<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/NCT02237248</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00055257</org_study_id>
    <nct_id>NCT02237248</nct_id>
  </id_info>
  <brief_title>Function and Scoliosis Surgery</brief_title>
  <official_title>Functional Testing, and Biomechanics Before and After Scoliosis Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to examine the changes in function and performance biomechanics&#xD;
      in patients undergoing spinal fusion corrective surgery for adolescent idiopathic scoliosis&#xD;
      (AIS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Methods will consist of movement studies, questionnaires, and chart review. The recruited&#xD;
      subjects will be followed at the usual clinical schedule of pre-op, 6-week, 3 -, 6- and&#xD;
      12-month post-operative follow-up visits. After signing informed consent, age at time of&#xD;
      surgery, height, weight, body composition, leg length will be recorded to be used during data&#xD;
      processing. Chart review will further yield data on Cobb angle, Lenke Scoliosis&#xD;
      classification, instrumentation used during surgery, and level of spinal fusion. All subjects&#xD;
      will be asked to complete assessments of activity level (Marx Score, Tegner Activity Score),&#xD;
      general health (EQ-5D), and a validated scoliosis survey (Scoliosis Research Study&#xD;
      questionnaire SRS-22). Movement studies will consist of the Lower Quarter Y Balance Test&#xD;
      (YBT-LQ), and Functional Movement Screen (FMS), and measures of forward flexion, right and&#xD;
      left lateral bending, and right and left trunk rotation. These measures will be assessed&#xD;
      preoperatively and at postoperative follow-up visits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2014</start_date>
  <completion_date type="Actual">June 19, 2017</completion_date>
  <primary_completion_date type="Actual">June 19, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Lower Quarter Y-Balance Test (YBT-LQ)</measure>
    <time_frame>Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively</time_frame>
    <description>The YBT-LQ is a test of dynamic balance in unilateral stance that has been deemed to be reliable and valid. The YBT-LQ consists of each patient standing on one leg and reaching as far as they can with their non-stance leg in the anterior, posteromedial and posterolateral direction while standing on the other foot on a centralized stance platform.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Functional Movement Screen (FMS)</measure>
    <time_frame>Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively</time_frame>
    <description>The FMS is a screening tool used to identify limitations or asymmetries in movement patterns by executing seven motions. Activities include a deep squat, lunges, hurdle steps, a push-up, straight-leg raises, shoulder mobility assessments, and rotary stability assessments.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Tegner Activity Scale</measure>
    <time_frame>Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Marx Activity Scale</measure>
    <time_frame>Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in EQ-5D</measure>
    <time_frame>Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in SRS-22</measure>
    <time_frame>Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">15</enrollment>
  <condition>Adolescent Idiopathic Scoliosis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients that are undergoing spinal fusion surgery to treat idiopathic scoliosis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of idiopathic scoliosis&#xD;
&#xD;
          -  Patients identified to undergo spinal fusion surgery&#xD;
&#xD;
          -  Treated at Duke University Medical Center&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neuromuscular or congenital scoliosis&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert K Lark, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>June 27, 2017</last_update_submitted>
  <last_update_submitted_qc>June 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adolescent Idiopathic Scoliosis</keyword>
  <keyword>Functional Movement Screen</keyword>
  <keyword>Y Balance Test</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/NCT02237248
org study id: Pro00055257
nct id: NCT02237248
lead sponsor: 
has dmc: No
The purpose of the study is to examine the changes in function and performance biomechanics
      in patients undergoing spinal fusion corrective surgery for adolescent idiopathic scoliosis
      (AIS).
Methods will consist of movement studies, questionnaires, and chart review. The recruited
      subjects will be followed at the usual clinical schedule of pre-op, 6-week, 3 -, 6- and
      12-month post-operative follow-up visits. After signing informed consent, age at time of
      surgery, height, weight, body composition, leg length will be recorded to be used during data
      processing. Chart review will further yield data on Cobb angle, Lenke Scoliosis
      classification, instrumentation used during surgery, and level of spinal fusion. All subjects
      will be asked to complete assessments of activity level (Marx Score, Tegner Activity Score),
      general health (EQ-5D), and a validated scoliosis survey (Scoliosis Research Study
      questionnaire SRS-22). Movement studies will consist of the Lower Quarter Y Balance Test
      (YBT-LQ), and Functional Movement Screen (FMS), and measures of forward flexion, right and
      left lateral bending, and right and left trunk rotation. These measures will be assessed
      preoperatively and at postoperative follow-up visits.
observational model: Cohort
time perspective: Prospective
measure: Change in Lower Quarter Y-Balance Test (YBT-LQ)
time frame: Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively
description: The YBT-LQ is a test of dynamic balance in unilateral stance that has been deemed to be reliable and valid. The YBT-LQ consists of each patient standing on one leg and reaching as far as they can with their non-stance leg in the anterior, posteromedial and posterolateral direction while standing on the other foot on a centralized stance platform.
measure: Change in Functional Movement Screen (FMS)
time frame: Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively
description: The FMS is a screening tool used to identify limitations or asymmetries in movement patterns by executing seven motions. Activities include a deep squat, lunges, hurdle steps, a push-up, straight-leg raises, shoulder mobility assessments, and rotary stability assessments.
measure: Change in Tegner Activity Scale
time frame: Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively
measure: Change in Marx Activity Scale
time frame: Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively
measure: Change in EQ-5D
time frame: Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively
measure: Change in SRS-22
time frame: Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 12 Years
maximum age: 18 Years
healthy volunteers: No
last name: Robert K Lark, MD
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Scoliosis