Neuroengineering and Medical Robotics Laboratory, Department of Electronics, Information Technology, and Bioengineering, Politecnico di Milano, Milan, Italy -
Rehabilitation Unit of Lissone Institute, Istituti Clinici Scientifici Maugeri IRCCS, Lissone, Monza e Brianza, Italy.
Eur J Phys Rehabil Med. 2020 Feb;56(1):24-33. doi: 10.23736/S1973-9087.19.05847-7. Epub 2019 Sep 26.
Early interventions maximizing patient's involvement are essential to promote gait restoration and motor recovery after stroke.
The aim of this study is to evaluate the effects of a multimodal biofeedback training involving cycling augmented by functional electrical stimulation (FES) and balance exercises on walking ability and motor recovery.
Randomized controlled trial (NCT02439515).
Inpatient rehabilitation facility.
Subacute stroke survivors (less than 6 months from the first event) aged up to 90 years old.
Sixty-eight participants were randomly allocated to an experimental group, performing 15 sessions of biofeedback FES-cycling training followed by 15 sessions of biofeedback balance training (20 minutes each) in addition to usual care (70 minutes), and a control group performing 30 sessions (90 minutes) of usual care. Participants were evaluated before training, after 15 sessions, after 30 sessions, and at 6-month follow-up through: gait speed (primary outcome), spatiotemporal gait parameters, Six-Minute Walking Test, Functional Independence Measure, Motricity Index, Trunk Control Test, Berg Balance Scale, and Fall Efficacy Scale.
Both groups significantly improved over time, but no group and interaction effects were found for any outcomes. The 73% of the experimental group achieved a clinically meaningful change in gait speed compared to the 38% of the control group (P=0.048). These percentages were even more unbalanced for patients with a moderate to severe gait impairment at baseline (91% versus 36%; P=0.008).
The multimodal biofeedback training was not statistically superior to usual care, showing only a positive trend in favor of the experimental group on locomotion recovery. Patients initially not able to walk might be the best candidates for such a training.
The multimodal biofeedback training is a task-specific, repetitive and intensive training requiring a minimal supervision, which might result in a lower staff to patient ratio if organized in group sessions. Therefore, it can represent a good alternative for early stroke rehabilitation.
最大限度地提高患者参与度的早期干预对于促进中风后步态恢复和运动功能恢复至关重要。
本研究旨在评估包含骑行动作的多模式生物反馈训练结合功能性电刺激（FES）和平衡练习对步行能力和运动功能恢复的影响。
随机对照试验（NCT02439515）。
住院康复设施。
亚急性脑卒中幸存者（发病后<6 个月），年龄在 90 岁以下。
68 名参与者被随机分配到实验组，进行 15 次生物反馈 FES 自行车训练，然后进行 15 次生物反馈平衡训练（每次 20 分钟），并接受常规护理（70 分钟），对照组则进行 30 次（90 分钟）的常规护理。参与者在训练前、15 次训练后、30 次训练后和 6 个月随访时接受评估，评估内容包括：步态速度（主要结局）、时空步态参数、6 分钟步行测试、功能独立性测量、运动指数、躯干控制测试、伯格平衡量表和跌倒效能量表。
两组在时间上均有显著改善，但在任何结果上均未发现组间和组间交互作用。实验组有 73%的患者步态速度达到了临床有意义的改善，而对照组仅有 38%（P=0.048）。对于基线时步态障碍程度为中度至重度的患者，这一比例更为不平衡（91%比 36%；P=0.008）。
多模式生物反馈训练在统计学上并不优于常规护理，仅显示出实验组在运动功能恢复方面的积极趋势。最初无法行走的患者可能是这种训练的最佳人选。
多模式生物反馈训练是一种特定任务、重复且强度高的训练，需要最小的监督，如果以小组形式组织，可以实现更低的员工与患者比例。因此，它可能是早期脑卒中康复的一个较好选择。
