Concussion Clinical Trial
Official title:
Cervicovestibular Rehabilitation and Aerobic Exercise in Children and Youth With Persistent Symptoms Following a Sport-related Concussion: A Randomized Controlled Trial.
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, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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