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Trial registered on ANZCTR

Registration number

ACTRN12622000931774p

Ethics application status

Submitted, not yet approved

Date submitted

18/05/2022

Date registered

30/06/2022

Date last updated

30/06/2022

Date data sharing statement initially provided

30/06/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Tracking recovery after sustaining a sports-related concussion in adolescent rugby players: A prospective study

Scientific title

Multi-system recovery after sports related concussion in adolescent rugby players: A prospective study

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Sport-Related Concussion

Condition category

Condition code

Neurological

Other neurological disorders

Injuries and Accidents

Other injuries and accidents

Intervention/exposure

Study type

Observational

Patient registry

False

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Sports-related concussive events will be recorded over a single playing season (2022/23).

A sports-related concussive event will be defined as a result of a direct blow to the head, face, neck or elsewhere on the body with an impulsive force transmitted to the head, resulting in one or more of the symptoms in one or more of the following clinical domains (which may or may not have involved loss of consciousness): somatic, cognitive, emotional/behavioural; sleep disturbance (McCrory et al., 2016).

Sport-related concussion events will be recorded by a data champion and the researcher will make contact with individual schools/clubs on a weekly basis to record any sport-related concussion incidents and begin follow-up. Participants do not have to make contact at any point.

All participants will complete baseline assessments of all outcomes at the time of enrolment (baseline). Those who sustain a sport-related concussion will be followed up at 3, 7, 14, 23, 90, 180, and 365 days after a concussive event. A study researcher will conduct a face-to-face session at these time points, which will involve the completion of two questionnaires; Post-Concussion Symptom Scale and PFAB-TBI, a test of balance (QYBT), and an examination of pupillary light reflex metrics.

Each assessment method is relatively quick: PLRM takes approximately 5 minutes per subject to complete, Y-Balance Testing takes approximately 5 minutes per subject to complete, PFAB-TBI and PCSS are questionnaires which take approximately 5 minutes each to complete. In total each subject will spend around 20 minutes completing tests.

Intervention code [1]

Diagnosis / Prognosis

Comparator / control treatment

Participants who do not sustain a sports-related concussive event during the 2022/23 playing season.

Control group

Active

Outcomes

Primary outcome [1]

Inertial sensor quantified Y-Balance Test (QYBT)

Timepoint [1]

Baseline and at 72 hours, 7 days, 14 days, 23 days, 90 days, 180 days, 365 days post-concussion event.

Secondary outcome [1]

Pediatric Fear Avoidance Behaviour-Traumatic Brain Injury (PFAB-TBI)

Timepoint [1]

Baseline and at 72 hours, 7 days, 14 days, 23 days, 90 days, 180 days, 365 days post-concussion event.

Secondary outcome [2]

Post-Concussion Symptom Scale (PCSS)

Timepoint [2]

Baseline and at 72 hours, 7 days, 14 days, 23 days, 90 days, 180 days, 365 days post-concussion event.

Secondary outcome [3]

Pupillary Light Reflex metrics (PLRM) using a pupillometer. The individual metrics measured in this study will be: Maximum Pupil Diameter, Minimum Pupil Diameter, Latency, Percentage of Constriction, Peak and Average Constriction Velocity, Peak and Average Dilation Velocity, and T75 (time to 75% pupil redilation). All pupillary light reflex metrics will be assessed as a composite secondary outcome.

Timepoint [3]

Baseline and at 72 hours, 7 days, 14 days, 23 days, 90 days, 180 days, 365 days post-concussion event.

Secondary outcome [4]

Time to the concussive event which will be plotted using survival curves. Suspected concussive events will be reported by the coach to the researcher following the suspected concussive event, in which subjects will be encouraged to be seen by a medical practitioner. Should this not be possible, concussions can be confirmed by a co-author of this paper who is a registered Sports-Medicine Physician.

Timepoint [4]

At the time of the concussive event.

Eligibility

Key inclusion criteria

Adolescent rugby union players

Minimum age

16 Years

Maximum age

18 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Adolescent rugby union players aged outside the 16-18-year-old specified range.

Study design

Purpose

Natural history

Duration

Longitudinal

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

We aim to enrol 250 participants into the study. This figure allows for a 20% loss to follow-up over the entire study and assumes a 10% concussion prevalence over a single playing season. This will generate recovery data from 20 participants presenting with a new concussion. Recruitment will be stratified to include equal numbers of male and female participants (n=125 male; n=125 female). A sample of 250 participants would also provide sufficient power for detect baseline difference in vestibular function. Our previous research (Matthews et al., 2021) had a medium effect difference (SMD 0.5), between adolescents with a history of concussion to those with no history, for vestibular function with standard deviation of 0.22 units (SEn). Based on an alpha level of 1%, 180 participants would provide 90% power for detecting a medium effect difference in SEn between groups at baseline.

All data will be analysed using the Statistical Package of Social Sciences (SPSS) (Version 26; SPSS Inc). Baseline outcomes (Concussion history, PCSS, QYBT, PLRM) will be summarized using means and standard deviations for scale variables and frequencies and percentages for nominal variables. We will use histograms to examine the frequency distributions of scale variables, and where normality is assumed, we will use independent t-tests to compare baseline data (PCSS, QYBT, PLRM), with players categorised into two groups based on self-reported history of concussion in the last 12 months (no concussion in the last 12 months or concussion within the last 12 months). The threshold for statistical significance will P < .01 for all tests. We will also present mean differences (95% confidence intervals) between groups for scale outcome data. Concussions occurring throughout the 2022/23 playing season will be summarized using counts (%). Time to concussion event will be plotted using survival curves, with participants censored at the end of the playing season. Serial outcome data (PCSS, QYBT, PLRM, PFAB-TBI) will be measured at 72 hours, 7 days, 14 days, 23 days, 90 days, 180 days and 365 days post-concussion; we will initially determine the number (%) of participants that had returned to baseline at each time point. We will also examine the growth/response curves for each participant, as well as compare curves between known groups such as sex, concussion history etc. As the shape of the time-response curve is uncertain, and may vary across each outcome variable, we will calculate summary measures for each participant based on either the peak value, the time to return to baseline, or the area under the curve. Area under the curve will be calculated using the trapezium rule (by adding the areas under the graph between each pair of consecutive observations). The most suitable summary measure will be used in the calculation of a median score (interquartile ranges) for each outcome variable. Between group comparisons will also be made, comparing curves across two known groups e.g. males/females, history of concussion/no history, age.
In an exploratory analysis, we will use logistic regression to examine the association between demographic variables (age, sex, weight, height, concussion history and playing position) and recovery at 23 day follow up. We will run separate models for each outcome measure (PCSS, QYBT, PLRM, PFAB-TBI). Our previous research (Archold et al., 2015) found that 90% of adolescent rugby players return to sport at 23 days post-concussion; this is also the minimal convalesce for adolescent players post-concussion, based on Irish Rugby Football Union guidance. Full recovery will be defined as a return to baseline (pre-season) values for each respective outcome. Initially we will conduct a series of univariate analyses to determine whether any predictor variables are associated with recovery. Correlations among predictor variables will be calculated to screen for any strong co-linearity (r>0.8). Predictors demonstrating a p-value less than 0.10 on univariate testing will be entered into a multiple logistic regression analysis. The strength of the predictive model will be determined using R2, p-values, Odds Ratios, with 95% confidence intervals (95% CI).

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/08/2022

Actual

Date of last participant enrolment

Anticipated

1/04/2023

Actual

Date of last data collection

Anticipated

1/04/2024

Actual

Sample size

Target

250

Accrual to date

Final

Recruitment outside Australia

Country [1]

United Kingdom

State/province [1]

Northern Ireland

Funding & Sponsors

Funding source category [1]

University

Name [1]

Ulster University

Address [1]

Ulster University
Shore Road
Newtownabbey
Co. Antrim
Northern Ireland
BT37 0QB

Country [1]

United Kingdom

Primary sponsor type

University

Name

Ulster University

Address

Ulster University
Shore Road
Newtownabbey
Co. Antrim
Northern Ireland
BT37 0QB

Country

United Kingdom

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Ulster University Research Ethics Committee

Ethics committee address [1]

Ulster University
Shore Road
Newtownabbey
Co. Antrim
BT37 0QB

Ethics committee country [1]

United Kingdom

Date submitted for ethics approval [1]

18/05/2022

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Few prospective studies have examined vestibular or oculomotor function post-concussion in adolescents, and the natural progression of recovery for these subsystems remains poorly understood. Utilizing innovative technology (Quantified Y-Balance Test and Pupillary Light Reflex Metrics) and demographic variables (Concussion History, Fear-Avoidance behaviors, Age, Sex), concussion recovery of adolescent rugby players will be mapped over 12 months to understand how these variables longitudinally affect concussion recovery. It is hypothesized that metrics utilized in this study will highlight deficits associated with SRC beyond the point of self-report symptom resolution and return-to-play.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Chris Bleakley

Address

Ulster University
Shore Road
Newtownabbey
Co.Antrim
Northern Ireland
BT37 0QB

Country

United Kingdom

Phone

+442890366025

Fax

[email protected]

Contact person for public queries

Name

Chris Bleakley

Address

Ulster University
Shore Road
Newtownabbey
Co.Antrim
Northern Ireland
BT37 0QB

Country

United Kingdom

Phone

+442890366025

Fax

[email protected]

Contact person for scientific queries

Name

Chris Bleakley

Address

Ulster University
Shore Road
Newtownabbey
Co.Antrim
Northern Ireland
BT37 0QB

Country

United Kingdom

Phone

+442890366025

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

Individual participant data after de-identification underlying published results only.

When will data be available (start and end dates)?

Immediately after publication with no end date.

Available to whom?

Anyone who wishes to access it.

Available for what types of analyses?

Any purpose

How or where can data be obtained?

All inquiries can be directed toward the principal investigator Dr Chris Bleakley.
([email protected])

What supporting documents are/will be available?

Doc. No.	Type	Email
15746	Study protocol	[email protected]
15747	Informed consent form	[email protected]
15748	Ethical approval	[email protected]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Multisystem recovery after sport-related concussion in adolescent rugby players: a prospective study protocol.	2023	https://dx.doi.org/10.1136/bmjopen-2023-073677

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically