<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/NCT03292601</url>
  </required_header>
  <id_info>
    <org_study_id>AAAP4760</org_study_id>
    <nct_id>NCT03292601</nct_id>
  </id_info>
  <brief_title>Brace Monitoring for Adolescent Idiopathic Scoliosis (AIS)</brief_title>
  <official_title>Effect of Feedback and Monitoring on Patient Compliance With Spinal Orthoses for Scoliosis Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wellinks, Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Columbia University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall aim of the study is to utilize a novel device and smartphone application in order&#xD;
      to improve measurement of patient compliance with at-home bracing for scoliosis as well as&#xD;
      create a more accurate assessment of brace fit via continuous and objective measures of&#xD;
      tension. These ground-breaking metrics will provide analyzable data to more accurately&#xD;
      reflect and predict actual patient compliance as well as allow for further exploration of how&#xD;
      to increase compliance, and thus, efficacy of bracing; it will additionally allow both&#xD;
      physicians and patients to have a more reliable measure for brace fit by providing them with&#xD;
      continuous data of fit via tension, and provide built-in feedback mechanisms to the patient&#xD;
      to ensure proper tightness of the brace.&#xD;
&#xD;
      Additionally, the study will investigate whether providing the wearer's own brace-wear&#xD;
      compliance information directly to the patient and their caregiver(s) via the mobile app will&#xD;
      further improve rates of compliance as compared to those who do not receive the same feedback&#xD;
      mechanism.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The current method to set brace tension is subjective; it is limited to the attending&#xD;
      clinician making a mark on the brace straps, to which the patient tightens the straps during&#xD;
      daily wear. Once the strap is set in place, the current standard-of-care does not involve any&#xD;
      more monitoring. Therefore, ideal strap tension is unknown and the effectiveness of bracing&#xD;
      may be unknowingly compromised by many as yet unidentified variables. In recent years, a&#xD;
      small number of studies have emerged related to the strap tension of bracing yet no clear&#xD;
      guidelines on correct strap tension currently exist. Considering the potential effects on&#xD;
      preventing scoliosis progression and brace-associated complications, the need for guidelines&#xD;
      regarding optimal brace fit are greatly needed for clinical use. Via this brace monitoring&#xD;
      study, continuous monitoring of tension at brace fitting, throughout the day, and related to&#xD;
      positional changes will be possible with a very minimal device and smartphone application.&#xD;
      The tremendous amounts of data generated by the device and its app will be used to create a&#xD;
      database from which our team will gather information about brace wear compliance and use&#xD;
      tension information for the development of standards for effective strap tension associated&#xD;
      with greater scoliosis curve correction. Lastly, the effect of a patient's engagement with&#xD;
      his or her brace - through the smartphone app - will be examined. It is well established in&#xD;
      the literature that observation increases compliance, but no studies investigating patient&#xD;
      self-monitoring through personal devices currently exists. This is a vital area of&#xD;
      investigation given the recent explosion in personal health-assessing devices e.g. the Apple&#xD;
      watch, Up band, fitbit, etc.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 18, 2017</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>
    <intervention_model_description>(No Feedback Group was removed in 2019)</intervention_model_description>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Wear Time Compliance</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Measured as number of hours that the patient actually wore the brace.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Wear Compliance: Valid Hours</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Measured as time (in hours) that the brace was worn to the provider-prescribed tightness</description>
  </primary_outcome>
  <primary_outcome>
    <measure>In-Brace Curve Correction Rate</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>In-brace curve correction will be analyzed by an in-brace radiograph to determine the degree of immediate curve correction (absolute change in degrees).</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Adolescent Idiopathic Scoliosis</condition>
  <arm_group>
    <arm_group_label>Feedback Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in the Feedback Group will receive their brace-wear (Cinch Smart Strap) compliance data via the Wellinks phone application (Cinch Mobile App). Patients will also receive their brace-wear compliance information at their standard of care follow-up visits.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cinch Smart Strap</intervention_name>
    <description>The study device is a small (with dimensions of 1.5&quot; x 2&quot; x 3/8&quot; and weighing approximately 0.9-oz) Bluetooth-enabled and battery-powered monitor with Velcro strap that attaches to orthopaedic braces for scoliosis in place of the traditional strap and buckle. When the Velcro strap is tightened, the device measures tension in Newtons with the vector of force parallel to and away from the device, reflecting the pulling force required to keep the brace fitted on the patient.</description>
    <arm_group_label>Feedback Group</arm_group_label>
    <other_name>Cinch Smart Strap manufactured by Wellinks, Inc.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cinch Mobile App</intervention_name>
    <description>The Cinch App allows patients and parents to track and edit treatment information, sync data from the Cinch Smart Strap, and view compliance data. The app connects via Bluetooth to the Cinch Smart Strap and allows patients and parents save and sync data from the device.</description>
    <arm_group_label>Feedback Group</arm_group_label>
    <other_name>Cinch Mobile App by Wellinks, Inc.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of Adolescent Idiopathic Scoliosis (AIS)&#xD;
&#xD;
          -  Sanders skeletal stage 4 or earlier&#xD;
&#xD;
          -  Clinician-recommended Rigo bracing&#xD;
&#xD;
          -  Patient receiving brace treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Prior spine surgery&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Benjamin Roye, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Benjamin D. Roye, MD, MPH</last_name>
    <phone>(212) 305-5475</phone>
    <email>bdr5@columbia.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Morgan Stanley Children's Hospital of NY Presbyterian/Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Afrain Boby, MS</last_name>
      <phone>212-305-9367</phone>
      <email>ab4789@cumc.columbia.edu</email>
    </contact>
    <contact_backup>
      <last_name>Hiroko Matsumoto, MA, PhDc</last_name>
      <phone>212-305-5028</phone>
      <email>hm2174@cumc.columbia.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>March 15, 2023</last_update_submitted>
  <last_update_submitted_qc>March 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Spinal Orthosis</keyword>
  <keyword>Spinal Brace</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>Undecided</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/NCT03292601
org study id: AAAP4760
nct id: NCT03292601
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The overall aim of the study is to utilize a novel device and smartphone application in order
      to improve measurement of patient compliance with at-home bracing for scoliosis as well as
      create a more accurate assessment of brace fit via continuous and objective measures of
      tension. These ground-breaking metrics will provide analyzable data to more accurately
      reflect and predict actual patient compliance as well as allow for further exploration of how
      to increase compliance, and thus, efficacy of bracing; it will additionally allow both
      physicians and patients to have a more reliable measure for brace fit by providing them with
      continuous data of fit via tension, and provide built-in feedback mechanisms to the patient
      to ensure proper tightness of the brace.

      Additionally, the study will investigate whether providing the wearer's own brace-wear
      compliance information directly to the patient and their caregiver(s) via the mobile app will
      further improve rates of compliance as compared to those who do not receive the same feedback
      mechanism.
The current method to set brace tension is subjective; it is limited to the attending
      clinician making a mark on the brace straps, to which the patient tightens the straps during
      daily wear. Once the strap is set in place, the current standard-of-care does not involve any
      more monitoring. Therefore, ideal strap tension is unknown and the effectiveness of bracing
      may be unknowingly compromised by many as yet unidentified variables. In recent years, a
      small number of studies have emerged related to the strap tension of bracing yet no clear
      guidelines on correct strap tension currently exist. Considering the potential effects on
      preventing scoliosis progression and brace-associated complications, the need for guidelines
      regarding optimal brace fit are greatly needed for clinical use. Via this brace monitoring
      study, continuous monitoring of tension at brace fitting, throughout the day, and related to
      positional changes will be possible with a very minimal device and smartphone application.
      The tremendous amounts of data generated by the device and its app will be used to create a
      database from which our team will gather information about brace wear compliance and use
      tension information for the development of standards for effective strap tension associated
      with greater scoliosis curve correction. Lastly, the effect of a patient's engagement with
      his or her brace - through the smartphone app - will be examined. It is well established in
      the literature that observation increases compliance, but no studies investigating patient
      self-monitoring through personal devices currently exists. This is a vital area of
      investigation given the recent explosion in personal health-assessing devices e.g. the Apple
      watch, Up band, fitbit, etc.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: (No Feedback Group was removed in 2019)
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Wear Time Compliance
time frame: Up to 1 year
description: Measured as number of hours that the patient actually wore the brace.
measure: Wear Compliance: Valid Hours
time frame: Up to 1 year
description: Measured as time (in hours) that the brace was worn to the provider-prescribed tightness
measure: In-Brace Curve Correction Rate
time frame: Up to 1 year
description: In-brace curve correction will be analyzed by an in-brace radiograph to determine the degree of immediate curve correction (absolute change in degrees).
arm group label: Feedback Group
arm group type: Experimental
description: Patients in the Feedback Group will receive their brace-wear (Cinch Smart Strap) compliance data via the Wellinks phone application (Cinch Mobile App). Patients will also receive their brace-wear compliance information at their standard of care follow-up visits.
intervention type: Device
intervention name: Cinch Smart Strap
description: The study device is a small (with dimensions of 1.5" x 2" x 3/8" and weighing approximately 0.9-oz) Bluetooth-enabled and battery-powered monitor with Velcro strap that attaches to orthopaedic braces for scoliosis in place of the traditional strap and buckle. When the Velcro strap is tightened, the device measures tension in Newtons with the vector of force parallel to and away from the device, reflecting the pulling force required to keep the brace fitted on the patient.
arm group label: Feedback Group
other name: Cinch Smart Strap manufactured by Wellinks, Inc.
intervention type: Other
intervention name: Cinch Mobile App
description: The Cinch App allows patients and parents to track and edit treatment information, sync data from the Cinch Smart Strap, and view compliance data. The app connects via Bluetooth to the Cinch Smart Strap and allows patients and parents save and sync data from the device.
arm group label: Feedback Group
other name: Cinch Mobile App by Wellinks, Inc.
criteria: 
gender: Female
minimum age: 8 Years
maximum age: 17 Years
healthy volunteers: No
last name: Benjamin Roye, MD, MPH
role: Principal Investigator
affiliation: Columbia University
last name: Benjamin D. Roye, MD, MPH
phone: (212) 305-5475
email: bdr5@columbia.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Sponsor
mesh term: Scoliosis
sharing ipd: Undecided