Department of Physical Therapy and Rehabilitation Sciences, University of Kansas Medical Center, 3901 Rainbow Blvd, Mail Stop 3051, Kansas City, KS 66160, USA.
Stroke. 2013 Jun;44(6):1660-9. doi: 10.1161/STROKEAHA.111.000334. Epub 2013 May 2.
Drop foot after stroke may be addressed using an ankle foot orthosis (AFO) or a foot drop stimulator (FDS). The Functional Ambulation: Standard Treatment versus Electric Stimulation Therapy (FASTEST) trial was a multicenter, randomized, single-blinded trial comparing FDS and AFO for drop foot among people ≥ 3 months after stroke with gait speed ≤ 0.8 m/s.
Participants (n=197; 79 females and 118 males; 61.14 ± 11.61 years of age; time after stroke 4.55 ± 4.72 years) were randomized to 30 weeks of either FDS or a standard AFO. Eight dose-matched physical therapy sessions were provided to both groups during the first 6 weeks of the trial.
There was significant improvement within both groups from baseline to 30 weeks in comfortable gait speed (95% confidence interval for mean change, 0.11-0.17 m/s for FDS and 0.12-0.18 m/s for AFO) and fast gait speed. However, no significant differences in gait speed were found in the between-group comparisons. Secondary outcomes (standard measures of body structure and function, activity, and participation) improved significantly in both groups, whereas user satisfaction was significantly higher in the FDS group than in the control group.
Using either an FDS or an AFO for 30 weeks yielded clinically and statistically significant improvements in gait speed and other functional outcomes. User satisfaction was higher in the FDS group. Although both groups did receive intervention, this large clinical trial provides evidence that FDS or AFO with initial physical therapy sessions can provide a significant and clinically meaningful benefit even years after stroke. Clinical Trial Registration Information- URL: http://www.clinicaltrials.gov. Unique Identifier: NCT01138995.
脑卒中后出现足下垂可通过踝足矫形器（AFO）或足下垂刺激器（FDS）来解决。功能步行：标准治疗与电刺激疗法（FASTEST）试验是一项多中心、随机、单盲试验，比较了 FDS 和 AFO 对脑卒中后 3 个月且步态速度≤0.8m/s 的患者的足下垂。
共有 197 名参与者（79 名女性和 118 名男性；61.14±11.61 岁；脑卒中后时间 4.55±4.72 年）被随机分为 FDS 或标准 AFO 组，接受 30 周的治疗。两组在试验的前 6 周内均接受了 8 次剂量匹配的物理治疗。
两组在舒适步态速度（FDS 组和 AFO 组的平均变化的 95%置信区间分别为 0.11-0.17m/s 和 0.12-0.18m/s）和快速步态速度方面均从基线到 30 周时都有显著改善。然而，两组之间的步态速度没有显著差异。次要结局（身体结构和功能、活动和参与的标准测量）在两组中均有显著改善，而 FDS 组的用户满意度显著高于对照组。
使用 FDS 或 AFO 治疗 30 周，在步态速度和其他功能结局方面均有临床和统计学上的显著改善。FDS 组的用户满意度更高。尽管两组都接受了干预，但这项大型临床试验提供了证据，表明即使在脑卒中后数年，FDS 或 AFO 与初始物理治疗相结合也能提供显著且具有临床意义的益处。
临床试验注册信息-网址：http://www.clinicaltrials.gov。唯一标识符：NCT01138995。
