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Cervicovestibular Physiotherapy and Aerobic Exercise in Concussion

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ClinicalTrials.gov Identifier: NCT02988323
Recruitment Status : Not yet recruiting
First Posted : December 9, 2016
Last Update Posted : December 9, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Concussion Other: Cervicovestibular Physio (CV PT) Other: Low-Level Aerobic Exercise (LLAE) Other: Combination (LLAE and CV PT)

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cervicovestibular Rehabilitation and Aerobic Exercise in Children and Youth With Persistent Symptoms Following a Sport-related Concussion: A Randomized Controlled Trial.
Study Start Date : December 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Cervicovestibular Physio (CV PT)
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.
Other: Cervicovestibular Physio (CV PT)
See description in CVPT arm
Experimental: Low-Level Aerobic Exercise (LLAE)
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.
Other: Low-Level Aerobic Exercise (LLAE)
See description in LLAE arm
Combination (LLAE and CV PT)
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.
Other: Combination (LLAE and CV PT)
See description in LLAE and CVPT arm


Outcome Measures

Primary Outcome Measures :
  1. Medical Clearance to return to sport [ Time Frame: 8 weeks ]

    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:

    1. Asymptomatic a rest
    2. Able to complete all steps of the return to play protocol with no recurrence of symptoms
    3. Able to return to school full time without accommodations
    4. 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.

  2. Pediatric Quality of Life [ Time Frame: Change from Initial assessment to 8 weeks ]
    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.


Secondary Outcome Measures :
  1. Sport Multidimensional Perfectionism Scale-2 [ Time Frame: Change from Initial assessment to 8 weeks ]
  2. Connor-Davidson Resilience Scale [ Time Frame: Change from Initial assessment to 8 weeks ]
  3. K6 Scale [ Time Frame: Change from Initial assessment to 8 weeks ]
    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.

  4. Supplemental Questions (Mrazick) [ Time Frame: Change from Initial assessment to 8 weeks ]
    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

  5. Self-efficacy questionnaire for children (Gagnon et al, 2009) [ Time Frame: Change from Initial assessment to 8 weeks ]
  6. Global Rating of Change [ Time Frame: Change from Initial assessment to 8 weeks ]
  7. Numeric Pain Rating Scale (Neck Pain) [ Time Frame: Change from Initial assessment to 8 weeks ]
    Neck pain rating from 0-10

  8. Numeric Pain Rating Scale (Headache) [ Time Frame: Change from Initial assessment to 8 weeks ]
    Headache rating from 0-10

  9. Numeric Dizziness Rating Scale [ Time Frame: Change from Initial assessment to 8 weeks ]
    Dizziness rating from 0-10

  10. Patient Specific Functional Scale (PSFS) [ Time Frame: Change from Initial assessment to 8 weeks ]
  11. Activities-specific Balance Confidence Scale [ Time Frame: Change from Initial assessment to 8 weeks ]
  12. Dizziness Handicap Inventory [ Time Frame: Change from Initial assessment to 8 weeks ]
  13. Sport Concussion Assessment Tool 3 [ Time Frame: Change from Initial assessment to 8 weeks ]
  14. Dynamic Visual Acuity [ Time Frame: Change from Initial assessment to 8 weeks ]
    Clinical test of dynamic visual acuity using ETDRS

  15. Balance Error Scoring System [ Time Frame: Change from Initial assessment to 8 weeks ]
  16. Functional Gait Assessment [ Time Frame: Change from Initial assessment to 8 weeks ]
    10 item standardized test of dynamic balance

  17. Head Thrust Test [ Time Frame: Change from Initial assessment to 8 weeks ]
  18. Motion Sensitivity Test [ Time Frame: Change from Initial assessment to 8 weeks ]
  19. Cervical Flexor Endurance [ Time Frame: Change from Initial assessment to 8 weeks ]
    Standardized test of cervical flexor endurance measured in seconds

  20. Cervical Flexion Rotation Test (CFRT) [ Time Frame: Change from Initial assessment to 8 weeks ]
  21. Palpation for Segmental Tenderness (PST) [ Time Frame: Change from Initial assessment to 8 weeks ]
    As per Schneider et al 2014, palpation for segmental tenderness in cervical spine

  22. Cervical Rotation Side Flexion Test [ Time Frame: Change from Initial assessment to 8 weeks ]
  23. Joint Position Error (JPE) [ Time Frame: Change from Initial assessment to 8 weeks ]
  24. Walk While Talking Test [ Time Frame: Change from Initial assessment to 8 weeks ]
  25. Vestibular/Ocular Motor Screen (VOMS) [ Time Frame: Change from Initial assessment to 8 weeks ]
    As per Mucha et al, 2014

  26. Manual Spinal Examination (MSE) [ Time Frame: Change from Initial assessment to 8 weeks ]
    As per Schneider et al, 2014

  27. Actigraphy [ Time Frame: Change from Initial Assessment to 8 weeks ]
    Use of a waist worn activity monitor to validly measure the amount of physical activity that an individual performs throughout their day.


Eligibility Criteria

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:

  • Inclusion Criteria:

    • Ages 10-18 years of age
    • Diagnosed by the study sport medicine physician with a sport related concussion as per the 4th International Consensus guidelines
    • Persistent symptoms of dizziness, neck pain and/or headaches (>10 days and less than one year post injury) reported on the Sport Concussion Assessment Tool 3 (SCAT3) at initial or follow-up visit to the study sport medicine physician
    • Clinical findings suggesting cervical spine and/or vestibular involvement (i.e. limitations in cervical range of motion, positive clinical tests suggesting cervicogenic headaches, altered patterns of neuromotor control, alterations on dynamic visual acuity, dynamic balance, motion sensitivity, positive test for BPPV, etc)

Exclusion Criteria:

  • • Inability to participate in physical activity for a reason other than sport related concussion

    • Inability to communicate in English language
    • Neurodevelopmental delays
    • Other orthopaedic injury affecting ability to participate
    • Medication known to affect neural adaptation as they may alter the response to treatment
Contacts and Locations

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): NCT02988323


Contacts
Contact: Kathryn Schneider 403-210-8951 kjschnei@ucalgary.ca
Contact: Carolyn Emery 403-220-4608 caemery@ucalgary.ca

Sponsors and Collaborators
Sport Injury Prevention Research Centre
University of Calgary
Investigators
Principal Investigator: Kathryn Schneider University of Calgary
More Information

Publications:

Responsible Party: KSchneider, Assistant Professor, Sport Injury Prevention Research Centre
ClinicalTrials.gov Identifier: NCT02988323     History of Changes
Other Study ID Numbers: Conc-PT-02
First Posted: December 9, 2016    Key Record Dates
Last Update Posted: December 9, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by KSchneider, Sport Injury Prevention Research Centre:
sport concussion
cervical spine
vestibular rehabilitation
exercise
rehabilitation
children
youth