Assessment and Treat Neglect Patients With a VR Application

Universiteit Antwerpen

Status: Not yet enrolling

Conditions: Virtual Reality Therapy; Neglect, Hemispatial; Stroke

Treatments: Device: Virtual reality training; Device: Assessment; Behavioral: physiotherapy and occupational therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06999473

241201ACADEM

Details and patient eligibility

About

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).

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 3 patient groups

VR group

Experimental group

Description:

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 experimental group will receive SpatialSense training 3 times a week for a consecutive 4 weeks (12 sessions in total of 30 minutes).

Treatment:

Device: Virtual reality training

Device: Assessment

Behavioral: physiotherapy and occupational therapy

Conventional

Active Comparator group

Description:

The control group will have the assessment on SpatialSense and then receive their regular dose-matched conventional OT and PT sessions without interference. All people with stroke receive conventional occupational (OT) and physical therapy (PT) for 1 hour each. In a total of 4 weeks, 5 times a week.

Treatment:

Device: Assessment

Behavioral: physiotherapy and occupational therapy

Non-neglect stroke group

Other group

Description:

Prior to the assessment in SpatialSense, the screen of the head-mounted display will be projected onto a laptop and the eye tracking will be calibrated to the participants' eye positions by the investigator. Then, all participants will perform the assessment part in SpatialSense. During assessments with SpatialSense, participants will sit in a wheelchair or on a straight-back chair. The trunk will be restricted to the chair. Finally, the data will be exported from SpatialSense and analyzed by investigators to define different search strategies while performing scanning tasks.

Treatment:

Device: Assessment