Effects of Robotic Neurorehabilitation Plus Virtual Reality on Attention Process and Executive Functions in Patients With Chronic Stroke: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Frontal Assessment Battery
研究概览
简要总结
Stroke can be classified as ischemic, i.e. due to the lack of blood flow, and haemorrhagic, caused by bleeding. Stroke results in focal signs and symptoms, with a devastating impact on a patient and his family. Although robotic rehabilitation is very useful in improving motor function, there is no a clear evidence on its role in improving cognitive abilities, which are often compromised in stroke patients.
To this end, the investigators designed a randomized controlled experimental study on stroke patients, with the aim of evaluating the effects of robotic neurorehabilitation using Lokomat with and without virtual reality on cognitive functioning in stroke patients, compared to traditional therapy.
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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neurological diagnosis of stroke in the post-acute phase (3 months from the acute event); age between 40 and 80; and Caucasian ethnicity; a FIM motor score equal to or greater than 30 and moderate to mild cognitive impairment (MoCA> 18); Fugl-Meyer scale score of> 18;
排除标准
- •Patients with a history of concomitant neurodegenerative diseases or brain surgery; severe cognitive or language impairment; systemic, bone or joint disorders; presence of disabling sensory alterations; concomitant medical and psychiatric illness that could interfere with VR training.
研究组 & 干预措施
Robotic Treatment plus VR
The patients included will be divided into three groups of 30 patients each. In this group patients will undergo a rehabilitation training with the Lokomat Pro, in which the exoskeleton device is equipped with a VR screen. The rehabilitation protocol consists of 24 training sessions (3 sessions per week, for 8 weeks, each session lasting about 45 minutes). Lokomat will be used to improve gait, whereas motor and cognitive function will be normally trained by using conventional neurorehabilitation. Patients will be evaluated at baseline (T0), immediately (T1) and after 3.month (T2) of treatment.
干预措施: Robotic Treatment plus VR (Device)
Robotic treatment without VR
The patients included will be divided into three groups of 30 patients each. In this group patients will undergo a rehabilitation training with the Lokomat-Nanos, in which the exoskeleton device is equipped with a screen with a visual feedback (but not virtual reality). The rehabilitation protocol consists of 24 training sessions (3 sessions per week, for 8 weeks, each session lasting about 45 minutes). The Lokomat-Nanos will be used to improve gait, whereas motor and cognitive function will be normally trained by using conventional neurorehabilitation. Patients will be evaluated at baseline (T0), immediately (T1) and after 3.month (T2) of treatement.
干预措施: Robotic Treatment plus VR (Device)
Conventional treatment
The patients included will be divided into three groups of 30 patients each. In this group patients will undergo a conventional gait rehabilitation. The rehabilitation protocol consists of 24 training sessions (3 sessions per week, for 8 weeks, each session lasting about 45 minutes). Beside conventional overground training for gait, motor and cognitive function will be normally trained by using conventional neurorehabilitation. Patients will be evaluated at baseline (T0), immediately (T1) and after 3.month (T2) of treatement.
干预措施: Robotic Treatment plus VR (Device)
结局指标
主要结局
Frontal Assessment Battery
时间窗: 3 months
This is a tool is used to examine global frontal abilities
次要结局
- Trial Making Test(3 months)
研究者
Rocco Salvatore Calabrò
Professor
IRCCS Centro Neurolesi "Bonino-Pulejo"