FES for foot-drop in hemiparesis

描述（由申请人提供）：中风是美国成年人致残的主要原因。偏瘫是中风的显著表现，是中风幸存者身体残疾的重要原因。在步态的摇摆阶段，足下垂或无力背屈麻痹的踝关节是一种重要的步态异常，导致中风幸存者的活动能力下降。在美国，解决这一缺陷的护理标准是定制模塑踝足矫形器（AFO）。然而，不断发展的数据表明，积极的重复性运动训练是促进中风后运动学习的主要基础。我们将运动再学习定义为中枢神经系统损伤后运动能力的再习得。因此，虽然AFO可以在短期内帮助中风幸存者行走，但从长期来看，它也可能抑制康复。先前的研究表明，由神经肌肉电刺激（NMES）介导的主动重复运动练习有助于中风幸存者的运动再学习。特别是，有研究报道，一些慢性中风幸存者使用腓神经刺激器进行足下垂治疗后，经历了充分的恢复，他们不再需要腓神经刺激器或AFO进行社区活动。然而，尚无随机盲法临床试验严格评估腓神经刺激器下行走训练对运动再学习的影响。因此，这个项目的目的是评估经皮腓神经刺激器的运动再学习效果，这反映了我对急性中风幸存者下肢运动损伤、下肢相关身体残疾和整体生活质量的测量。将进行一项单盲随机临床试验，以评估腓神经刺激器行走训练与AFO行走训练对急性卒中幸存者的影响。受试者治疗8周，随访6个月。本研究结果将指导今后对剂量效应、机制和最佳处方参数的研究

DESCRIPTION (provided by applicant): Stroke is the leading cause of disability among adults in the United States. Hemiplegia is a striking manifestation of stroke and contributes significantly to the physical disability of stroke survivors. Foot-drop, or inability to dorsiflex the paretic ankle during the swing phase of gait is an important gait abnormality that contributes to decreased mobility among stroke survivors. In the United States, the standard of care in addressing this deficit is the custom molded ankle-foot-orthosis (AFO). However, evolving data now demonstrate that active repetitive movement training is the principal substrate for facilitating motor learning after stroke. We define motor relearning as the reacquisition of motor ability after central nervous system injury. Thus, while an AFO may assist stroke survivors to ambulate in the short-term, it is possible that it also inhibits recovery in the long-term. Previous studies have demonstrated that active repetitive movement exercises mediated by neuromuscular electrical stimulation (NMES) facilitate motor relearning among stroke survivors. In particular, studies have reported that some chronic stroke survivors treated with a peroneal nerve stimulator for foot-drop experience sufficient recovery that they no longer need the peroneal nerve stimulator or an AFO for community ambulation. However, there are no blinded randomized clinical trials that rigorously evaluate the motor relearning effects of ambulation training with peroneal nerve stimulators. Thus, the aim of this project is to assess the motor relearning effects of a transcutaneous peroneal nerve stimulator as reflected my measures of lower limb motor impairment, lower limb related physical disability and overall quality of life of acute stroke survivors. A single-blinded randomized clinical trial will be carried out to assess the effects of ambulation training with a peroneal nerve stimulator among acute stroke survivors compared to ambulation training with an AFO. Subjects will be treated for 8 weeks and followed for a total of 6 months. Results of this study will direct future investigations with respect to dose effect, mechanism and optimal prescriptive parameters