Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001051730
Ethics application status
Approved
Date submitted
10/07/2022
Date registered
28/07/2022
Date last updated
30/11/2023
Date data sharing statement initially provided
28/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Validation of the `10 metre shuttle test as a measure of post concussion syndrome in children aged 8-18 years.
Scientific title
Validation of the `10 metre shuttle test as a measure of post concussion syndrome in children aged 8-18 years.
Secondary ID [1] 307454 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Concussion 326848 0
Condition category
Condition code
Physical Medicine / Rehabilitation 324062 324062 0 0
Physiotherapy
Neurological 324285 324285 0 0
Other neurological disorders
Injuries and Accidents 324286 324286 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each year, many children present to emergency departments with concussion (or mild head injury). These children are given advice and education on how to assist in their recovery from the injury including a gradual return to exercise and many (n=240) are referred to the Queensland Paediatric Rehabilitation Service (QPRS) Complex Concussion Clinic. We are hoping to provide a more structured approach for returning to exercise using a tele-health physiotherapy led program for those referred to our service (QPRS). Before we can start the telehealth program, we first need to make sure that the exercise test (10 m Shuttle Test) is a good option to be used in children who have experience a concussion. We will test this against a treadmill test (Buffalo Concussion Treadmill Test) that has good evidence for adolescent who have experienced a concussion.
The 10m 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 that elicit participant concussion symptoms.

The child 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 upper arm.

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 Visual Analogue Scale (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 heart rate (HR) and symptoms will be recorded and the testing will begin as per the Modified Shuttle Test protocol. A YouTube video 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 Rate of Perceived Exertion (OMNI 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 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.

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

After this, the participant will attend their appointment at QPRS with the Complex Concussion Clinic team. At the end of their appointment (approximately 60 minutes later), they will then return to the QPRS gym to finish their exercise testing with the Buffalo Concussion Treadmill Test.
Intervention code [1] 323915 0
Early detection / Screening
Comparator / control treatment
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. The BCTT consists of the participant walking on a treadmill at a 'brisk' walking pace for 1 minute. After each subsequent minute, the incline on the treadmill increases 1 degree up to a maximum of 15 degrees. A brisk walking pace is determined via the participants height as per protocol however as we are completing this with younger children, we may reduce the speed to accomodate lower heights. It differs from the 10m Shuttle Test as the 10m shuttle uses increases in speed while the BCTT uses increase in incline. The test is terminated as per recommendations outlined below or after 15 minutes.

The Physiotherapist will explain next section of the study. The child/adolescent will then 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 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.

At any point, consent for the study can be withdrawn with no negative impact on their care at QCH.
Control group
Active

Outcomes
Primary outcome [1] 331848 0
Post Concussion Symptom Inventory (PSCI)
Timepoint [1] 331848 0
1. Initial Phone Call (within 7 days of receiving referral to QPRS)
2. Initial Complex Concussion Clinic appointment (can be up to 3 months depending on appointment availability)
Primary outcome [2] 331849 0
Phase 1:
OMNI Perceived Rate of Exertion.
Timepoint [2] 331849 0
Before the exercise test starts to have a baseline.,
During - at each minute interval during the exercise tests.
After the exercise Tests
Primary outcome [3] 332096 0
Heart Rate will be measured using Polar OH1 Heart Rate Sensor fitted to their upper arm.
Timepoint [3] 332096 0
Before the exercise test starts to have a baseline.,
During - at each minute interval during the exercise tests.
After the exercise Tests
Secondary outcome [1] 411389 0
1. Visual Analogue Scale - Symptom Severity
Timepoint [1] 411389 0
Before the exercise test starts to have a baseline.,
During - at each minute interval during the exercise tests.
After the exercise Tests

Eligibility
Key inclusion criteria
Inclusion criteria
- Any child age 8 to 18 years of age
- Mild traumatic brain injury/concussion
- Any increase in symptoms compared to pre-injury symptoms score
- Overall symptoms of less than 6/10 at rest
- Ability to walk independently (eg. Dizziness/imbalance, not a risk factor for falls)
Minimum age
8 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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
- parents unable to provide informed consent (diminished understanding or comprehension, or a language other than English spoken and an interpreter unavailable)

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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will be comparing the HR/OMNI scores for patients with concussion in the MST and validating those with HR/OMNI scores in the BCTT. Patient details, demographics and perceived symptoms during the test will be described using charts and graphs.

We will use a correlation analysis to determine links between
- OMNI score between MST & BCTT
- HR between MST & BCTT

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2023
Actual
1/06/2023
Date of last participant enrolment
Anticipated
2/05/2024
Actual
Date of last data collection
Anticipated
23/05/2024
Actual
Sample size
Target
15
Accrual to date
6
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 37931 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 311725 0
Charities/Societies/Foundations
Name [1] 311725 0
Children's Health Queensland - Study Education and Research Trust Account (SERTA)
Country [1] 311725 0
Australia
Primary sponsor type
Hospital
Name
Queensland Children's Hospital
Address
Queensland Paediatric Rehabilitation Service - Level 6G
501 Stanley Street, South Brisbane QLD 4101
Country
Australia
Secondary sponsor category [1] 313390 0
Charities/Societies/Foundations
Name [1] 313390 0
Children's Health Queensland: Study, Education and Research Trust Account
Address [1] 313390 0
Queensland Children's Hospital
Level 12 Executive
PO Box 3474
South Brisbane QLD 4101
Country [1] 313390 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311173 0
Children’s Health Queensland Human Research Ethics Committee [EC00175]
Ethics committee address [1] 311173 0
Ethics committee country [1] 311173 0
Australia
Date submitted for ethics approval [1] 311173 0
06/06/2022
Approval date [1] 311173 0
20/07/2022
Ethics approval number [1] 311173 0
HREC/22/QCHQ/87292

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

Contacts
Principal investigator
Name 120210 0
Mrs Kirrilee Smith
Address 120210 0
Children’s Health Queensland Hospital and Health Service
Level 6G
Queensland Children’s Hospital, 501 Stanley Street, South Brisbane QLD 4101
Country 120210 0
Australia
Phone 120210 0
+61 7 30682950
Fax 120210 0
Email 120210 0
[email protected]
Contact person for public queries
Name 120211 0
Kirrilee Smith
Address 120211 0
Children’s Health Queensland Hospital and Health Service
Level 6G
Queensland Children’s Hospital, 501 Stanley Street, South Brisbane QLD 4101
Country 120211 0
Australia
Phone 120211 0
+61 7 30682950
Fax 120211 0
Email 120211 0
[email protected]
Contact person for scientific queries
Name 120212 0
Kirrilee Smith
Address 120212 0
Children’s Health Queensland Hospital and Health Service
Level 6G
Queensland Children’s Hospital, 501 Stanley Street, South Brisbane QLD 4101
Country 120212 0
Australia
Phone 120212 0
+61 7 30682950
Fax 120212 0
Email 120212 0
[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?
De-identified data ONLY. Demographic and injury characteristics, outcome measures, dose, trial data report
When will data be available (start and end dates)?
Upon publication of the study but no end date determined
Available to whom?
Researchers with a reasonable research question will be considered
Available for what types of analyses?
Any reasonable research question
How or where can data be obtained?
Data will be shared via secure link from the principle investigator. Principle Investigator (Kirrilee Smith) can be contacted via email [email protected]


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.