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Feasibility and preliminary efficacy of an Occupation-based, Virtual-Reality-based intervention (VR-BrainAware) in inpatient brain injury rehabilitation

Feasibility and preliminary efficacy of an occupation-based, virtual-reality-based intervention (VR-BrainAware) in inpatient brain injury rehabilitation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000467336
Acronym
VR-BrainAware
Enrollment
1
Registered
2026-04-15
Start date
2026-05-12
Completion date
2027-05-10
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This project aims to determine the acceptability, feasibility, and preliminary effectiveness of an occupation-based, virtual reality intervention (VR-Brain Aware) for improving health outcomes including self-awareness, confidence and preparedness for home of people with acquired brain injury (ABI). Eligible people with ABI will be identified by treating occupational therapists. After informed consent is obtained, patients will be randomised into either either the usual care only group or the usual care plus VR-BrainAware group. Patients in the VR-BrainAware group will be provided with training to use VR and they will receive two additional VR-BrainAware treatment sessions per week over a three-week period by a trained, qualified occupational therapist. This study will explore the acceptability and feasibility of VR-BrainAware and the results will inform the feasibility of a larger, adequately powered RCT. We will describe and explore the clinical outcomes from this pilot RCT with due caution to not extrapolate results beyond the feasibility and pilot nature of the study.

Interventions

The research design is a single-centre, two parallel arm, assessor-blinded pilot and feasibility randomised controlled trial. Participants will be randomised to receive either VR-BrainAware plus usual care or usual care alone. VR-BrainAware VR-BrainAware is a manualised intervention designed to facilitate opportunities for planning, decision-making and completion of multi-step tasks in virtual scenarios (home and transport simulations). Completion and practice of multi-step tasks are require

The research design is a single-centre, two parallel arm, assessor-blinded pilot and feasibility randomised controlled trial. Participants will be randomised to receive either VR-BrainAware plus usual care or usual care alone. VR-BrainAware VR-BrainAware is a manualised intervention designed to facilitate opportunities for planning, decision-making and completion of multi-step tasks in virtual scenarios (home and transport simulations). Completion and practice of multi-step tasks are required for interventions targeting executive function impairment including self-awareness, to enable opportunities for making, self-correcting and reflecting upon errors, as well as metacognitive approaches (i.e., feedback, reflection about performance). The VR-BrainAware tools include a tutorial, facilitator app and two occupation-based simulations (home and transport). The tools were codesigned over a 12-month period. The codesign team included 5 consumers (3 people with TBI, a person with stroke, and significant other), 4 clinicians and 7 clinician/researchers (with backgrounds in occupational therapy, neuropsychology, speech pathology and physiotherapy) as well as 4 technology developers. Codesign team members participated in a series of structured workshops to create the VR-Brain Aware tools. The facilitator app is accessed via a web application whereas the tutorial and the occupation-based scenarios are accessed by users wearing an Occulus 3 virtual reality headset. Users can interact with the virtual environment using minimal hand movements and are not required to use hand controls. The VR-based tutorial prepares users with the necessary skills to interact with the VR environment (e.g., moving, picking up and storing items). The facilitator app enables clinicians to customise interventions based on user needs and to monitor patient performance in the VR scenarios via a separate computer or tablet. 1. Home simulation-based tasks: planning to leave the house, finding and taking necessary items, completing tasks such as identifying and addressing hazards, locking doors or turning off appliances. 2. Public transport-based tasks: navigating the community environment including dealing with hazards, making decisions and dealing with unexpected situations and environmental distractors or events (i.e.. noise, other people). Planning a bus trip including deciding on a route, money/card handling, monitoring time, and taking the planned trip. VR-Brain Aware will be delivered by qualified, trained occupational therapists. Participants will receive VR-BrainAware twice weekly for three weeks. The intervention will be delivered in a inpatient rehabilitation treatment space. Each session will be 1 hour in duration. VR-BrainAware will be provided to the intervention group in addition to usual care, in keeping with the recommended use of VR in addition to traditional approaches in clinical guidelines.

Sponsors

The University of Queensland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Patients with diagnosis of Acquired Brain Injury (ABI) including TBI or stroke (by CT/MRI scan or clinical diagnosis) admitted to inpatient rehabilitation 2. Emerged from post-traumatic amnesia (PTA ) or PTA assessment has ceased 3. Aged 16 years or older 4. Expected to have admission length of stay of at least 4 weeks to enable completion of study activities 5. Willing to participate and able to provide written, informed consent 6. Presence of self-awareness impairment (based on report of treating occupational therapist) 7. Expected to tolerate an additional session of therapy for one hour, twice weekly 8. Adequate hand and upper limb function to use the VR (with at least one upper limb), which is: a. Ability to perform a reach (i.e.. could reach for a water-bottle on a table in front), gross grasp and with minimal finger flexion and release (i.e.. could pick up and put down a large plastic cone), b. able to point with one index finger whilst holding forearm in mid position (thumb up and extended) 9. Either independent sitting balance or in absence of independent sitting balance, can maintain an upright position in a hospital bed or chair (i.e., wheelchair) for up to 1 hour 10. Sufficient visual acuity to be able to navigate the physical environment (i.e., find and locate items in a kitchen)

Exclusion criteria

1. Not medically cleared to participate due to contraindications (e.g. unable to wear VR headset due to craniotomy/bone plate removal, uncontrolled seizures, significant visual impairment, behavioural disturbance) 2. Unable to provide informed consent (e.g. lacking cognitive capacity to provide own consent) 3. Needs to wear an eye patch to manage diplopia, where participants have diplopia as a condition 4. Presence of inattention or neglect 5. Severe dyspraxia which precludes performing the required hand and upper limb functional movements (outlined in inclusion criteria) 6. Fatigue, arousal level, sustained attention or other factors not sufficient to enable tolerance of additional session of therapy for one hour, twice weekly 7. Severe receptive aphasia or inability to comprehend nature of engagement

Outcome results

None listed

Source: ANZCTR · Data processed: Jun 29, 2026