<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/NCT03237468</url>
  </required_header>
  <id_info>
    <org_study_id>HSR#17-4360</org_study_id>
    <nct_id>NCT03237468</nct_id>
  </id_info>
  <brief_title>Neck Strengthening Program for the Prevention or Mitigation of Sports Concussion</brief_title>
  <acronym>PCONS</acronym>
  <official_title>Effectiveness of a Neck Strengthening Program for the Prevention or Mitigation of Sports Concussion Injuries in Student Athletes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CentraCare</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CentraCare</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study looks to determine effectiveness of neck strengthening to reduce the incident,&#xD;
      duration, and severity of sports related concussion in student athletes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After recruitment, subjects will have neck strength measured as baseline in addition to doing&#xD;
      SCAT5 for baseline and eye tracking, funding pending, in order to compare later assessment&#xD;
      for concussion. Throughout study, subject will perform basic, unweighted and weighted neck&#xD;
      strengthening exercises twice a week. Periodic re evaluations of neck strength will be&#xD;
      performed in order to determine progress. Any time a subject incurs a sports related&#xD;
      concussion, a SCAT5 assessment, and eye tracking funding pending, will be done and compared&#xD;
      to baseline to measure severity of injury. Weekly follow ups will be done to assess duration&#xD;
      of concussion. All measurements, assessments, and exercises are non-invasive and provide&#xD;
      minimal risk to subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">August 11, 2017</start_date>
  <completion_date type="Anticipated">July 2022</completion_date>
  <primary_completion_date type="Anticipated">June 2021</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effect of increase in neck strength in reducing risk of concussion</measure>
    <time_frame>One year</time_frame>
    <description>Neck strength, as measured by a dynamometer, will be assessed and compared to baseline. Magnitude in strength will be analyzed in relation to incidence, severity, and duration of concussion.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect of baseline neck strength on risk of concussion</measure>
    <time_frame>One year</time_frame>
    <description>Risk of concussion will be analyzed in relation to baseline strength measurements to assess overall effect of neck strength.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">1500</enrollment>
  <condition>Concussion, Brain</condition>
  <arm_group>
    <arm_group_label>Exercise arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm will perform twice weekly neck strengthening exercises.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Neck strengthening exercise to prevent concussion</intervention_name>
    <description>Neck strengthening exercise to prevent concussion in student athletes.</description>
    <arm_group_label>Exercise arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Involved in programmatic athletic activities with an ongoing duration of at least 4&#xD;
             weeks.&#xD;
&#xD;
          -  Written informed consent obtained by the subject or subject's legal guardian.&#xD;
&#xD;
          -  Written assent from subjects ages 8 years old and above&#xD;
&#xD;
          -  Subject is between the ages of 5 and 22 years, male or female.&#xD;
&#xD;
          -  Subjects from all racial and ethnic origins will have an opportunity to participate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Corrected vision less than 20/500.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>22 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Uzma Samadani, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hennepin County Medical Center, Minneapolis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hennepin County Medical Center</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55415</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Eckner JT, Oh YK, Joshi MS, Richardson JK, Ashton-Miller JA. Effect of neck muscle strength and anticipatory cervical muscle activation on the kinematic response of the head to impulsive loads. Am J Sports Med. 2014 Mar;42(3):566-76. doi: 10.1177/0363546513517869. Epub 2014 Jan 31.</citation>
    <PMID>24488820</PMID>
  </reference>
  <reference>
    <citation>Dugan S, Seymour L, Roesler J, Glover L, Kinde M. This is your brain on sports. Measuring concussions in high school athletes in the Twin Cities metropolitan area. Minn Med. 2014 Sep;97(9):43-6.</citation>
    <PMID>25282771</PMID>
  </reference>
  <reference>
    <citation>Hildenbrand KJ, Vasavada AN. Collegiate and high school athlete neck strength in neutral and rotated postures. J Strength Cond Res. 2013 Nov;27(11):3173-82. doi: 10.1519/JSC.0b013e31828a1fe2.</citation>
    <PMID>23439331</PMID>
  </reference>
  <reference>
    <citation>Daneshvar DH, Riley DO, Nowinski CJ, McKee AC, Stern RA, Cantu RC. Long-term consequences: effects on normal development profile after concussion. Phys Med Rehabil Clin N Am. 2011 Nov;22(4):683-700, ix. doi: 10.1016/j.pmr.2011.08.009. Epub 2011 Sep 23.</citation>
    <PMID>22050943</PMID>
  </reference>
  <reference>
    <citation>Collins CL, Fletcher EN, Fields SK, Kluchurosky L, Rohrkemper MK, Comstock RD, Cantu RC. Neck strength: a protective factor reducing risk for concussion in high school sports. J Prim Prev. 2014 Oct;35(5):309-19. doi: 10.1007/s10935-014-0355-2.</citation>
    <PMID>24930131</PMID>
  </reference>
  <reference>
    <citation>Gutierrez GM, Conte C, Lightbourne K. The relationship between impact force, neck strength, and neurocognitive performance in soccer heading in adolescent females. Pediatr Exerc Sci. 2014 Feb;26(1):33-40. doi: 10.1123/pes.2013-0102. Epub 2013 Oct 2.</citation>
    <PMID>24091298</PMID>
  </reference>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>February 2, 2021</last_update_submitted>
  <last_update_submitted_qc>February 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>concussion</keyword>
  <keyword>football</keyword>
  <keyword>student</keyword>
  <keyword>athlete</keyword>
  <keyword>sports</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Concussion</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 12, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/68/NCT03237468/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03237468
org study id: HSR#17-4360
nct id: NCT03237468
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Study looks to determine effectiveness of neck strengthening to reduce the incident,
      duration, and severity of sports related concussion in student athletes.
After recruitment, subjects will have neck strength measured as baseline in addition to doing
      SCAT5 for baseline and eye tracking, funding pending, in order to compare later assessment
      for concussion. Throughout study, subject will perform basic, unweighted and weighted neck
      strengthening exercises twice a week. Periodic re evaluations of neck strength will be
      performed in order to determine progress. Any time a subject incurs a sports related
      concussion, a SCAT5 assessment, and eye tracking funding pending, will be done and compared
      to baseline to measure severity of injury. Weekly follow ups will be done to assess duration
      of concussion. All measurements, assessments, and exercises are non-invasive and provide
      minimal risk to subjects.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Effect of increase in neck strength in reducing risk of concussion
time frame: One year
description: Neck strength, as measured by a dynamometer, will be assessed and compared to baseline. Magnitude in strength will be analyzed in relation to incidence, severity, and duration of concussion.
measure: Effect of baseline neck strength on risk of concussion
time frame: One year
description: Risk of concussion will be analyzed in relation to baseline strength measurements to assess overall effect of neck strength.
arm group label: Exercise arm
arm group type: Experimental
description: This arm will perform twice weekly neck strengthening exercises.
intervention type: Other
intervention name: Neck strengthening exercise to prevent concussion
description: Neck strengthening exercise to prevent concussion in student athletes.
arm group label: Exercise arm
criteria: 
gender: All
minimum age: 12 Years
maximum age: 22 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Uzma Samadani, MD, PhD
role: Principal Investigator
affiliation: Hennepin County Medical Center, Minneapolis
facility: 
country: United States
citation: Eckner JT, Oh YK, Joshi MS, Richardson JK, Ashton-Miller JA. Effect of neck muscle strength and anticipatory cervical muscle activation on the kinematic response of the head to impulsive loads. Am J Sports Med. 2014 Mar;42(3):566-76. doi: 10.1177/0363546513517869. Epub 2014 Jan 31.
PMID: 24488820
citation: Dugan S, Seymour L, Roesler J, Glover L, Kinde M. This is your brain on sports. Measuring concussions in high school athletes in the Twin Cities metropolitan area. Minn Med. 2014 Sep;97(9):43-6.
PMID: 25282771
citation: Hildenbrand KJ, Vasavada AN. Collegiate and high school athlete neck strength in neutral and rotated postures. J Strength Cond Res. 2013 Nov;27(11):3173-82. doi: 10.1519/JSC.0b013e31828a1fe2.
PMID: 23439331
citation: Daneshvar DH, Riley DO, Nowinski CJ, McKee AC, Stern RA, Cantu RC. Long-term consequences: effects on normal development profile after concussion. Phys Med Rehabil Clin N Am. 2011 Nov;22(4):683-700, ix. doi: 10.1016/j.pmr.2011.08.009. Epub 2011 Sep 23.
PMID: 22050943
citation: Collins CL, Fletcher EN, Fields SK, Kluchurosky L, Rohrkemper MK, Comstock RD, Cantu RC. Neck strength: a protective factor reducing risk for concussion in high school sports. J Prim Prev. 2014 Oct;35(5):309-19. doi: 10.1007/s10935-014-0355-2.
PMID: 24930131
citation: Gutierrez GM, Conte C, Lightbourne K. The relationship between impact force, neck strength, and neurocognitive performance in soccer heading in adolescent females. Pediatr Exerc Sci. 2014 Feb;26(1):33-40. doi: 10.1123/pes.2013-0102. Epub 2013 Oct 2.
PMID: 24091298
responsible party type: Sponsor
mesh term: Brain Concussion
provided document: 