&#xD;
      configuration to set the pad size and location once the plaster cast has been applied.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>In-brace Cobb angle</measure>
    <time_frame>6 weeks</time_frame>
    <description>In-brace radiographs will be obtained after patients use their braces for 6 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of adjustments</measure>
    <time_frame>6 weeks</time_frame>
    <description>Check if brace adjustment is required</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Scoliosis; Adolescence</condition>
  <arm_group>
    <arm_group_label>Traditional method</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The traditional brace design method will be used to design a spinal brace.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A custom Providence brace standing frame, a medical ultrasound system, a custom pressure measurement system, and in-house Ultrasound measurement software were used to assist brace casting for the intervention group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultrasound Assisted Group</intervention_name>
    <description>A custom brace standing frame, a medical ultrasound system, a custom pressure measurement system, and in-house Ultrasound measurement software were used to assist brace casting for the intervention group.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  AIS patients who are prescribed braces to treat their spinal deformity.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any one does not want to participate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Edmond Lou, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alberta</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medicine and Dentistry</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G2R7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>December 14, 2016</last_update_submitted>
  <last_update_submitted_qc>December 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 19, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adolescent Idiopathic Scoliosis</keyword>
  <keyword>Brace Treatment</keyword>
  <keyword>Ultrasound Imaging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Scoliosis</mesh_term>
  </condition_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/NCT02996643
org study id: Pro000028133
nct id: NCT02996643
lead sponsor: 
has dmc: No
Adolescent Idiopathic Scoliosis (AIS) is a three-dimensional deformity of the spine
      associated with vertebral rotation. Brace treatment is the most commonly used non-surgical
      treatment. To obtain the best possible outcome, the best in-brace correction within the
      patient's accepted tolerance must be provided. However, in the existing clinical practice,
      the immediate in-brace correction cannot be measured during the design and fitting of the
      brace because the correction is determined using a radiograph. This study is to evaluate the
      effect of applying ultrasound to measure the stimulated in-brace correction during brace
      casting.
Background: Adolescent Idiopathic Scoliosis (AIS) is a three-dimensional deformity of the
      spine associated with vertebral rotation. Brace treatment is the most commonly used
      non-surgical treatment. To obtain the best possible outcome, the best in-brace correction
      within the patient's accepted tolerance must be provided. However, in the existing clinical
      practice, the immediate in-brace correction cannot be measured during the design and fitting
      of the brace because the correction is determined using a radiograph.

      Objectives: The objective of this study is to use ultrasound method to determine the optimum
      tolerable applied pressure level that can provide maximum in-brace correction.

      Procedure:

      Control Group: In the traditional method, each brace will be constructed using a plaster cast
      of the patient's trunk. Before the plaster cast hardens, the subject will lie on a casting
      board with multiple brace pads applied to correct the curve(s). The trim lines, pad
      placement, and areas of relief are then determined by the orthotist and guided by the
      curvature seen on the pre-brace PA spine radiograph.

      Intervention Group: Before applying the plaster, subjects will lie on the custom designed
      frame. Two ultrasound scans will be performed and the average Cobb value will be used as the
      baseline. Multiple adjustable brace pads, each allowing for 6° of freedom and variable
      forces, will be applied to the patients' body according to orthotist suggestion. The apical
      brace pad that is used to control the major curve will be marked relative to the casting
      board as the reference location. The major pressure pad will be moved up 1 inch, then down 1
      inch relative to the reference location. The 1 inch increment corresponds to the casting
      board, but finer adjustment is available. Two repeated ultrasound scans will be performed at
      each pad location (total 3 locations), and the average in-brace Cobb values will be estimated
      to determine optimum apical brace pad location. Next, pressure will be increased
      incrementally up to the tolerance level of the subject; this will be done by inflating the
      bladder at the apical brace pad. Another two ultrasound scans will then be performed to
      confirm that the maximum in-brace Cobb value is obtained. The orthotist will use this
      configuration to set the pad size and location once the plaster cast has been applied.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: In-brace Cobb angle
time frame: 6 weeks
description: In-brace radiographs will be obtained after patients use their braces for 6 weeks
measure: Number of adjustments
time frame: 6 weeks
description: Check if brace adjustment is required
arm group label: Traditional method
arm group type: No Intervention
description: The traditional brace design method will be used to design a spinal brace.
arm group label: Intervention
arm group type: Active Comparator
description: A custom Providence brace standing frame, a medical ultrasound system, a custom pressure measurement system, and in-house Ultrasound measurement software were used to assist brace casting for the intervention group.
intervention type: Device
intervention name: Ultrasound Assisted Group
description: A custom brace standing frame, a medical ultrasound system, a custom pressure measurement system, and in-house Ultrasound measurement software were used to assist brace casting for the intervention group.
arm group label: Intervention
criteria: 
gender: All
minimum age: 10 Years
maximum age: 18 Years
healthy volunteers: No
last name: Edmond Lou, PhD
role: Principal Investigator
affiliation: University of Alberta
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Scoliosis
sharing ipd: No