ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12622001549718

Ethics application status

Approved

Date submitted

2/12/2022

Date registered

15/12/2022

Date last updated

23/09/2026

Date data sharing statement initially provided

15/12/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Concussion GYM-T: Graded exercise in Youth to Maximise early recovery using Tele-exercise model: A feasibility study of the Modified Shuttle Test.

Scientific title

Concussion GYM-T: Graded exercise in Youth to Maximise early recovery using Tele-exercise model: A feasibility study of the Modified Shuttle Test.

Additional trial identifiers [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Related trial records

Health condition

Health condition(s) studied:

Concussion / Mild Traumatic Brain Injury

Condition category

Condition code

Neurological

Other neurological disorders

Physical Medicine / Rehabilitation

Physiotherapy

Intervention/exposure

Study type

Interventional

Description of the intervention or exposure

This study is a single-arm, prospective feasibility trial using a mixed methods approach. It aims to evaluate the feasibility and acceptability of delivering the Modified Shuttle Test via telehealth for youth recovering from concussion. Participants will undergo the MST remotely as part of a graded exercise protocol. Quantitative data will include recruitment and retention rates, Visual Analogue Scale (VAS) ratings and OMNI Perceived Exertion rating scale during the MST, as well as Likert-scale survey items assessing participant and caregiver perceptions of the tele-exercise model. Qualitative data will be gathered through open ended survey questions to explore individual experiences, perceived benefits, challenges and suggestions for improvement. This combination of numerical and narrative data will provide a comprehensive understanding of the interventions practicality and acceptability and will inform future refinement and scaling of the telehealth model. No control or comparison group is included as the primary aim is to determine whether the intervention is practical and acceptable in this population and setting.

Participants will be given a graded exercise program that will be updated weekly for up to 4 weeks or less if they have resolution of their exercise induced symptoms during this time.

Our study will differ from other studies as we will be aiming to complete all sessions via a Tele-health model without the need for a heart rate monitor or any other specialized equipment other than access to the internet/video phone. The telehealth sessions with take between 20-45 minutes. These appointments will be conducted weekly, with a minimum of 6 days between appointments and a maximum of 10 days between appointments. The sessions will be run using the same telehealth platform. The physiotherapist will review the participants progress by looking at their Symptom Progress Exercise Diary. If the participant has been able to complete the exercise at the required level for 3 or more days, the exercise intensity will be increased for the following week. If the participant was unable or did not complete the required exercise intervention over the week, the therapist will troubleshoot with the participant to determine the barriers to exercise.

The level of exercise intensity prescribed will initially be low (as per results from the 10m MST) with increasing intensity dependent on the participants recovery and symptoms as per the Return to Sport Guidelines for Concussion.
Week 1: 20 minutes of exercise at least 5 days per week at their sub-symptomatic OMNI level.
Week 2: 20 minutes of exercise at least 5 days per week at their baseline OMNI + 1 level
Week 3: 20 minutes of exercise at least 5 times per week at their week 2 OMNI + 1 level
Week 4: 30 Minutes of exercise at least 5 times per week at their week 3 OMNI + 1 level

The exercises will be based on participant previous physical activities/available home equipment but can include walking around the block, using a stationary bike, using a stationary rowing machine, boxing using a boxing bag - any activity which increases their aerobic output to a level that is comparable to the MST. A specific exercise will not be uniform between patients.

Intervention code [1]

Rehabilitation

Description of the comparator or control

All participants will receive the same care. There is no longer a control group as it is a feasibility study.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Feasibility Indicators Recruitment Rate: Number of eligible participants enrolled Retention Rate: Number of participants who complete the MST via telehealth Completion Rate: Number of scheduled sessions completed Safety: Incidence of adverse events or safety concerns during sessions Technical Issues: Frequency and nature of technical problems encountered during telehealth delivery

Timepoint [1]

Collected during the project. Survey will be sent to families at completion of the initial MST via telehealth for feedback and final survey sent at completion of the telehealth sessions.

Primary outcome [2]

Acceptability measures: Participant and caregiver responses to Likert-scale survey items Open ended survey responses exploring experiences, barriers and suggestions

Timepoint [2]

Survey to be sent via RedCap at end of telehealth sessions. Will be followed up via phone call if not completed.

Secondary outcome [1]

The PCSI is a well validated measure of PPCS in children, used widely, including in the Complex Concussion Clinic (Barlow, 2020). The PCSI is a self-reporting (and parent reporting) tool that focuses on symptoms across 4 domains; cognitive, emotional, sleep and physical. Interrater relatability has been shown to be moderate to high for the child’s report (Sady, 2014) "

Timepoint [1]

PSCI - Initial Contact with PSCI or Week 1 (Initial Tele-exercise appointment) PSCI - Week 5 Either via RedCap or Phone Call

Eligibility

Key inclusion criteria

- Any child age 8 to 18 years of age
- Mild traumatic brain injury/concussion (as above)
- Any increase in symptoms compared to pre-injury symptoms score
- Access to device and internet to complete telehealth sessions (Telehealth in the Home checklist)
- Overall symptoms of less than 6/10 at rest
- Ability to walk independently (eg. Dizziness/imbalance not a risk factor for falls)
- Access to space for exercise

Minimum age

8 Years

Maximum age

18 Years

Sex

Both males and females

Healthy volunteers

Key exclusion criteria

- a significant medical history that would contraindicate a home exercise program
- 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), or
- inability to provide intervention due to a lack of computer, internet service, or mobile phone

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)

No allocation required - not a RCT but feasibility study

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

Statistical methods / analysis

The study will use descriptive statistics on feasibility, acceptability, usefulness to the exercise program and adherence to the program. We will look at a correlation analysis exploring relationship between VAS and OMNI. We will also use Likert-Scale analysis for those survey questions.

We will also review the PSCI change pre and post exercise program to determine the effect (allowing for age, gender and time post injury).

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

20/04/2026

Actual

5/05/2026

Date of last participant enrolment

Anticipated

31/12/2026

Actual

Date of last data collection

Anticipated

1/02/2027

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Queensland Children's Hospital - South Brisbane

Recruitment postcode(s) [1]

4101 - South Brisbane

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Children's Health Queensland - Study and Education Research Trust Account

Address [1]

Children's Health Queensland Hospital and Health Service Stanley St South Brisbane QLD 4101

Country [1]

Australia

Primary sponsor type

Hospital

Name

Queensland Children's Hospital - Queensland Paediatric Rehabilitation Service

Address

Queensland Children's Hospital -
Queensland Paediatric Rehabilitation Service
Level 6G
Stanley St
South Brisbane QLD 4101

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Children's Health Queensland Hospital and Health Service Human Research Ethics Committee

Ethics committee address [1]

Level 7, Centre for Children's Health Research
Queensland Children's Hospital Precinct
62 Graham St
South Brisbane QLD 4101

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

12/07/2022

Approval date [1]

20/07/2022

Ethics approval number [1]

HREC/22/QCHQ/87292

Summary

Brief summary

Concussion is a significant public health concern among Australian children and adolescents. A large population of children who experience a concussion (approximately 30%) will go on to experience persistence post-concussion symptoms for more than 4 weeks following their injury. These symptoms can limit their ability to attend and engage in school, extra-curricular activities and can lead to reduced quality of life. International consensus on Concussion recommends a brief period of physical rest immediately after concussion (24-48 hours) followed by a graduated return to physical activity at a level that does not provoke significant symptom exacerbation . Active rehabilitation involving sub-symptom threshold aerobic activity is a growing area of research with evidence showing reduced symptoms and improvements in recovery following concussion.

The primary aim of the study is to determine if the modified Shuttle Test delivered via telehealth is a feasible and acceptable method for assessing graded exercise tolerance in youth aged 8-18 years recovering from a concussion.  

The initial phase of this study was to validate the use of the 10m Modified Shuttle Test with the Buffalo Concussion Treadmill Test.  This has been completed with pleasing results to move on to determine the feasibility of using the 10m Modified Shuttle Test over telehealth.    

We aim to see children by 3 months post-injury in the Complex Concussion Clinic: our current wait time is 3 months.  While the child is waiting to be seen, PPCS limits physical activity and quality of life limiting their ability to participate in school and recreational activities. The longer symptoms persist the more difficult it is to treat these persistent symptoms and more health-related interventions are often needed to aid the child to return to normal school and sport activities. If the trial is successful, children will be able to return to these activities quicker, with a resultant decrease in the burden of the injury, and improvement in quality of life. A later cost-effectiveness of the intervention will be performed.

The projected outcome of the project is to have a fully completed study protocol, with ethics approval, and a completed feasibility study by the end of 2026. This project is significant because not only will it impact QPRS, but the results of the study will have a far reach, Queensland wide with a more equitable service able to be provided to patients across the state. Information gained from the study could potentially lead to a change in current practice within QPRS and lead to future studies looking a how to translate this knowledge across QLD and Australia.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mrs Kirrilee Smith

Address

Queensland Children's Hospital Queensland Paediatric Rehabilitation Service Level 6G 401 Stanley St South Brisbane QLD 4101

Country

Australia

Phone

+61 7 30682950

Fax

[email protected]

Contact person for public queries

Name

Kirrilee Smith

Address

Queensland Children's Hospital Queensland Paediatric Rehabilitation Service Level 6G 401 Stanley St South Brisbane QLD 4101

Country

Australia

Phone

+61 7 30682950

Fax

[email protected]

Contact person for scientific queries

Name

Kirrilee Smith

Address

Queensland Children's Hospital Queensland Paediatric Rehabilitation Service Level 6G 401 Stanley St South Brisbane QLD 4101

Country

Australia

Phone

+61 7 30682950

Fax

[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:
• Researchers with a reasonable research question will be considered

Conditions for requesting access:
• -

What individual participant data might be shared?

• De-identified data ONLY. Demographic and injury characteristics, outcome measures, dose, trial report data

What types of analyses could be done with individual participant data?

• Any reasonable research question

When can requests for individual participant data be made (start and end dates)?

From:
Upon publication of the study. No end date determined

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• Data will be shared via a secure link from the principle investigator (Kirrilee Smith). Contacted via email [email protected]

Are there extra considerations when requesting access to individual participant data?

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.

Trial Review

Documents added manually

Documents added automatically