A Study of Neurorehabilitation Based on Robotics, Brain-Computer Interface (BCI) and Virtual Reality (VR) in Patients with Upper Limb Paresis Due to Stroke in the Early Rehabilitation Period
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- FMA-UE A-D
研究概览
简要总结
This clinical trial aims to investigate the effectiveness of a novel neurorehabilitation technology for treating stroke in adults. The study will evaluate a simulator that combines robotic orthosis, a non-invasive brain-computer interface (BCI), and a virtual reality (VR) display. The goal of this trial is to advance stroke rehabilitation by exploring the potential benefits of these cutting-edge technologies.
Key Research Questions:
Efficacy: Does the new simulator significantly improve arm function compared to standard rehabilitation techniques?
BCI Technology: Which approach - motor imagery of only the paretic arm or both the paretic and healthy arm - yields greater functional improvements?
VR Contribution: How does the integration of VR enhance rehabilitation outcomes?
Safety and Tolerability: What potential side effects or adverse events may arise from using the new simulator?
Participants who have suffered a stroke will undergo a standard rehabilitation course, during which 10-12 sessions will take place using the innovative simulator: a robotic device moves a patient's paralyzed arm at the command of a non-invasive brain-computer interface to perform a game task resembling real-life activities, augmented by a virtual reality display.
Researchers will assess the impact of the new technology on arm function to determine its efficacy in promoting recovery.
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
- Single (Outcomes Assessor)
盲法说明
Participants will be evaluated by blinded assessors before being assigned to one of the study arms, and their rehabilitation outcomes will also be assessed by blinded assessors.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent.
- •Age 18 to 80 years at the time of stroke onset.
- •Early rehabilitation period (up to 6 months post-stroke).
- •Diagnosis of acute cerebrovascular accident confirmed by MRI or CT.
- •Upper limb paresis severity between 0 and 3 on the 6-point Medical Research Council (MRC) muscle strength scale.
- •Ability and willingness to comply with the study protocol.
- •Demonstrated motivation for rehabilitation.
排除标准
- •Montreal Cognitive Assessment scale (MoCA) score less than 10 points.
- •Hamilton Depression Rating Scale (Ham-D) score greater than 18 points.
- •Modified Rankin Scale (mRS) score greater than 4 points.
- •Pre-existing conditions that cause decreased muscle strength or increased muscle tone in the upper limbs (e.g., cerebral palsy, traumatic brain injury) or rigidity (e.g., Parkinson's disease, contractures).
- •Advanced arthritis or significant limitation of upper limb range of motion.
- •Absence of part of the upper limb due to amputation for any reason.
- •Any medical condition that may affect the conduct of the study or patient safety (e.g., mental illness).
- •Alcohol abuse or recreational drug use within the 12 months preceding the study.
- •Use of experimental medications or medical devices within the 30 days preceding the study.
- •Inability to comply with research procedures, as determined by the researcher.
- •The severity of the patient's condition, based on neurological or physical status, does not permit full rehabilitation.
- •Visual acuity less than 0.2 in the weakest eye according to the Sivtsev visual acuity chart.
- •Unstable angina and/or heart attack within the 30 days preceding the study.
- •Recurrent stroke.
- •Uncontrolled arterial hypertension.
- •Presence of a pacemaker and/or other implanted electronic devices.
- •Use of muscle relaxants.
- •Peripheral neuropathy.
- •Coexisting diseases in an exacerbation or decompensated stage requiring active treatment.
- •Allergic reactions or other skin lesions at the EEG electrode application sites at the time of the study.
- •Acute urinary tract infections.
- •Acute thrombophlebitis.
- •Any form of epilepsy.
- •Benign and malignant neoplasms.
结局指标
主要结局
FMA-UE A-D
时间窗: From enrollment to the end of treatment at 2-3 weeks
The Fugl-Meyer Assessment for Upper Extremity, parts A-D (FMA-UE A-D) evaluates a patient's motor function, with scores ranging from 0 (indicating the most severe impairment) to 66 (indicating no impairment). Details available at https://www.gu.se/en/neuroscience-physiology/fugl-meyer-assessment.
ARAT
时间窗: From enrollment to the end of treatment at 2-3 weeks
The Action Research Arm Test (ARAT) evaluates a patient's ability to handle objects of various sizes, weights, and shapes, making it a specific measure of arm-related activity limitations. Scores range from 0 (indicating the most severe impairment) to 57 (indicating no impairment). Details available at https://strokengine.ca/en/assessments/action-research-arm-test-arat.
次要结局
- NIHSS(From enrollment to the end of treatment at 2-3 weeks)
- Ashworth(From enrollment to the end of treatment at 2-3 weeks)
- RMI(From enrollment to the end of treatment at 2-3 weeks)
- MRS(From enrollment to the end of treatment at 2-3 weeks)
- SF-36(From enrollment to the end of treatment at 2-3 weeks)