Long-Term Follow-up to a Randomized Controlled Trial Comparing Peroneal Nerve Functional Electrical Stimulation to an Ankle Foot Orthosis for Patients With Chronic Stroke
Long-Term Follow-up to a Randomized Controlled Trial Comparing Peroneal Nerve Functional Electrical Stimulation to an Ankle Foot Orthosis for Patients With Chronic Stroke
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DOI：
10.1177/1545968315570325
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发表时间：
2015-11-01
影响因子：
4.2
通讯作者：
Kufta, Conrad
中科院分区：
文献类型：
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作者：
Bethoux, Francois;Rogers, Helen L.;Kufta, Conrad
背景证据支持腓神经功能性电刺激（FES）作为踝足矫形器（AFO）治疗卒中后足下垂的有效替代方案，但很少有长期随机对照比较。Objective.比较FES和AFO治疗卒中后足下垂患者12个月内步态质量和功能的变化。方法.在30个康复中心进行的一项非盲随机对照试验（ClinicalTrials.gov#NCT01087957）的随访分析，比较了6个月内FES与AFO的情况。受试者继续佩戴随机器械6个月，直至最终12个月评估。受试者使用研究器械进行所有家庭和社区活动。采用多重插补意向治疗分析;检验主要终点的非劣效性和次要终点的优效性。主要终点：10米步行试验（10 MWT）和器械相关严重不良事件发生率。次要终点：6分钟步行试验（6 MWT）、GaitRite功能性Ampere曲线和改良Emory功能性Ampere曲线（mEFAP）。结果共有495例受试者接受了随机化，384例完成了12个月随访。在所有主要终点方面，FES均不劣于AFO。与初始测量值相比，FES和AFO组的10 MWT均显示出统计学和临床显著改善。对于主要或次要终点，未发现具有统计学意义的组间差异。FES组在6 MWT和mEFAP楼梯时间分项评分方面表现出统计学显著性改善。结论.在12个月时，FES和AFO在步态速度方面继续表现出等同的增益。结果表明，长期使用FES可能会导致步行耐力和功能性步行的额外改善，需要进一步的研究来证实这些发现。
Background. Evidence supports peroneal nerve functional electrical stimulation (FES) as an effective alternative to ankle foot orthoses (AFO) for treatment of foot drop poststroke, but few long-term, randomized controlled comparisons exist. Objective. Compare changes in gait quality and function between FES and AFOs in individuals with foot drop poststroke over a 12-month period. Methods. Follow-up analysis of an unblinded randomized controlled trial (ClinicalTrials.gov #NCT01087957) conducted at 30 rehabilitation centers comparing FES to AFOs over 6 months. Subjects continued to wear their randomized device for another 6 months to final 12-month assessments. Subjects used study devices for all home and community ambulation. Multiply imputed intention-to-treat analyses were utilized; primary endpoints were tested for noninferiority and secondary endpoints for superiority. Primary endpoints: 10 Meter Walk Test (10MWT) and device-related serious adverse event rate. Secondary endpoints: 6-Minute Walk Test (6MWT), GaitRite Functional Ambulation Profile, and Modified Emory Functional Ambulation Profile (mEFAP). Results. A total of 495 subjects were randomized, and 384 completed the 12-month follow-up. FES proved noninferior to AFOs for all primary endpoints. Both FES and AFO groups showed statistically and clinically significant improvement for 10MWT compared with initial measurement. No statistically significant between-group differences were found for primary or secondary endpoints. The FES group demonstrated statistically significant improvements for 6MWT and mEFAP Stair-time subscore. Conclusions. At 12 months, both FES and AFOs continue to demonstrate equivalent gains in gait speed. Results suggest that long-term FES use may lead to additional improvements in walking endurance and functional ambulation; further research is needed to confirm these findings.