融合视听觉引导肌电反馈与生物电刺激的新型神经康复仪的研制

Development of a Novel Neurorehabilitation Equipment by Integrating Visual-audio Guiding,EMG Feedback and Bioelectrical Stimulation

目的:研制一种融合视听觉引导、肌电反馈与生物电刺激的新型神经康复诊疗仪,用于脑卒中患者的肢体运动功能恢复治疗。方法:结合神经病学与康复医学理论,利用计算机多媒体技术、肌电反馈技术和生物电刺激技术,通过示范效应,让患者跟随进行肢体训练,即收缩训练肢体的骨骼肌肉,用患者自己的肌电信号反馈回仪器,控制电刺激输出,综合认知再学习、生物反馈和电刺激训练,促进本体感觉恢复,实现肢体运动的神经网络重建。结果:将120例患者随机分配到试验组或对照组(各60例)进行试验,试验组和对照组在治疗前后通过对瘫痪肢体的运动功能的Fugl-Meyer肢体运动功能评价和对生活自理能力的Barthel指数评价,结果表明,采用t检验进行统计学分析存在显著性差异(p<0.01),且试验组优于对照组。临床试验验证了新研发设备的有效性和安全性,目前该设备已获得医疗器械注册证书。结论:该设备能自动检测瘫痪肌肉的肌电信号,动态设定阈值,帮助重建大脑和瘫痪肌肉间的功能联系;视听觉引导能进一步调动病人的积极性,促进病人达到越来越高的康复目标。融合多媒体人机交互技术、生物反馈技术和电刺激技术有助于提高神经康复治疗的效果。

Objective： To develop a novel neurorehabilitation equipment for limb motor functional recovery of stroke patients by integrating visual-audio guiding, EMG feedback and bioelectrical stimulation. Methods：According to the neurology and rehabilitation medicine theory,computer multimedia technology, EMG feedback,and bioelectrical stimulation were used to reconstruct neural network for limb movement. Patients were guided to complete physical training, that is, exercise their muscles. Then the electromyographic signal was recorded and fed back to medical device which controls the output of electric stimulation. The device integrates cognitive relearning, biofeedback and electrical stimulation training to promote proprioception recovery and achieve neural network reconstruction of limb movement. Results： 120 patients were randomly assigned to experimental group or control group （each of 60 cases）. Patients from both groups were evaluated by Fugl-Meyer index for limb motor function assessment and Barthel index for live ability assessment before and after therapies. The results were evaluated by ttest which showed that there was significant difference between the two groups （p 〈 0.01 ）,and the experimental group＇ s result is better than the control group. Clinical trials also verified that the newly developed equipment was validity and safety, and has got Medical Device Registration Certificate. Conclusions： The device can automatically detect EMG of the paralyzed muscle, dynamically set thresholds, help to reconstruct the linkage between brain and paralytic muscles, lead patients to conquer the disease proactively by audio-visual guidance, and achieve the goal of rehabilitation. Integration of interactive multimedia technology, biofeedback technique and electrical stimulation can help to improve neurological rehabilitation therapy.