Assessment and Treat Neglect Patients With a VR Application

NCT06999473 | Not Yet Recruiting

• 1 other identifier: 241201ACADEM
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Neglect, Hemispatial; Stroke; Virtual Reality Therapy

Outcome Measures

Primary Outcomes (1)

• Change in searching performance and visuospatial neglect

  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.

  Baseline (Day 1) and End of Study (Day 30)

Secondary Outcomes (6)

• Change in visuospatial neglect

  Baseline (Day 1) and End of Study (Day 30)

• Change in functional neglect symptoms

  Baseline (Day 1) and End of Study (Day 30)

• Change in visual search reaction time

  Baseline (Day 1) and End of Study (Day 30)

• Change in spatial and searching performance

  Baseline (Day 1) and End of Study (Day 30). Through study completion, an average of 7days

• Change in trunk control

  Baseline (Day 1) and End of Study (Day 30)

Other Outcomes (7)

• Change in perceived postural alignment

  Baseline (Day 1) and End of Study (Day 30)

• Change in perceived visual verticality

  Baseline (Day 1) and End of Study (Day 30)

• Change in cognitive function

  Baseline (Day 1) and End of Study (Day 30)

Study Arms (3)

VR group

EXPERIMENTAL

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).

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

Conventional

ACTIVE COMPARATOR

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.

Behavioral: physiotherapy and occupational therapy; Device: Assessment

Non-neglect stroke group

OTHER

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.

Device: Assessment

Interventions

Virtual reality training DEVICE

This training is built 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.

VR group

physiotherapy and occupational therapy BEHAVIORAL

The conventional treatment consists of a problem-solving approach mainly based on the neurodevelopmental treatment approach. For VSN, the conventional treatment mainly consists of a mix of prism adaptation, visual scanning, and compensatory strategies based on the individual needs of the patient.

Conventional; VR group

Assessment DEVICE

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.

Conventional; Non-neglect stroke group; VR group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Able to provide informed consent
• have had a hemispheric stroke

You may not qualify if:

• Have a severe comorbid psychiatric (E.g. psychotic symptoms) disorder
• Have a premorbid neurodegenerative disease (E.g. Alzheimer's dementia, vascular dementia)
• Have severe written language comprehension deficits
• Have a medical implant, such as a cochlear implant or a pacemaker
• Have a severe visual impairment that cannot be corrected by wearing glasses while training
• Do not show signs of a spatial asymmetry in performance on a battery of screening tasks
• Having visual field deficits or lesions in the occipital lobe

Sponsors & Collaborators

• Universiteit Antwerpen: lead

Study Sites (1)

Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, University of Antwerp

Antwerp, 2610, Belgium

Location

MeSH Terms

Conditions

Perceptual Disorders; Stroke

Interventions

Physical Therapy Modalities; Occupational Therapy; Physical Examination

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Wim Saeys

  +32 496804347

  STUDY CHAIR

Central Study Contacts

MENGDI LU

CONTACT

+32 456705412; Mengdi.Lu@uantwerpen.be

Wim Saeys

CONTACT

+32 496804347; wim.saeys@uantwerpen.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 27, 2025
• First Posted: May 31, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)