Clinical trial NCT06999473: Assessment and Treat Neglect Patients With a VR Application
Official title: Assess and Treat Visuospatial Neglect in Central Neurological Conditions Via an Innovative Virtual Reality Software
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Neglect, Hemispatial
Stroke
Virtual Reality Therapy
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this project is to investigate the effectiveness of neglect training in our self-developed VR application "SpatialSense". The investigators aim to reach the following goals:

i. Compare conventional neglect therapy for neglect training with SpatialSense to evaluate the impacts on neglect recovery to see whether the VR therapy improves the clinical outcomes, such as balance recovery, perception of verticality, quality of life, independence in daily activities, and cognitive impairment, after rehabilitation training.

ii. Analyze and compare the search strategies employed by stroke patients with VSN and those without VSN during the execution of the search task with SpatialSense to summarize typical visual scanning strategies for facilitation, rehabilitation training, and improving the transfer effect in daily activities.

The experimental group will receive both conventional OT and PT treatment, but 3 days a week, half an hour of conventional treatment will be replaced by treatment with SpatialSense software. The control group will receive their regular dose-matched conventional OT and PT sessions without interference. The experimental group will receive SpatialSense training 3 times a week for a consecutive 4 weeks (12 sessions in total of 30 minutes).

Detailed description: Technical information: Our VR application is made with the game engine Unity (version 2020.2.5f1). We built this for the HMD Pico 4 Enterprise, which has six degrees of freedom, a 4K RGB display, a 101-degree field of view, and built-in eye-tracking hardware and software. The virtual environment is a 3-dimensional immersive environment in which the participant will be placed in three different virtual scenes: a picnic table, a kitchen, and a playground. This allows for the placement of stimuli in three different regions: near peripersonal (reaching) space, far peripersonal space, and extrapersonal (far) space. The goal of the game is to search for items that appear in front of the view, as accurately and quickly as possible.

Eligibility criteria: Inclusion Criteria:

1. Age 18 years or older
2. Able to provide informed consent
3. have had a hemispheric stroke

Exclusion Criteria:

1. Have a severe comorbid psychiatric (E.g. psychotic symptoms) disorder
2. Have a premorbid neurodegenerative disease (E.g. Alzheimer's dementia, vascular dementia)
3. Have severe written language comprehension deficits
4. Have a medical implant, such as a cochlear implant or a pacemaker
5. Have a severe visual impairment that cannot be corrected by wearing glasses while training
6. Have a history of epileptic seizures The following exclusion criteria do not apply to the Non-VSN stroke group.
7. Do not show signs of a spatial asymmetry in performance on a battery of screening tasks
8. Having visual field deficits or lesions in the occipital lobe

Primary outcomes:
measure: Change in searching performance and visuospatial neglect
timeFrame: Baseline (Day 1) and End of Study (Day 30)
Secondary outcomes:
measure: Change in visuospatial neglect
timeFrame: Baseline (Day 1) and End of Study (Day 30)
measure: Change in functional neglect symptoms
timeFrame: Baseline (Day 1) and End of Study (Day 30)
measure: Change in visual search reaction time
timeFrame: Baseline (Day 1) and End of Study (Day 30)
measure: Change in spatial and searching performance
timeFrame: Baseline (Day 1) and End of Study (Day 30). Through study completion, an average of 7days
measure: Change in trunk control
timeFrame: Baseline (Day 1) and End of Study (Day 30)
measure: Change in balance ability
timeFrame: Baseline (Day 1) and End of Study (Day 30)
Other outcomes:
measure: Change in perceived postural alignment
timeFrame: Baseline (Day 1) and End of Study (Day 30)
measure: Change in perceived visual verticality
timeFrame: Baseline (Day 1) and End of Study (Day 30)
measure: Change in cognitive function
timeFrame: Baseline (Day 1) and End of Study (Day 30)
measure: Change in quality of life
timeFrame: Baseline (Day 1) and End of Study (Day 30)
measure: Change in functional independence
timeFrame: Baseline (Day 1) and End of Study (Day 30)
measure: Change in simulator-induced symptoms
timeFrame: Baseline (Day 1) and End of Study (Day 30)
measure: Change in dynamic balance
timeFrame: Baseline (Day 1) and End of Study (Day 30)
Locations:
city: Antwerpen
country: Belgium
facility: Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, University of Antwerp
Study officials:
affiliation: +32 496804347
name: Wim Saeys
role: STUDY_CHAIR
References: