Keune Philipp M, Cocks Adam J, Young William R, Burschka Janina M, Hansen Sascha, Hofstadt-van Oy Ulrich, Oschmann Patrick, Muenssinger Jana
Department of Neurology, Klinikum Bayreuth GmbH, Hohe Warte 8, 95445, Bayreuth, Germany.
Department of Physiological Psychology, Otto-Friedrich-University Bamberg, Bamberg, Germany.
BMC Neurol. 2015 Sep 24;15:171. doi: 10.1186/s12883-015-0431-0.
Impaired walking capacity is a frequent confinement in Multiple Sclerosis (MS). Patients are affected by limitations in coordination, walking speed and the distance they may cover. Also abnormal dynamic walking patterns have been reported, involving continuous deceleration over time. Fampridine (4-aminopyridine), a potassium channel blocker, may improve walking in MS. The objective of the current study was to comprehensively examine dynamic walking characteristics and improved walking capacity in MS patients treated with fampridine.
A sample of N = 35 MS patients (EDSS median: 4) underwent an electronic walking examination prior to (Time 1), and during treatment with fampridine (Time 2). Patients walked back and forth a distance of 25 ft for a maximum period of 6 min (6-minute 25-foot-walk). Besides the total distance covered, average speed on the 25-foot distance and on turns was determined separately for each test minute, at Time 1 and Time 2.
Prior to fampridine administration, 27/35 patients (77 %) were able to complete the entire 6 min of walking, while following the administration, 34/35 patients (97 %) managed to walk for 6 min. In this context, walking distance considerably increased and treatment was associated with faster walking and turning across all six test minutes (range of effect sizes: partial eta squared = .34-.72). Importantly, previously reported deceleration across test minutes was consistently observable at Time 1 and Time 2.
Fampridine administration is associated with improved walking speed and endurance. Regardless of a treatment effect of fampridine, the previously identified, abnormal dynamic walking feature, i.e. the linear decline in walking speed, may represent a robust feature.
The dynamic walking feature might hence be considered as a candidate for a new outcome measure in clinical studies involving interventions other than symptomatic treatment, such as immune-modulating medication.
DRKS00009228 (German Clinical Trials Register). Date obtained: 25.08.2015.
步行能力受损是多发性硬化症(MS)患者常见的限制因素。患者受到协调能力、步行速度和行走距离的限制。此外,还报告了异常的动态步行模式,包括随着时间的推移持续减速。4-氨基吡啶(法吡拉定)是一种钾通道阻滞剂,可能改善MS患者的步行能力。本研究的目的是全面检查接受法吡拉定治疗的MS患者的动态步行特征和改善的步行能力。
35例MS患者(扩展残疾状态量表中位数:4)在接受法吡拉定治疗前(时间1)和治疗期间(时间2)进行了电子步行检查。患者在25英尺的距离上来回行走,最长时间为6分钟(6分钟25英尺步行)。除了行走的总距离外,在时间1和时间2的每个测试分钟分别确定25英尺距离和转弯处的平均速度。
在服用法吡拉定之前,27/35例患者(77%)能够完成整个6分钟的步行,而服药后,34/35例患者(97%)能够步行6分钟。在此背景下,步行距离显著增加,治疗与所有六个测试分钟内更快的步行和转弯相关(效应大小范围:偏 eta 平方 = 0.34 - 0.72)。重要的是,在时间1和时间2始终可以观察到先前报告的各测试分钟内的减速情况。
服用法吡拉定与步行速度和耐力的改善有关。无论法吡拉定的治疗效果如何,先前确定的异常动态步行特征,即步行速度的线性下降,可能是一个稳定的特征。
因此,在涉及除对症治疗以外的干预措施(如免疫调节药物)的临床研究中,动态步行特征可能被视为一种新的结局指标的候选指标。
DRKS00009228(德国临床试验注册)。获取日期:2015年8月25日。