McCrimmon Colin M, King Christine E, Wang Po T, Cramer Steven C, Nenadic Zoran, Do An H
Department of Biomedical Engineering, University of California, Irvine, CA, 92697, USA.
Department of Neurology, University of California, Irvine, Orange, CA, 92868, USA.
J Neuroeng Rehabil. 2015 Jul 11;12:57. doi: 10.1186/s12984-015-0050-4.
Many stroke survivors have significant long-term gait impairment, often involving foot drop. Current physiotherapies provide limited recovery. Orthoses substitute for ankle strength, but they provide no lasting therapeutic effect. Brain-computer interface (BCI)-controlled functional electrical stimulation (FES) is a novel rehabilitative approach that may generate permanent neurological improvements. This study explores the safety and feasibility of a foot-drop-targeted BCI-FES physiotherapy in chronic stroke survivors.
Subjects (n = 9) operated an electroencephalogram-based BCI-FES system for foot dorsiflexion in 12 one-hour sessions over four weeks. Gait speed, dorsiflexion active range of motion (AROM), six-minute walk distance (6MWD), and Fugl-Meyer leg motor (FM-LM) scores were assessed before, during, and after therapy. The primary safety outcome measure was the proportion of subjects that deteriorated in gait speed by ≥0.16 m/s at one week or four weeks post-therapy. The secondary outcome measures were the proportion of subjects that experienced a clinically relevant decrease in dorsiflexion AROM (≥2.5°), 6MWD (≥20 %), and FM-LM score (≥10 %) at either post-therapy assessment.
No subjects (0/9) experienced a clinically significant deterioration in gait speed, dorsiflexion AROM, 6MWT distance, or FM-LM score at either post-therapy assessment. Five subjects demonstrated a detectable increase (≥0.06 m/s) in gait speed, three subjects demonstrated a detectable increase (≥2.5°) in dorsiflexion AROM, five subjects demonstrated a detectable increase (≥10 %) in 6MWD, and three subjects demonstrated a detectable increase (≥10 %) in FM-LM. Five of the six subjects that exhibited a detectable increase in either post-therapy gait speed or 6MWD also exhibited significant (p < 0.01 using a Mann-Whitney U test) increases in electroencephalogram event-related synchronization/desynchronization. Additionally, two subjects experienced a clinically important increase (≥0.16 m/s) in gait speed, and four subjects experienced a clinically important increase (≥20 %) in 6MWD. Linear mixed models of gait speed, dorsiflexion AROM, 6MWD, and FM-LM scores suggest that BCI-FES therapy is associated with an increase in lower motor performance at a statistically, yet not clinically, significant level.
BCI-FES therapy is safe. If it is shown to improve post-stroke gait function in future studies, it could provide a new gait rehabilitation option for severely impaired patients. Formal clinical trials are warranted.
许多中风幸存者存在明显的长期步态障碍，常伴有足下垂。目前的物理治疗恢复效果有限。矫形器可替代踝关节力量，但无持久治疗效果。脑机接口（BCI）控制的功能性电刺激（FES）是一种新型康复方法，可能产生永久性神经功能改善。本研究探讨针对足下垂的BCI-FES物理治疗在慢性中风幸存者中的安全性和可行性。
9名受试者在四周内进行12次为时1小时的基于脑电图的BCI-FES系统操作，以实现足背屈。在治疗前、治疗期间和治疗后评估步态速度、背屈主动活动范围（AROM）、6分钟步行距离（6MWD）和Fugl-Meyer腿部运动（FM-LM）评分。主要安全性结局指标是治疗后1周或4周时步态速度下降≥0.16 m/s的受试者比例。次要结局指标是在治疗后评估中背屈AROM（≥2.5°）、6MWD（≥20%）和FM-LM评分（≥10%）出现临床相关下降的受试者比例。
在任何一次治疗后评估中，均无受试者（0/9）出现步态速度、背屈AROM、6MWT距离或FM-LM评分的临床显著恶化。5名受试者步态速度出现可检测到的增加（≥0.06 m/s），3名受试者背屈AROM出现可检测到的增加（≥2.5°），5名受试者6MWD出现可检测到的增加（≥10%），3名受试者FM-LM出现可检测到的增加（≥10%）。在治疗后步态速度或6MWD出现可检测到增加的6名受试者中，有5名脑电图事件相关同步/去同步也出现显著增加（使用Mann-Whitney U检验，p<0.01）。此外，2名受试者步态速度出现临床重要增加（≥0.16 m/s），4名受试者6MWD出现临床重要增加（≥20%）。步态速度、背屈AROM、6MWD和FM-LM评分的线性混合模型表明，BCI-FES治疗与较低运动表现的增加相关，在统计学上有显著意义，但在临床上无显著意义。
BCI-FES治疗是安全的。如果在未来研究中证明其能改善中风后步态功能，可为严重受损患者提供一种新的步态康复选择。有必要进行正式的临床试验。
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