Primary Prevention of Concussion in Youth Ice Hockey Players
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03360786|
Recruitment Status : Recruiting
First Posted : December 4, 2017
Last Update Posted : December 4, 2017
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.
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.
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.
|Condition or disease||Intervention/treatment|
|Concussion||Other: Specific intervention Other: Control intervention|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||An assessor who is blinded to group allocation will perform the pre and post assessment measures.|
|Official Title:||Primary Prevention of Concussion in Youth Ice Hockey Players|
|Actual Study Start Date :||October 4, 2017|
|Estimated Primary Completion Date :||August 31, 2018|
|Estimated Study Completion Date :||December 29, 2018|
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
- Efficacy of Concussion prevention protocol [ Time Frame: 6 months (length of hockey season) ]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.
- Number of participants able to complete protocol. [ Time Frame: 6 months (length of hockey season) ]Number of participants completing each intervention will be calculated
- Pediatric Quality of Life Scale (PedsQL) [ Time Frame: Time 0, 4 weeks, end of hockey season (approximately 6 months) ]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
- Numeric Pain Rating Scale for Neck pain [ Time Frame: Time 0, 4 weeks, end of hockey season (approximately 6 months) ]Neck pain rated from 0-10/10
- Numeric Pain Rating Scale for Headache [ Time Frame: Time 0, 4 weeks, end of hockey season (approximately 6 months) ]Headache pain rated from 0-10/10
- Numeric Dizziness Rating Scale [ Time Frame: Time 0, 4 weeks, end of hockey season (approximately 6 months) ]Dizziness rated from 0-10/10
- Sport Concussion Assessment Tool 5 (SCAT5) [ Time Frame: Time 0, 4 weeks, end of hockey season (approximately 6 months) ]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)
- Dynamic Visual Acuity (DVA) [ Time Frame: Time 0, 4 weeks, end of hockey season (approximately 6 months) ]Clinical test of dynamic visual acuity using ETDRS chart
- Head Thrust Test (HTT) [ Time Frame: Time 0, 4 weeks, end of hockey season (approximately 6 months) ]Clinical test to evaluate ability to maintain eyes on a stationary target. Performed to right and left. (+ve/-ve)
- Functional Gait Assessment (FGA) [ Time Frame: Time 0, 4 weeks, end of hockey season (approximately 6 months) ]Dynamic balance measure including 10 different walking tasks that are rated on a scale of 0-3 for a total score out of 30
- Advanced Functional Gait Assessment (A-FGA) [ Time Frame: Time 0, 4 weeks, end of hockey season (approximately 6 months) ]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
- Walking While Talking Test (WWTT) [ Time Frame: Time 0, 4 weeks, end of hockey season (approximately 6 months) ]Test of walking and performing cognitive tasks of increasing difficulty, Time (seconds) for each task is recorded.
- Cervical Flexion Endurance test (CFE) [ Time Frame: Time 0, 4 weeks, end of hockey season (approximately 6 months) ]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)
- Cervical Flexion Rotation Test (CFRT) [ Time Frame: Time 0, 4 weeks, end of hockey season (approximately 6 months) ]Screening test for upper cervical spine involvement. Positive/negative and is performed to both right and left.
- Anterolateral cervical spine strength [ Time Frame: Time 0, 4 weeks, end of hockey season (approximately 6 months) ]Measured using a head held dynamometer with subject in supine position. Test is repeated 3 times. Output measured in kg.
- Head perturbation test (HPT) [ Time Frame: Time 0, 4 weeks, end of hockey season (approximately 6 months) ]Ability to maintain head in a neutral position with external perturbation applied. Score out of 8 is recorded
- Vestibular/Ocular Motor Screening Assessment (VOMS) [ Time Frame: Time 0, 4 weeks, end of hockey season (approximately 6 months) ]As per Mucha et al, 2014
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03360786
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03360786
|Contact: Kathryn J Schneider, PT, PhD||403 210 firstname.lastname@example.org|
|Contact: Carolyn A Emery, PT, PhDemail@example.com|
|University of Calgary Sport||Recruiting|
|Calgary, Alberta, Canada, T2N 1N4|
|Contact: Kathryn Schneider, PT, PhD (403) 210-8951 firstname.lastname@example.org|
|Contact: Carolyn Emery, PT, PhD 403-220-4608 email@example.com|
|Principal Investigator:||Kathryn J Schneider, PT, PhD||Sport Injury Prevention Research Centre|