<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/NCT02988323</url>
  </required_header>
  <id_info>
    <org_study_id>Conc-PT-02</org_study_id>
    <nct_id>NCT02988323</nct_id>
  </id_info>
  <brief_title>Cervicovestibular Physiotherapy and Aerobic Exercise in Concussion</brief_title>
  <official_title>Cervicovestibular Rehabilitation and Aerobic Exercise in Children and Youth With Persistent Symptoms Following a Sport-related Concussion: A Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sport Injury Prevention Research Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Calgary</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sport Injury Prevention Research Centre</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sport concussions are among the most commonly occurring injuries in sport and recreation and&#xD;
      pose significant public health implications for Canadians. Many individuals who sustain a&#xD;
      concussion recover in the initial 7-10 days but up to 74% of youth and 31% of adults may&#xD;
      suffer from persistent symptoms. Little research is currently available evaluating the&#xD;
      effects of treatment for individuals who are slower to recover following sport-related&#xD;
      concussion. An initial RCT identified a significant treatment effect in individuals with&#xD;
      persistent symptoms of dizziness, neck pain and/or headaches following sport-related&#xD;
      concussion when treated with a combination of cervical and vestibular physiotherapy compared&#xD;
      to a typical protocol of rest followed by graded exertion (Schneider et al, 2014). Low level&#xD;
      aerobic exercise in combination with sport specific training may also be of benefit to&#xD;
      facilitate recovery in children and youth following concussion (Gagnon et al, 2009, 2016).&#xD;
      Further evaluation of these treatments is required to better understand the effects of each&#xD;
      treatment in isolation and in combination. This trial will have the ability to inform future&#xD;
      multifaceted clinical trials as well as clinical practice. Ultimately, identification of&#xD;
      optimal treatment paradigms will lead to a decrease in persistent symptoms and functional&#xD;
      alterations in children and youth from this commonly occurring injury.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Although awareness regarding sport-related concussion is growing, rehabilitative strategies&#xD;
      for this commonly occuring injury have been a focus of very little research. With the&#xD;
      exception of our pilot RCT, no RCTs to date have evaluated the efficacy of cervical spine&#xD;
      physiotherapy in combination with vestibular rehabilitation in sport-related concussion.&#xD;
      Current evidence has suggested positive effects of low-level aerobic exercise in youth and&#xD;
      adults who are slow to recover following a concussion (Gagnon et al, 2016). However,&#xD;
      low-level aerobic exercise has not yet been compared to cervicovestibular physiotherapy. A&#xD;
      shift in clinical practice (to implement cervicovestibular physiotherapy or low level aerobic&#xD;
      exercise) is occurring, but a direct comparison of the effects of low level aerobic exercise&#xD;
      and multimodal physiotherapy treatment has not yet been conducted. A combination of these two&#xD;
      forms of treatment may be more beneficial than either in isolation. Thus, the combination of&#xD;
      physiotherapy and low level aerobic exercise treatment also requires evaluation.&#xD;
      Identification of management strategies for individuals with persistent symptoms following&#xD;
      concussion is urgently required to inform practice and optimize treatment strategies in this&#xD;
      commonly occuring health problem.&#xD;
&#xD;
      OBJECTIVES:&#xD;
&#xD;
      Primary Research Question:&#xD;
&#xD;
      1. Does cervical and vestibular rehabilitation (CVPT) 1) result in a greater proportion of&#xD;
      individuals medically cleared to return to sport (yes/no); 2) improve quality of life&#xD;
      compared to a control group of low level aerobic exercise (LLAE) (following an 8-week&#xD;
      intervention in individuals with persistent symptoms of dizziness, neck pain and/or headaches&#xD;
      following concussion)?&#xD;
&#xD;
      Secondary Research Questions:&#xD;
&#xD;
      1. Does a combination of CVPT and LLAE 1) result in a greater proportion of individuals&#xD;
      medically cleared to return to sport; 2) Improve quality of life compared to CVPT or LLAE&#xD;
      alone (following an 8-week intervention in individuals with persistent symptoms of dizziness,&#xD;
      neck pain and/or headaches following concussion)?&#xD;
&#xD;
      Exploratory Research Questions:&#xD;
&#xD;
        1. Does cervical and vestibular rehabilitation (CVPT) result in a greater proportion of&#xD;
           individuals medically cleared to return to sport compared to a control group of low&#xD;
           level aerobic exercise (LLAE) (following an 8-week intervention in individuals with&#xD;
           persistent symptoms of dizziness, neck pain and/or headaches following concussion) when&#xD;
           stratified by subgroups based on time since injury, previous history of concussion, sex&#xD;
           and age?&#xD;
&#xD;
        2. Does a combination of CVPT and LLAE result in a greater proportion of individuals&#xD;
           medically cleared to return to sport compared to CVPT or LLAE alone when stratified by&#xD;
           subgroups based on time since injury, previous history of concussion, sex and age?&#xD;
&#xD;
        3. What clinical characteristics predict response to treatment?&#xD;
&#xD;
        4. What changes in symptoms and clinical measures of cervical and vestibular function occur&#xD;
           with treatment?&#xD;
&#xD;
        5. What changes in measures of disability, self-efficacy, neuropsychological and&#xD;
           psychosocial function occur with treatment?&#xD;
&#xD;
        6. What other factors may affect treatment outcome (i.e. medical clearance) and quality of&#xD;
           life in youth with persisting symptoms following concussion?&#xD;
&#xD;
      METHODS:&#xD;
&#xD;
      The study design is a single blind randomized controlled trial (RCT). Participants will be&#xD;
      recruited through the University of Calgary Acute Sport Concussion Clinic and through&#xD;
      community sport medicine offices, family physicians and allied health in the City of Calgary&#xD;
      and surrounding areas.&#xD;
&#xD;
      All participants will undergo an initial physiotherapy assessment at inclusion into the&#xD;
      study. This assessment will be repeated at the time of medical clearance to return to sport&#xD;
      (if less than 8 weeks) or at 8 weeks following initiation of treatment. Participants will be&#xD;
      randomized into a cervicovestibular physiotherapy intervention (CVPT) group, a low level&#xD;
      aerobic exercise group (LLAE), or a combination of cervicovestibular physiotherapy and low&#xD;
      level aerobic exercise group (combination). All study participants will meet weekly (30&#xD;
      minute appointment) with a study physiotherapist for eight weeks (or until the time of&#xD;
      medical clearance to return to sport if clearance occurs prior to 8 weeks). All groups will&#xD;
      follow a protocol of graded exertion as per the 4th International Consensus Guidelines&#xD;
      (Zurich 2012, McCrory et al, 2013).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">March 2018</completion_date>
  <primary_completion_date type="Anticipated">March 2018</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Medical Clearance to return to sport</measure>
    <time_frame>8 weeks</time_frame>
    <description>The primary outcomes of interest will be: 1) Medical clearance to return to sport by 8-weeks (as per the 4th International Consensus Guidelines on Concussion in Sport). Medical clearance was selected because it is the most clinically relevant measure and will reflect not only symptom resolution but also functional improvement. We have chosen to further standardize this outcome as follows to minimize risk of bias:&#xD;
Asymptomatic a rest&#xD;
Able to complete all steps of the return to play protocol with no recurrence of symptoms&#xD;
Able to return to school full time without accommodations&#xD;
No other clinical findings suggesting an inability to return to play Some individuals may choose not to return to sport (i.e. retire) or to have coaching decisions influence their return to sport (i.e. may return prior to medical clearance). Therefore, medical clearance to return to sport (as opposed to actual return) is felt to most accurately reflect recovery.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pediatric Quality of Life</measure>
    <time_frame>Change from Initial assessment to 8 weeks</time_frame>
    <description>Paediatric Quality of Life Inventory (Peds-QL): The Pediatric Quality of Life Scale (PedsQL) is a measure of quality of life that is specific to children and measures four health domains including: Physical, emotional, social and school functioning. It is a measure that has demonstrated reliability and validity in multiple disease types in children, including traumatic brain injury.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sport Multidimensional Perfectionism Scale-2</measure>
    <time_frame>Change from Initial assessment to 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Connor-Davidson Resilience Scale</measure>
    <time_frame>Change from Initial assessment to 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>K6 Scale</measure>
    <time_frame>Change from Initial assessment to 8 weeks</time_frame>
    <description>The K6 scale is a 6-item rating scale designed to assess psychological distress. It was developed with support from the U.S. government's National Center for Health Statistics for use in the redesigned U.S. National Health Interview Survey (NHIS). As described in more detail in Kessler et al. (2003), the scale was designed to be sensitive around the threshold for the clinically significant range of the distribution of nonspecific distress in an effort to maximize the ability to discriminate cases of serious mental illness (SMI) from non-cases.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Supplemental Questions (Mrazick)</measure>
    <time_frame>Change from Initial assessment to 8 weeks</time_frame>
    <description>Questions related to distress about injury at the time of injury, time of assessment and belief to make a full recovery rated on a 0-10 point scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-efficacy questionnaire for children (Gagnon et al, 2009)</measure>
    <time_frame>Change from Initial assessment to 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global Rating of Change</measure>
    <time_frame>Change from Initial assessment to 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numeric Pain Rating Scale (Neck Pain)</measure>
    <time_frame>Change from Initial assessment to 8 weeks</time_frame>
    <description>Neck pain rating from 0-10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numeric Pain Rating Scale (Headache)</measure>
    <time_frame>Change from Initial assessment to 8 weeks</time_frame>
    <description>Headache rating from 0-10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numeric Dizziness Rating Scale</measure>
    <time_frame>Change from Initial assessment to 8 weeks</time_frame>
    <description>Dizziness rating from 0-10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Specific Functional Scale (PSFS)</measure>
    <time_frame>Change from Initial assessment to 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activities-specific Balance Confidence Scale</measure>
    <time_frame>Change from Initial assessment to 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dizziness Handicap Inventory</measure>
    <time_frame>Change from Initial assessment to 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sport Concussion Assessment Tool 3</measure>
    <time_frame>Change from Initial assessment to 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dynamic Visual Acuity</measure>
    <time_frame>Change from Initial assessment to 8 weeks</time_frame>
    <description>Clinical test of dynamic visual acuity using ETDRS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Balance Error Scoring System</measure>
    <time_frame>Change from Initial assessment to 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Gait Assessment</measure>
    <time_frame>Change from Initial assessment to 8 weeks</time_frame>
    <description>10 item standardized test of dynamic balance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Head Thrust Test</measure>
    <time_frame>Change from Initial assessment to 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motion Sensitivity Test</measure>
    <time_frame>Change from Initial assessment to 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cervical Flexor Endurance</measure>
    <time_frame>Change from Initial assessment to 8 weeks</time_frame>
    <description>Standardized test of cervical flexor endurance measured in seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cervical Flexion Rotation Test (CFRT)</measure>
    <time_frame>Change from Initial assessment to 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Palpation for Segmental Tenderness (PST)</measure>
    <time_frame>Change from Initial assessment to 8 weeks</time_frame>
    <description>As per Schneider et al 2014, palpation for segmental tenderness in cervical spine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cervical Rotation Side Flexion Test</measure>
    <time_frame>Change from Initial assessment to 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Joint Position Error (JPE)</measure>
    <time_frame>Change from Initial assessment to 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Walk While Talking Test</measure>
    <time_frame>Change from Initial assessment to 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vestibular/Ocular Motor Screen (VOMS)</measure>
    <time_frame>Change from Initial assessment to 8 weeks</time_frame>
    <description>As per Mucha et al, 2014</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Manual Spinal Examination (MSE)</measure>
    <time_frame>Change from Initial assessment to 8 weeks</time_frame>
    <description>As per Schneider et al, 2014</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Actigraphy</measure>
    <time_frame>Change from Initial Assessment to 8 weeks</time_frame>
    <description>Use of a waist worn activity monitor to validly measure the amount of physical activity that an individual performs throughout their day.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">96</enrollment>
  <condition>Concussion</condition>
  <arm_group>
    <arm_group_label>Cervicovestibular Physio (CV PT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In addition to the standard protocol of rest followed by exertion, the CV PT group will participate in a combination of cervical spine and vestibular rehabilitation as per a standardized treatment algorithm based on individual assessment findings. This form of therapy combines treatment techniques for both the cervical spine and vestibular system that are commonly used in physiotherapy practice. Cervical spine treatments may include neuromotor retraining, sensorimotor retraining, manual therapy, soft tissue techniques, and range of motion exercises. Vestibular rehabilitation may include gaze stabilization, habituation, standing balance, dynamic balance and canalith repositioning maneouvers.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low-Level Aerobic Exercise (LLAE)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will exercise at 60% maximum heart rate for 15 minutes. This heart rate will be calculated by taking 220-age (in years) and multiplying by 0.6 to determine the target heart rate while performing the low level aerobic exercise. Aerobic exercises may include treadmill, walking or stationary cycling. Exercise will be performed 5-6 times per week independently at home and monitored by their parents. Individuals will be taught how to monitor their heart rate. This protocol has previously been found to be feasible and of minimal risk to participants.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Combination (LLAE and CV PT)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The combination group will complete a protocol that includes both the cervicovestibular physiotherapy and LLAE interventions described above. As described above, the study participants will be seen once weekly by the study physiotherapist for CV PT and also complete a protocol of LLAE at home.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cervicovestibular Physio (CV PT)</intervention_name>
    <description>See description in CVPT arm</description>
    <arm_group_label>Cervicovestibular Physio (CV PT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Low-Level Aerobic Exercise (LLAE)</intervention_name>
    <description>See description in LLAE arm</description>
    <arm_group_label>Low-Level Aerobic Exercise (LLAE)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Combination (LLAE and CV PT)</intervention_name>
    <description>See description in LLAE and CVPT arm</description>
    <arm_group_label>Combination (LLAE and CV PT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inclusion Criteria:&#xD;
&#xD;
               -  Ages 10-18 years of age&#xD;
&#xD;
               -  Diagnosed by the study sport medicine physician with a sport related concussion&#xD;
                  as per the 4th International Consensus guidelines&#xD;
&#xD;
               -  Persistent symptoms of dizziness, neck pain and/or headaches (&gt;10 days and less&#xD;
                  than one year post injury) reported on the Sport Concussion Assessment Tool 3&#xD;
                  (SCAT3) at initial or follow-up visit to the study sport medicine physician&#xD;
&#xD;
               -  Clinical findings suggesting cervical spine and/or vestibular involvement (i.e.&#xD;
                  limitations in cervical range of motion, positive clinical tests suggesting&#xD;
                  cervicogenic headaches, altered patterns of neuromotor control, alterations on&#xD;
                  dynamic visual acuity, dynamic balance, motion sensitivity, positive test for&#xD;
                  BPPV, etc)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Inability to participate in physical activity for a reason other than sport related&#xD;
             concussion&#xD;
&#xD;
               -  Inability to communicate in English language&#xD;
&#xD;
               -  Neurodevelopmental delays&#xD;
&#xD;
               -  Other orthopaedic injury affecting ability to participate&#xD;
&#xD;
               -  Medication known to affect neural adaptation as they may alter the response to&#xD;
                  treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kathryn Schneider</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Calgary</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kathryn Schneider</last_name>
    <phone>403-210-8951</phone>
    <email>kjschnei@ucalgary.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Carolyn Emery</last_name>
    <phone>403-220-4608</phone>
    <email>caemery@ucalgary.ca</email>
  </overall_contact_backup>
  <reference>
    <citation>McCrory P, Meeuwisse WH, Aubry M, Cantu RC, Dvorak J, Echemendia RJ, Engebretsen L, Johnston K, Kutcher JS, Raftery M, Sills A, Benson BW, Davis GA, Ellenbogen R, Guskiewicz KM, Herring SA, Iverson GL, Jordan BD, Kissick J, McCrea M, McIntosh AS, Maddocks D, Makdissi M, Purcell L, Putukian M, Schneider K, Tator CH, Turner M. Consensus statement on concussion in sport: the 4th International Conference on Concussion in Sport, Zurich, November 2012. J Athl Train. 2013 Jul-Aug;48(4):554-75. doi: 10.4085/1062-6050-48.4.05. No abstract available.</citation>
    <PMID>23855364</PMID>
  </reference>
  <reference>
    <citation>Gagnon I, Galli C, Friedman D, Grilli L, Iverson GL. Active rehabilitation for children who are slow to recover following sport-related concussion. Brain Inj. 2009 Nov;23(12):956-64. doi: 10.3109/02699050903373477.</citation>
    <PMID>19831492</PMID>
  </reference>
  <reference>
    <citation>Schneider KJ, Meeuwisse WH, Nettel-Aguirre A, Barlow K, Boyd L, Kang J, Emery CA. Cervicovestibular rehabilitation in sport-related concussion: a randomised controlled trial. Br J Sports Med. 2014 Sep;48(17):1294-8. doi: 10.1136/bjsports-2013-093267. Epub 2014 May 22.</citation>
    <PMID>24855132</PMID>
  </reference>
  <reference>
    <citation>Schneider KJ, Iverson GL, Emery CA, McCrory P, Herring SA, Meeuwisse WH. The effects of rest and treatment following sport-related concussion: a systematic review of the literature. Br J Sports Med. 2013 Apr;47(5):304-7. doi: 10.1136/bjsports-2013-092190.</citation>
    <PMID>23479489</PMID>
  </reference>
  <reference>
    <citation>Gagnon I, Grilli L, Friedman D, Iverson GL. A pilot study of active rehabilitation for adolescents who are slow to recover from sport-related concussion. Scand J Med Sci Sports. 2016 Mar;26(3):299-306. doi: 10.1111/sms.12441. Epub 2015 Mar 3.</citation>
    <PMID>25735821</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>October 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>December 7, 2016</last_update_submitted>
  <last_update_submitted_qc>December 7, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 9, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sport Injury Prevention Research Centre</investigator_affiliation>
    <investigator_full_name>KSchneider</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>sport concussion</keyword>
  <keyword>cervical spine</keyword>
  <keyword>vestibular rehabilitation</keyword>
  <keyword>exercise</keyword>
  <keyword>rehabilitation</keyword>
  <keyword>children</keyword>
  <keyword>youth</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/NCT02988323
org study id: Conc-PT-02
nct id: NCT02988323
lead sponsor: 
collaborator: 
has dmc: Yes
Sport concussions are among the most commonly occurring injuries in sport and recreation and
      pose significant public health implications for Canadians. Many individuals who sustain a
      concussion recover in the initial 7-10 days but up to 74% of youth and 31% of adults may
      suffer from persistent symptoms. Little research is currently available evaluating the
      effects of treatment for individuals who are slower to recover following sport-related
      concussion. An initial RCT identified a significant treatment effect in individuals with
      persistent symptoms of dizziness, neck pain and/or headaches following sport-related
      concussion when treated with a combination of cervical and vestibular physiotherapy compared
      to a typical protocol of rest followed by graded exertion (Schneider et al, 2014). Low level
      aerobic exercise in combination with sport specific training may also be of benefit to
      facilitate recovery in children and youth following concussion (Gagnon et al, 2009, 2016).
      Further evaluation of these treatments is required to better understand the effects of each
      treatment in isolation and in combination. This trial will have the ability to inform future
      multifaceted clinical trials as well as clinical practice. Ultimately, identification of
      optimal treatment paradigms will lead to a decrease in persistent symptoms and functional
      alterations in children and youth from this commonly occurring injury.
Although awareness regarding sport-related concussion is growing, rehabilitative strategies
      for this commonly occuring injury have been a focus of very little research. With the
      exception of our pilot RCT, no RCTs to date have evaluated the efficacy of cervical spine
      physiotherapy in combination with vestibular rehabilitation in sport-related concussion.
      Current evidence has suggested positive effects of low-level aerobic exercise in youth and
      adults who are slow to recover following a concussion (Gagnon et al, 2016). However,
      low-level aerobic exercise has not yet been compared to cervicovestibular physiotherapy. A
      shift in clinical practice (to implement cervicovestibular physiotherapy or low level aerobic
      exercise) is occurring, but a direct comparison of the effects of low level aerobic exercise
      and multimodal physiotherapy treatment has not yet been conducted. A combination of these two
      forms of treatment may be more beneficial than either in isolation. Thus, the combination of
      physiotherapy and low level aerobic exercise treatment also requires evaluation.
      Identification of management strategies for individuals with persistent symptoms following
      concussion is urgently required to inform practice and optimize treatment strategies in this
      commonly occuring health problem.

      OBJECTIVES:

      Primary Research Question:

      1. Does cervical and vestibular rehabilitation (CVPT) 1) result in a greater proportion of
      individuals medically cleared to return to sport (yes/no); 2) improve quality of life
      compared to a control group of low level aerobic exercise (LLAE) (following an 8-week
      intervention in individuals with persistent symptoms of dizziness, neck pain and/or headaches
      following concussion)?

      Secondary Research Questions:

      1. Does a combination of CVPT and LLAE 1) result in a greater proportion of individuals
      medically cleared to return to sport; 2) Improve quality of life compared to CVPT or LLAE
      alone (following an 8-week intervention in individuals with persistent symptoms of dizziness,
      neck pain and/or headaches following concussion)?

      Exploratory Research Questions:

        1. Does cervical and vestibular rehabilitation (CVPT) result in a greater proportion of
           individuals medically cleared to return to sport compared to a control group of low
           level aerobic exercise (LLAE) (following an 8-week intervention in individuals with
           persistent symptoms of dizziness, neck pain and/or headaches following concussion) when
           stratified by subgroups based on time since injury, previous history of concussion, sex
           and age?

        2. Does a combination of CVPT and LLAE result in a greater proportion of individuals
           medically cleared to return to sport compared to CVPT or LLAE alone when stratified by
           subgroups based on time since injury, previous history of concussion, sex and age?

        3. What clinical characteristics predict response to treatment?

        4. What changes in symptoms and clinical measures of cervical and vestibular function occur
           with treatment?

        5. What changes in measures of disability, self-efficacy, neuropsychological and
           psychosocial function occur with treatment?

        6. What other factors may affect treatment outcome (i.e. medical clearance) and quality of
           life in youth with persisting symptoms following concussion?

      METHODS:

      The study design is a single blind randomized controlled trial (RCT). Participants will be
      recruited through the University of Calgary Acute Sport Concussion Clinic and through
      community sport medicine offices, family physicians and allied health in the City of Calgary
      and surrounding areas.

      All participants will undergo an initial physiotherapy assessment at inclusion into the
      study. This assessment will be repeated at the time of medical clearance to return to sport
      (if less than 8 weeks) or at 8 weeks following initiation of treatment. Participants will be
      randomized into a cervicovestibular physiotherapy intervention (CVPT) group, a low level
      aerobic exercise group (LLAE), or a combination of cervicovestibular physiotherapy and low
      level aerobic exercise group (combination). All study participants will meet weekly (30
      minute appointment) with a study physiotherapist for eight weeks (or until the time of
      medical clearance to return to sport if clearance occurs prior to 8 weeks). All groups will
      follow a protocol of graded exertion as per the 4th International Consensus Guidelines
      (Zurich 2012, McCrory et al, 2013).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Medical Clearance to return to sport
time frame: 8 weeks
description: The primary outcomes of interest will be: 1) Medical clearance to return to sport by 8-weeks (as per the 4th International Consensus Guidelines on Concussion in Sport). Medical clearance was selected because it is the most clinically relevant measure and will reflect not only symptom resolution but also functional improvement. We have chosen to further standardize this outcome as follows to minimize risk of bias:
Asymptomatic a rest
Able to complete all steps of the return to play protocol with no recurrence of symptoms
Able to return to school full time without accommodations
No other clinical findings suggesting an inability to return to play Some individuals may choose not to return to sport (i.e. retire) or to have coaching decisions influence their return to sport (i.e. may return prior to medical clearance). Therefore, medical clearance to return to sport (as opposed to actual return) is felt to most accurately reflect recovery.
measure: Pediatric Quality of Life
time frame: Change from Initial assessment to 8 weeks
description: Paediatric Quality of Life Inventory (Peds-QL): The Pediatric Quality of Life Scale (PedsQL) is a measure of quality of life that is specific to children and measures four health domains including: Physical, emotional, social and school functioning. It is a measure that has demonstrated reliability and validity in multiple disease types in children, including traumatic brain injury.
measure: Sport Multidimensional Perfectionism Scale-2
time frame: Change from Initial assessment to 8 weeks
measure: Connor-Davidson Resilience Scale
time frame: Change from Initial assessment to 8 weeks
measure: K6 Scale
time frame: Change from Initial assessment to 8 weeks
description: The K6 scale is a 6-item rating scale designed to assess psychological distress. It was developed with support from the U.S. government's National Center for Health Statistics for use in the redesigned U.S. National Health Interview Survey (NHIS). As described in more detail in Kessler et al. (2003), the scale was designed to be sensitive around the threshold for the clinically significant range of the distribution of nonspecific distress in an effort to maximize the ability to discriminate cases of serious mental illness (SMI) from non-cases.
measure: Supplemental Questions (Mrazick)
time frame: Change from Initial assessment to 8 weeks
description: Questions related to distress about injury at the time of injury, time of assessment and belief to make a full recovery rated on a 0-10 point scale
measure: Self-efficacy questionnaire for children (Gagnon et al, 2009)
time frame: Change from Initial assessment to 8 weeks
measure: Global Rating of Change
time frame: Change from Initial assessment to 8 weeks
measure: Numeric Pain Rating Scale (Neck Pain)
time frame: Change from Initial assessment to 8 weeks
description: Neck pain rating from 0-10
measure: Numeric Pain Rating Scale (Headache)
time frame: Change from Initial assessment to 8 weeks
description: Headache rating from 0-10
measure: Numeric Dizziness Rating Scale
time frame: Change from Initial assessment to 8 weeks
description: Dizziness rating from 0-10
measure: Patient Specific Functional Scale (PSFS)
time frame: Change from Initial assessment to 8 weeks
measure: Activities-specific Balance Confidence Scale
time frame: Change from Initial assessment to 8 weeks
measure: Dizziness Handicap Inventory
time frame: Change from Initial assessment to 8 weeks
measure: Sport Concussion Assessment Tool 3
time frame: Change from Initial assessment to 8 weeks
measure: Dynamic Visual Acuity
time frame: Change from Initial assessment to 8 weeks
description: Clinical test of dynamic visual acuity using ETDRS
measure: Balance Error Scoring System
time frame: Change from Initial assessment to 8 weeks
measure: Functional Gait Assessment
time frame: Change from Initial assessment to 8 weeks
description: 10 item standardized test of dynamic balance
measure: Head Thrust Test
time frame: Change from Initial assessment to 8 weeks
measure: Motion Sensitivity Test
time frame: Change from Initial assessment to 8 weeks
measure: Cervical Flexor Endurance
time frame: Change from Initial assessment to 8 weeks
description: Standardized test of cervical flexor endurance measured in seconds
measure: Cervical Flexion Rotation Test (CFRT)
time frame: Change from Initial assessment to 8 weeks
measure: Palpation for Segmental Tenderness (PST)
time frame: Change from Initial assessment to 8 weeks
description: As per Schneider et al 2014, palpation for segmental tenderness in cervical spine
measure: Cervical Rotation Side Flexion Test
time frame: Change from Initial assessment to 8 weeks
measure: Joint Position Error (JPE)
time frame: Change from Initial assessment to 8 weeks
measure: Walk While Talking Test
time frame: Change from Initial assessment to 8 weeks
measure: Vestibular/Ocular Motor Screen (VOMS)
time frame: Change from Initial assessment to 8 weeks
description: As per Mucha et al, 2014
measure: Manual Spinal Examination (MSE)
time frame: Change from Initial assessment to 8 weeks
description: As per Schneider et al, 2014
measure: Actigraphy
time frame: Change from Initial Assessment to 8 weeks
description: Use of a waist worn activity monitor to validly measure the amount of physical activity that an individual performs throughout their day.
arm group label: Cervicovestibular Physio (CV PT)
arm group type: Experimental
description: In addition to the standard protocol of rest followed by exertion, the CV PT group will participate in a combination of cervical spine and vestibular rehabilitation as per a standardized treatment algorithm based on individual assessment findings. This form of therapy combines treatment techniques for both the cervical spine and vestibular system that are commonly used in physiotherapy practice. Cervical spine treatments may include neuromotor retraining, sensorimotor retraining, manual therapy, soft tissue techniques, and range of motion exercises. Vestibular rehabilitation may include gaze stabilization, habituation, standing balance, dynamic balance and canalith repositioning maneouvers.
arm group label: Low-Level Aerobic Exercise (LLAE)
arm group type: Experimental
description: Participants will exercise at 60% maximum heart rate for 15 minutes. This heart rate will be calculated by taking 220-age (in years) and multiplying by 0.6 to determine the target heart rate while performing the low level aerobic exercise. Aerobic exercises may include treadmill, walking or stationary cycling. Exercise will be performed 5-6 times per week independently at home and monitored by their parents. Individuals will be taught how to monitor their heart rate. This protocol has previously been found to be feasible and of minimal risk to participants.
arm group label: Combination (LLAE and CV PT)
arm group type: Other
description: The combination group will complete a protocol that includes both the cervicovestibular physiotherapy and LLAE interventions described above. As described above, the study participants will be seen once weekly by the study physiotherapist for CV PT and also complete a protocol of LLAE at home.
intervention type: Other
intervention name: Cervicovestibular Physio (CV PT)
description: See description in CVPT arm
arm group label: Cervicovestibular Physio (CV PT)
intervention type: Other
intervention name: Low-Level Aerobic Exercise (LLAE)
description: See description in LLAE arm
arm group label: Low-Level Aerobic Exercise (LLAE)
intervention type: Other
intervention name: Combination (LLAE and CV PT)
description: See description in LLAE and CVPT arm
arm group label: Combination (LLAE and CV PT)
criteria: 
gender: All
minimum age: 10 Years
maximum age: 18 Years
healthy volunteers: No
last name: Kathryn Schneider
role: Principal Investigator
affiliation: University of Calgary
last name: Kathryn Schneider
phone: 403-210-8951
email: kjschnei@ucalgary.ca
last name: Carolyn Emery
phone: 403-220-4608
email: caemery@ucalgary.ca
citation: McCrory P, Meeuwisse WH, Aubry M, Cantu RC, Dvorak J, Echemendia RJ, Engebretsen L, Johnston K, Kutcher JS, Raftery M, Sills A, Benson BW, Davis GA, Ellenbogen R, Guskiewicz KM, Herring SA, Iverson GL, Jordan BD, Kissick J, McCrea M, McIntosh AS, Maddocks D, Makdissi M, Purcell L, Putukian M, Schneider K, Tator CH, Turner M. Consensus statement on concussion in sport: the 4th International Conference on Concussion in Sport, Zurich, November 2012. J Athl Train. 2013 Jul-Aug;48(4):554-75. doi: 10.4085/1062-6050-48.4.05. No abstract available.
PMID: 23855364
citation: Gagnon I, Galli C, Friedman D, Grilli L, Iverson GL. Active rehabilitation for children who are slow to recover following sport-related concussion. Brain Inj. 2009 Nov;23(12):956-64. doi: 10.3109/02699050903373477.
PMID: 19831492
citation: Schneider KJ, Meeuwisse WH, Nettel-Aguirre A, Barlow K, Boyd L, Kang J, Emery CA. Cervicovestibular rehabilitation in sport-related concussion: a randomised controlled trial. Br J Sports Med. 2014 Sep;48(17):1294-8. doi: 10.1136/bjsports-2013-093267. Epub 2014 May 22.
PMID: 24855132
citation: Schneider KJ, Iverson GL, Emery CA, McCrory P, Herring SA, Meeuwisse WH. The effects of rest and treatment following sport-related concussion: a systematic review of the literature. Br J Sports Med. 2013 Apr;47(5):304-7. doi: 10.1136/bjsports-2013-092190.
PMID: 23479489
citation: Gagnon I, Grilli L, Friedman D, Iverson GL. A pilot study of active rehabilitation for adolescents who are slow to recover from sport-related concussion. Scand J Med Sci Sports. 2016 Mar;26(3):299-306. doi: 10.1111/sms.12441. Epub 2015 Mar 3.
PMID: 25735821
responsible party type: Principal Investigator
investigator affiliation: Sport Injury Prevention Research Centre
investigator full name: KSchneider
investigator title: Assistant Professor
sharing ipd: No