The Effect of Prismatic Lenses in Association With tDCS in Patients With Neglect: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Neuropsychological outcome
研究概览
简要总结
The goal of this study is to to evaluate the effect and feasibility of a rehabilitation protocol with prismatic lenses associated with tDCS, compared to a prismatic lens rehabilitation protocol associated with sham stimulation, in reducing the signs of neglect in a group of patients with spatial heminegligence following ischemic stroke of the right hemisphere.
The secondary objective is to evaluate the impact of this rehabilitation protocol on functional outcome.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age >18 years
- •ischemic stroke
- •hospitalization within 90 days of the event
排除标准
- •heamorrhagic stroke
- •history of neurological disease
- •history of psychiatric disease
- •use of alchool and drugs
结局指标
主要结局
Neuropsychological outcome
时间窗: Change from baseline the Bergegò Scale at 2 weeks.
Bergegò Scale (0-30); high score means a better outcome
Functional outcome
时间窗: Change from baseline the Barthel Index at 2 weeks
Barthel Index (0-100); high score means a better outcome
次要结局
未报告次要终点
研究者
Simona Spaccavento
Principal Investigator
Istituti Clinici Scientifici Maugeri SpA