Assessment and Treat Neglect Patients With a VR Application

Официальное название

Assess and Treat Visuospatial Neglect in Central Neurological Conditions Via an Innovative Virtual Reality Software

Обзор

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).

Подробное описание

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.

Вмешательства

• Устройство 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
• Поведенческое 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.
• Устройство 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.

Первичные конечные точки

• Change in searching performance and visuospatial neglect [Срок оценки: Baseline (Day 1) and End of Study (Day 30)]

Вторичные конечные точки (6)

• Change in visuospatial neglect [Срок оценки: Baseline (Day 1) and End of Study (Day 30)]
• Change in functional neglect symptoms [Срок оценки: Baseline (Day 1) and End of Study (Day 30)]
• Change in visual search reaction time [Срок оценки: Baseline (Day 1) and End of Study (Day 30)]
• Change in spatial and searching performance [Срок оценки: Baseline (Day 1) and End of Study (Day 30). Through study completion, an average of 7days]
• Change in trunk control [Срок оценки: Baseline (Day 1) and End of Study (Day 30)]
• Change in balance ability [Срок оценки: Baseline (Day 1) and End of Study (Day 30)]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Бельгия · 1 центр

• Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, Univer — Antwerp

Идентификаторы

NCT: NCT06999473 · 241201ACADEM

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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