Trial Review

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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] 306886 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sport-Related Concussion 326014 0
Condition category
Condition code
Neurological 323320 323320 0 0
Other neurological disorders
Injuries and Accidents 323771 323771 0 0
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] 323357 0
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] 331057 0
Inertial sensor quantified Y-Balance Test (QYBT)
Timepoint [1] 331057 0
Baseline and at 72 hours, 7 days, 14 days, 23 days, 90 days, 180 days, 365 days post-concussion event.
Secondary outcome [1] 408608 0
Pediatric Fear Avoidance Behaviour-Traumatic Brain Injury (PFAB-TBI)
Timepoint [1] 408608 0
Baseline and at 72 hours, 7 days, 14 days, 23 days, 90 days, 180 days, 365 days post-concussion event.
Secondary outcome [2] 409433 0
Post-Concussion Symptom Scale (PCSS)
Timepoint [2] 409433 0
Baseline and at 72 hours, 7 days, 14 days, 23 days, 90 days, 180 days, 365 days post-concussion event.
Secondary outcome [3] 409434 0
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] 409434 0
Baseline and at 72 hours, 7 days, 14 days, 23 days, 90 days, 180 days, 365 days post-concussion event.
Secondary outcome [4] 410638 0
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] 410638 0
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] 24726 0
United Kingdom
State/province [1] 24726 0
Northern Ireland

Funding & Sponsors
Funding source category [1] 311197 0
University
Name [1] 311197 0
Ulster University
Country [1] 311197 0
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] 312589 0
None
Name [1] 312589 0
Address [1] 312589 0
Country [1] 312589 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310729 0
Ulster University Research Ethics Committee
Ethics committee address [1] 310729 0
Ulster University
Shore Road
Newtownabbey
Co. Antrim
BT37 0QB
Ethics committee country [1] 310729 0
United Kingdom
Date submitted for ethics approval [1] 310729 0
18/05/2022
Approval date [1] 310729 0
Ethics approval number [1] 310729 0

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 118666 0
Dr Chris Bleakley
Address 118666 0
Ulster University
Shore Road
Newtownabbey
Co.Antrim
Northern Ireland
BT37 0QB
Country 118666 0
United Kingdom
Phone 118666 0
+442890366025
Fax 118666 0
Email 118666 0
c.bleakley@ulster.ac.uk
Contact person for public queries
Name 118667 0
Dr Chris Bleakley
Address 118667 0
Ulster University
Shore Road
Newtownabbey
Co.Antrim
Northern Ireland
BT37 0QB
Country 118667 0
United Kingdom
Phone 118667 0
+442890366025
Fax 118667 0
Email 118667 0
c.bleakley@ulster.ac.uk
Contact person for scientific queries
Name 118668 0
Mr Chris Bleakley
Address 118668 0
Ulster University
Shore Road
Newtownabbey
Co.Antrim
Northern Ireland
BT37 0QB
Country 118668 0
United Kingdom
Phone 118668 0
+442890366025
Fax 118668 0
Email 118668 0
c.bleakley@ulster.ac.uk

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.
(c.bleakley@ulster.ac.uk)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15746Study protocol  c.bleakley@ulster.ac.uk
15747Informed consent form  c.bleakley@ulster.ac.uk
15748Ethical approval  c.bleakley@ulster.ac.uk



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseMultisystem recovery after sport-related concussion in adolescent rugby players: a prospective study protocol.2023https://dx.doi.org/10.1136/bmjopen-2023-073677
N.B. These documents automatically identified may not have been verified by the study sponsor.