1 Douglas Grant Rehabilitation Centre, Ayrshire Central Hospital, NHS Ayrshire & Arran, Irvine, UK.
2 School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, UK.
Clin Rehabil. 2019 Jul;33(7):1150-1162. doi: 10.1177/0269215519842254. Epub 2019 Apr 11.
To compare the clinical- and cost-effectiveness of ankle-foot orthoses (AFOs) and functional electrical stimulation (FES) over 12 months in people with Multiple Sclerosis with foot drop.
Multicentre, powered, non-blinded, randomized trial.
Seven Multiple Sclerosis outpatient centres across Scotland.
Eighty-five treatment-naïve people with Multiple Sclerosis with persistent (>three months) foot drop.
Participants randomized to receive a custom-made, AFO ( = 43) or FES device ( = 42).
Assessed at 0, 3, 6 and 12 months; 5-minute self-selected walk test (primary), Timed 25 Foot Walk, oxygen cost of walking, Multiple Sclerosis Impact Scale-29, Multiple Sclerosis Walking Scale-12, Modified Fatigue Impact Scale, Euroqol five-dimension five-level questionnaire, Activities-specific Balance and Confidence Scale, Psychological Impact of Assistive Devices Score, and equipment and National Health Service staff time costs of interventions.
Groups were similar for age (AFO, 51.4 (11.2); FES, 50.4(10.4) years) and baseline walking speed (AFO, 0.62 (0.21); FES 0.73 (0.27) m/s). In all, 38% dropped out by 12 months (AFO, = 21; FES, = 11). Both groups walked faster at 12 months with device ( < 0.001; AFO, 0.73 (0.24); FES, 0.79 (0.24) m/s) but no difference between groups. Significantly higher Psychological Impact of Assistive Devices Scores were found for FES for Competence ( = 0.016; AFO, 0.85(1.05); FES, 1.53(1.05)), Adaptability ( = 0.001; AFO, 0.38(0.97); FES 1.53 (0.98)) and Self-Esteem ( = 0.006; AFO, 0.45 (0.67); FES 1 (0.68)). Effects were comparable for other measures. FES may offer value for money alternative to usual care.
AFOs and FES have comparable effects on walking performance and patient-reported outcomes; however, high drop-outs introduces uncertainty.
比较踝足矫形器（AFO）和功能性电刺激（FES）在 12 个月内对患有足下垂的多发性硬化症患者的临床和成本效益。
多中心、有能力、非盲、随机试验。
苏格兰的七个多发性硬化症门诊中心。
85 名未经治疗的多发性硬化症患者，患有持续性（>3 个月）足下垂。
参与者随机接受定制的 AFO（=43）或 FES 设备（=42）。
在 0、3、6 和 12 个月时进行评估；5 分钟自选步行测试（主要）、定时 25 英尺步行、步行耗氧量、多发性硬化症影响量表-29、多发性硬化症步行量表-12、改良疲劳影响量表、Euroqol 五维五水平问卷、活动特异性平衡和信心量表、心理影响辅助设备评分以及干预措施的设备和国家卫生服务人员时间成本。
两组在年龄（AFO，51.4（11.2）；FES，50.4（10.4）岁）和基线步行速度（AFO，0.62（0.21）；FES，0.73（0.27）m/s）方面相似。在所有情况下，有 38%的患者在 12 个月时退出（AFO，=21；FES，=11）。两组在使用设备后 12 个月时步行速度都更快（<0.001；AFO，0.73（0.24）；FES，0.79（0.24）m/s），但两组之间没有差异。FES 的辅助设备评分的心理影响得分更高，包括能力（=0.016；AFO，0.85（1.05）；FES，1.53（1.05））、适应性（=0.001；AFO，0.38（0.97）；FES，1.53（0.98））和自尊（=0.006；AFO，0.45（0.67）；FES 1（0.68））。其他措施的效果相当。FES 可能是一种具有成本效益的替代常规护理的选择。
