A Pilot Study to Assess the Effects of Concussion on Adolescent Rugby Union Players and the Development of a Concussion Passport
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 211
- 试验地点
- 1
- 主要终点
- 4) King Devick Test - assessing change from baseline and between post-concussion visits
研究概览
简要总结
200 adolescent rugby players (aged 15-19) from the Senior Cup Teams of 5 Rugby Playing schools (Members of Irish Schools Rugby) will be invited to enroll for inclusion in the study. The study will collect data on brain health, including computer based skill testing, eye tracking and balance and on task completion, cover existing tests in the established SCAT 3 alongside response to exercise testing and a clinical examination including baseline blood tests known to influence recovery from concussion in a rugby playing population of adolescent schoolboys.
The initial data will be taken before the 2016/2017 season starts. The volume of rugby training and match play will be recorded along with activity monitoring in general. For those subjects who sustain concussion a dedicated clinic will provide all after care including repeat clinical examination and magnetic resonance imaging along with a graduated return to exercise and a compressive rehabilitation programme at Sports Surgery Clinic (SSC). A Consultant Sports Physician will manage the return to play programme with an exercise, cognitive, balance, eye movement and neck strength programme.
详细描述
Concussion is a traumatic injury to the brain and is a common condition in those athletes who play a contact sport, such as Rugby Union. It is a complex process in which forces are transmitted to the brain and result in temporary impairment of brain function. Governing bodies have done much good work to improve the recognition of concussion and the removal of those players from the field but there still remains much confusion and a lack of data on what measures can be used to help manage the return to school and play after a concussion.
Currently assessment and management of concussion relies heavily on subjective symptom analysis with little in the way of objective measures to help make decisions on diagnosis and safe return to play time frames. There is growing evidence for objective measures of cognition, balance, oculomotor, brain imaging, blood biomarkers and exercise physiology in assisting with concussion diagnosis and management. The importance of the study is to decide on the minimum level of tracking of pre season data to safely enhance the care for rugby playing schoolboys.
Study Methodology
Preseason Baseline assessment (all participants)
All participants will be invited to complete a preseason screening session at SSC comprising:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 19 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Playing Rugby Union aged 15-19
- •Be able to understand and cooperate with testing
- •Have parental or guardian consent available
排除标准
- •Unavailable to attend for preseason screening
- •History of neurological or psychiatric disease
结局指标
主要结局
4) King Devick Test - assessing change from baseline and between post-concussion visits
时间窗: 1 Rugby season -2016-2017. All participants will be assessed in preseason (August 2016 - September 2016). Participants who sustain a concussion will have the assessment repeated within 72hours of the concussion and on a weekly basis until fully recovered
Score reported in seconds (s)
5) Vestibulo-ocular assessment - assessing change from baseline and between post-concussion visits
时间窗: 1 Rugby season -2016-2017. All participants will be assessed in preseason (August 2016 - September 2016). Participants who sustain a concussion will have the assessment repeated within 72hours of the concussion and on a weekly basis until fully recovered
Will provide qualitative data on saccades
1) Clinical assessment - assessing change from baseline and between post-concussion visits
时间窗: 1 Rugby season -2016-2017. All participants will be assessed in preseason (August 2016 - September 2016). Participants who sustain a concussion will have the assessment repeated within 72hours of the concussion and on a weekly basis until fully recovered
Assessment by physician to determine diagnosis and return to play time frame
6) Balance assessment (BESS) - assessing change from baseline and between post-concussion visits
时间窗: 1 Rugby season -2016-2017. All participants will be assessed in preseason (August 2016 - September 2016). Participants who sustain a concussion will have the assessment repeated within 72hours of the concussion and on a weekly basis until fully recovered
BESS scores are presented as numeric values
8) Accusway balance assessment - assessing change from baseline and between post-concussion visits
时间窗: 1 Rugby season -2016-2017. All participants will be assessed in preseason (August 2016 - September 2016). Participants who sustain a concussion will have the assessment repeated within 72hours of the concussion and on a weekly basis until fully recovered
Results presented as Change of pressure velocity (mm/s) and sway path length (mm)
2) Questionnaire - assessing change from baseline and between post-concussion visits
时间窗: 1 Rugby season -2016-2017. All participants will be assessed in preseason (August 2016 - September 2016). Participants who sustain a concussion will have the assessment repeated within 72hours of the concussion and on a weekly basis until fully recovered
Questionnaire responses will provide qualitative data
11) Activity monitoring - assessing change from baseline and between post-concussion visits
时间窗: 1 Rugby season -2016-2017. All participants will be assessed in preseason (August 2016 - September 2016). Participants who sustain a concussion will have the assessment repeated within 72hours of the concussion and on a weekly basis until fully recovered
FitBit activity monitor will produce scores for steps taken and distance covered (m)
3) Computerised cognitive assessment - assessing change from baseline and between post-concussion visits
时间窗: 1 Rugby season -2016-2017. All participants will be assessed in preseason (August 2016 - September 2016). Participants who sustain a concussion will have the assessment repeated within 72hours of the concussion and on a weekly basis until fully recovered
Results described as Valid / Invalid
7) Neck strength - assessing change from baseline and between post-concussion visits
时间窗: 1 Rugby season -2016-2017. All participants will be assessed in preseason (August 2016 - September 2016). Participants who sustain a concussion will have the assessment repeated within 72hours of the concussion and on a weekly basis until fully recovered
Results presented in N and N/kg
9) Exercise Challenge Test - assessing change from baseline and between post-concussion visits
时间窗: 1 Rugby season -2016-2017. All participants will be assessed in preseason (August 2016 - September 2016). Participants who sustain a concussion will have the assessment repeated within 72hours of the concussion and on a weekly basis until fully recovered
Scores obtained for heart rate (bpm), RPE and VO2 (ml/kg)
10) Haematology - assessing change from baseline and between post-concussion visits
时间窗: 1 Rugby season -2016-2017. All participants will be assessed in preseason (August 2016 - September 2016). Participants who sustain a concussion will have the assessment repeated within 72hours of the concussion and on a weekly basis until fully recovered
Blood analysed for the following biomarkers: NFL, NSE, UCH-L1, MBP, S100B, GFAP and Tau protein
次要结局
- Time to recover from concussion will be recorded(1 Rugby season -2016-2017. All participants will be assessed in preseason (August 2016 - September 2016). Participants who sustain a concussion will have the assessment repeated within 72hours of the concussion and on a weekly basis until fully recovered)
研究者
Dr Neil Welch ASCC
Head of lab services and research
Sports Surgery Clinic, Santry, Dublin