HEROES: Human Extremity Robotic Rehabilitation and Outcome Enhancement for Stroke
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- BCI control
研究概览
简要总结
HEROES is a multidisciplinary neurophysiological & neural rehabilitation engineering project, developed by the Lab of Medical Physics & Digital Innovation, School of Medicine, Faculty of Health Science Aristotle University of Thessaloniki and supported by a Neurosurgical Department. The website for the project can be accessed at https://heroes.med.auth.gr.
The investigation's primary objectives include the development, testing and optimization of an intervention based on multiple immersive man-machine interfaces offering rich feedback, that include a) mountable robotic arm controlled with wireless Brain-Computer Interface and b) wearable robotics jacket & gloves in combination with a serious game application and c) augmented reality module for the presentation of the previous two, as well as the development and validation of a self-paced neuro-rehabilitation protocol for patients after chronic stroke with severe residual motor disability.
详细描述
HEROES project's full title is <Human Extremity Robotic Rehabilitation and Outcome Enhancement for Stroke>. It is a multidisciplinary neurophysiological & neural rehabilitation engineering project, developed by the Lab of Medical Physics & Digital Innovation, School of Medicine, Faculty of Health Science Aristotle University of Thessaloniki and supported by a Neurosurgical Department. The website for the project can be accessed at https://heroes.med.auth.gr .
The HEROES project involves:
- A clinical study for rehabilitation of patients with Chronic Stroke (CS), using multiple immersive man-machine interfaces (Brain-Computer Interface (BCI) controlled robotic arms device, Wearable Robotics Jacket & Gloves, Serious Gaming Application, Augmented Reality presentation)
- A secondary off-line neurophysiological analysis of brain activation, connectivity and plasticity as well as muscle electrophysiology in patients with CS undergoing motor imagery (MI) and BCI training and assistance through electrical muscle stimulation
Milestones of the study:
- The investigators aim to develop, test and optimize an intervention based on multiple immersive man-machine interfaces
- The investigators aim to develop and validate self-paced neuro-rehabilitation protocols for patients with CS.
- The investigators aim to identify and study the neurophysiological functionality and alteration of brain activity in chronic CS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 14 years of age
- •Female & male stroke survivors and healthy individuals (age and gender matched)
- •Sufficient documentation of stroke in case of patients (clinical neurological examination, MRI)
排除标准
- •Other neurological condition that has a possibility to significantly affect the neurological status of the participants (or) the ability to control a BCI (or) the neurophysiological recordings:
- •Traumatic brain injury
- •Central Nervous System tumors
- •Multiple Sclerosis
- •Amyotrophic Lateral Sclerosis
- •Parkinson's disease
- •Refractory Epilepsy
- •Other grave medical condition that could affect the participation (or) the safety of the participants:
- •Cardiac deficiency
- •Pulmonary deficiency
- •Hearing and visual impairments that can affect the participant's understanding of the --intervention and performance.
- •Illegal drug use
- •Chronic alcoholism
结局指标
主要结局
BCI control
时间窗: 1 week
The ability of participants to modulate brainwave activity in order to achieve control of the BCI will be established. BCI control is evaluated as achieved or not (there are cases of BCI-illiteracy when the participants cannot modulate their brainwaves in order to control the BCI).
Serious game performance (in-game scoring system)
时间窗: 2 weeks
The ability of participants to control the wearables robotic jacket in order to complete in-game tasks and collect more points will be evaluated. The points will be gathered be matching the speed and position of the in-game task instructions while receiving assistance from electrical muscle stimulation.
次要结局
- Initial Functional Improvement (Greek translation of the Modified Rankin Scale (mRS-9Q)(12 months)
研究者
Panos Bamidis
Professor
Aristotle University Of Thessaloniki