Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001167358
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
25/08/2026
Date registered
Help: Date registered
18/09/2026
Date last updated
Help: Date last updated
18/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
18/09/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of soccer heading on the brain in adolescents and young adults
Scientific title
Accelerating clinical trials for the treatment of youth concussion through an innovative standardised soccer heading model
Additional trial identifiers [1] 317363 0
Nil known
Universal Trial Number (UTN)
U1111-1341-2935
Trial acronym
KICKSTART
Related trial records

Health condition
Health condition(s) studied:
Non-concussive head impacts 342019 0
Head Trauma 343552 0
Condition category
Condition code
Injuries and Accidents 338102 338102 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Intervention: Soccer Heading Task
Participants will be instructed to stand 40 ft (~12 m) away from a JUGS Soccer Machine in an outdoor field. The machine will be used by an experience trial coordinator to launch weight-matched FIFA regulation size 5 soccer balls inflated to 13 psi at a speed of 25 mi·h-1 (~40 km·h-1). The launch angle will initially be set at 40° to the horizontal; however, a ‘practice’ launch, during which participants will observe the trajectory of the ball (without heading it), will be performed (and repeated if required) to calibrate this to each participant’s preference. Participants will then perform 10 soccer headers at 1-minute intervals. Individuals will be instructed to hit the ball with their forehead and aim at a target 15 m in front of them. If a header is unsuccessful (i.e., there is no contact between the head and the ball), another ball will be launched within the 1-minute interval (this procedure will be repeated if required until a successful header occurs). As such, every participant will complete exactly 10 headers, as observed by the trial coordinator, ensuring intervention fidelity.
The intervention will be administered on one occasion, only; with participants randomly allocated to complete the intervention or comparator condition (see below).
Intervention code [1] 334153 0
Diagnosis / Prognosis
Intervention code [2] 335304 0
Prevention
Description of the comparator or control
Kicking Task

The control condition will be administered exactly as the intervention except that participants will be instructed to kick, rather than head, the soccer balls. The launch angle will also be reduced to aid kicking. The control task will take 10 minutes to complete, and participants will kick the ball exactly 10 times.
Control group
Active

Outcomes
Primary outcome [1] 346587 0
Plasma concentrations of Glial Acidic Fibrillary Protein (GFAP)
Timepoint [1] 346587 0
Baseline and 24hrs post soccer heading task (SHT) and kicking task
Secondary outcome [1] 466510 0
Plasma concentrations of GFAP
Timepoint [1] 466510 0
Baseline and 7d post SHT and kicking task
Secondary outcome [2] 466511 0
Plasma concentrations of Neurofilament Light (Nf-L)
Timepoint [2] 466511 0
Baseline, 24hrs and 7d post SHT and kicking task
Secondary outcome [3] 466524 0
Plasma concentrations of Interleukin 6 (IL-6)
Timepoint [3] 466524 0
Baseline, 24hrs and 7d post SHT and kicking task
Secondary outcome [4] 466528 0
Plasma concentrations of Glycoprotein 130 (GP130)
Timepoint [4] 466528 0
Baseline, 24hrs and 7d post SHT and kicking task
Secondary outcome [5] 466540 0
Time to complete cognitive/visual task
Timepoint [5] 466540 0
Baseline and 24hrs post SHT and kicking task
Secondary outcome [6] 466541 0
Number of errors on cognitive/visual task
Timepoint [6] 466541 0
Baseline and 24hrs post SHT and kicking task
Secondary outcome [7] 466543 0
Concussion signs and symptoms
Timepoint [7] 466543 0
Baseline, 1h, 24hrs and 7d post SHT and kicking task
Secondary outcome [8] 467753 0
High density resting electrical activity over the entire frequency band
Timepoint [8] 467753 0
Baseline and 1h post SHT and kicking task
Secondary outcome [9] 467754 0
High density resting brain connectivity
Timepoint [9] 467754 0
Baseline and 1h post SHT and kicking task
Secondary outcome [10] 467755 0
High density task-based electrical activity over the entire frequency band
Timepoint [10] 467755 0
Baseline and 1h post SHT and kicking task
Secondary outcome [11] 467757 0
High density task-based brain connectivity
Timepoint [11] 467757 0
Baseline and 1h post SHT and kicking task
Secondary outcome [12] 467758 0
Resting-state oxygenated hemoglobin (HbO)
Timepoint [12] 467758 0
Baseline and 1h post SHT and kicking task
Secondary outcome [13] 467759 0
Resting-state deoxygenated hemoglobin (HbR)
Timepoint [13] 467759 0
Baseline and 1h post SHT and kicking task
Secondary outcome [14] 467760 0
Resting-state haemodynamic brain connectivity
Timepoint [14] 467760 0
Baseline and 1h post SHT and kicking task
Secondary outcome [15] 467761 0
Task-based HbO
Timepoint [15] 467761 0
Baseline and 1h post SHT and kicking task
Secondary outcome [16] 467762 0
Task-based HbR
Timepoint [16] 467762 0
Baseline and 1h post SHT and kicking task
Secondary outcome [17] 467763 0
Task-based haemodynamic brain connectivity
Timepoint [17] 467763 0
Baseline and 1h post SHT and kicking task

Eligibility
Key inclusion criteria
Healthy males and females (~50% of each) with greater than or equal to 2 years of soccer heading experience (to ensure safe and controlled head impacts).
Minimum age
14 Years
Maximum age
24 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
(a) A self-reported head, neck, face and/or eye injury (including concussion; as assessed via questions 2 and 3 of the Concussion History Questionnaire in the last 6 months
(b) A current, self-reported injury (any type) that requires some degree of medical intervention (e.g., RICE, pain-relief medication)
(c) A self-reported history of neurological disorders (e.g., seizure disorders, spinal cord injury, stroke)
(d) A history of a major psychiatric disorder within the previous 12 months, as per the Diagnostic and Statistical Manual of Mental Disorders (DSM)-V criteria
(e) Current use of platelet-active agents such as aspirin, ticagrelor, clopidogrel and prasugrel, warfarin and direct oral anticoagulants (DOACs)
(f) Inability to avoid soccer heading or any other activity involving head impacts (e.g., contact sports) 7 days prior to and while participating in this project
(g) Inability to refrain from consuming alcohol (24 hours) and caffeine (12 hours) prior to each experimental trial
(h) Inability to refrain from using central nervous system (CNS) active drugs (i.e., cocaine, cannabis, amphetamines, methamphetamine, benzodiazepines, methadone, opioids, oxycodone, barbiturates) 7 days prior to and while participating in this project
(i) Pregnant or lactating, as indicated by self-report of such and last menses
(j) Use of eyeglasses (contact lenses permitted)

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes containing the allocation will be opened at the time of intervention only
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation using a random number generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The samples size is powered to determine the effect of SHT on the primary hypothesis (i.e., plasma GFAP concentration at 24 hours). This is based on an effect estimate of 0.64 from our pilot data in adults, and similar research in adults (effect estimates between 0.2 – 0.8). To identify a between-group difference in a two-sided test (a of 0.05, ß of 0.8), 80 participants would be required.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/09/2026
Actual
Date of last participant enrolment
Anticipated
24/12/2027
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 321935 0
University
Name [1] 321935 0
The University of Queensland
Country [1] 321935 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 325699 0
None
Name [1] 325699 0
Address [1] 325699 0
Country [1] 325699 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320470 0
Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 320470 0
Ethics committee country [1] 320470 0
Australia
Date submitted for ethics approval [1] 320470 0
19/01/2026
Approval date [1] 320470 0
08/04/2026
Ethics approval number [1] 320470 0
HREC/2026/QCHQ/125700
Ethics committee name [2] 321259 0
The University of Queensland Human Research Ethics Committee A
Ethics committee address [2] 321259 0
Ethics committee country [2] 321259 0
Australia
Date submitted for ethics approval [2] 321259 0
08/04/2026
Approval date [2] 321259 0
05/05/2026
Ethics approval number [2] 321259 0
2026/HE010810

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

Contacts
Principal investigator
Name 150578 0
Dr Nathan Delang
Address 150578 0
Child Health Research Centre, 62 Graham Street, South Brisbane, QLD, 4101
Country 150578 0
Australia
Phone 150578 0
+61 7 3069 7178
Fax 150578 0
Email 150578 0
[email protected]
Contact person for public queries
Name 150579 0
Nathan Delang
Address 150579 0
Child Health Research Centre, 62 Graham Street, South Brisbane, QLD, 4101
Country 150579 0
Australia
Phone 150579 0
+61 7 3069 7178
Fax 150579 0
Email 150579 0
[email protected]
Contact person for scientific queries
Name 150580 0
Nathan Delang
Address 150580 0
Child Health Research Centre, 62 Graham Street, South Brisbane, QLD, 4101
Country 150580 0
Australia
Phone 150580 0
+61 7 3069 7178
Fax 150580 0
Email 150580 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Anyone
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: Nathan Delang; [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.