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Assessment of the Effects of Concussion on Adolescent Rugby Union Players

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ClinicalTrials.gov Identifier: NCT03624634
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
Andrew Franklyn-Miller, Sports Surgery Clinic, Santry, Dublin

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.


Condition or disease
Concussion, Mild Concussion, Intermediate Concussion, Severe

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 131 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Study to Assess the Effects of Concussion on Adolescent Rugby Union Players and the Development of a Concussion Passport
Actual Study Start Date : August 1, 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018



Primary Outcome Measures :
  1. 1) Clinical assessment - assessing change from baseline and between post-concussion visits [ 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 ]
    Assessment by physician to determine diagnosis and return to play time frame

  2. 2) Questionnaire - assessing change from baseline and between post-concussion visits [ 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 ]
    Questionnaire responses will provide qualitative data

  3. 3) Computerised cognitive assessment - assessing change from baseline and between post-concussion visits [ 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 ]
    Results described as Valid / Invalid

  4. 4) King Devick Test - assessing change from baseline and between post-concussion visits [ 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 ]
    Score reported in seconds (s)

  5. 5) Vestibulo-ocular assessment - assessing change from baseline and between post-concussion visits [ 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 ]
    Will provide qualitative data on saccades

  6. 6) Balance assessment (BESS) - assessing change from baseline and between post-concussion visits [ 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 ]
    BESS scores are presented as numeric values

  7. 7) Neck strength - assessing change from baseline and between post-concussion visits [ 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 ]
    Results presented in N and N/kg

  8. 8) Accusway balance assessment - assessing change from baseline and between post-concussion visits [ 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 ]
    Results presented as Change of pressure velocity (mm/s) and sway path length (mm)

  9. 9) Exercise Challenge Test - assessing change from baseline and between post-concussion visits [ 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 ]
    Scores obtained for heart rate (bpm), RPE and VO2 (ml/kg)

  10. 10) Haematology - assessing change from baseline and between post-concussion visits [ 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 ]
    Blood analysed for the following biomarkers: NFL, NSE, UCH-L1, MBP, S100B, GFAP and Tau protein

  11. 11) Activity monitoring - assessing change from baseline and between post-concussion visits [ 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 ]
    FitBit activity monitor will produce scores for steps taken and distance covered (m)


Secondary Outcome Measures :
  1. Time to recover from concussion will be recorded [ 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 ]
    Results presented in days


Biospecimen Retention:   Samples With DNA
Blood sample retained for analysis for 24 months and the destroyed.


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Ages Eligible for Study:   15 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Unavailable to attend for preseason screening
  2. History of neurological or psychiatric disease

Information from the National Library of Medicine

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): NCT03624634


Contacts
Contact: Ciaran Cosgrave, MB,MRCP +35315262030 ciarancosgrave@sportssurgeryclinic.com

Locations
Ireland
Sports Surgery Clinic Recruiting
Dublin, Leinster, Ireland
Contact: Andy D Franklyn-Miller, MBBS    00 353 1 526 2030    afranklynmiller@me.com   
Contact: Enda A King, BSc, MSc    00 353 1 526 2030    endaking@sportssurgeryclinic.com   
Sponsors and Collaborators
Sports Surgery Clinic, Santry, Dublin
Investigators
Study Director: Paul McCrory The Florey Institute of Neuroscience and Mental Health

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andrew Franklyn-Miller, Director of SSC Sports Medicine, Sports Surgery Clinic, Santry, Dublin
ClinicalTrials.gov Identifier: NCT03624634     History of Changes
Other Study ID Numbers: SSC-Concussion-001
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Brain Concussion
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