Primary Prevention of Concussion in Youth Ice Hockey Players
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Efficacy of Concussion prevention protocol
研究概览
简要总结
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
An assessor who is blinded to group allocation will perform the pre and post assessment measures.
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria will broadly include individuals aged 13 - 17 years of age who are currently participating in organized ice hockey.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Specific intervention (Other)
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.
干预措施: Control intervention (Other)
结局指标
主要结局
Efficacy of Concussion prevention protocol
时间窗: 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.
时间窗: 6 months (length of hockey season)
Number of participants completing each intervention will be calculated
次要结局
- Numeric Pain Rating Scale for Headache(Time 0, 4 weeks, end of hockey season (approximately 6 months))
- Advanced Functional Gait Assessment (A-FGA)(Time 0, 4 weeks, end of hockey season (approximately 6 months))
- Head perturbation test (HPT)(Time 0, 4 weeks, end of hockey season (approximately 6 months))
- Numeric Pain Rating Scale for Neck pain(Time 0, 4 weeks, end of hockey season (approximately 6 months))
- Numeric Dizziness Rating Scale(Time 0, 4 weeks, end of hockey season (approximately 6 months))
- Sport Concussion Assessment Tool 5 (SCAT5)(Time 0, 4 weeks, end of hockey season (approximately 6 months))
- Dynamic Visual Acuity (DVA)(Time 0, 4 weeks, end of hockey season (approximately 6 months))
- Head Thrust Test (HTT)(Time 0, 4 weeks, end of hockey season (approximately 6 months))
- Anterolateral cervical spine strength(Time 0, 4 weeks, end of hockey season (approximately 6 months))
- Pediatric Quality of Life Scale (PedsQL)(Time 0, 4 weeks, end of hockey season (approximately 6 months))
- Functional Gait Assessment (FGA)(Time 0, 4 weeks, end of hockey season (approximately 6 months))
- Cervical Flexion Endurance test (CFE)(Time 0, 4 weeks, end of hockey season (approximately 6 months))
- Cervical Flexion Rotation Test (CFRT)(Time 0, 4 weeks, end of hockey season (approximately 6 months))
- Vestibular/Ocular Motor Screening Assessment (VOMS)(Time 0, 4 weeks, end of hockey season (approximately 6 months))
- Walking While Talking Test (WWTT)(Time 0, 4 weeks, end of hockey season (approximately 6 months))