Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000837325
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
24/06/2026
Date registered
Help: Date registered
10/07/2026
Date last updated
Help: Date last updated
11/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
10/07/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Ballet for Brain Injury - Telehealth Program Feasibility Study
Scientific title
Ballet for Brain Injury - Telehealth Program Feasibility Study
Additional trial identifiers [1] 317666 0
Nil
Universal Trial Number (UTN)
Trial acronym
TELE-BRAIN
Related trial records

Health condition
Health condition(s) studied:
Brain injury 342471 0
Condition category
Condition code
Neurological 338596 338596 0 0
Other neurological disorders
Injuries and Accidents 338803 338803 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Participants in the intervention group will receive 10 x 45 minute weekly online sessions of Queensland Ballet's (QB) 'Ballet for Brain Injury' dance intervention over 10 weeks via live videoconferencing into the participant's home. These sessions will be delivered in a group format (maximum of 10 participants per session) by a Dance Teaching Artist employed by QB. The tailored dance intervention is designed specifically for people living with brain injury. Modified ballet movements will incorporate held positions and dynamic movements of upper limbs, torso and lower limbs, weight shifting, multidirectional stepping, balance activities, dual task activities, motor sequencing prompts and functional transitions. These sessions will be delivered at low to moderate intensity and monitored by the talk test [between a point where participants can comfortably talk without restriction (low intensity), and where they can talk but not sing (moderate intensity)]. The class structure and exercises will be similar for the telehealth and in-person groups, with only slight modifications to the telehealth group in consideration of both the online space and at home environment they will be participating in. The Ballet for Brain Injury program is designed to help people living with brain injury to re-inhabit their bodies and cope with emotional, cognitive and physical impairments that can result from brain injury. Each session will last for 45 minutes, with the first 15 minutes allocated for introduction and set-up. Email reminders will be sent to participants prior to each class to promote attendance and adherence. Prospective monitoring of videoconference attendance records will assess intervention adherence (sessions scheduled / sessions attended). Participants will be allocated to the telehealth group if they reside in a regional, rural or remote area of Queensland and fit the TELE-BRAIN inclusion criteria, and the in-person group if they reside in Brisbane and fit the in-person Ballet for Brain Injury class inclusion criteria.
Intervention code [1] 334516 0
Lifestyle
Intervention code [2] 334607 0
Rehabilitation
Description of the comparator or control
Participants in the comparator group will receive 10x 1hr weekly sessions of Queensland Ballet's (QB) 'Ballet for Brain Injury' dance intervention over 10 weeks in-person at QB facilities in West End, Brisbane, Australia. These sessions will be delivered in a group format (maximum of 10 participants per session) by a Dance Teaching Artist employed by QB. The dance intervention will be the same for the telehealth and in-person groups and are designed to help people living with brain injury to re-inhabit their bodies and cope with emotional, cognitive and physical impairments that can result from brain injury. Each session will last for 45 minutes, with 15 minute introduction and warm-up. Email and SMS reminders will be sent to participants prior to each class to promote attendance and adherence.
Control group
Active

Outcomes
Primary outcome [1] 345902 0
Feasibility of the intervention (composite score)
Timepoint [1] 345902 0
End of study
Secondary outcome [1] 463697 0
Safety
Timepoint [1] 463697 0
Each dance session, once per week for 10 weeks, after dance session
Secondary outcome [2] 463698 0
Acceptability - quantitative assessment
Timepoint [2] 463698 0
End of program (10 weeks from baseline)
Secondary outcome [3] 463699 0
Quality of life
Timepoint [3] 463699 0
Baseline, End of program (10 weeks from baseline)
Secondary outcome [4] 463700 0
Engagement
Timepoint [4] 463700 0
Baseline, End of program (10 weeks after baseline)
Secondary outcome [5] 464121 0
Acceptability - qualitative assessment
Timepoint [5] 464121 0
End of program (10 weeks from baseline)

Eligibility
Key inclusion criteria
Inclusion criteria for telehealth participants:
1. Living with an acquired brain injury, medically stable, and >6 months post-injury.
2. Living in a home/community setting.
3. Survivors of brain cancer and stroke may also be included in this feasibility study.
4. Participants and their caregivers residing in a rural/regional area (MM2 or higher using the Modified Monash Model) in Queensland.
5. Willing to participate in a telehealth version of a ‘Ballet for Brain Injury’ 10-week intervention.
6. Have access to a mobile device or computer hardware with Internet access and webcam capability suitable for telehealth.
7. Are aged 18 and above

Inclusion criteria for in-person participants:
1. Living with an acquired brain injury, medically stable, and >6 months post-injury.
2. Living in a home/community setting.
3. Survivors of brain cancer and stroke may also be included in this feasibility study.
4. Willing to participate in-person in a 10-week ‘Ballet for Brain Injury’ class intervention in West End, Brisbane.
5. Are aged 18 and above
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Exclusion criteria for telehealth and in-person participants:
1. Any medical condition in which exercise or physical activity could be contraindicated (e.g. vertigo, heart disease, late-stage pregnancy).
2. Significant cognitive or communication impairment preventing the understanding of basic instructions or English expression.
3. Substantial history and experience with ‘Ballet for Brain Injury’ in-person classes facilitated by Queensland Ballet (=4 sessions over the last 12 months).
4. Participant unable to provide informed consent of their own accord

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
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
No sample size calculation was completed for this pragmatic, feasibility pilot trial. Descriptive statistics will be used to examine baseline demographic information, safety, feasibility and acceptability (Likert scale) outcomes. Qualitative interview analysis will consist of two stages: i) independent thematic analysis of interview transcripts to identify pertinent themes and, ii) aligning the derived themes with constructs of the theoretical framework of acceptability. Initial potential efficacy will be analysed using a combination of visual and statistical analyses.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/07/2026
Actual
28/07/2026
Date of last participant enrolment
Anticipated
16/09/2026
Actual
Date of last data collection
Anticipated
25/11/2026
Actual
Sample size
Target
20
Accrual to date
9
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 322207 0
Government body
Name [1] 322207 0
National Injury Insurance Scheme, Queensland
Country [1] 322207 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 325118 0
Commercial sector/Industry
Name [1] 325118 0
Queensland Ballet
Address [1] 325118 0
Country [1] 325118 0
Australia
Other collaborator category [1] 284004 0
Government body
Name [1] 284004 0
Motor Accident Insurance Commission
Address [1] 284004 0
Country [1] 284004 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320733 0
The University of Queensland Human Research Ethics Committee B
Ethics committee address [1] 320733 0
Ethics committee country [1] 320733 0
Australia
Date submitted for ethics approval [1] 320733 0
29/04/2026
Approval date [1] 320733 0
29/06/2026
Ethics approval number [1] 320733 0
2026/HE010207

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

Contacts
Principal investigator
Name 151446 0
Dr Riley Brown
Address 151446 0
School of Human Movement and Nutrition Sciences, The University of Queensland Rm 517, Human Movement Studies Building (#26B) Blair Drive St Lucia, 4072 Queensland
Country 151446 0
Australia
Phone 151446 0
+61 459206801
Fax 151446 0
Email 151446 0
[email protected]
Contact person for public queries
Name 151447 0
Riley Brown
Address 151447 0
School of Human Movement and Nutrition Sciences, The University of Queensland Rm 517, Human Movement Studies Building (#26B) Blair Drive St Lucia, 4072 Queensland
Country 151447 0
Australia
Phone 151447 0
+61 459206801
Fax 151447 0
Email 151447 0
[email protected]
Contact person for scientific queries
Name 151448 0
Riley Brown
Address 151448 0
School of Human Movement and Nutrition Sciences, The University of Queensland Rm 517, Human Movement Studies Building (#26B) Blair Drive St Lucia, 4072 Queensland
Country 151448 0
Australia
Phone 151448 0
+61 459206801
Fax 151448 0
Email 151448 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.