Cervicovestibular Physiotherapy and Aerobic Exercise in Concussion

NCT02988323 | Unknown DMC

• 1 other identifier: Conc-PT-02
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Concussion

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Change from Initial assessment to 8 weeks

Secondary Outcomes (27)

• Sport Multidimensional Perfectionism Scale-2

  Change from Initial assessment to 8 weeks

• Connor-Davidson Resilience Scale

  Change from Initial assessment to 8 weeks

• K6 Scale

  Change from Initial assessment to 8 weeks

• Supplemental Questions (Mrazick)

  Change from Initial assessment to 8 weeks

• Self-efficacy questionnaire for children (Gagnon et al, 2009)

  Change from Initial assessment to 8 weeks

Study Arms (3)

Cervicovestibular Physio (CV PT)

EXPERIMENTAL

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.

Other: Cervicovestibular Physio (CV PT)

Low-Level Aerobic Exercise (LLAE)

EXPERIMENTAL

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.

Other: Low-Level Aerobic Exercise (LLAE)

Combination (LLAE and CV PT)

OTHER

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.

Other: Combination (LLAE and CV PT)

Interventions

Cervicovestibular Physio (CV PT) OTHER

See description in CVPT arm

Cervicovestibular Physio (CV PT)

Low-Level Aerobic Exercise (LLAE) OTHER

See description in LLAE arm

Low-Level Aerobic Exercise (LLAE)

Combination (LLAE and CV PT) OTHER

See description in LLAE and CVPT arm

Combination (LLAE and CV PT)

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sport Injury Prevention Research Centre: lead
• University of Calgary: collaborator

Related Publications (5)

• 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.

  PMID: 23855364 BACKGROUND

• 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.

  PMID: 19831492 BACKGROUND

• 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.

  PMID: 24855132 BACKGROUND

• 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.

  PMID: 23479489 BACKGROUND

• 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.

  PMID: 25735821 BACKGROUND

MeSH Terms

Conditions

Brain Concussion; Motor Activity

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Behavior

Study Officials

• Kathryn Schneider

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathryn Schneider

CONTACT

403-210-8951; kjschnei@ucalgary.ca

Carolyn Emery

CONTACT

403-220-4608; caemery@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 12, 2016
• First Posted: December 9, 2016
• Study Start: December 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: December 9, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share