<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/NCT02257749</url>
  </required_header>
  <id_info>
    <org_study_id>13-459</org_study_id>
    <nct_id>NCT02257749</nct_id>
  </id_info>
  <brief_title>Trial Study of an Exercise Program for Youth With Persistent Symptoms After Concussion</brief_title>
  <official_title>Comparing Active Rehabilitation to a Comprehensive Education Intervention for Youth With Persistent Post-concussion Symptoms Following Concussion.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Holland Bloorview Kids Rehabilitation Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Holland Bloorview Kids Rehabilitation Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this randomized control trial study is to determine if an active&#xD;
      rehabilitation (low intensity exercise program) in combination with a comprehensive education&#xD;
      intervention (standard care) is more effective than the comprehensive education intervention&#xD;
      alone in reducing post-concussion symptoms and improving participation in daily activities in&#xD;
      youth who have persistent post-concussion symptoms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is a portion of youth who continue to experience persistent post-concussion symptoms&#xD;
      beyond the first few weeks of injury. There is limited evidence with respect to the best ways&#xD;
      to treat persistent post-concussion symptoms in youth following concussion. There is a small&#xD;
      amount of literature that suggests active rehabilitation as a positive intervention for&#xD;
      promotion of recovery of persistent post-concussion symptoms. However, this approach to&#xD;
      rehabilitation has yet to be explored using a randomized control trial protocol.&#xD;
&#xD;
      Therefore, this study aims to answer the following question: Is a 6 week active&#xD;
      rehabilitation program in combination with a comprehensive education intervention (standard&#xD;
      care) effective in reducing post-concussive symptoms and improving functional recovery&#xD;
      compared to receiving comprehensive education intervention alone among youth experiencing&#xD;
      persistent post-concussion symptoms?&#xD;
&#xD;
      We hypothesize:&#xD;
&#xD;
        1. youth ages 10 to 18 years who present with persistent self-reported post-concussion&#xD;
           symptoms 4 weeks after the initial injury and receive the active rehabilitation&#xD;
           intervention, will present with decreased post-concussion symptoms at the completion of&#xD;
           the intervention.&#xD;
&#xD;
        2. youth ages 10 to 18 years who receive the active rehabilitation intervention, will&#xD;
           present with more complete functional recovery and increased participation in&#xD;
           unrestricted physical activity at the completion of the active rehabilitation&#xD;
           intervention compared to children receiving the comprehensive education intervention&#xD;
           only&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    feasibility; challenges with recruitment&#xD;
  </why_stopped>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 2017</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>Post-Concussion Symptoms</measure>
    <time_frame>Week 0 (Baseline)</time_frame>
    <description>The Post-Concussion Symptom Inventory will be used. This is a self report questionnaire that asks about subjectively experienced symptoms (presence and severity) such as headache, dizziness, memory troubles, after concussion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post Concussion Symptoms</measure>
    <time_frame>Week 2</time_frame>
    <description>The Post-Concussion Symptom Inventory will be used. This is a self report questionnaire that asks about subjectively experienced symptoms (presence and severity) such as headache, dizziness, memory troubles, after concussion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post Concussion Symptoms</measure>
    <time_frame>Week 6 (upon completion of intervention)</time_frame>
    <description>The Post-Concussion Symptom Inventory will be used. This is a self report questionnaire that asks about subjectively experienced symptoms (presence and severity) such as headache, dizziness, memory troubles, after concussion.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mood</measure>
    <time_frame>Week 0 (Baseline)</time_frame>
    <description>The Beck Depression Inventory for Youth- Second Edition will be used. This is a screen that was designed for youth and provides insight into negative thoughts and feelings towards self, life and future.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mood</measure>
    <time_frame>Week 6 (upon completion of the intervention)</time_frame>
    <description>The Beck Depression Inventory for Youth- Second Edition will be used. This is a screen that was designed for youth and provides insight into negative thoughts and feelings towards self, life and future.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavior</measure>
    <time_frame>Week 0 (Baseline)</time_frame>
    <description>The Child Behavior Checklist will be used. It is designed to identify emotional and behavioral concerns in youth.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Behavior</measure>
    <time_frame>Week 6 (upon completion of the intervention)</time_frame>
    <description>The Child Behavior Checklist will be used. It is designed to identify emotional and behavioral concerns in youth.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Energy Level</measure>
    <time_frame>Week 0 (Baseline)</time_frame>
    <description>Pediatric Quality of Life Multidimensional Fatigue Scale will be used to examine fatigue</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Energy Level</measure>
    <time_frame>Week 6 (upon completion of the intervention)</time_frame>
    <description>Pediatric Quality of Life Multidimensional Fatigue Scale will be used to examine fatigue</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Level</measure>
    <time_frame>Week 0 (Baseline)</time_frame>
    <description>Pediatric Quality of Life Generic Module will be used to look at quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Level</measure>
    <time_frame>Week 6 (upon completion of the intervention)</time_frame>
    <description>Pediatric Quality of Life Generic Module will be used to look at quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SCAT Balance</measure>
    <time_frame>Week 0 (Baseline)</time_frame>
    <description>Sport Concussion Assessment Tool- 3rd Edition Balance Subtest will be used. This measure looks at static balance and postural stability. Youth are asked to perform three different stances on a firm surface for 20 seconds each.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Balance</measure>
    <time_frame>Week 0 (Baseline)</time_frame>
    <description>Bruininks-Oseretsky Test of Motor Proficiency, Second Edition Balance Subtest will be used. This is used to assess static and dynamic balance with focus on the youth's anticipatory postural control.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Balance</measure>
    <time_frame>Week 6 (upon completion of the intervention)</time_frame>
    <description>Bruininks-Oseretsky Test of Motor Proficiency, Second Edition Balance Subtest will be used. This is used to assess static and dynamic balance with focus on the youth's anticipatory postural control.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurocognitive</measure>
    <time_frame>Week 0 (Baseline)</time_frame>
    <description>ImPACT testing will be done. This is a computer based program designed to assess multiple aspects of cognitive functioning following a concussion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurocognitive</measure>
    <time_frame>Week 6 (upon completion of the intervention)</time_frame>
    <description>ImPACT testing will be done. This is a computer based program designed to assess multiple aspects of cognitive functioning following a concussion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>Week 0 (Baseline)</time_frame>
    <description>State Trait Anxiety Scale will be used to look at parental anxiety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>Week 6 (upon completion of the intervention)</time_frame>
    <description>State Trait Anxiety Scale will be used to look at parental anxiety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity Participation</measure>
    <time_frame>Week 0 (Baseline)</time_frame>
    <description>Physical Activity Questionnaire for Children and Adolescents will be used to look at the physical activities performed in the 7 days prior to evaluation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction Level</measure>
    <time_frame>Week 0 (Baseline)</time_frame>
    <description>Pediatric Quality of Life Health Care Satisfaction Generic Module will be used to gain an understanding of the participants' perceptions of the quality and effectiveness of the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute Concussion Evaluation</measure>
    <time_frame>Week 0 (Baseline)</time_frame>
    <description>Acute Concussion Evaluation will be used to collect demographic information such as characteristics of the injury, signs and symptoms of the injury, and risk factors that may predict prolonged recovery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occupational Performance</measure>
    <time_frame>Week 0 (Baseline)</time_frame>
    <description>The Canadian Occupational Performance Measure will be used to identify occupational performance issues as a platform for goal setting. Participants' rate their satisfaction and performance in self-identified activities that they would like to improve their satisfaction and performance in.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occupational Performance</measure>
    <time_frame>Week 6 (upon completion of the intervention)</time_frame>
    <description>Participants re-rate their satisfaction and performance in the three areas they self-identified as occupational concerns at week 0 (baseline)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Balance</measure>
    <time_frame>Week 6 (upon completion of intervention)</time_frame>
    <description>Sport Concussion Assessment Tool- 3rd Edition Balance Subtest will be used. This measure looks at static balance and postural stability. Youth are asked to perform three different stances on a firm surface for 20 seconds each.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity Participation</measure>
    <time_frame>Week 6 (upon completion of the intervention)</time_frame>
    <description>Physical Activity Questionnaire for Children and Adolescents will be used to look at the physical activities performed in the 7 days prior to evaluation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activity Participation</measure>
    <time_frame>Week 2</time_frame>
    <description>Physical Activity Questionnaire for Children and Adolescents will be used to look at the physical activities performed in the 7 days prior to evaluation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction Level</measure>
    <time_frame>Week 6 (upon completion of the intervention)</time_frame>
    <description>Pediatric Quality of Life Health Care Satisfaction Generic Module will be used to gain an understanding of the participants' perceptions of the quality and effectiveness of the intervention.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>Concussion</condition>
  <condition>Sport-Related Concussion</condition>
  <condition>Mild Traumatic Brain Injury</condition>
  <arm_group>
    <arm_group_label>Active Rehabilitation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Active Rehabilitation Intervention and Comprehensive Education Intervention (Standard Care)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Comprehensive Education Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Comprehensive Education Intervention (Standard Care) only</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Active Rehabilitation</intervention_name>
    <description>The active rehabilitation intervention is a 6-week graded rehabilitation program, consisting of four components that are anchored in neuroscience evidence.The four components include: 1) aerobic exercise 2) coordination exercise 3) visualization 4) home program.</description>
    <arm_group_label>Active Rehabilitation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Comprehensive Education Intervention (Standard Care)</intervention_name>
    <description>An initial education session will be provided by an occupational therapist related to general concussion information and outcomes, as well as strategies for symptom management following concussion.</description>
    <arm_group_label>Active Rehabilitation</arm_group_label>
    <arm_group_label>Comprehensive Education Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  confirmed diagnosis of concussion&#xD;
&#xD;
          -  have at least one post-concussion symptom (as measured by the Post Concussion Symptom&#xD;
             Inventory)&#xD;
&#xD;
          -  are at least 4 weeks post injury&#xD;
&#xD;
          -  between the ages of 10 and 18 years&#xD;
&#xD;
          -  ability to speak English&#xD;
&#xD;
          -  ability to demonstrate capacity to consent to study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  prior moderate or severe brain injury&#xD;
&#xD;
          -  neck pain/dysfunction or oculormotor/vestibular dysfunction, developmental delays,&#xD;
             mental health disorders or chronic pain conditions that prevent participation in&#xD;
             active rehabilitation, assessment of gait and balance, or participation in cognitive&#xD;
             testing&#xD;
&#xD;
          -  participating in any other physical rehabilitation interventions for post-concussion&#xD;
             symptoms (e.g., physiotherapy, massage therapy, chiropractic) at time of enrollment&#xD;
             and throughout the duration of the study&#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>Nick Reed, PhD, MSc(OT)</last_name>
    <role>Principal Investigator</role>
    <affiliation>Holland Bloorview Kids Rehabilitation Hospital/ Bloorview Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Holland Bloorview Kids Rehabilitation Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4G 1R8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <last_update_submitted>March 10, 2022</last_update_submitted>
  <last_update_submitted_qc>March 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Concussion</keyword>
  <keyword>Persistent Symptoms</keyword>
  <keyword>Children</keyword>
  <keyword>Exercise</keyword>
  <keyword>Adolescents</keyword>
  <keyword>Active Rehabilitation</keyword>
  <keyword>Education</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Brain Concussion</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/NCT02257749
org study id: 13-459
nct id: NCT02257749
lead sponsor: 
has dmc: No
The purpose of this randomized control trial study is to determine if an active
      rehabilitation (low intensity exercise program) in combination with a comprehensive education
      intervention (standard care) is more effective than the comprehensive education intervention
      alone in reducing post-concussion symptoms and improving participation in daily activities in
      youth who have persistent post-concussion symptoms.
There is a portion of youth who continue to experience persistent post-concussion symptoms
      beyond the first few weeks of injury. There is limited evidence with respect to the best ways
      to treat persistent post-concussion symptoms in youth following concussion. There is a small
      amount of literature that suggests active rehabilitation as a positive intervention for
      promotion of recovery of persistent post-concussion symptoms. However, this approach to
      rehabilitation has yet to be explored using a randomized control trial protocol.

      Therefore, this study aims to answer the following question: Is a 6 week active
      rehabilitation program in combination with a comprehensive education intervention (standard
      care) effective in reducing post-concussive symptoms and improving functional recovery
      compared to receiving comprehensive education intervention alone among youth experiencing
      persistent post-concussion symptoms?

      We hypothesize:

        1. youth ages 10 to 18 years who present with persistent self-reported post-concussion
           symptoms 4 weeks after the initial injury and receive the active rehabilitation
           intervention, will present with decreased post-concussion symptoms at the completion of
           the intervention.

        2. youth ages 10 to 18 years who receive the active rehabilitation intervention, will
           present with more complete functional recovery and increased participation in
           unrestricted physical activity at the completion of the active rehabilitation
           intervention compared to children receiving the comprehensive education intervention
           only
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Post-Concussion Symptoms
time frame: Week 0 (Baseline)
description: The Post-Concussion Symptom Inventory will be used. This is a self report questionnaire that asks about subjectively experienced symptoms (presence and severity) such as headache, dizziness, memory troubles, after concussion.
measure: Post Concussion Symptoms
time frame: Week 2
description: The Post-Concussion Symptom Inventory will be used. This is a self report questionnaire that asks about subjectively experienced symptoms (presence and severity) such as headache, dizziness, memory troubles, after concussion.
measure: Post Concussion Symptoms
time frame: Week 6 (upon completion of intervention)
description: The Post-Concussion Symptom Inventory will be used. This is a self report questionnaire that asks about subjectively experienced symptoms (presence and severity) such as headache, dizziness, memory troubles, after concussion.
measure: Mood
time frame: Week 0 (Baseline)
description: The Beck Depression Inventory for Youth- Second Edition will be used. This is a screen that was designed for youth and provides insight into negative thoughts and feelings towards self, life and future.
measure: Mood
time frame: Week 6 (upon completion of the intervention)
description: The Beck Depression Inventory for Youth- Second Edition will be used. This is a screen that was designed for youth and provides insight into negative thoughts and feelings towards self, life and future.
measure: Behavior
time frame: Week 0 (Baseline)
description: The Child Behavior Checklist will be used. It is designed to identify emotional and behavioral concerns in youth.
measure: Behavior
time frame: Week 6 (upon completion of the intervention)
description: The Child Behavior Checklist will be used. It is designed to identify emotional and behavioral concerns in youth.
measure: Energy Level
time frame: Week 0 (Baseline)
description: Pediatric Quality of Life Multidimensional Fatigue Scale will be used to examine fatigue
measure: Energy Level
time frame: Week 6 (upon completion of the intervention)
description: Pediatric Quality of Life Multidimensional Fatigue Scale will be used to examine fatigue
measure: Quality of Life Level
time frame: Week 0 (Baseline)
description: Pediatric Quality of Life Generic Module will be used to look at quality of life
measure: Quality of Life Level
time frame: Week 6 (upon completion of the intervention)
description: Pediatric Quality of Life Generic Module will be used to look at quality of life
measure: SCAT Balance
time frame: Week 0 (Baseline)
description: Sport Concussion Assessment Tool- 3rd Edition Balance Subtest will be used. This measure looks at static balance and postural stability. Youth are asked to perform three different stances on a firm surface for 20 seconds each.
measure: Balance
time frame: Week 0 (Baseline)
description: Bruininks-Oseretsky Test of Motor Proficiency, Second Edition Balance Subtest will be used. This is used to assess static and dynamic balance with focus on the youth's anticipatory postural control.
measure: Balance
time frame: Week 6 (upon completion of the intervention)
description: Bruininks-Oseretsky Test of Motor Proficiency, Second Edition Balance Subtest will be used. This is used to assess static and dynamic balance with focus on the youth's anticipatory postural control.
measure: Neurocognitive
time frame: Week 0 (Baseline)
description: ImPACT testing will be done. This is a computer based program designed to assess multiple aspects of cognitive functioning following a concussion.
measure: Neurocognitive
time frame: Week 6 (upon completion of the intervention)
description: ImPACT testing will be done. This is a computer based program designed to assess multiple aspects of cognitive functioning following a concussion.
measure: Anxiety
time frame: Week 0 (Baseline)
description: State Trait Anxiety Scale will be used to look at parental anxiety
measure: Anxiety
time frame: Week 6 (upon completion of the intervention)
description: State Trait Anxiety Scale will be used to look at parental anxiety
measure: Activity Participation
time frame: Week 0 (Baseline)
description: Physical Activity Questionnaire for Children and Adolescents will be used to look at the physical activities performed in the 7 days prior to evaluation.
measure: Satisfaction Level
time frame: Week 0 (Baseline)
description: Pediatric Quality of Life Health Care Satisfaction Generic Module will be used to gain an understanding of the participants' perceptions of the quality and effectiveness of the intervention.
measure: Acute Concussion Evaluation
time frame: Week 0 (Baseline)
description: Acute Concussion Evaluation will be used to collect demographic information such as characteristics of the injury, signs and symptoms of the injury, and risk factors that may predict prolonged recovery.
measure: Occupational Performance
time frame: Week 0 (Baseline)
description: The Canadian Occupational Performance Measure will be used to identify occupational performance issues as a platform for goal setting. Participants' rate their satisfaction and performance in self-identified activities that they would like to improve their satisfaction and performance in.
measure: Occupational Performance
time frame: Week 6 (upon completion of the intervention)
description: Participants re-rate their satisfaction and performance in the three areas they self-identified as occupational concerns at week 0 (baseline)
measure: Balance
time frame: Week 6 (upon completion of intervention)
description: Sport Concussion Assessment Tool- 3rd Edition Balance Subtest will be used. This measure looks at static balance and postural stability. Youth are asked to perform three different stances on a firm surface for 20 seconds each.
measure: Activity Participation
time frame: Week 6 (upon completion of the intervention)
description: Physical Activity Questionnaire for Children and Adolescents will be used to look at the physical activities performed in the 7 days prior to evaluation.
measure: Activity Participation
time frame: Week 2
description: Physical Activity Questionnaire for Children and Adolescents will be used to look at the physical activities performed in the 7 days prior to evaluation.
measure: Satisfaction Level
time frame: Week 6 (upon completion of the intervention)
description: Pediatric Quality of Life Health Care Satisfaction Generic Module will be used to gain an understanding of the participants' perceptions of the quality and effectiveness of the intervention.
arm group label: Active Rehabilitation
arm group type: Experimental
description: Active Rehabilitation Intervention and Comprehensive Education Intervention (Standard Care)
arm group label: Comprehensive Education Intervention
arm group type: Active Comparator
description: Comprehensive Education Intervention (Standard Care) only
intervention type: Other
intervention name: Active Rehabilitation
description: The active rehabilitation intervention is a 6-week graded rehabilitation program, consisting of four components that are anchored in neuroscience evidence.The four components include: 1) aerobic exercise 2) coordination exercise 3) visualization 4) home program.
arm group label: Active Rehabilitation
intervention type: Other
intervention name: Comprehensive Education Intervention (Standard Care)
description: An initial education session will be provided by an occupational therapist related to general concussion information and outcomes, as well as strategies for symptom management following concussion.
arm group label: Active Rehabilitation
arm group label: Comprehensive Education Intervention
criteria: 
gender: All
minimum age: 10 Years
maximum age: 18 Years
healthy volunteers: No
last name: Nick Reed, PhD, MSc(OT)
role: Principal Investigator
affiliation: Holland Bloorview Kids Rehabilitation Hospital/ Bloorview Research Institute
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Brain Concussion