Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619001165178
Ethics application status
Approved
Date submitted
31/07/2019
Date registered
20/08/2019
Date last updated
20/08/2019
Date data sharing statement initially provided
20/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The use of padded headgear in Australian youth football players: Video footage analysis of player behaviour and impact severity
Scientific title
A pilot study exploring the effect of soft padded headgear in youth Australian football players: Analysing player behaviour, head accelerations events and attitudes towards concussion.
Secondary ID [1] 297313 0
Nil known
Universal Trial Number (UTN)
U1111-1228-0667
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sports Related Concussion 311449 0
Sports Related Orthopaedic Injuries 311450 0
Condition category
Condition code
Injuries and Accidents 310090 310090 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
NAME
1. A pseudo randomised control trial with use of padded headgear in Australian youth football players: Analysis of impact severity and player behaviour
WHY
2. In junior metropolitan Australian rules football, the use of headgear is not mandated in a controlled way. Although the Australian Football League has a position statement (AFL Community: Helmets & Mouthguards), large, prospective randomised controlled trials regarding efficacy are lacking. Whether or not youth football clubs encourage or mandate the use of headgear is entirely at the clubs’ discretion. This has the potential to leave young players open to risk which is currently unknown. A few preliminary studies conducted in the early 2000s investigated attitudes towards the use of headgear in youth football and found that players largely cited discomfort as the reason for not wearing protective headgear and the lack of evidence of effectiveness. This was, however, prior to the recent proliferation of sports concussion research and introduction of mandated headgear use at a number of junior metropolitan football clubs. This prior work also only reported on outcomes for male athletes. This study aims to address evidence gaps on the topic of headgear in Australian youth football, by investigating the association between player use of headgear and player behaviour on the field through video footage analysis of game play behaviour and analysis of impact severity with use of biosensing equipment.
WHAT
3. Materials. Use of commercially available Steeden® Padded Headgear (i.e., a lightweight, soft padded head gear) https://steeden.gnsports.com/16969/Super-Lite-Headgear/pd.php , and use of the commercially purchased X-Patch. This is a 1 cm × 2 cm electronic device which contains a triaxial linear accelerometer and measures continuously at a frequency of 1 kHz. It records time stamped 100 ms of data for linear acceleration that exceed 10 g. Video footage analysis for verification of X-Patch recorded impacts and observation of player behaviour will be conducted using the Video Surveillance of Concussive Injury in Australian Football, developed by Makdissi & Davis, 2016 (https://doi.org/10.1016/j.jsams.2016.02.014).
4. Procedure. Participants will have the X-Patch attached to the skin behind the ear using a double-sided adhesive and secured with sporting tape by trained research assistants. All teams will be allocated to wear headgear in the first (Q1 + Q2) or second half (Q3 +Q4) across 5 games.
WHO
5. Research assistants will consist of undergraduate and postgraduate psychology students who were selected on the basis of academic and professional experience. These staff will receive basic training in handling and attaching the X-Patch/headgear. There is no further expert knowledge required for this intervention.
6. Delivery will be provided individually to players and face-to-face. Researcher assistants will provide headgear to players and determine when it should be worn by randomising halves in which headgear will be worn by the team.
WHERE
7. The intervention will occur during ‘in-vivo’ settings, at the time and field location participants are scheduled to play throughout the football season in 2019 (southern metropolitan Melbourne).
WHEN/HOW MUCH
8. Each youth football game lasts 1.5 hours. We aim to observe 2 male and 2 female teams for 5 games each resulting in a total of 20 games (i.e., 20 observations). All games are scheduled on Sunday as per the South Metro Junior Football League. As abovementioned, the teams will wear headgear for one half of the game (approximately 30 minutes) with efforts to counterbalance allocation across the 20 games between teams. 100% of participating players will wear the X-Patch for the entirety of the game behind the ear with a counterbalance between the left and right ear.
TAILORING
9. We will ensure the appropriately sized headgear will be worn by each player. We will do this by fitting the headgear ahead of time during the first game using visual inspection and player self-report of comfort.
MODIFICATIONS
10. We don’t expect any modification occurring throughout the season. The study was not modified at all after its commencement.
HOW WELL
11. Adherence was assessed by research assistants documenting whether or not player wore headgear during their assigned half of the match across the five matches observed.
12. Actual adherence or fidelity cannot be assessed at this point in time.
Intervention code [1] 313598 0
Prevention
Intervention code [2] 313954 0
Early detection / Screening
Comparator / control treatment
Repeated Measures study (Crossover study). For this research project, the description of the active control group intervention, mode of administration, duration, etc. is as per described under 'Description of intervention/exposure'.
Control group
Active

Outcomes
Primary outcome [1] 319447 0
1. Within-subject differences in the incidence of injuries (players behavior) with and without headgear during the same junior Australian football game. A total of five games for four teams (20 games observed) throughout the season will be measured.

Instrument: Injuries will be reported by Research Assistants on-site (at each game venue), utilizing an injury surveillance protocol developed for the study by our research team. The injury surveillance protocol clearly defines what constitutes an injury. Injuries will also be verified utilizing recorded video footage. A video coding protocol to record or verify injuries during the games was also developed by the team to document injuries.
Timepoint [1] 319447 0
Injury surveillance will occur at five games for four different teams (20 observations) during the 2019 Southern Metropolitan Junior Football League. Additionally, video footage analysis will occur at each game (20 observations). Depending on the age range of players on field game time maybe be 60-90 minutes (approximately 1.5 hours) for each game. Data will be analyzed post-season to finalize and confirm the incidence of injuries.
Primary outcome [2] 320995 0
2. Self-reported knowledge and attitudes towards concussions and other injuries will be our secondary primary outcome. This is a composite variable.

Instrument: Self-reported knowledge/attitudes towards concussions/injuries will be measured using the national survey developed within the lab group in conjunction with the Australian Football League (AFL).
Timepoint [2] 320995 0
Players will complete the survey when consented to the study. Players will be provided an online link to the survey on REDCAP via email after signing up to the study. Players will be encouraged to complete the national survey at their earliest possible convenience but may do so in anytime from the time of consent through to the last game observed by the research team during the study.
Secondary outcome [1] 368235 0
Within-subjects analysis of impact severity measured by the use of accelerometer outputs provided by the X-Patch. All time-stamped accelerometer output will be verified by concomitant video review for the incidence of actual physical contact to the accelerometer wearing player during the game.
Timepoint [1] 368235 0
X-Patch measurements will be conducted at all 20 observations for the entirety of each observation (i.e., each game of approximately 1.5 hours) throughout the youth amateur football season of 2019.
Secondary outcome [2] 373857 0
Within-subjects analysis of impact frequency measured by the use of accelerometer outputs provided by the X-Patch. All time-stamped accelerometer output will be verified by concomitant video review for the incidence of actual physical contact to the accelerometer wearing player during the game.
Timepoint [2] 373857 0
X-Patch measurements will be conducted at all 20 observations for the entirety of each observation (i.e., each game of approximately 1.5 hours) throughout the youth amateur football season of 2019.

Eligibility
Key inclusion criteria
All players must be above or equal to 10 years old and below or equal to 17 years of age, as the research is primarily concerned with player behaviour and impact severity in a youth sample with and without wearing headgear. A body of evidence suggests that rates of sports injury and headgear use largely differ among this population. Participant will be recruited from youth football clubs that do not mandate headgear. The teams will be selected from Junior Football Clubs: Southern Metropolitan Junior Football League or the Eastern League or Yarra Junior League.
Minimum age
10 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Australian Football players above or equal to 18 years of age.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed or applicable in this within-subjects study. All youth participants will be subject to the intervention and active control arms.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Continuous variables will be presented using means and standard deviations and compared using student's t-test or 1-way ANOVAs. Ordinal variables will be presented using medians and inter-quartile range and compared using Wilcoxon Rank sum test. Proportions will be compared using chi-square analysis. Statistical significance is set at p -value 0.05. It is estimated the sample size will range from 60 to 72 participants.

Data for the primary outcome, using x-Patch output, is known to be heavily skewed and leptokurtic. It is often found a logarithm transformation does not significantly aid normality. Therefore, this data will be presented using median and IQR and assessed using non-parametric tests including Mann-Whitnney or Kruskal Wallis tests depending on ther number of factors (e.g., between sex; between divisions).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/05/2019
Date of last participant enrolment
Anticipated
Actual
16/05/2019
Date of last data collection
Anticipated
Actual
14/07/2019
Sample size
Target
60
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 26070 0
3145 - Malvern East

Funding & Sponsors
Funding source category [1] 301876 0
Charities/Societies/Foundations
Name [1] 301876 0
Equity Trustees - The Walter Thomas Cottman Charitable Trust.
Country [1] 301876 0
Australia
Funding source category [2] 302299 0
Commercial sector/Industry
Name [2] 302299 0
Australian Football League
Country [2] 302299 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash University
Victoria 3800
Australia
Country
Australia
Secondary sponsor category [1] 302174 0
None
Name [1] 302174 0
Address [1] 302174 0
Country [1] 302174 0
Other collaborator category [1] 280616 0
University
Name [1] 280616 0
The National Trauma Research Institute
Address [1] 280616 0
85-89 Commercial Rd, Melbourne VIC 3004
Country [1] 280616 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302568 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 302568 0
Ethics committee country [1] 302568 0
Australia
Date submitted for ethics approval [1] 302568 0
24/01/2019
Approval date [1] 302568 0
25/01/2019
Ethics approval number [1] 302568 0
18039

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90686 0
Dr Catherine Willmott
Address 90686 0
Monash Psychology Centre, Monash University, 1/270 Ferntree Gully Rd Notting Hill, Victoria, Australia 3168
Country 90686 0
Australia
Phone 90686 0
+61 3 990 24480
Fax 90686 0
+61 3 9905 0605
Email 90686 0
catherine.willmott@moash.edu.au
Contact person for public queries
Name 90687 0
Christopher Andara
Address 90687 0
Monash Psychology Centre, Monash University, 1/270 Ferntree Gully Rd Notting Hill, Victoria, Australia 3168
Country 90687 0
Australia
Phone 90687 0
+61 3 990 24480
Fax 90687 0
Email 90687 0
christopher.andara@monash.edu
Contact person for scientific queries
Name 90688 0
Catherine Willmott
Address 90688 0
Monash Psychology Centre, Monash University, 1/270 Ferntree Gully Rd Notting Hill, Victoria, Australia 3168
Country 90688 0
Australia
Phone 90688 0
+61 3 990 24480
Fax 90688 0
Email 90688 0
catherine.willmott@moash.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.