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Trial Study of an Exercise Program for Youth With Persistent Symptoms After Concussion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02257749
Recruitment Status : Terminated (feasibility; challenges with recruitment)
First Posted : October 6, 2014
Last Update Posted : December 1, 2016
Sponsor:
Information provided by (Responsible Party):
Holland Bloorview Kids Rehabilitation Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Concussion Sport-Related Concussion Mild Traumatic Brain Injury Other: Active Rehabilitation Other: Comprehensive Education Intervention (Standard Care) Not Applicable

Detailed Description:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparing Active Rehabilitation to a Comprehensive Education Intervention for Youth With Persistent Post-concussion Symptoms Following Concussion.
Study Start Date : January 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Active Rehabilitation
Active Rehabilitation Intervention and Comprehensive Education Intervention (Standard Care)
Other: Active Rehabilitation
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.

Other: Comprehensive Education Intervention (Standard Care)
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.

Active Comparator: Comprehensive Education Intervention
Comprehensive Education Intervention (Standard Care) only
Other: Comprehensive Education Intervention (Standard Care)
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.




Primary Outcome Measures :
  1. Post-Concussion Symptoms [ Time Frame: Week 0 (Baseline) ]
    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.

  2. Post Concussion Symptoms [ Time Frame: Week 2 ]
    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.

  3. Post Concussion Symptoms [ Time Frame: Week 6 (upon completion of intervention) ]
    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.


Secondary Outcome Measures :
  1. Mood [ Time Frame: Week 0 (Baseline) ]
    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.

  2. Mood [ Time Frame: Week 6 (upon completion of the intervention) ]
    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.

  3. Behavior [ Time Frame: Week 0 (Baseline) ]
    The Child Behavior Checklist will be used. It is designed to identify emotional and behavioral concerns in youth.

  4. Behavior [ Time Frame: Week 6 (upon completion of the intervention) ]
    The Child Behavior Checklist will be used. It is designed to identify emotional and behavioral concerns in youth.

  5. Energy Level [ Time Frame: Week 0 (Baseline) ]
    Pediatric Quality of Life Multidimensional Fatigue Scale will be used to examine fatigue

  6. Energy Level [ Time Frame: Week 6 (upon completion of the intervention) ]
    Pediatric Quality of Life Multidimensional Fatigue Scale will be used to examine fatigue

  7. Quality of Life [ Time Frame: Week 0 (Baseline) ]
    Pediatric Quality of Life Generic Module will be used to look at quality of life

  8. Quality of Life [ Time Frame: Week 6 (upon completion of the intervention) ]
    Pediatric Quality of Life Generic Module will be used to look at quality of life

  9. Balance [ Time Frame: Week 0 (Baseline) ]
    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.

  10. Balance [ Time Frame: Week 0 (Baseline) ]
    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.

  11. Balance [ Time Frame: Week 6 (upon completion of the intervention) ]
    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.

  12. Neurocognitive [ Time Frame: Week 0 (Baseline) ]
    ImPACT testing will be done. This is a computer based program designed to assess multiple aspects of cognitive functioning following a concussion.

  13. Neurocognitive [ Time Frame: Week 6 (upon completion of the intervention) ]
    ImPACT testing will be done. This is a computer based program designed to assess multiple aspects of cognitive functioning following a concussion.

  14. Anxiety [ Time Frame: Week 0 (Baseline) ]
    State Trait Anxiety Scale will be used to look at parental anxiety

  15. Anxiety [ Time Frame: Week 6 (upon completion of the intervention) ]
    State Trait Anxiety Scale will be used to look at parental anxiety

  16. Activity Participation [ Time Frame: Week 0 (Baseline) ]
    Physical Activity Questionnaire for Children and Adolescents will be used to look at the physical activities performed in the 7 days prior to evaluation.

  17. Satisfaction [ Time Frame: Week 0 (Baseline) ]
    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.

  18. Acute Concussion Evaluation [ Time Frame: Week 0 (Baseline) ]
    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.

  19. Occupational Performance [ Time Frame: Week 0 (Baseline) ]
    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.

  20. Occupational Performance [ Time Frame: Week 6 (upon completion of the intervention) ]
    Participants re-rate their satisfaction and performance in the three areas they self-identified as occupational concerns at week 0 (baseline)

  21. Balance [ Time Frame: Week 6 (upon completion of intervention) ]
    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.

  22. Activity Participation [ Time Frame: Week 6 (upon completion of the intervention) ]
    Physical Activity Questionnaire for Children and Adolescents will be used to look at the physical activities performed in the 7 days prior to evaluation.

  23. Activity Participation [ Time Frame: Week 2 ]
    Physical Activity Questionnaire for Children and Adolescents will be used to look at the physical activities performed in the 7 days prior to evaluation.

  24. Satisfaction [ Time Frame: Week 6 (upon completion of the intervention) ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • confirmed diagnosis of concussion
  • have at least one post-concussion symptom (as measured by the Post Concussion Symptom Inventory)
  • are at least 4 weeks post injury
  • between the ages of 10 and 18 years
  • ability to speak English
  • ability to demonstrate capacity to consent to study

Exclusion Criteria:

  • prior moderate or severe brain injury
  • neck pain/dysfunction or oculormotor/vestibular dysfunction, developmental delays, mental health disorders or chronic pain conditions that prevent participation in active rehabilitation, assessment of gait and balance, or participation in cognitive testing
  • participating in any other physical rehabilitation interventions for post-concussion symptoms (e.g., physiotherapy, massage therapy, chiropractic) at time of enrollment and throughout the duration of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02257749


Locations
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Canada, Ontario
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, Canada, M4G 1R8
Sponsors and Collaborators
Holland Bloorview Kids Rehabilitation Hospital
Investigators
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Principal Investigator: Nick Reed, PhD, MSc(OT) Holland Bloorview Kids Rehabilitation Hospital/ Bloorview Research Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Holland Bloorview Kids Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT02257749    
Other Study ID Numbers: 13-459
First Posted: October 6, 2014    Key Record Dates
Last Update Posted: December 1, 2016
Last Verified: January 2016
Keywords provided by Holland Bloorview Kids Rehabilitation Hospital:
Concussion
Persistent Symptoms
Children
Exercise
Adolescents
Active Rehabilitation
Education
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Head Injuries, Closed
Wounds, Nonpenetrating