Assessment of the Effects of Concussion on Adolescent Rugby Union Players

NCT03624634 | Completed

• 1 other identifier: SSC-Concussion-001
• Study Type: observational
• Target: 211
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Concussion, Mild; Concussion, Intermediate; Concussion, Severe

Outcome Measures

Primary Outcomes (11)

• 1) Clinical assessment - assessing change from baseline and between post-concussion visits

  Assessment by physician to determine diagnosis and return to play time frame

  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

• 2) Questionnaire - assessing change from baseline and between post-concussion visits

  Questionnaire responses will provide qualitative data

  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

• 3) Computerised cognitive assessment - assessing change from baseline and between post-concussion visits

  Results described as Valid / Invalid

  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

• 4) King Devick Test - assessing change from baseline and between post-concussion visits

  Score reported in seconds (s)

  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

• 5) Vestibulo-ocular assessment - assessing change from baseline and between post-concussion visits

  Will provide qualitative data on saccades

  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

• 6) Balance assessment (BESS) - assessing change from baseline and between post-concussion visits

  BESS scores are presented as numeric values

  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

• 7) Neck strength - assessing change from baseline and between post-concussion visits

  Results presented in N and N/kg

  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

• 8) Accusway balance assessment - assessing change from baseline and between post-concussion visits

  Results presented as Change of pressure velocity (mm/s) and sway path length (mm)

  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

• 9) Exercise Challenge Test - assessing change from baseline and between post-concussion visits

  Scores obtained for heart rate (bpm), RPE and VO2 (ml/kg)

  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

• 10) Haematology - assessing change from baseline and between post-concussion visits

  Blood analysed for the following biomarkers: NFL, NSE, UCH-L1, MBP, S100B, GFAP and Tau protein

  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

• 11) Activity monitoring - assessing change from baseline and between post-concussion visits

  FitBit activity monitor will produce scores for steps taken and distance covered (m)

  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

Secondary Outcomes (1)

• 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

Eligibility Criteria

• Age: 15 Years - 19 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Playing Rugby Union aged 15-19
• Be able to understand and cooperate with testing
• Have parental or guardian consent available

You may not qualify if:

• Unavailable to attend for preseason screening
• History of neurological or psychiatric disease

Sponsors & Collaborators

• Sports Surgery Clinic, Santry, Dublin: lead

Study Sites (1)

Sports Surgery Clinic

Dublin, Leinster, Ireland

Location

Related Publications (1)

• Cosgrave C, Fuller C, Franklyn-Miller A, Falvey E, Beirne C, Ryan J, McCrory P. Concussion in adolescent rugby union players: comprehensive acute assessment protocol and development of the SSC concussion passport to monitor long-term health. BMJ Open Sport Exerc Med. 2018 Nov 5;4(1):e000455. doi: 10.1136/bmjsem-2018-000455. eCollection 2018.

  PMID: 30498576 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample retained for analysis for 24 months and the destroyed.

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Paul McCrory

  The Florey Institute of Neuroscience and Mental Health

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of lab services and research

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: August 10, 2018
• Study Start: August 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2023
• Last Updated: April 22, 2024

Record last verified: 2024-04

Locations

IE (1)