Cervicovestibular Physiotherapy and Aerobic Exercise in Concussion

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02988323
• Other study ID #: Conc-PT-02
• Status: Not yet recruiting
• Phase: N/A
• First received: October 12, 2016
• Last updated: December 7, 2016
• Start date: December 2016
• Est. completion date: March 2018

Study information

• Verified date: December 2016
• Source: Sport Injury Prevention Research Centre
• Contact: Kathryn Schneider
• Phone: 403-210-8951
• Email: kjschnei[@]ucalgary.ca
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Concussion

Intervention

Other:
• Cervicovestibular Physio (CV PT)
See description in CVPT arm
• Low-Level Aerobic Exercise (LLAE)
See description in LLAE arm
• Combination (LLAE and CV PT)
See description in LLAE and CVPT arm

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sport Injury Prevention Research Centre	University of Calgary

References & Publications (5)

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. — View 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. — View Citation

McCrory P, Meeuwisse WH, Aubry M, Cantu RC, Dvorák 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: Asymptomatic a rest; Able to complete all steps of the return to play protocol with no recurrence of symptoms; Able to return to school full time without accommodations; 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.	8 weeks	No
Primary	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.	Change from Initial assessment to 8 weeks	No
Secondary	Sport Multidimensional Perfectionism Scale-2		Change from Initial assessment to 8 weeks	No
Secondary	Connor-Davidson Resilience Scale		Change from Initial assessment to 8 weeks	No
Secondary	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.	Change from Initial assessment to 8 weeks	No
Secondary	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	Change from Initial assessment to 8 weeks	No
Secondary	Self-efficacy questionnaire for children (Gagnon et al, 2009)		Change from Initial assessment to 8 weeks	No
Secondary	Global Rating of Change		Change from Initial assessment to 8 weeks	No
Secondary	Numeric Pain Rating Scale (Neck Pain)	Neck pain rating from 0-10	Change from Initial assessment to 8 weeks	No
Secondary	Numeric Pain Rating Scale (Headache)	Headache rating from 0-10	Change from Initial assessment to 8 weeks	No
Secondary	Numeric Dizziness Rating Scale	Dizziness rating from 0-10	Change from Initial assessment to 8 weeks	No
Secondary	Patient Specific Functional Scale (PSFS)		Change from Initial assessment to 8 weeks	No
Secondary	Activities-specific Balance Confidence Scale		Change from Initial assessment to 8 weeks	No
Secondary	Dizziness Handicap Inventory		Change from Initial assessment to 8 weeks	No
Secondary	Sport Concussion Assessment Tool 3		Change from Initial assessment to 8 weeks	No
Secondary	Dynamic Visual Acuity	Clinical test of dynamic visual acuity using ETDRS	Change from Initial assessment to 8 weeks	No
Secondary	Balance Error Scoring System		Change from Initial assessment to 8 weeks	No
Secondary	Functional Gait Assessment	10 item standardized test of dynamic balance	Change from Initial assessment to 8 weeks	No
Secondary	Head Thrust Test		Change from Initial assessment to 8 weeks	No
Secondary	Motion Sensitivity Test		Change from Initial assessment to 8 weeks	No
Secondary	Cervical Flexor Endurance	Standardized test of cervical flexor endurance measured in seconds	Change from Initial assessment to 8 weeks	No
Secondary	Cervical Flexion Rotation Test (CFRT)		Change from Initial assessment to 8 weeks	No
Secondary	Palpation for Segmental Tenderness (PST)	As per Schneider et al 2014, palpation for segmental tenderness in cervical spine	Change from Initial assessment to 8 weeks	No
Secondary	Cervical Rotation Side Flexion Test		Change from Initial assessment to 8 weeks	No
Secondary	Joint Position Error (JPE)		Change from Initial assessment to 8 weeks	No
Secondary	Walk While Talking Test		Change from Initial assessment to 8 weeks	No
Secondary	Vestibular/Ocular Motor Screen (VOMS)	As per Mucha et al, 2014	Change from Initial assessment to 8 weeks	No
Secondary	Manual Spinal Examination (MSE)	As per Schneider et al, 2014	Change from Initial assessment to 8 weeks	No
Secondary	Actigraphy	Use of a waist worn activity monitor to validly measure the amount of physical activity that an individual performs throughout their day.	Change from Initial Assessment to 8 weeks	No