Clinical trial NCT02988323: Cervicovestibular Physiotherapy and Aerobic Exercise in Concussion
Official title: Cervicovestibular Rehabilitation and Aerobic Exercise in Children and Youth With Persistent Symptoms Following a Sport-related Concussion: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Concussion
Keywords: sport concussion
cervical spine
vestibular rehabilitation
exercise
rehabilitation
children
youth
Lead sponsor: Sport Injury Prevention Research Centre
Sponsor class: OTHER
Collaborators: name: University of Calgary
First posted: 2016-12-09
Enrollment: 96
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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).

Eligibility 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

Primary outcomes:
measure: Medical Clearance to return to sport
timeFrame: 8 weeks
measure: Pediatric Quality of Life
timeFrame: Change from Initial assessment to 8 weeks
Secondary outcomes:
measure: Sport Multidimensional Perfectionism Scale-2
timeFrame: Change from Initial assessment to 8 weeks
measure: Connor-Davidson Resilience Scale
timeFrame: Change from Initial assessment to 8 weeks
measure: K6 Scale
timeFrame: Change from Initial assessment to 8 weeks
measure: Supplemental Questions (Mrazick)
timeFrame: Change from Initial assessment to 8 weeks
measure: Self-efficacy questionnaire for children (Gagnon et al, 2009)
timeFrame: Change from Initial assessment to 8 weeks
measure: Global Rating of Change
timeFrame: Change from Initial assessment to 8 weeks
measure: Numeric Pain Rating Scale (Neck Pain)
timeFrame: Change from Initial assessment to 8 weeks
measure: Numeric Pain Rating Scale (Headache)
timeFrame: Change from Initial assessment to 8 weeks
measure: Numeric Dizziness Rating Scale
timeFrame: Change from Initial assessment to 8 weeks
measure: Patient Specific Functional Scale (PSFS)
timeFrame: Change from Initial assessment to 8 weeks
measure: Activities-specific Balance Confidence Scale
timeFrame: Change from Initial assessment to 8 weeks
measure: Dizziness Handicap Inventory
timeFrame: Change from Initial assessment to 8 weeks
measure: Sport Concussion Assessment Tool 3
timeFrame: Change from Initial assessment to 8 weeks
measure: Dynamic Visual Acuity
timeFrame: Change from Initial assessment to 8 weeks
measure: Balance Error Scoring System
timeFrame: Change from Initial assessment to 8 weeks
measure: Functional Gait Assessment
timeFrame: Change from Initial assessment to 8 weeks
measure: Head Thrust Test
timeFrame: Change from Initial assessment to 8 weeks
measure: Motion Sensitivity Test
timeFrame: Change from Initial assessment to 8 weeks
measure: Cervical Flexor Endurance
timeFrame: Change from Initial assessment to 8 weeks
measure: Cervical Flexion Rotation Test (CFRT)
timeFrame: Change from Initial assessment to 8 weeks
measure: Palpation for Segmental Tenderness (PST)
timeFrame: Change from Initial assessment to 8 weeks
measure: Cervical Rotation Side Flexion Test
timeFrame: Change from Initial assessment to 8 weeks
measure: Joint Position Error (JPE)
timeFrame: Change from Initial assessment to 8 weeks
measure: Walk While Talking Test
timeFrame: Change from Initial assessment to 8 weeks
measure: Vestibular/Ocular Motor Screen (VOMS)
timeFrame: Change from Initial assessment to 8 weeks
measure: Manual Spinal Examination (MSE)
timeFrame: Change from Initial assessment to 8 weeks
measure: Actigraphy
timeFrame: Change from Initial Assessment to 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Calgary
name: Kathryn Schneider
role: PRINCIPAL_INVESTIGATOR
References:
citation: McCrory P, Meeuwisse WH, Aubry M, Cantu RC, Dvorak J, Echemendia RJ, Engebretsen L, Johnston K, Kutcher JS, Raftery M, Sills A, Benson BW, Davis GA, Ellenbogen R, Guskiewicz KM, Herring SA, Iverson GL, Jordan BD, Kissick J, McCrea M, McIntosh AS, Maddocks D, Makdissi M, Purcell L, Putukian M, Schneider K, Tator CH, Turner M. Consensus statement on concussion in sport: the 4th International Conference on Concussion in Sport, Zurich, November 2012. J Athl Train. 2013 Jul-Aug;48(4):554-75. doi: 10.4085/1062-6050-48.4.05. No abstract available.
citation: Gagnon I, Galli C, Friedman D, Grilli L, Iverson GL. Active rehabilitation for children who are slow to recover following sport-related concussion. Brain Inj. 2009 Nov;23(12):956-64. doi: 10.3109/02699050903373477.
citation: Schneider KJ, Meeuwisse WH, Nettel-Aguirre A, Barlow K, Boyd L, Kang J, Emery CA. Cervicovestibular rehabilitation in sport-related concussion: a randomised controlled trial. Br J Sports Med. 2014 Sep;48(17):1294-8. doi: 10.1136/bjsports-2013-093267. Epub 2014 May 22.
citation: Schneider KJ, Iverson GL, Emery CA, McCrory P, Herring SA, Meeuwisse WH. The effects of rest and treatment following sport-related concussion: a systematic review of the literature. Br J Sports Med. 2013 Apr;47(5):304-7. doi: 10.1136/bjsports-2013-092190.
citation: Gagnon I, Grilli L, Friedman D, Iverson GL. A pilot study of active rehabilitation for adolescents who are slow to recover from sport-related concussion. Scand J Med Sci Sports. 2016 Mar;26(3):299-306. doi: 10.1111/sms.12441. Epub 2015 Mar 3.