The Andago for overground gait training in patients with gait disorders after stroke - results from a usability study

D. Marks, R. Schweinfurther, A. Dewor, T. Huster, Liliana P Paredes, D. Zutter, Jens C Möller
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引用次数: 9

Abstract

Background: Mobility training is an important goal of rehabilitation. The Andago is a recently developed device allowing body weight supported overground mobility training. Objective: The aim of this study was to evaluate the usability of the prototype Andago V2.0 and its acceptance by patients and therapists. Methods: The trial was designed as an exploratory study without control group. Patients were recruited from inpatients training on the Lokomat. The Andago was first tested in a training session to familiarize the participants with the device. The following therapy session included a course predefined by our infrastructure. Therapists/ patients rated handling, usability and satisfaction. Results: Fifteen patients were eligible and gave informed consent. Two patients were excluded due to protocol violation. Patient characteristics: age 58, NIHSS 8.3, FAC 1.3 (all mean), male 8, days since stroke onset 65 (median). All sessions were performed safely. No Adverse Events (AE) or Adverse Device Effects (ADE) occurred. Patients reported feeling safe. Therapists had to steer accurately, e.g., while passing through doors or turning. Hemianopia and/or neglect frequently led to interruptions of the Andago sessions. Conclusions: Most of the patients appreciated the device. This study shows, that Andago can be used safely under therapeutic supervision for overground gait training in stroke patients presenting moderate to severe gait disorders. Trial registration: The study was registered under ClinicalTrials.gov (Identifier: NCT02735460) and in the Swiss National Clinical Trials Portal. *Correspondence to: Detlef Marks, Rehaklinik Zihlschlacht Hauptstr. 2-4 CH-8588 Zihlschlacht, Switzerland, Tel: +41-71-424-3751; E-mail: d.marks@ rehaklinik-zihlschlacht.ch
Andago用于中风后步态障碍患者的地面步态训练-来自一项可用性研究的结果
背景:活动能力训练是康复治疗的重要目标。Andago是最近开发的一种设备,允许体重支持地面移动训练。目的:本研究的目的是评估原型Andago V2.0的可用性及其患者和治疗师的接受程度。方法:采用探索性研究,不设对照组。患者是从接受Lokomat培训的住院患者中招募的。Andago首先在培训课程中进行测试,以使参与者熟悉该设备。接下来的治疗包括我们的基础设施预先定义的课程。治疗师/患者对处理、可用性和满意度进行了评分。结果:15例患者符合条件并给予知情同意。2例患者因违反方案而被排除。患者特征:年龄58岁,NIHSS 8.3, FAC 1.3(所有平均值),男性8,卒中发生后天数65天(中位数)。所有的会话都安全进行。无不良事件(AE)或不良设备效应(ADE)发生。患者报告感觉安全。治疗师必须准确地驾驶,例如,在通过门或转弯时。偏视和/或忽视经常导致安达戈会议的中断。结论:大多数患者对该装置表示赞赏。这项研究表明,Andago可以在治疗监督下安全地用于出现中度至重度步态障碍的脑卒中患者的地上步态训练。试验注册:该研究在ClinicalTrials.gov(标识符:NCT02735460)和瑞士国家临床试验门户网站注册。*通信:Detlef Marks, Rehaklinik Zihlschlacht Hauptstr. 2-4 CH-8588 Zihlschlacht,瑞士,电话:+41-71-424-3751;电子邮件:d.marks@ rehaklinik-zihlschlacht.ch
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