Effects of Virtual Prism Adaptation Therapy in Stroke Patients With Hemispatial Neglect
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Behavioral Inattention Test (BIT) Score
研究概览
简要总结
The purpose of this study is to investigate the effect of virtual prism adaptation therapy on hemispatial neglect in chronic stroke patients. This study is the randomized, double-blind, sham-controlled, cross-over design. Total 10 patients will be allocated randomly to either real virtual prism adaptation therapy or sham therapy with the wash-out period of more than 2 weeks. Two sessions (20min/session) per day, for 5days (total 10 sessions) will be provided. Behavioral outcomes will be measured before and after completing a total of 10 sessions therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •3 months after stroke onset
- •2 or more tests indicative of hemispatial neglect in following 3 tests: 1)line bisection test, 2)Albert's test, 3)Drawing test.
- •Ability to recognize the target object, hand trajectory in the immersive virtual reality
- •16 points or more in the Korean version of mini-mental state examination
排除标准
- •Previous stroke or traumatic brain injury history
- •Can not cooperate during the therapy, due to delirium or aphasia
- •Unstable medical conditions
- •Severe psychiatric symptoms that interfere with the therapy participation (e.g. severe depression, agitation, psychotic symptoms)
- •Pregnancy
- •Can not maintain sitting posture
研究组 & 干预措施
Virtual Prism Adaptation Therapy
This group will be provided with real virtual prism adaptation therapy. In the real therapy session, the hand trajectory will deviate to the right side in the virtual reality. The deviation angle will be adjusted according to the subject's adaptation. 20min-session will be provided twice a day for 5 days, then the total 10 sessions of therapy will be provided.
干预措施: Virtual Prism Adaptation Therapy (Device)
Sham Therapy
The therapy is the same as the real virtual prism adaptation therapy, but there will be no deviation of the hand trajectory in the virtual reality.
干预措施: Sham Therapy (Device)
结局指标
主要结局
Behavioral Inattention Test (BIT) Score
时间窗: Change from Baseline at 5 days
Range: 0(best) to 227(worst)
次要结局
- Comb and Razor Test(Change from Baseline at 5 days)
- BIT Conventional subtest score (BITC)(Change from Baseline at 5 days)
- BIT Behavioral subtest score (BITB)(Change from Baseline at 5 days)
- Catherine Bergego Scale (CBS)(Change from baseline at 5 days)
研究者
Won-Seok Kim
Assistant Professor
Seoul National University Hospital