Clinical trial NCT03360786: Primary Prevention of Concussion in Youth Ice Hockey Players
Official title: Primary Prevention of Concussion in Youth Ice Hockey Players
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Concussion
Keywords: sport concussion
cervical spine
youth
Lead sponsor: Sport Injury Prevention Research Centre
Sponsor class: OTHER
First posted: 2017-12-04
Enrollment: 120
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 1. Background and Rationale:

   Little is currently known about intrinsic risk factors for sport-related concussion in youth ice hockey players. Emerging research suggests that alterations in cervical and balance function increase the risk of concussion in youth ice hockey players. Thus, evaluation of a primary prevention program aimed at addressing alterations in cervical and vestibular function may result in a protective effect in reducing the risk of concussion. Such a program targeting intrinsic risk factors for concussion has not previously been evaluated and thus a pilot Randomized control trial (RCT) to inform the feasibility and efficacy of such a program is needed prior to proceeding to evaluation of such a program on a larger scale.
2. Research Question and Objectives

   The primary objectives of this pilot RCT study are: 1) To evaluate the feasibility of a concussion prevention program in youth ice hockey players; and 2) To evaluate the efficacy of a concussion prevention program in decreasing the risk of concussion. Exploratory objectives include evaluating the changes in quality of life, clinical measures of cervical and vestibular function measures and Hockey Canada on-ice skills testing in youth ice hockey players following a concussion prevention program.
3. Methods

This study will be a pilot RCT. Prior to the 2017 hockey season, 120 players from 8 youth ice hockey teams ages 13-17 will be recruited to participate. Once parental consent and/or player assent has been obtained, players will complete a series of initial intake forms. Baseline tests and measures, including a standardized preseason baseline questionnaire (regarding playing history, past medical history, participation in sport) and a battery of questionnaires and clinical measures. Individuals will be randomly allocated into either a control protocol (general cardiovascular warm-up, general stretching and strengthening, education on concussion identification) or a specific protocol (balance, neuromotor control, strength, vestibulo-ocular and oculomotor training + concussion education). Both groups will meet with the study physiotherapist once weekly for 4 weeks and exercises will be progressed. A previously validated prospective injury surveillance system will be implemented. As part of this process, a team designate will collect data throughout the season regarding individual player participation in games, practices and dry land training sessions. Individuals with a suspected concussion will be referred to the study sport medicine physician for evaluation, diagnosis and standard of care management. At this time all baseline tests and measures will be repeated.


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria will broadly include individuals aged 13 - 17 years of age who are currently participating in organized ice hockey.

Exclusion Criteria:

* Inability to participate in physical activity for a reason other than sport related concussion.
* Inability to communicate in English language.
* Neurodevelopmental delays expected to affect ability to adapt with treatment.
* Orthopaedic or other injury affecting ability to participate.
* Medication known to affect neural adaptation as they may alter the response to treatment.

Primary outcomes:
measure: Efficacy of Concussion prevention protocol
timeFrame: 6 months (length of hockey season)
measure: Number of participants able to complete protocol.
timeFrame: 6 months (length of hockey season)
Secondary outcomes:
measure: Pediatric Quality of Life Scale (PedsQL)
timeFrame: Time 0, 4 weeks, end of hockey season (approximately 6 months)
measure: Numeric Pain Rating Scale for Neck pain
timeFrame: Time 0, 4 weeks, end of hockey season (approximately 6 months)
measure: Numeric Pain Rating Scale for Headache
timeFrame: Time 0, 4 weeks, end of hockey season (approximately 6 months)
measure: Numeric Dizziness Rating Scale
timeFrame: Time 0, 4 weeks, end of hockey season (approximately 6 months)
measure: Sport Concussion Assessment Tool 5 (SCAT5)
timeFrame: Time 0, 4 weeks, end of hockey season (approximately 6 months)
measure: Dynamic Visual Acuity (DVA)
timeFrame: Time 0, 4 weeks, end of hockey season (approximately 6 months)
measure: Head Thrust Test (HTT)
timeFrame: Time 0, 4 weeks, end of hockey season (approximately 6 months)
measure: Functional Gait Assessment (FGA)
timeFrame: Time 0, 4 weeks, end of hockey season (approximately 6 months)
measure: Advanced Functional Gait Assessment (A-FGA)
timeFrame: Time 0, 4 weeks, end of hockey season (approximately 6 months)
measure: Walking While Talking Test (WWTT)
timeFrame: Time 0, 4 weeks, end of hockey season (approximately 6 months)
measure: Cervical Flexion Endurance test (CFE)
timeFrame: Time 0, 4 weeks, end of hockey season (approximately 6 months)
measure: Cervical Flexion Rotation Test (CFRT)
timeFrame: Time 0, 4 weeks, end of hockey season (approximately 6 months)
measure: Anterolateral cervical spine strength
timeFrame: Time 0, 4 weeks, end of hockey season (approximately 6 months)
measure: Head perturbation test (HPT)
timeFrame: Time 0, 4 weeks, end of hockey season (approximately 6 months)
measure: Vestibular/Ocular Motor Screening Assessment (VOMS)
timeFrame: Time 0, 4 weeks, end of hockey season (approximately 6 months)
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary Sport
state: Alberta
Study officials:
affiliation: Sport Injury Prevention Research Centre
name: Kathryn J Schneider, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: