A Randomized Controlled Pilot Study of Gait Rehabilitation in Stroke Patients Using Functional Electrical Stimulation and Visual Feedback
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 10 Meter Walk Test
研究概览
简要总结
recoveriX PRO system is a Brain-Computer Interface (BCI) device that combines Motor Imagination (MI), with Functional Electrical Stimulation (FES) and Virtual Reality (VR) as feedback devices. The user wears an electroencephalography (EEG) cap that registers the neural activity during the mental practice. This system allows the user to control the feedback devices (FES +VR) with the MI.
The goal of this clinical trial is to know the safety and clinical effectiveness of recoveriX-based treatment for improving gait functions in stroke patients. Researchers will compare the functional results obtained by recoveriX system, to the standard treatment based in FES + VR + MI without monitoring the EEG activity.
The questions to answer are:
- Will stroke patients who undergo recoveriX therapy significantly improve their gait ability?
- Is the functional improvement (gait speed) achieved with the BCI treatment superior to the standard MI+FES+VR treatment?
- Is the recoveriX-based therapy as safe as the standard treatment?
Participants will have to perform a complete assessment to evaluate their functionality before and after the intervention (motor skills, walking ability, impact of the disease in daily living activities).
Patients in the BCI group will receive 25 sessions (3 sessions per week) of BCI training with FES and VR feedback (24 sessions in total).
Patients in the control group will receive 25 sessions (3 sessions per week) of FES + VR therapy. Patients in the control group will receive the same instructions as the experimental but will not wear the EEG cap.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •6-months or more post stroke
- •With a restriction of the lower extremities preventing the persons from activities of daily life
- •Participants must be German speaking.
- •Demonstrate intact cognition to provide informed consent and follow instructions.
- •Be able to perform TUG and 10MWT (3 times).
排除标准
- •Debilitating conditions or vision impairment that would impede full participation in the study.
- •Other neurological conditions affecting the motor system or the compliance to the therapy (for example Polyneuropathy or Musculoskeletal Diseases).
- •Uncontrolled epilepsy or seizures
- •Significant circulatory disturbances of the stimulated extremities
- •Inability to independently maintain the seated position (without assistance) for about 60 minutes.
- •Active or passive implanted medical devices such as pacemakers which do not allow the use of FES.
- •Implanted metallic fragments in the upper and lower extremities which can limit the use of FES.
- •Under the influence of anesthesia or similar medication.
- •With fractures or lesions in the extremity to be stimulated.
- •Inadequate control of a BCI system.
- •Sensory disorders which can significantly affect the patient's ability to feel pain and to react to unsuitable proprioceptive stimuli.
- •Botulinum toxin treatment of his/her paretic lower limb during this study
研究组 & 干预措施
BCI
Patients in the BCI group will receive 25 sessions (3 times per week) of BCI training with FES and VR feedback.
干预措施: recoveriX (Device)
Control
Patients in the control group receive 25 sessions (3 times per week) of FES and VR therapy. Patients in the control group will receive the same instructions as the experimental but will not wear the EEG cap.
干预措施: Control (Device)
结局指标
主要结局
10 Meter Walk Test
时间窗: From enrollment to the end of treatment at 8 weeks
The 10MWT assesses walking speed in meters per second over a short distance and is one of the most used to evaluate functional mobility, gait, and balance for lower limb therapy. This is a metric and continuous variable. The 10MWT is used for clinical purposes and in research. It supports the assessment of the degree of damage and describes the recovery of lower extremity after a stroke. Individuals walk 10 meters without assistance and the time is measured for the intermediate 6 meters to allow for acceleration and deceleration. Assistive devices can be used but should be kept consistent and documented from test to test. If physical assistance is required to walk, the 10MWT should not be performed. Patients will receive the following instructions: "Walk as fast as you can safely walk and stop when you reach the far mark."
次要结局
- Timed Up and Go test(From enrollment to the end of treatment at 8 weeks)
- Modified Ashworth Scale(From enrollment to the end of treatment at 8 weeks)