Assessment and Treat Neglect Patients With a VR Application

Not Applicable

Not yet recruiting

• Conditions: Neglect, Hemispatial; Stroke; Virtual Reality Therapy

• Registration Number: NCT06999473
• Lead Sponsor: Universiteit Antwerpen

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.

Study Timeline

• Study First Submitted: 2025-04-27
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-22
• Last Update Submitted: 2025-05-22
• Study First Posted: 2025-05-31
• Last Update Posted: 2025-05-31
• Study Start: 2025-06-01
• Primary Completion: 2027-05-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in searching performance and visuospatial neglect	Baseline (Day 1) and End of Study (Day 30)	The Broken Hearts Cancellation Test is a paper-and-pencil assessment used to measure searching performance and spatial neglect. Participants are asked to identify and cancel out complete heart shapes among distractor stimuli (broken hearts) within a fixed time frame. Performance is evaluated based on the number of correct cancellations and errors (false positives and omissions).; The total score is calculated as: Total Correct Hits: Number of correctly cancelled complete hearts (max score: 50) Errors: Number of incorrectly marked broken hearts or missed targets Higher total correct scores indicate better performance. Improvement is defined as an increase in correct hits and/or a reduction in errors.

Secondary Outcome Measures

Name	Time	Method
Change in visuospatial neglect	Baseline (Day 1) and End of Study (Day 30)	The Schenkenberg Line Bisection Test assesses visuospatial neglect by requiring participants to mark the perceived midpoint of horizontal lines printed on a sheet. The test evaluates the presence and severity of spatial attention deficits, particularly following brain injury or stroke.; Performance is quantified as the average deviation (in millimeters) from the true midpoint of each line: Positive values indicate a rightward deviation Negative values indicate a leftward deviation A score closer to 0 mm indicates better spatial accuracy
Change in functional neglect symptoms	Baseline (Day 1) and End of Study (Day 30)	The Catherine Bergego Scale (CBS) is a standardized observational tool used to assess the presence and severity of unilateral spatial neglect in activities of daily living. A set of 10 real-life tasks (e.g., grooming, navigating through doorways) will be scored from 0 to 3: 0 = No neglect; 1. = Mild neglect; 2. = Moderate neglect; 3. = Severe neglect The total score ranges from 0 to 30, with higher scores indicating more severe neglect.
Change in visual search reaction time	Baseline (Day 1) and End of Study (Day 30)	The Computerized Visual Search Time Test assesses visual attention and processing speed by requiring participants to locate and identify a target stimulus among distractors on a computer screen. The test records the response time (in milliseconds) needed to correctly identify the target.; Shorter reaction times indicate better visual processing and attention.
Change in spatial and searching performance	Baseline (Day 1) and End of Study (Day 30). Through study completion, an average of 7days	To assess neglect in our application, we will extract Embedded game parameters from SpatialSense, the maximal rightward angle is compared with the maximal leftward angle on low, medium, and high difficulty levels: the trajectory of the gaze ray (GR), head movement (HR), and eye movement (ER). The maximum angles are added to form the search area middle (SAM) which should be close to 0. A positive SAM indicates the participant searched further to the right than to the left, and a negative SAM means the participant searched further to the left than to the right.
Change in trunk control	Baseline (Day 1) and End of Study (Day 30)	The Trunk Impairment Scale (TIS) assesses motor impairment of the trunk after neurological injury, especially stroke. It includes three subscales: Static Sitting Balance (0-7); Dynamic Sitting Balance (0-10); Coordination (0-6).; The total score ranges from 0 to 23, with higher scores indicating better trunk function and postural control.
Change in balance ability	Baseline (Day 1) and End of Study (Day 30)	The Berg Balance Scale (BBS) is a performance-based measure of balance and fall risk. It consists of 14 functional tasks (e.g., standing up, reaching forward, turning) that are each scored from 0 to 4, based on performance.; Total score range: 0 to 56. Higher scores indicate better balance. A score below 45 is associated with increased fall risk.

Trial Locations

Locations (1)

Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, University of Antwerp; 🇧🇪 Antwerpen, Belgium