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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
96
See description in CVPT arm
See description in LLAE arm
See description in LLAE and CVPT arm
Medical Clearance to return to sport
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.
Time frame: 8 weeks
Pediatric Quality of Life
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.
Time frame: Change from Initial assessment to 8 weeks
Sport Multidimensional Perfectionism Scale-2
Time frame: Change from Initial assessment to 8 weeks
Connor-Davidson Resilience Scale
Time frame: Change from Initial assessment to 8 weeks
K6 Scale
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.
Time frame: Change from Initial assessment to 8 weeks
Supplemental Questions (Mrazick)
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
Time frame: Change from Initial assessment to 8 weeks
Self-efficacy questionnaire for children (Gagnon et al, 2009)
Time frame: Change from Initial assessment to 8 weeks
Global Rating of Change
Time frame: Change from Initial assessment to 8 weeks
Numeric Pain Rating Scale (Neck Pain)
Neck pain rating from 0-10
Time frame: Change from Initial assessment to 8 weeks
Numeric Pain Rating Scale (Headache)
Headache rating from 0-10
Time frame: Change from Initial assessment to 8 weeks
Numeric Dizziness Rating Scale
Dizziness rating from 0-10
Time frame: Change from Initial assessment to 8 weeks
Patient Specific Functional Scale (PSFS)
Time frame: Change from Initial assessment to 8 weeks
Activities-specific Balance Confidence Scale
Time frame: Change from Initial assessment to 8 weeks
Dizziness Handicap Inventory
Time frame: Change from Initial assessment to 8 weeks
Sport Concussion Assessment Tool 3
Time frame: Change from Initial assessment to 8 weeks
Dynamic Visual Acuity
Clinical test of dynamic visual acuity using ETDRS
Time frame: Change from Initial assessment to 8 weeks
Balance Error Scoring System
Time frame: Change from Initial assessment to 8 weeks
Functional Gait Assessment
10 item standardized test of dynamic balance
Time frame: Change from Initial assessment to 8 weeks
Head Thrust Test
Time frame: Change from Initial assessment to 8 weeks
Motion Sensitivity Test
Time frame: Change from Initial assessment to 8 weeks
Cervical Flexor Endurance
Standardized test of cervical flexor endurance measured in seconds
Time frame: Change from Initial assessment to 8 weeks
Cervical Flexion Rotation Test (CFRT)
Time frame: Change from Initial assessment to 8 weeks
Palpation for Segmental Tenderness (PST)
As per Schneider et al 2014, palpation for segmental tenderness in cervical spine
Time frame: Change from Initial assessment to 8 weeks
Cervical Rotation Side Flexion Test
Time frame: Change from Initial assessment to 8 weeks
Joint Position Error (JPE)
Time frame: Change from Initial assessment to 8 weeks
Walk While Talking Test
Time frame: Change from Initial assessment to 8 weeks
Vestibular/Ocular Motor Screen (VOMS)
As per Mucha et al, 2014
Time frame: Change from Initial assessment to 8 weeks
Manual Spinal Examination (MSE)
As per Schneider et al, 2014
Time frame: Change from Initial assessment to 8 weeks
Actigraphy
Use of a waist worn activity monitor to validly measure the amount of physical activity that an individual performs throughout their day.
Time frame: Change from Initial Assessment to 8 weeks
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