<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/NCT03013231</url>
  </required_header>
  <id_info>
    <org_study_id>47659</org_study_id>
    <secondary_id>27659</secondary_id>
    <nct_id>NCT03013231</nct_id>
  </id_info>
  <brief_title>Effect of Patient Resilience on Return to Sport Post ACL Reconstruction Surgery</brief_title>
  <official_title>Effect of Patient Resilience on Return to Sport Post ACL Reconstruction Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Louis University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Louis University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite the large majority of patients that undergo ACL reconstruction reporting successful&#xD;
      outcomes in regard to tests of knee function, only about 2/3 return to their prior level or&#xD;
      athletic activity after surgery. A large amount of research has been conducted investigating&#xD;
      the effects of psychological factors on return to sports after ACL reconstruction; however,&#xD;
      the specific role of resilience has yet to be solely analyzed. This study aims to determine&#xD;
      the effect of variations in patient resilience on their return to sports after surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Meta-analysis of post ACL reconstruction return to sport suggests that despite approximately&#xD;
      90% of patients achieving successful outcomes in terms of objectively measurable knee&#xD;
      function, only 63% return to their pre-injury sport participation rate. This leads one to&#xD;
      question what factors other than knee function may contribute to such a discrepancy. Prior&#xD;
      studies have shown psychological factors, such as fear of re-injury, can play in role in&#xD;
      whether a patient returns to play. However, the role of patient resilience on recovery is&#xD;
      less clear. This research will examine the effect of patient resilience on post-ACLR return&#xD;
      to sport. The Brief Resiliency Scale (BRS), a proven method of assessing ability to recover&#xD;
      from stressful situations, will be used to evaluate patient resilience. The role of&#xD;
      resilience on recovery post shoulder surgery, as well as rehabilitation in post-operative&#xD;
      orthopaedic geriatric patients has been examined; however, the effect of resilience on&#xD;
      specifically ACLR return to sport has yet to be studied.&#xD;
&#xD;
      This research will provide insight as to how to identify patients at high risk for not&#xD;
      returning to sport, the first step in improving return to sport outcomes in ACL&#xD;
      reconstruction patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 20, 2017</start_date>
  <completion_date type="Actual">August 30, 2019</completion_date>
  <primary_completion_date type="Actual">August 30, 2019</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>Return to Sport</measure>
    <time_frame>1 year</time_frame>
    <description>Whether the patient has returned to sport s/p ACLR</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">50</enrollment>
  <condition>Anterior Cruciate Ligament Reconstruction</condition>
  <arm_group>
    <arm_group_label>s/p ACLR</arm_group_label>
    <description>Patients having undergone ACL Reconstruction Surgery with goal of returning to sport. 6 months post-op, patients will complete the BRS survey as a method of evaluating resilience.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brief Resilience Scale</intervention_name>
    <description>6 months post-op, patients will complete the BRS survey as a method of evaluating resilience.</description>
    <arm_group_label>s/p ACLR</arm_group_label>
    <other_name>BRS</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        English speaking patients 14 yrs of age or older with isolated ACL tear and having&#xD;
        undergone surgical reconstruction.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English speaking patients&#xD;
&#xD;
          -  Isolated ACL tear having undergone surgical reconstruction.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-English speaking patients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Scott Kaar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Louis University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>SSM Health Saint Louis University Hospital</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194-200. doi: 10.1080/10705500802222972.</citation>
    <PMID>18696313</PMID>
  </reference>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>September 3, 2019</last_update_submitted>
  <last_update_submitted_qc>September 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Louis University</investigator_affiliation>
    <investigator_full_name>Scott Kaar, MD</investigator_full_name>
    <investigator_title>Associate Professor, Dept. of Orthopaedic Surgery</investigator_title>
  </responsible_party>
  <keyword>ACL Reconstruction</keyword>
  <keyword>Return to Sport</keyword>
  <keyword>Resilience</keyword>
  <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/NCT03013231
org study id: 47659
secondary id: 27659
nct id: NCT03013231
lead sponsor: 
has dmc: No
Despite the large majority of patients that undergo ACL reconstruction reporting successful
      outcomes in regard to tests of knee function, only about 2/3 return to their prior level or
      athletic activity after surgery. A large amount of research has been conducted investigating
      the effects of psychological factors on return to sports after ACL reconstruction; however,
      the specific role of resilience has yet to be solely analyzed. This study aims to determine
      the effect of variations in patient resilience on their return to sports after surgery.
Meta-analysis of post ACL reconstruction return to sport suggests that despite approximately
      90% of patients achieving successful outcomes in terms of objectively measurable knee
      function, only 63% return to their pre-injury sport participation rate. This leads one to
      question what factors other than knee function may contribute to such a discrepancy. Prior
      studies have shown psychological factors, such as fear of re-injury, can play in role in
      whether a patient returns to play. However, the role of patient resilience on recovery is
      less clear. This research will examine the effect of patient resilience on post-ACLR return
      to sport. The Brief Resiliency Scale (BRS), a proven method of assessing ability to recover
      from stressful situations, will be used to evaluate patient resilience. The role of
      resilience on recovery post shoulder surgery, as well as rehabilitation in post-operative
      orthopaedic geriatric patients has been examined; however, the effect of resilience on
      specifically ACLR return to sport has yet to be studied.

      This research will provide insight as to how to identify patients at high risk for not
      returning to sport, the first step in improving return to sport outcomes in ACL
      reconstruction patients.
observational model: Cohort
time perspective: Prospective
measure: Return to Sport
time frame: 1 year
description: Whether the patient has returned to sport s/p ACLR
arm group label: s/p ACLR
description: Patients having undergone ACL Reconstruction Surgery with goal of returning to sport. 6 months post-op, patients will complete the BRS survey as a method of evaluating resilience.
intervention type: Behavioral
intervention name: Brief Resilience Scale
description: 6 months post-op, patients will complete the BRS survey as a method of evaluating resilience.
arm group label: s/p ACLR
other name: BRS
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 14 Years
maximum age: 50 Years
healthy volunteers: No
last name: Scott Kaar, MD
role: Principal Investigator
affiliation: St. Louis University
facility: 
country: United States
citation: Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194-200. doi: 10.1080/10705500802222972.
PMID: 18696313
responsible party type: Principal Investigator
investigator affiliation: St. Louis University
investigator full name: Scott Kaar, MD
investigator title: Associate Professor, Dept. of Orthopaedic Surgery
sharing ipd: No