The Italian Network of Telerehabilitation: Evaluation of Telerehabilitation System in Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- Change in long term episodic verbal memory
研究概览
简要总结
The main aim of the study is to evaluate the efficacy of the Virtual Reality Rehabilitation System (VRRS) compared to usual care treatment for patients with Mild Cognitive Impairment (MCI). Moreover, we will assess the possibility to prolong the beneficial effects of the treatment with an innovative telerehabilitation system. In the second phase of the present study we aim to evaluate the short and long term effects induced by the treatment of active (anodal) transcranial Direct Current Stimulation (tDCS) applied to the left dorsolateral prefrontal cortex combined with VRRS compared to placebo tDCS stimulation combined with VRRS.
The effects of the intervention on outcome variables will be assessed using a randomized controlled trial design with five groups. The investigators will assess the effects of VRRS system and of the implementation of the at-home treatment on the quality of life, cognitive and functional abilities.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of MCI, defined according to standard criteria (Petersen et al., 2011)
- •Mini Mental State Examination (MMSE) ≥24
- •Education ≥ 5 years
- •All of the subjects will have normal or corrected-to-normal vision and will be native Italian speakers.
- •All participants reported subjective memory complaints and objective memory impairment, but no impairment of function in daily life.
排除标准
- •visual perception disorder and/or hearing loss
- •history of major psychiatric disorders
- •any contraindication for tDCS such as a history of seizures, major head trauma, past brain surgery, a brain metal implant or a pacemaker.
结局指标
主要结局
Change in long term episodic verbal memory
时间窗: Baseline up to 12 weeks and 4 and 7 months
Free and Cued Selective Reminding Test (FCSRT)
次要结局
- Change in global cognition(Baseline up to 12 weeks and 4 and 7 months)
- Change in nonverbal long term memory(Baseline up to 12 weeks and 4 and 7 months)
- Change in visual attention and task switching(Baseline up to 12 weeks and 4 and 7 months)
- Change in naming abilities(Baseline up to 12 weeks and 4 and 7 months)
- Change in dementia severity(Baseline up to 12 weeks and 4 and 7 months)
- Change in memory complaints(Baseline up to 12 weeks and 4 and 7 months)
- Change in non-verbal abstract reasoning(Baseline up to 12 weeks and 4 and 7 months)
- Change in verbal fluency(Baseline up to 12 weeks and 4 and 7 months)
- Change in measure of quality of life(Baseline up to 12 weeks and 4 and 7 months)
- Change in visual constructional abilities(Baseline up to 12 weeks and 4 and 7 months)