Assessment and Treat Neglect Patients With a VR Application
NCT ID: NCT06999473
Last Updated: 2025-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2025-06-01
2027-07-01
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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VR group
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).
Virtual reality training
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 therapy
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.
Assessment
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
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.
physiotherapy and occupational therapy
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.
Assessment
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.
Non-neglect stroke group
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.
Assessment
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.
Interventions
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Virtual reality training
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 therapy
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.
Assessment
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.
Eligibility Criteria
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Inclusion Criteria
2. Able to provide informed consent
3. have had a hemispheric stroke
Exclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Universiteit Antwerpen
OTHER
Responsible Party
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Wim Saeys
Professor
Principal Investigators
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Wim Saeys
Role: STUDY_CHAIR
+32 496804347
Locations
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Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, University of Antwerp
Antwerp, , Belgium
Countries
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Central Contacts
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Facility Contacts
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MENGDI LU
Role: primary
Other Identifiers
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241201ACADEM
Identifier Type: -
Identifier Source: org_study_id