A Pilot Study on the Feasibility Study of a Novel VR-based Post-stroke Hemineglect Evaluation System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- 8 items of virtual reality-based hemineglect evaluation system
研究概览
简要总结
The normal value of the new virtual reality (VR)-based hemineglect evaluation system is obtained and its validity is checked by whether there is a difference in the evaluation results between normal people, stroke patients with hemineglect, and stroke patients without hemineglect. And, the usability of the virtual reality-based hemineglect evaluation system is confirmed.
详细描述
This pilot study included 50 stroke patients with right hemisphere lesion and 25 healthy people.
The normal value for each item is determined based on the result value for each item of the virtual reality (VR)-based hemineglect evaluation system in normal people.
It is checked whether there is a difference in the results measured using the VR-based hemineglect evaluation system in normal persons, stroke patients with hemineglect, and stroke patients without hemineglect.
Structural validity is confirmed by examining the correlation between the measured values of the virtual VR-based hemineglect evaluation system and Korean Version of Modified Barthel Index (K-MBI), Mini Mental State Examination (MMSE), and Behavioral Inattention Test-Conventional (BIT-C) in stroke patients with hemineglect.
Check the required time and test stability of the evaluation using the VR-based hemineglect evaluation system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(Stroke patients)
- •Right handed
- •Patients with first onset stroke, with right brain lesions confirmed by imaging tests (MRI, CT)
- •Onset of stroke more than 1week (Normal people)
- •Right handed
- •Who has no problem in identifying objects with wearing VR head gear.
排除标准
- •(Stroke patients)
- •Patients with unilateral neglect due to other causes.
- •Patients with neurological diseases other than stroke (Parkinson's disease, Alzheimer's disease, etc.)
- •Patients with severe cognitive impairment.
- •Patients with underlying diseases or medical history that may cause visual impairment.
- •(Normal people)
- •Who has a neurological disease such as stroke, traumatic brain injury, Parkinson's disease, or Alzheimer's disease.
- •Who has a severe cognitive impairment.
- •Who has a underlying diseases or medical history that may cause visual impairment.
研究组 & 干预措施
Normal people
干预措施: VR-based post-stroke hemineglect evaluation system (Device)
Right hemispheric stroke with hemineglect
干预措施: VR-based post-stroke hemineglect evaluation system (Device)
Right hemispheric stroke without hemineglect
干预措施: VR-based post-stroke hemineglect evaluation system (Device)
结局指标
主要结局
8 items of virtual reality-based hemineglect evaluation system
时间窗: up to 1 year
(1)Visual extinction, (2)Visual tracking, (3-6)Visual scanning, (7)Auditory, (8)Activities of Daily Living (ADL)
次要结局
未报告次要终点
研究者
Nam-Jong Paik
Professor
Seoul National University Bundang Hospital