Effectiveness of Virtual Reality Training on Unilateral Spatial Neglect After Stroke - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- BITC test
研究概览
简要总结
The aim of this study is to examine the effect of an additional VR training program on unilateral spatial neglect (USN) after stroke. Principally, clinical assessment of the presence of unilateral spatial neglect and additionally the severity of USN will be measured using the Behavioral Inattention test (BIT), using only the BIT Conventional subtest (BITC). Secondarily, the VR outcomes will be included as well.
Finally, we want to determine if the effects last over a short period of time. It is important to know whether the potential effects of the VR-training remain without continuing the intervention. Therefore, we will perform a follow-up assessment after 1 week.
详细描述
STUDY DESIGN
The design of this study is a 1-week, assessor-blinded randomized controlled trial with a 1-week follow up.
MATERIALS
The HMD VR system 'Oculus Rift' (Oculus, LLS, US) is a low-cost HMD that fully integrates the user into the virtual environment by blocking out perception of the real-world. It includes a headset, two oculus touch controllers and two sensors. To power the Oculus Rift, a compatible laptop will be used. The "Oculus Rift" will assure a fully immersive virtual environment.
PROCEDURE
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
There will be an external assessor, who will be blinded during the clinical assessments.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a right-hemisphere hemorrhagic or ischemic stroke, confirmed by CT or MRI
- •only subacute (>2 weeks) and chronic (>6 months) unilateral spatial neglect patients
- •scoring below the cut-off value of 129 points on the standard BITC test
- •being 18 years or older at the time of lesion
排除标准
- •patients with dementia (Mini Mental State Examination (MMSE) < 24) or aphasia (Mississippi Aphasia Screening Test (MAST) < 45)
- •patients whose visual or hearing impairment does not allow possibility of interaction with the VR system
- •patients with depression (Patient Health Questionnaire (PHQ-9) >= 10)
- •patients unable to sit for at least 30 minutes in a wheelchair or chair
- •patients with sensorimotor alterations that can interfere with the performance with the VR system
研究组 & 干预措施
Intervention group
VR+ training
干预措施: VR neglect training (Device)
Control group
VR- training
干预措施: VR control training (Device)
结局指标
主要结局
BITC test
时间窗: through study completion, i.e. 12 days
The BITC test will be taken before, immediately after and 1-week after the intervention.
次要结局
- VR specific outcome: time(through study completion, i.e. 12 days)
- VR specific outcome: head rotations(through study completion, i.e. 12 days)
- VR specific outcome: number of errors(through study completion, i.e. 12 days)
研究者
Emma De Keersmaecker
Principal Investigator
Vrije Universiteit Brussel