PDF(Pubmed)
Abstract：
Individuals with neuromuscular disorders display a combination of motor control deficits and lower limb weakness contributing to knee extension deficiency characterized by exaggerated stance phase knee flexion. There is a lack of evidence for long-term improvement of knee extension deficiency with currently available clinical treatment programs. Our previous work testing a wearable robotic exoskeleton with precisely timed assistive torque applied at the knee showed immediate increases in knee extension during walking for children with cerebral palsy, which continued to improve over an acute practice period. When we applied interleaved assistance and resistance to knee extension, we observed improvements in knee extension and increased muscle activation indicating the potential for muscle strengthening when used over time. There is a need for additional, high-quality trials to assess the impact of dosage, intensity and volume of training necessary to see persistent improvement in lower limb function for these patient populations. This randomized crossover study (ClinicalTrials.gov: NCT05726591) was designed to determine whether 12 weeks of overground gait training with a robotic exoskeleton outside of the clinical setting, following an initial in clinic accommodation period, has a beneficial effect on walking ability, muscle activity and overall motor function. Participants will be randomized to either complete the exoskeleton intervention or continue their standard therapy for 12 weeks first, followed by a crossover to the other study component. The primary outcome measure is change in peak knee extension angle during walking; secondary outcome measures include gait speed, strength, and validated clinical scales of motor function and mobility. Assessments will be completed before and after the intervention and at 6 weeks post-intervention, and safety and compliance will be monitored throughout. We hypothesize that the 12-week exoskeleton intervention outside the clinical setting will show greater improvements in study outcome measures than the standard therapy.
摘要：
患有神经肌肉疾病的个体表现出运动控制缺陷和下肢无力的组合，从而导致膝关节伸展不足，其特征在于过度的站立阶段膝关节屈曲。目前可用的临床治疗方案缺乏长期改善膝关节伸展功能不足的证据。我们之前的工作测试了可穿戴式机器人外骨骼，在膝盖上施加了精确定时的辅助扭矩，结果显示，对于脑瘫儿童来说，在行走过程中膝盖伸展力立即增加。在一个急性的实践期间持续改善。当我们对膝盖伸展施加交错辅助和阻力时，我们观察到膝关节伸展的改善和肌肉激活的增加，表明随着时间的推移，肌肉增强的潜力。需要额外的,高质量的试验，以评估剂量的影响，对于这些患者人群，观察下肢功能持续改善所需的训练强度和数量。这项随机交叉研究（ClinicalTrials.gov：NCT05726591）旨在确定是否在临床环境之外使用机器人外骨骼进行12周的地面步态训练，在最初的诊所住宿期之后，对行走能力有有益的影响，肌肉活动和整体运动功能。参与者将被随机分配完成外骨骼干预或继续他们的标准治疗12周。然后交叉到另一个研究部分。主要结果指标是步行过程中膝盖伸展角的峰值变化；次要结果指标包括步态速度，力量,以及经过验证的运动功能和活动能力的临床量表。评估将在干预前后和干预后6周完成，安全和合规性将在整个过程中受到监控。我们假设在临床环境之外的12周外骨骼干预将在研究结果测量方面显示出比标准疗法更大的改善。
