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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03544372
Other study ID # JCunningham2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 15, 2017
Est. completion date December 20, 2017

Study information

Verified date June 2018
Source University of Dublin, Trinity College
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Perhaps no issue in sports medicine has attracted so much media attention and academic interest in recent years as the potential long-term neurodegenerative sequelae of sports-related concussion on athlete's brain health. Rugby has a high incidence of concussion. Recent research findings from a cohort of former professional players found that the number of concussions sustained during their professional careers was associated with the rate of diagnosed clinical depression and late-life cognitive impairment. A limitation of these studies is the use of a self-reported history of concussion. The reliability of professional rugby players to recall and self-report concussion history has never been quantified in the literature to date. Imperfect recall can generate bias in epidemiologic studies when the proportion of events recalled is associated with the health end points of interest. Associations observed may be spurious and due to recall bias if athletes differ in their knowledge and recognition of concussion symptomology in a manner that is associated with the health outcome of interest ie. under/overreporting of concussion. It is difficult to estimate the magnitude of the bias in the absence of any "gold-standard" measure of concussion history. Due to these concerns about the quality of self-reported concussion history, the investigators considered that it was important to evaluate the reliability of self-reported concussion history.


Description:

The primary aim of this study is to investigate the reliability of self-reported concussion history in current rugby union players

Objectives:

The objectives will be to:

Investigate player's self-report history of sports-related concussion (number and nature of concussions) in this elite rugby playing group.

Correlate player self-report with established individual player medical data. Repeat this process approximately 6 months later on a sub sample of this cohort, in order to test the reliability of player's reported concussion.


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date December 20, 2017
Est. primary completion date December 20, 2017
Accepts healthy volunteers
Gender Male
Age group N/A and older
Eligibility Inclusion Criteria:

•> 18 years old

- Contracted to Leinster rugby as a professional rugby player

- Players who have given informed consent and are willing to participate in the study.

- Players with a history of sports-related concussion/mild traumatic brain injury.

Exclusion Criteria:

• Any players with a history of non-sports related concussion/severe traumatic brain injury due to road traffic collisions etc. will be excluded.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Assessment of Concussion History using NIH Concussion History Tool
NIH concussion tool

Locations

Country Name City State
Ireland Trinity College Dublin Dublin

Sponsors (1)

Lead Sponsor Collaborator
University of Dublin, Trinity College

Country where clinical trial is conducted

Ireland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Self-report Concussion History reliability study, agreement between self-report history of concussion via the NIH concussion history tool and documented concussion history. The higher the intraclass correlation between the two-the greater the reliability of the NIH concussion tool 30 minutes
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