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Specific Protocol for Concussion

N/A
Waitlist Available
Led By Kathryn J Schneider, PT, PhD
Research Sponsored by Sport Injury Prevention Research Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Inclusion criteria will broadly include individuals aged 13 - 17 years of age who are currently participating in organized ice hockey.
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time 0, 4 weeks, end of hockey season (approximately 6 months)
Awards & highlights
No Placebo-Only Group

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

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time 0, 4 weeks, end of hockey season (approximately 6 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and time 0, 4 weeks, end of hockey season (approximately 6 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Efficacy of Concussion prevention protocol
Number of participants able to complete protocol.
Secondary study objectives
Advanced Functional Gait Assessment (A-FGA)
Anterolateral cervical spine strength
Cervical Flexion Endurance test (CFE)
+12 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Specific ProtocolExperimental Treatment1 Intervention
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.
Group II: Control ProtocolActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Sport Injury Prevention Research CentreLead Sponsor
8 Previous Clinical Trials
4,244 Total Patients Enrolled
Kathryn J Schneider, PT, PhDPrincipal InvestigatorSport Injury Prevention Research Centre
1 Previous Clinical Trials
31 Total Patients Enrolled
~15 spots leftby Nov 2025