<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/NCT03022656</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00058476</org_study_id>
    <nct_id>NCT03022656</nct_id>
  </id_info>
  <brief_title>A Randomized Clinical Trial of Brace Treatment</brief_title>
  <official_title>A Randomized Clinical Trial of Brace Treatment</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>
      Brace treatment is the most effective non-surgical method for the treatment of Adolescent&#xD;
      idiopathic scoliosis (AIS). The goal of bracing is to stop the curve progression during the&#xD;
      high risk period of the adolescent growth spurt. A spinal brace is a hard plastic shell with&#xD;
      pressure pads installed inside the liner to provide mechanical support to the curvature of&#xD;
      the spine. It is a big commitment for adolescents to wear a brace because it is physically&#xD;
      restrictive, uncomfortable and draws unwanted attention. Therefore, it is very important to&#xD;
      make the brace treatment as effective as possible to get patient buy-in to compromise their&#xD;
      lifestyle by wearing a brace. Patients' belief in the treatment outcomes is also a factor to&#xD;
      attain their compliance.&#xD;
&#xD;
      This randomized clinical study will investigate if the effectiveness of brace treatment can&#xD;
      be maximized by combining ultrasound imaging assistance during brace design with the smart&#xD;
      brace to automatically maintain corrective brace pressures at the optimum level during the&#xD;
      whole treatment period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Brace treatment is the most effective non-surgical method for the treatment of&#xD;
      AIS. The goal of bracing is to stop the curve progression during the high risk period of the&#xD;
      adolescent growth spurt. A spinal brace is a hard plastic shell with pressure pads installed&#xD;
      inside the liner to provide mechanical support to the curvature of the spine. It is a big&#xD;
      commitment for adolescents to wear a brace because it is physically restrictive,&#xD;
      uncomfortable and draws unwanted attention. Therefore, it is very important to make the brace&#xD;
      treatment as effective as possible to get patient buy-in to compromise their lifestyle by&#xD;
      wearing a brace. Patients' belief in the treatment outcomes is also a factor to attain their&#xD;
      compliance.&#xD;
&#xD;
      Study Objective: This randomized clinical study will investigate if the effectiveness of&#xD;
      brace treatment can be maximized by combining ultrasound imaging assistance during brace&#xD;
      design with the smart brace to automatically maintain corrective brace pressures at the&#xD;
      optimum level during the whole treatment period.&#xD;
&#xD;
      Methodology:&#xD;
&#xD;
      Subject Selection: One hundred and twenty-eight brace candidates with AIS will be recruited&#xD;
      over the next 5 years. During the scoliosis clinic, the attending orthopaedic surgeon&#xD;
      identifies a potential candidate. He will ask the potential patient if he/she is interested&#xD;
      in speaking with the research coordinator about research projects that he/she is eligible.&#xD;
      The inclusion criteria are patients 1) age 10 - 16 years, 2) diagnosis of AIS, 3) require&#xD;
      full-time brace wear, 4) Cobb angle between 20° - 40°, 5) Risser sign ≤3 and 6) premenarchal&#xD;
      or less than 1 year postmenarchal. Subjects will be randomly selected to 1 of the 2 groups:&#xD;
      a) An ultrasound assisted designed brace and a brace monitor, and b) An ultrasound assisted&#xD;
      designed brace and a smart brace device. Figure 1 shows the flow chart of the study. Each&#xD;
      subject will have 50% chance of being in any one of the groups. An extra 15 minutes will be&#xD;
      needed for both groups during the brace fitting clinic to install the brace monitor or smart&#xD;
      brace device. An extra 30 minutes will be added to your casting. Participants will be&#xD;
      monitored until the brace treatment is finished.&#xD;
&#xD;
      Detailed description: The brace monitor is a small electronic device which will be embedded&#xD;
      inside the brace. It is a very low power system operating at 3.3 V and 2 milliampere (mA) (on&#xD;
      average). It is able to store 12 months of data and the battery can last for 9 months. It&#xD;
      will record how much time and how tightly the subject wears the brace. The brace with the&#xD;
      monitor looks exactly the same as a standard brace. The subject won't feel any different and&#xD;
      don't need to do anything beyond. We will replace the monitor with a new one at every&#xD;
      standard follow up clinic.&#xD;
&#xD;
      A smart brace device is a small electronic device. It will have a small air bag embedded at&#xD;
      the major pad area covered with stretchable leather. It will record how much time and how&#xD;
      tightly the brace is worn. The air bag will inflate if the contact pressure between the brace&#xD;
      and the body is lower than expected. The air bag will deflate if the contact pressure between&#xD;
      the brace and the body is higher than expected. This automatic pressure adjustment will only&#xD;
      be activated during daytime which is individualized based on the patient's sleep pattern. The&#xD;
      system will also be activated only if breathing motion is detected (which means brace is&#xD;
      worn). The smart brace monitor is able to store 6 months of data but requiring to recharge&#xD;
      every day for 30 minutes. The smart brace monitor is a low power system (operating at 4.2 V&#xD;
      and 150 mA max). It has an on-off switch and a pressure enable-disable regulation switch&#xD;
      safety functions. Switching enable-disable regulation to off will make the smart brace device&#xD;
      becomes a standard brace monitor. Turing off the on-off switch will disable all the functions&#xD;
      and this brace will become a standard brace. We will replace the monitor with a new one at&#xD;
      every standard follow up clinic.&#xD;
&#xD;
      The ultrasound assisted design requires to get 4 ultrasound images: normal standing, normal&#xD;
      supine, bending left supine and bending right supine. Each scan takes approximately 1 minute.&#xD;
      These 4 scans will provide spine flexibility information. After this, the subject will be&#xD;
      asked to stand in a wooden positioning frame with pressure pads allow to move&#xD;
      3-dimensionally. Multiple adjustable brace pads will be applied to the patients' body&#xD;
      according to orthotist suggestion. An ultrasound scan will be performed after the pads are&#xD;
      applied. The orthotist will use the ultrasound image to decide if the pads are at the optimum&#xD;
      locations and applied proper pressures. If the orthotist is satisfied with the correction,&#xD;
      he/ she will use this setup to build the brace. Otherwise, he/she will adjust the position&#xD;
      and orientation of the pads and repeated the ultrasound scan.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    COVID Pandemic&#xD;
  </why_stopped>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effectiveness of active brace treatment</measure>
    <time_frame>2 years after completing the brace treatment</time_frame>
    <description>The proportions of successful treatment between two arms b to determine the overall effectiveness</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Immediate Active effect</measure>
    <time_frame>1 year after enrollment</time_frame>
    <description>Review the out of brace Cobb angle 1 year after using the spinal brace</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">128</enrollment>
  <condition>Scoliosis; Idiopathic, Infantile</condition>
  <arm_group>
    <arm_group_label>Monitor Only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A brace monitor will be embedded inside the brace to monitor compliance.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Brace System</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>An active brace device will be embedded inside the brace to dynamically control interface pressure and monitor compliance.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Active Brace system</intervention_name>
    <arm_group_label>Active Brace System</arm_group_label>
    <arm_group_label>Monitor Only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age 10 - 16 years&#xD;
&#xD;
          2. diagnosed of AIS&#xD;
&#xD;
          3. require full-time brace wear&#xD;
&#xD;
          4. have Cobb angle between 20° - 40°&#xD;
&#xD;
          5. have Risser sign ≤3&#xD;
&#xD;
          6. premenarchal or less than 1 year postmenarchal.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. patients who require surgery&#xD;
&#xD;
          2. presenting with associated musculoskeletal, neurological or other conditions possibly&#xD;
             responsible for the curvature&#xD;
&#xD;
          3. physical or mental disability that prevent patients from complying with the bracing&#xD;
             protocol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>May 23, 2023</last_update_submitted>
  <last_update_submitted_qc>May 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Orthotic treatment, Ultrasound Imaging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Scoliosis</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/NCT03022656
org study id: Pro00058476
nct id: NCT03022656
lead sponsor: 
has dmc: No
Brace treatment is the most effective non-surgical method for the treatment of Adolescent
      idiopathic scoliosis (AIS). The goal of bracing is to stop the curve progression during the
      high risk period of the adolescent growth spurt. A spinal brace is a hard plastic shell with
      pressure pads installed inside the liner to provide mechanical support to the curvature of
      the spine. It is a big commitment for adolescents to wear a brace because it is physically
      restrictive, uncomfortable and draws unwanted attention. Therefore, it is very important to
      make the brace treatment as effective as possible to get patient buy-in to compromise their
      lifestyle by wearing a brace. Patients' belief in the treatment outcomes is also a factor to
      attain their compliance.

      This randomized clinical study will investigate if the effectiveness of brace treatment can
      be maximized by combining ultrasound imaging assistance during brace design with the smart
      brace to automatically maintain corrective brace pressures at the optimum level during the
      whole treatment period.
Background: Brace treatment is the most effective non-surgical method for the treatment of
      AIS. The goal of bracing is to stop the curve progression during the high risk period of the
      adolescent growth spurt. A spinal brace is a hard plastic shell with pressure pads installed
      inside the liner to provide mechanical support to the curvature of the spine. It is a big
      commitment for adolescents to wear a brace because it is physically restrictive,
      uncomfortable and draws unwanted attention. Therefore, it is very important to make the brace
      treatment as effective as possible to get patient buy-in to compromise their lifestyle by
      wearing a brace. Patients' belief in the treatment outcomes is also a factor to attain their
      compliance.

      Study Objective: This randomized clinical study will investigate if the effectiveness of
      brace treatment can be maximized by combining ultrasound imaging assistance during brace
      design with the smart brace to automatically maintain corrective brace pressures at the
      optimum level during the whole treatment period.

      Methodology:

      Subject Selection: One hundred and twenty-eight brace candidates with AIS will be recruited
      over the next 5 years. During the scoliosis clinic, the attending orthopaedic surgeon
      identifies a potential candidate. He will ask the potential patient if he/she is interested
      in speaking with the research coordinator about research projects that he/she is eligible.
      The inclusion criteria are patients 1) age 10 - 16 years, 2) diagnosis of AIS, 3) require
      full-time brace wear, 4) Cobb angle between 20° - 40°, 5) Risser sign ≤3 and 6) premenarchal
      or less than 1 year postmenarchal. Subjects will be randomly selected to 1 of the 2 groups:
      a) An ultrasound assisted designed brace and a brace monitor, and b) An ultrasound assisted
      designed brace and a smart brace device. Figure 1 shows the flow chart of the study. Each
      subject will have 50% chance of being in any one of the groups. An extra 15 minutes will be
      needed for both groups during the brace fitting clinic to install the brace monitor or smart
      brace device. An extra 30 minutes will be added to your casting. Participants will be
      monitored until the brace treatment is finished.

      Detailed description: The brace monitor is a small electronic device which will be embedded
      inside the brace. It is a very low power system operating at 3.3 V and 2 milliampere (mA) (on
      average). It is able to store 12 months of data and the battery can last for 9 months. It
      will record how much time and how tightly the subject wears the brace. The brace with the
      monitor looks exactly the same as a standard brace. The subject won't feel any different and
      don't need to do anything beyond. We will replace the monitor with a new one at every
      standard follow up clinic.

      A smart brace device is a small electronic device. It will have a small air bag embedded at
      the major pad area covered with stretchable leather. It will record how much time and how
      tightly the brace is worn. The air bag will inflate if the contact pressure between the brace
      and the body is lower than expected. The air bag will deflate if the contact pressure between
      the brace and the body is higher than expected. This automatic pressure adjustment will only
      be activated during daytime which is individualized based on the patient's sleep pattern. The
      system will also be activated only if breathing motion is detected (which means brace is
      worn). The smart brace monitor is able to store 6 months of data but requiring to recharge
      every day for 30 minutes. The smart brace monitor is a low power system (operating at 4.2 V
      and 150 mA max). It has an on-off switch and a pressure enable-disable regulation switch
      safety functions. Switching enable-disable regulation to off will make the smart brace device
      becomes a standard brace monitor. Turing off the on-off switch will disable all the functions
      and this brace will become a standard brace. We will replace the monitor with a new one at
      every standard follow up clinic.

      The ultrasound assisted design requires to get 4 ultrasound images: normal standing, normal
      supine, bending left supine and bending right supine. Each scan takes approximately 1 minute.
      These 4 scans will provide spine flexibility information. After this, the subject will be
      asked to stand in a wooden positioning frame with pressure pads allow to move
      3-dimensionally. Multiple adjustable brace pads will be applied to the patients' body
      according to orthotist suggestion. An ultrasound scan will be performed after the pads are
      applied. The orthotist will use the ultrasound image to decide if the pads are at the optimum
      locations and applied proper pressures. If the orthotist is satisfied with the correction,
      he/ she will use this setup to build the brace. Otherwise, he/she will adjust the position
      and orientation of the pads and repeated the ultrasound scan.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Effectiveness of active brace treatment
time frame: 2 years after completing the brace treatment
description: The proportions of successful treatment between two arms b to determine the overall effectiveness
measure: Immediate Active effect
time frame: 1 year after enrollment
description: Review the out of brace Cobb angle 1 year after using the spinal brace
arm group label: Monitor Only
arm group type: Active Comparator
description: A brace monitor will be embedded inside the brace to monitor compliance.
arm group label: Active Brace System
arm group type: Active Comparator
description: An active brace device will be embedded inside the brace to dynamically control interface pressure and monitor compliance.
intervention type: Device
intervention name: Active Brace system
arm group label: Active Brace System
arm group label: Monitor Only
criteria: 
gender: All
minimum age: 10 Years
maximum age: 16 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Scoliosis