BCI-Based Control for Ankle Exoskeleton T-FLEX: Comparison of Visual and Haptic Feedback With Stroke Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- EEG signals from primary motor cortex
研究概览
简要总结
This protocol will developed an assessment of the T-FLEX device controlled by Brain-Computer Interface in patients with Stroke.
详细描述
Brain-Computer Interface (BCI) remains an emerging tool that seeks to improve the patient interaction with the therapeutic mechanisms and to generate neuroplasticity progressively through neuromotor abilities. Motor Imagery (MI) analysis is the most used paradigm based on the motor cortex's electrical activity to detect movement intention. It has been shown that motor imagery mental practice with movement-associated feedback may offer an effective strategy to facilitate motor recovery in brain injury patients. This protocol will study a BCI system associated with visual and haptic feedback to facilitate MI generation and, to control a T-FLEX ankle exoskeleton. In this study, a group of five post-stroke patients will test four different strategies using T-FLEX: Passive movement, Active movement, Motor Imagination with Visual stimulation and Motor Imagination with Visual-Haptic stimuli. The quantitative characterization of BCI performance will be made by using statistical analysis of electroencephalographic data. Finally, the patient's satisfaction will be evaluated by a questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral lower extremity paresis
- •Hemorrhagic or ischemic stroke
- •A minimum of six months after the acute infarction/onset of the disease
- •Full passive range of motion in lower extremity or at least at neutral position
- •Be able to stand freely
- •Be able to walk with or without aid for at least 20 meters in less than 2 minutes
排除标准
- •Peripheral nervous system pathology
- •Weight over 100 kg
- •No cognitive ability to follow the study instructions
- •Pregnancy
- •Use of implanted devices
- •Instable lower extremity joints or fixed contracture
研究组 & 干预措施
Implementation of a BCI system integrated to the T-FLEX lower-limb exoskeleton in post-stroke
The participants will carry out tests for the evaluation of the functionality of the BCI system integrated to the T-FLEX device. The test consists of 1 session that includes four conditional experiments. Real Movement, Continuous Stationary Therapy, Motor Imagery Detection with Visual Stimulation, and Motor Imagery Detection with Tactile Stimulation.
干预措施: Implementation of a BCI system integrated to the T-FLEX lower-limb exoskeleton in post-stroke patients. (Device)
结局指标
主要结局
EEG signals from primary motor cortex
时间窗: Baseline
continuous signals will be acquired from the primary motor cortex of lower limbs (FcZ, C2, Cz, C1, Cpz) according to the 10-20 International EEG System. Power spectral density in the frequency band of motor imagery (8-32Hz) will be obtained by OpenVibe Software and Matlab. The measure unit is Decibels per Hertz(dB/Hz).
Response time
时间窗: Baseline
The response time for each task will be automatically measured by a Visual Studio Code Software during the use of the Brain-Computer Interface. This variable will consider the response time of a specific command, since the subject receives the stimulation until the software detects the EEG Signal. The measure unit is milliseconds
次要结局
- Patient satisfaction with device: Quebec User Evaluation of Satisfaction with Assistive Technology(Baseline)