Cervicovestibular Physiotherapy and Aerobic Exercise in Concussion

NCT ID: NCT02988323

Last Updated: 2016-12-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2018-03-31

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).

Conditions

Concussion

Keywords

sport concussion; cervical spine; vestibular rehabilitation; exercise; rehabilitation; children; youth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cervicovestibular Physio (CV PT)

Intervention Type: OTHER

See description in CVPT arm

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.

Group Type: EXPERIMENTAL

Low-Level Aerobic Exercise (LLAE)

Intervention Type: OTHER

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.

Group Type: OTHER

Combination (LLAE and CV PT)

Intervention Type: OTHER

See description in LLAE and CVPT arm

Interventions

Cervicovestibular Physio (CV PT)

See description in CVPT arm

Intervention Type: OTHER

Low-Level Aerobic Exercise (LLAE)

See description in LLAE arm

Intervention Type: OTHER

Combination (LLAE and CV PT)

See description in LLAE and CVPT arm

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Calgary

OTHER

Sponsor Role: collaborator

Sport Injury Prevention Research Centre

OTHER

Sponsor Role: lead

Responsible Party

KSchneider

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathryn Schneider

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Central Contacts

Kathryn Schneider

Role: CONTACT

Phone: 403-210-8951

Email: kjschnei@ucalgary.ca

Carolyn Emery

Role: CONTACT

Phone: 403-220-4608

Email: caemery@ucalgary.ca

References

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.

Reference Type: BACKGROUND

PMID: 23855364 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19831492 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24855132 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23479489 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25735821 (View on PubMed)

Other Identifiers

Conc-PT-02

Identifier Type: -

Identifier Source: org_study_id