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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001319369
Ethics application status
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Approved
Date submitted
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18/09/2026
Date registered
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2/11/2026
Date last updated
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2/11/2026
Date data sharing statement initially provided
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2/11/2026
Type of registration
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Retrospectively registered

Titles & IDs
Public title
Using a modified 10m Shuttle Test to compare to the Buffalo Concussion Treadmill Test in children aged 8-18 years without a concussion.
Scientific title
Validation of a modified 10 metre shuttle test compared to the Buffalo Concussion Treadmill test in children aged 8-18 years without concussion.
Additional trial identifiers [1] 318468 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records
ACTRN12622001051730: 10 metre shuttle test as a measure of post concussion syndrome in children aged 8-18 years
This study is a follow up from the ACTRN12622001051730: It is the exact same protocol which has been adapted to determine if the results from the previous trial can be made more robust.

Health condition
Health condition(s) studied:
Persistent Post Concussion Symptoms 343645 0
Concussion 343905 0
Mild Traumatic Brain Injury 343906 0
Condition category
Condition code
Physical Medicine / Rehabilitation 339757 339757 0 0
Physiotherapy
Neurological 340048 340048 0 0
Other neurological disorders
Injuries and Accidents 340049 340049 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Participants will complete two exercise tolerance tests.
1. Buffalo Concussion Treadmill Test (BCTT)
2. Modified 10m Shuttle Test.(MST)

This is being delivered by a physiotherapist + research student as a one off assessment. The participant will be attending the Queensland Children's Hospital for a total of 2-2.5 hours (including explanation times). They will participate in either the BCTT or MST (approx 20-25 mins); have at least a 60 minute break (or until Heart Rate (HR) and Perceived Level of Exertion (OMNI) return to baseline - whichever is longer) then complete the other test.

The Modified Shuttle Test is a graded exercise test that is usually used as a test to exertion however we will be using this test in a modified fashion to measure the intensity of exercise as rated by OMNI scale, heart rate and if it causes any symptoms in non-concussion patients..

The participant will be asked to sit on a chair in a clinic room. They will rest in this position for 2 minutes with Polar OH1 Heart Rate Sensor fitted to their chest.

During their rest period, the testing process will be explained to the child and attending parent. The child will be fitted with the Heart Rate monitor and this will be worn throughout the tests. They will have the OMNI exertion measure and VAS Symptom Severity Scale explained to them and that they will be asked during the test to use the number and pictorial system to explain how they are feeling in regard to their level of exertion and symptoms. The OMNI and VAS will be printed out and laminated in front of the child. After the rest period, the baseline HR and symptoms will be recorded and the testing will begin as per the Modified Shuttle Test protocol An modified auditory recording will be used throughout the test with an auditory metronome to maintain pace of the circuit. After each phase (1 minute), the child will be asked to rate their RPE via a number/picture with how they are feeling. The HR will recorded throughout the test and will be added into the data after download. The test will be stopped if the child experiences
• a RPE score of 10 or
• if their symptoms increase by more than 2 on the VAS.
• if the child is unable to keep up with the required pace of the test by missing the metronome sound more than two (2) times.
• If the child or parent requests the test to be ceased, we will stop the test immediately, without the need for any of the above criteria to be met.

The participant will be able to sit for 2 minutes to rest at the end of the test.

The Buffalo Concussion Treadmill Test (BCTT) is a validated test to measure the amount of aerobic exercise that is appropriate to perform, even in the acute phase after concussion. It involves walking on the treadmill at a constant speed with the incline on the treadmill increased by one degree each minute to a maximum of 15 degree incline.

The child/adolescent will also participate in the Buffalo Concussion Treadmill Test as per protocol.. The protocol will be explained to the family and participant. Although the BCTT protocol uses a different exertion scale, studies have shown the OMNI scale to have reliability and validity between the two measures and therefore, for simplicity, we will use the OMNI scale for this test. They will then complete the BCTT. The test will stop if the child experiences:
• a RPE score of 10 (as measured via the OMNI) or
• if their symptoms increase by more than 2 on the VAS.
• if the child is unable to keep up with the required pace of the test by missing the metronome sound more than three (3) times.
• If the child or parent requests the test to be ceased, we will stop the test immediately, without the need for any of the above criteria to be met.

This is a once off assessment for research purposes only.

The participants will be non-randomly assigned to complete either BCTT or MST first. This will be determined by space/room availability as it is being completed within a hospital clinical space, where clinical patients are first priority. Each participant will complete each section of the study as an individual/one-on-one with the researcher.

This record is an extension of ACTRN12622001051730 but children without concussion. The findings from ACTRN12622001051730 study indicated a good correlation however had a slower start with a more rapid finish. This trial uses a modified 10m Shuttle Test audio recording with an increased starting point and a lower ramp speed to determine if we are able to better correlated HR and OMNI changes between the two tests.
Intervention code [1] 335375 0
Rehabilitation
Description of the comparator or control
The Buffalo Concussion Treadmill Test (gold standard) can be considered control test however all participants will complete both the Control & the Intervention (10m Modified Shuttle Test) so that comparison between tests, within-subjects can be completed.
Control group
Active

Outcomes
Primary outcome [1] 346929 0
OMNI Perceived Rate of Exertion Scale (0-10). Perceived Rate of Exertion during physical activity. The OMNI is a visual assessment scale for children to effectively self-report perceived rate of exertion during physical activity by means of a verbal, numerical, and pictorial representation scale. This scale has been validated to be a reliable measure of perceived exertion for aerobic activity in children.
Timepoint [1] 346929 0
Baseline & at each minute of each test. The total duration of each test is determined by the ability of the participant on the BCTT with the protocol increasing speed by 0.5km/hr after the incline has been maxed at 15 degrees until OMNI/RPE is at 10. The 10m Shuttle Test has a max duration of 16 minutes.
Primary outcome [2] 346930 0
Heart Rate
Timepoint [2] 346930 0
Baseline & at each minute of each test. The total duration of each test is determined by the ability of the participant on the BCTT with the protocol increasing speed by 0.5km/hr after the incline has been maxed at 15 degrees until OMNI/RPE is at 10. The 10m Shuttle Test has a max duration of 16 minutes.
Primary outcome [3] 346931 0
Visual Analogue Scale will measure any concussion type symptoms that may be present for this cohort despite not being concussion patients eg. to determine if any concussion symptoms are also present in typically developing youth.
Timepoint [3] 346931 0
Baseline & at each minute of each test. The total duration of each test is determined by the ability of the participant on the BCTT with the protocol increasing speed by 0.5km/hr after the incline has been maxed at 15 degrees until OMNI/RPE is at 10. The 10m Shuttle Test has a max duration of 16 minutes.
Secondary outcome [1] 469670 0
Number of Adverse Events Recorded eg. asthma attack, seizure, severe headache requiring medical attention
Timepoint [1] 469670 0
Throughout the whole data collection period, encompassing both exercises test durations and the between-test rest (~2h total)

Eligibility
Key inclusion criteria
- Any typically developing child aged 8 to 18 years
- No self-reported concussion, or if concussion reported in last 3 months, having returned to baseline function with full participation in regular activities without symptoms
- Aged 8-18 years
Minimum age
8 Years
Maximum age
18 Years
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
- a significant medical history that would contraindicate exercise on a treadmill or flat ground within a clinic setting
- a previous concussion within the last 3 months,
- persistent symptoms following a previous concussion
- inability to complete questionnaires
- parent unable to provide informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Our estimated sample size is 30, allowing for 10% attrition, at 90% power and significance of p less than or equal to 0.05 and r greater than or equal to 0.7, and additional 15 participants to improve precision estimates due to the small required sample size. Indeed, increasing the sample size from 15 to 30 reduces the 95% confidence interval width for r from 0.60 to 0.39, representing a 35% improvement in precision. A larger sample will also mitigate the influence of outliers, enhance generalizability, and allow for potential missing data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
7/04/2026
Date of last participant enrolment
Anticipated
Actual
22/09/2026
Date of last data collection
Anticipated
Actual
22/09/2026
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 323051 0
Hospital
Name [1] 323051 0
Queensland Children's Hospital - QPRS (in-kind)
Country [1] 323051 0
Australia
Funding source category [2] 323052 0
University
Name [2] 323052 0
University of Queensland (in-kind)
Country [2] 323052 0
Australia
Primary sponsor type
Hospital
Name
Queensland Children's Hospital
Address
Country
Australia
Secondary sponsor category [1] 325994 0
University
Name [1] 325994 0
University of Queensland
Address [1] 325994 0
Country [1] 325994 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321453 0
Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 321453 0
Ethics committee country [1] 321453 0
Australia
Date submitted for ethics approval [1] 321453 0
12/02/2026
Approval date [1] 321453 0
10/03/2026
Ethics approval number [1] 321453 0
HREC/22/QCHQ/87292

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

Contacts
Principal investigator
Name 153774 0
Mrs Kirrilee Smith
Address 153774 0
Queensland Children's Hospital, Level 6G QPRS, 501 Stanley St, South Brisbane QLD 4101
Country 153774 0
Australia
Phone 153774 0
+61 730682950
Fax 153774 0
Email 153774 0
[email protected]
Contact person for public queries
Name 153775 0
Kirrilee Smith
Address 153775 0
Queensland Children's Hospital, Level 6G QPRS, 501 Stanley St, South Brisbane QLD 4101
Country 153775 0
Australia
Phone 153775 0
+61 730682950
Fax 153775 0
Email 153775 0
[email protected]
Contact person for scientific queries
Name 153776 0
Kirrilee Smith
Address 153776 0
Queensland Children's Hospital, Level 6G QPRS, 501 Stanley St, South Brisbane QLD 4101
Country 153776 0
Australia
Phone 153776 0
+61 730682950
Fax 153776 0
Email 153776 0
[email protected]

Data sharing statement
Will the study consider sharing 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.