Recruiting

Concussion Prevention

Sponsor:

Sport Injury Prevention Research Centre

Code:

NCT03360786

Conditions

Concussion

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Accepted

Interventions

Specific intervention

Control intervention

Study Details

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.

Conditions

Concussion

Study ID

NCT03360786

Start date

Oct 4, 2017

Status verified date

Nov, 2017

Completion date

Dec 29, 2018

Anticipated

Primary completion date

Aug 31, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Accepted

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 Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Specific intervention

Series of progressive exercises targeted at balance, adaptation, dividing attention, head on neck control, visual + education on concussion identification and concussion education

Control intervention

Education on concussion and concussion identification in addition to typical cardiovascular warmups

Primary outcome measure

  • Efficacy of Concussion prevention protocol [ Time Frame: 6 months (length of hockey season) ]
  • Number of participants able to complete protocol. [ Time Frame: 6 months (length of hockey season) ]

Central Contacts and Locations

Central contacts

Kathryn J Schneider, PT, PhD

403 210 8951kjschnei@ucalgary.ca

Carolyn A Emery, PT, PhD

403-220-4608caemery@ucalgary.ca

Locations

University of Calgary Sport

Recruiting

Calgary, Alberta, Canada, T2N 1N4

Contacts

Kathryn Schneider, PT, PhD

(403) 210-8951kjschnei@ucalgary.ca

Carolyn Emery, PT, PhD

403-220-4608caemery@ucalgary.ca

More Information

Sponsor

Sport Injury Prevention Research Centre

Last update posted

Dec 4, 2017

Last verified

Nov, 2017

Keywords

  • sport concussion
  • cervical spine
  • youth

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sport Injury Prevention Research Centre on 2017-12-04.