Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000979358
Ethics application status
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Approved
Date submitted
Help: Date submitted
15/07/2026
Date registered
Help: Date registered
10/08/2026
Date last updated
Help: Date last updated
10/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
10/08/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
Virtual reality-based gradual exposure program for persistent dizziness after brain injury: a feasibility and acceptability study
Scientific title
Feasibility and acceptability of a virtual reality graded exposure intervention for persistent dizziness following brain injury in outpatient rehabilitation: a single-arm pilot feasibility study
Additional trial identifiers [1] 317873 0
None
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Vestibular dysfunction 342812 0
Acquired brain injury 342869 0
Persistent dizziness 342871 0
Concussion 343082 0
Traumatic Brain Injury 343083 0
Condition category
Condition code
Physical Medicine / Rehabilitation 338932 338932 0 0
Other physical medicine / rehabilitation
Injuries and Accidents 338933 338933 0 0
Other injuries and accidents
Physical Medicine / Rehabilitation 338986 338986 0 0
Physiotherapy
Ear 338987 338987 0 0
Other ear disorders
Neurological 339175 339175 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The intervention: a single-arm feasibility pilot study of a virtual reality (VR)-based graded exposure program for persistent dizziness following acquired brain injury.

Who delivers it: Experienced, trained clinicians including physiotherapists of the multidisciplinary brain injury rehabilitation team.

Materials: A commercially available head-mounted VR display presenting a set of immersive footage of real-world environments that vary in visual complexity, motion, and sensory load (e.g., quiet vs busy environments, movement-based scenes). The VR content was co-produced by the clinical and research team prior to study commencement (co-production is not part of the research procedures).

Procedures: The intervention is based on graded exposure principles consistent with optokinetic stimulation and habituation approaches used in vestibular rehabilitation. Environments are not individually created for each
participant; the treating clinician selects and progresses environments from the predefined set based on individual symptom triggers, tolerance, symptom severity, response to previous exposures, and rehabilitation goals. Progression occurs through graded increases in visual complexity, motion, and duration of exposure. Participants can pause or cease the VR experience at any time.

How is it delivered: Face-to-face, individual sessions are integrated within routine outpatient rehabilitation sessions at the Metro South Health Brain Injury Rehabilitation Service (BIRS) Day Hospital and Concussion Clinic, Princess Alexandra Hospital, Brisbane. The VR intervention is not part of standard care and is delivered as part of this research study.

Study sessions: Individual VR sessions run for approximately 30 minutes, inclusive of equipment set-up and symptom monitoring. Session frequency will vary according to patient presentation, symptoms and stage of rehabilitation. This may occur weekly or fortnightly, reflecting real-world service delivery. Videos will be 1- 5 minute duration and occur over a 30-minute rehabilitation session.

The intervention period spans from approximately 2 weeks to 6 weeks of rehabilitation. This will be dependent on patient symptom severity and clinician clinical reasoning.
Selection and progression of the VR program are tailored by the treating clinician.

Adherence: Adherence is recorded via therapist session logs (session attendance, duration of VR exposure). Simulator sickness is monitored pre- and post-session using the Simulator Sickness Questionnaire; sessions are
modified, paused or discontinued if symptoms exceed tolerable levels.

Exploratory data: Where supported by the headset and consented to, basic de-identified eye-tracking metrics (e.g., gaze direction, fixation duration, visual exploration patterns) may be recorded during VR exposure for exploratory, descriptive purposes.
Intervention code [1] 334767 0
Rehabilitation
Intervention code [2] 334768 0
Treatment: Devices
Description of the comparator or control
No control group. This is a single-arm pilot feasibility study. All participants receive the VR-based graded exposure program in addition to usual multidisciplinary outpatient rehabilitation.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 346221 0
Feasibility of delivering the VR-based graded exposure program within an outpatient brain injury rehabilitation service, assessed as a composite of: recruitment rate (proportion of eligible patients approached who consent), retention rate (proportion of recruited participants completing baseline and post-intervention assessments), adherence (number of VR sessions attended), and resource requirements (staffing, equipment needs and workflow considerations).
Timepoint [1] 346221 0
Assessed continuously throughout the 10-month recruitment/intervention period and summarised at study completion. Screening and enrolment logs will be assessed at the end of recruitment period. Therapist session logs will be assessed at each stage they are recorded through the intervention (e.g weekly, fortnightly).
Primary outcome [2] 346222 0
Safety and tolerability of the VR program, assessed as a composite of simulator sickness symptom severity and VR-related adverse events (symptom provocation and any adverse events reported during or after sessions).
Timepoint [2] 346222 0
SSQ administered immediately before and immediately after each VR session; adverse events monitored during and after every session, throughout the intervention period.
Primary outcome [3] 346223 0
Acceptability of the VR program to participants
Timepoint [3] 346223 0
Following completion of the VR program (post-intervention).
Secondary outcome [1] 465058 0
Dizziness-related disability.
Timepoint [1] 465058 0
Baseline and post-intervention (immediately following completion of the VR program). This is expected to occur 2–6 weeks after intervention commencement, depending on patient symptoms and clinician clinical reasoning/timing of discharge from the service.
Secondary outcome [2] 465059 0
Visual motion sensitivity.
Timepoint [2] 465059 0
Baseline and post-intervention (immediately following completion of the VR program). This is expected to occur 2–6 weeks after intervention commencement, depending on patient symptoms and clinician clinical reasoning/timing of discharge from the service.
Secondary outcome [3] 465060 0
Fear-avoidance behaviours.
Timepoint [3] 465060 0
Baseline and post-intervention (immediately following completion of the VR program). This is expected to occur 2–6 weeks after intervention commencement, depending on patient symptoms and clinician clinical reasoning/timing of discharge from the service.
Secondary outcome [4] 465061 0
Balance
Timepoint [4] 465061 0
Baseline and post-intervention (immediately following completion of the VR program). This is expected to occur 2–6 weeks after intervention commencement, depending on patient symptoms and clinician clinical reasoning/timing of discharge from the service.
Secondary outcome [5] 465062 0
Symptoms of depression, anxiety and stress as part of a composite outcome.
Timepoint [5] 465062 0
Baseline and post-intervention (immediately following completion of the VR program). This is expected to occur 2–6 weeks after intervention commencement, depending on patient symptoms and clinician clinical reasoning/timing of discharge from the service.
Secondary outcome [6] 465063 0
Patient-defined functional goal attainment.
Timepoint [6] 465063 0
Baseline and post-intervention (immediately following completion of the VR program). This is expected to occur 2–6 weeks after intervention commencement, depending on patient symptoms and clinician clinical reasoning/timing of discharge from the service.
Secondary outcome [7] 465064 0
Visual engagement during VR exposure will be assessed as a multi-component exploratory measure comprising number of fixations, average fixation duration, and dwell time on predefined areas of interest.
Timepoint [7] 465064 0
Baseline and post-intervention (immediately following completion of the VR program). This is expected to occur 2–6 weeks after intervention commencement, depending on patient symptoms and clinician clinical reasoning/timing of discharge from the service.
Secondary outcome [8] 466011 0
Acceptability of the VR program to participants and treating clinicians.
Timepoint [8] 466011 0
Following completion of the VR program (post-intervention).

Eligibility
Key inclusion criteria
- Adults aged 18 to 70 years.
- Diagnosis of acquired brain injury (ABI), including concussion and mild, moderate or severe traumatic brain injury.
- Clinically significant dizziness, defined as a Dizziness Handicap Inventory (DHI) score greater than or equal to 16.
- Dizziness or motion sensitivity that persists despite initial vestibular management or is considered appropriate for graded exposure-based rehabilitation.
- Receiving rehabilitation at the BIRS Day Hospital Service or Concussion Clinic, Princess Alexandra Hospital.
- Able to participate in supervised VR-based activities
- Capacity to provide informed consent, assessed clinically or via a formal capacity assessment (University of California Brief Assessment of Capacity to Consent) if required.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
- Unstable or severe medical conditions that contraindicate VR use (e.g. uncontrolled seizures, acute migraine).
- Cognitive impairment that prevents informed consent or participation, where capacity assessment indicates inability to consent.
- Significant history or ongoing pattern of substance or alcohol use that impairs the ability to safely participate and engage in the intervention.
- Significant psychiatric history or comorbidity (e.g., psychosis, acute psychiatric instability) that may interfere with the ability to engage safely or consistently in the intervention.
- Isolated benign paroxysmal positional vertigo (BPPV) that has resolved following repositioning manoeuvres and does not require further vestibular rehabilitation.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size: Power simulation (simr package, R) indicated 20 participants provide greater than or equal to 80% power (a = .81 [95% CI .71–.88]) to detect a moderate pre-to-post effect (d = 0.50, residual error 0.50) using a 2 (time: baseline, post-VR) × 2 (week: week 1, week 2) linear mixed model with participant as a random intercept, at 5% significance. Allowing for 25% attrition, 26 participants will be recruited; actual power will range from 81% to 92% depending on completion. This sample is sufficient to evaluate feasibility and acceptability and provide
preliminary estimates for a larger trial.

Analysis: Descriptive statistics for feasibility outcomes (recruitment, retention, adherence, resource use, safety). Linear mixed models (time as fixed factor; participant as random intercept) for preliminary efficacy outcomes, accommodating variation in intervention weeks between patients and allowing covariates (e.g. pre-to-post change in simulator sickness). Exploratory eye-gaze metrics extracted algorithmically in R and compared baseline vs post-intervention (2 × 2 model). Qualitative interview data analysed using inductive qualitative content analysis (Elo & Kyngäs, 2008).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/08/2026
Actual
Date of last participant enrolment
Anticipated
12/02/2027
Actual
Date of last data collection
Anticipated
26/03/2027
Actual
Sample size
Target
26
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 29858 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 46212 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 322410 0
University
Name [1] 322410 0
The Hopkins Centre Seed Grant (The Hopkins Centre, Griffith University)
Country [1] 322410 0
Australia
Funding source category [2] 322458 0
Hospital
Name [2] 322458 0
Metro South Health (in-kind support from clinicians of the Princess Alexandra Hospital Brain Injury Rehabilitation Outpatient Services)
Country [2] 322458 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Country
Australia
Secondary sponsor category [1] 325386 0
None
Name [1] 325386 0
Address [1] 325386 0
Country [1] 325386 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320908 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 320908 0
Ethics committee country [1] 320908 0
Australia
Date submitted for ethics approval [1] 320908 0
04/03/2026
Approval date [1] 320908 0
10/04/2026
Ethics approval number [1] 320908 0
HREC/QMS/125555
Ethics committee name [2] 320950 0
Griffith University Human Research Ethics Committee
Ethics committee address [2] 320950 0
Ethics committee country [2] 320950 0
Australia
Date submitted for ethics approval [2] 320950 0
13/05/2026
Approval date [2] 320950 0
14/05/2026
Ethics approval number [2] 320950 0
HREC/2026/0587

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

Contacts
Principal investigator
Name 152034 0
Mrs Kate Graving
Address 152034 0
Physiotherapy Department, Brain Injury Rehabilitation Service, Princess Alexandra Hospital, Metro South Health 199 Ipswich Road, Woolloongabba QLD 4102
Country 152034 0
Australia
Phone 152034 0
+61 7 3176 2401
Fax 152034 0
Email 152034 0
[email protected]
Contact person for public queries
Name 152035 0
Dr Michael Norwood
Address 152035 0
Research Fellow, The Hopkins Centre, Griffith University, 170 Kessels Road, Nathan, QLD 4111
Country 152035 0
Australia
Phone 152035 0
+61 7 3382 1191
Fax 152035 0
Email 152035 0
[email protected]
Contact person for scientific queries
Name 152036 0
Dr Michael Norwood
Address 152036 0
Research Fellow, The Hopkins Centre, Griffith University, 170 Kessels Road, Nathan, QLD 4111
Country 152036 0
Australia
Phone 152036 0
+61 7 3382 1191
Fax 152036 0
Email 152036 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
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
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: [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.