Primary Prevention of Concussion in Youth Ice Hockey Players

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.

Study Overview

• Status: Unknown
• Conditions: Concussion
• Intervention / Treatment: Other: Specific intervention; Other: Control intervention

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 1N4
      • Recruiting
      • University of Calgary Sport
      • Contact: Carolyn Emery, PT, PhD; Phone Number: 403-220-4608; Email: caemery@ucalgary.ca
      • Contact: Kathryn Schneider, PT, PhD; Phone Number: (403) 210-8951; Email: kjschnei@ucalgary.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Specific Protocol; The intervention group will work with the study physiotherapist and perform a 10-20 minute progressive exercises twice per week. The intervention will include a series of exercises including dynamic balance, adaptation, cervical spine strength, cervical spine neuromotor control and divided attention exercises. Exercises will begin at a lower level and progress to increasingly difficult levels of each exercise type over the course of the intervention. Concussion education and injury identification will also be completed.	Other: Specific intervention; Series of progressive exercises targeted at balance, adaptation, dividing attention, head on neck control, visual + education on concussion identification and concussion education
Active Comparator: Control Protocol; The control group will continue with their standard warm up and practice schedule but have the addition of contact time with the study physiotherapist for education regarding concussion education and injury identification.	Other: Control intervention; Education on concussion and concussion identification in addition to typical cardiovascular warmups

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of Concussion prevention protocol	A primary outcome of interest is diagnosis of concussion. This will be determined by the study sport medicine physician in accordance with current standards of care and as per the 5th International Consensus on Concussion in Sport Statement. Medical clearance to return to sport will be determined by the study sport medicine physician according to the 5th Consensus on Concussion in Sport Statement.	6 months (length of hockey season)
Number of participants able to complete protocol.	Number of participants completing each intervention will be calculated	6 months (length of hockey season)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pediatric Quality of Life Scale (PedsQL)	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. 0-100/100	Time 0, 4 weeks, end of hockey season (approximately 6 months)
Numeric Pain Rating Scale for Neck pain	Neck pain rated from 0-10/10	Time 0, 4 weeks, end of hockey season (approximately 6 months)
Numeric Pain Rating Scale for Headache	Headache pain rated from 0-10/10	Time 0, 4 weeks, end of hockey season (approximately 6 months)
Numeric Dizziness Rating Scale	Dizziness rated from 0-10/10	Time 0, 4 weeks, end of hockey season (approximately 6 months)
Sport Concussion Assessment Tool 5 (SCAT5)	Multifaceted assessment tool including symptom reports (rated 0-6 for 22 different symptoms), Cognitive Screen (score /30), Neurological screen (Y/N for 5 questions and balance exam /30)	Time 0, 4 weeks, end of hockey season (approximately 6 months)
Dynamic Visual Acuity (DVA)	Clinical test of dynamic visual acuity using ETDRS chart	Time 0, 4 weeks, end of hockey season (approximately 6 months)
Head Thrust Test (HTT)	Clinical test to evaluate ability to maintain eyes on a stationary target. Performed to right and left. (+ve/-ve)	Time 0, 4 weeks, end of hockey season (approximately 6 months)
Functional Gait Assessment (FGA)	Dynamic balance measure including 10 different walking tasks that are rated on a scale of 0-3 for a total score out of 30	Time 0, 4 weeks, end of hockey season (approximately 6 months)
Advanced Functional Gait Assessment (A-FGA)	Newly created balance measure that represents a more difficult measure of dynamic balance and is a combination of progressively more difficult tasks included in the FGA. Clinician rated score 0-3 for each task. Total score out of 18	Time 0, 4 weeks, end of hockey season (approximately 6 months)
Walking While Talking Test (WWTT)	Test of walking and performing cognitive tasks of increasing difficulty, Time (seconds) for each task is recorded.	Time 0, 4 weeks, end of hockey season (approximately 6 months)
Cervical Flexion Endurance test (CFE)	Test performed in crook lying that measures the ability of a subject to maintain head in a craniovertebral flexion position and slightly lifted off pillow. Time (seconds)	Time 0, 4 weeks, end of hockey season (approximately 6 months)
Cervical Flexion Rotation Test (CFRT)	Screening test for upper cervical spine involvement. Positive/negative and is performed to both right and left.	Time 0, 4 weeks, end of hockey season (approximately 6 months)
Anterolateral cervical spine strength	Measured using a head held dynamometer with subject in supine position. Test is repeated 3 times. Output measured in kg.	Time 0, 4 weeks, end of hockey season (approximately 6 months)
Head perturbation test (HPT)	Ability to maintain head in a neutral position with external perturbation applied. Score out of 8 is recorded	Time 0, 4 weeks, end of hockey season (approximately 6 months)
Vestibular/Ocular Motor Screening Assessment (VOMS)	As per Mucha et al, 2014	Time 0, 4 weeks, end of hockey season (approximately 6 months)

Collaborators and Investigators

• Sponsor: Sport Injury Prevention Research Centre
• Investigators: Principal Investigator: Kathryn J Schneider, PT, PhD, Sport Injury Prevention Research Centre

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2017
• Primary Completion (Anticipated): August 31, 2018
• Study Completion (Anticipated): December 29, 2018

Study Registration Dates

• First Submitted: October 24, 2017
• First Submitted That Met QC Criteria: November 27, 2017
• First Posted (Actual): December 4, 2017

Study Record Updates

• Last Update Posted (Actual): December 4, 2017
• Last Update Submitted That Met QC Criteria: November 27, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: youth; cervical spine; sport concussion
• Other Study ID Numbers: Conc-PT-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: At this time there is no plan to share individual participant data with others outside of the research team.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No