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临床试验/NCT02971371
NCT02971371已完成不适用

The Role of Mirror Neuron System in Improving Motor Performance by Using Virtual Reality, as Revealed by EEG: a Randomized Clinical Trial

IRCCS Centro Neurolesi "Bonino-Pulejo"0 个研究点目标入组 24 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
主要终点
gait evaluated by Rivermead Mobility Index (RMI)

研究概览

简要总结

Many studies have demonstrated the usefulness of repetitive task practice by using robotic devices, including Lokomat, for the treatment of lower limb paresis. Virtual reality (VR) has proved to be a valuable tool to improve neurorehabilitation training. Our pilot randomized clinical trial aimed at evaluating the correlation between the modifications of brain oscillations during a VR neurorehabilitative training of gait and the motor function recovery in patients with chronic stroke.

Twenty-four patients suffering from a first unilateral ischemic stroke in the chronic phase were randomized into two groups. One group performed 40 sessions of Lokomat with VR (RAGT+VR) whereas the other group underwent Lokomat without VR (RAGT-VR). Outcomes (clinical, kinematic, and event-related synchronization, ERS, and desynchronization, ERD, at the EEG) were measured before and after the robotic intervention.

The robotic-based rehabilitation combined with VR could be associated with improvements in several measurements of lower limb function, gait, and balance in patient with chronic hemiparesis. Moreover, ERS/ERD analysis can be proposed as a tool to monitor motor performance and to develop non-invasive brain-computer interfaces controlling robotic devices.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Investigator)

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥55 years
  • A first-ever ischemic supra-tentorial stroke (confirmed by MRI scan) at least 6 months before their enrollment;
  • An unilateral hemiparesis, with a Muscle Research Council -MCR- score ≤3
  • Ability to follow verbal instructions, with a Mini-Mental State Examination (MMSE) >24
  • A mild to moderate spasticity according to a Modified Ashworth Scale (MAS) ≤2
  • No severe bone or joint disease
  • No history of concomitant neurodegenerative diseases or brain surgery.

排除标准

  • Severe cognitive and behavioral impairments
  • Severe osteoporosis and previous bone fractures

结局指标

主要结局

gait evaluated by Rivermead Mobility Index (RMI)

时间窗: Six months

次要结局

  • Spasticity evaluated by Modified Ashworth Scale (MAS)(Six months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rocco Salvatore Calabrò

Principal investigator

IRCCS Centro Neurolesi "Bonino-Pulejo"

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