Neglect, HemispatialNCT06999473
Assessment and Treat Neglect Patients With a VR Application
A study testing Virtual reality training, physiotherapy and occupational therapy and Assessment in people with Neglect, Hemispatial and Stroke, run by Universiteit Antwerpen at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neglect, Hemispatial, Stroke, Virtual Reality Therapy
- What is being tested?
- Virtual reality training, physiotherapy and occupational therapy and Assessment
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jun 2025to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Able to provide informed consent
- have had a hemispheric stroke
Who cannot join
- 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
- Have a history of epileptic seizures The following exclusion criteria do not apply to the Non-VSN stroke group.
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site
Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, University of Antwerp
Antwerp, 2610
MENGDI LU, 18725891619, mengdi_lu2023@outlook.com
About this study
Official title: Assess and Treat Visuospatial Neglect in Central Neurological Conditions Via an Innovative Virtual Reality Software
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:
- 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).
Read the 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.
- Conditions
- Neglect, Hemispatial, Stroke, Virtual Reality Therapy
- Being tested
- Virtual reality training, physiotherapy and occupational therapy, Assessment
- Medical subject headings
- Perceptual Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality trainingDevice
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.
physiotherapy and occupational therapyBehavioural
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.
AssessmentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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. Receives: Device: Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day 1) and End of Study (Day 30)
Secondary outcomes (6)
Change in visuospatial neglect
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
Measured: Baseline (Day 1) and End of Study (Day 30)
Change in functional neglect symptoms
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
- = Mild neglect
- = Moderate neglect
- = Severe neglect The total score ranges from 0 to 30, with higher scores indicating more severe neglect.
Measured: Baseline (Day 1) and End of Study (Day 30)
Change in visual search reaction time
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.
Measured: Baseline (Day 1) and End of Study (Day 30)
Change in spatial and searching performance
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.
Measured: Baseline (Day 1) and End of Study (Day 30). Through study completion, an average of 7days
Change in trunk control
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.
Measured: Baseline (Day 1) and End of Study (Day 30)
Change in balance ability
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.
Measured: Baseline (Day 1) and End of Study (Day 30)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neglect, HemispatialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wim Saeys, Universiteit Antwerpen
- Investigators
- Wim Saeys, Study chair, +32 496804347
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06999473
- Sponsor's protocol ID
- 241201ACADEM
- Status last verified
- May 2025
- First submitted
- 27 Apr 2025
- Last updated
- 31 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assess and Treat Visuospatial Neglect in Central Neurological Conditions Via an Innovative Virtual Reality Software
- ClinicalTrials.gov ID
- NCT06999473
- Acronym / sponsor ID
- 241201ACADEM
- Conditions
- Neglect, Hemispatial, Stroke, Virtual Reality Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VR group | Experimental | Device: Virtual reality training, Behavioral: physiotherapy and occupational therapy, Device: AssessmentThe 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). |
| Conventional | Active comparator | Behavioral: physiotherapy and occupational therapy, Device: AssessmentThe 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. |
| Non-neglect stroke group | Other | Device: AssessmentPrior 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- Able to provide informed consent
- have had a hemispheric stroke
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality trainingThis 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. | Device | VR group |
| physiotherapy and occupational therapyThe 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. | Behavioural | Conventional, VR group |
| AssessmentDuring 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 | Conventional, Non-neglect stroke group, VR group |
Primary outcome
Change in searching performance and visuospatial neglect
Time frame: 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.
6 secondary outcomes
Change in visuospatial neglect
Time frame: Baseline (Day 1) and End of Study (Day 30)
Change in functional neglect symptoms
Time frame: Baseline (Day 1) and End of Study (Day 30)
Change in visual search reaction time
Time frame: Baseline (Day 1) and End of Study (Day 30)
Change in spatial and searching performance
Time frame: Baseline (Day 1) and End of Study (Day 30). Through study completion, an average of 7days
Change in trunk control
Time frame: Baseline (Day 1) and End of Study (Day 30)
Change in balance ability
Time frame: Baseline (Day 1) and End of Study (Day 30)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wim Saeys study chair
+32 496804347
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality training, physiotherapy and occupational therapy and Assessment in people with Neglect, Hemispatial and Stroke, run by Universiteit Antwerpen at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MENGDI LU (+32 456705412, Mengdi.Lu@uantwerpen.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in searching performance and visuospatial neglect (time frame: Baseline (Day 1) and End of Study (Day 30)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.