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临床试验/NCT03787199
NCT03787199已完成不适用

Feasibility of the Overground Bodyweight Supporting Walking System Andago

University Children's Hospital, Zurich2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年5月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Stride to stride variability

研究概览

简要总结

The overall aim of this project is to investigate the clinical utility of the Andago System, a CE certified mobile bodyweight supporting walking robot, in children with neuromotor disorders. Clinical utility encompasses practicability, acceptability, appropriateness, and accessibility. In this study, the investigators would like to investigate several aspects of clinical utility that belong to the first three components.

详细描述

The specific aims of the current project are:

  1. To investigate the practicability, the investigators plan to determine the accuracy of the weight-supporting system of the Andago and the time needed for donning and doffing. The investigators also evaluate the number of times that the device stops and the nature of these stops (due to errors, sitting of the patient, when preventing falls, or when the patient moves too fast).
  2. To evaluate acceptability, the investigators plan to evaluate differences in motivation and measures reflecting safety (i.e. number of falls prevented) and subjective feeling of safety when patients walk with the Andago compared to walking with their usual walking aids.
  3. To evaluate the appropriateness, the investigators are interested in differences between walking on a treadmill and walking overground with this device or changes that occur during walking overground when changing the level of BWS through the unloading system. Therapists should be aware of these differences to know what the advantage of such a system could be or how adjustments in settings influence the walking pattern. The investigators plan two investigations: (a) To determine differences in stride-to-stride variability, leg muscle activation, hip, knee and ankle joint kinematics and other gait parameters during walking in the Andago (overground) versus walking on a treadmill. (b) To determine differences in the same parameters when walking in the Andago with different levels of BWS. These levels are the minimal required level of BWS to walk without buckling the knees (ref BWS), ref BWS plus 15% and ref BWS plus 30%.

To investigate these aims, the patients will be asked to participate in 3 appointments, which should be scheduled within 10 days.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Neuromotor or orthopaedic disorders
  • taller than 135 cm
  • able to understand simple instructions
  • able to walk 10 meters with or without walking aid
  • maximal age of 18 years (a minimal age is not defined as according to the growth curve, children younger than 7-8 years cannot be included because of insufficient height)
  • given informed consent.

排除标准

  • not consolidated fractures or bone fragility of the lower extremities
  • skin lesions in the harness' area which cannot be protected
  • unstable hip, knee and/or ankle Joints
  • reduced head control or inability to maintain an upright Position
  • inability to communicate discomfort or pain
  • surgery in the last 3 months
  • newly implanted baclofen-pump (or children highly sensitive to it)
  • implanted pacemakers
  • passive knee extension deficit > 30°
  • self-selected walking speed > 3.2 km/h.
  • weight > 135 kg
  • height > 2 m.

研究组 & 干预措施

Andago

Experimental

Application of walking over-ground with body-weight support in the Andago

干预措施: Andago (Device)

Treadmill

Active Comparator

Application of walking on a treadmill with body-weight support

干预措施: Treadmill (Other)

结局指标

主要结局

Stride to stride variability

时间窗: Appointment 3 (between minute 25 and minute 55 )

Variability in stride length recorded during at least 20 steps for each of the following conditions: Andago with reference bodyweight support; Andago with 15% more bodyweight support; Andago with 30% more bodyweight support; and treadmill condition with reference bodyweight support

次要结局

  • Leg muscle activity(Appointment 3 (between minute 25 and minute 55 ))
  • Leg joint angles(Appointment 3 (between minute 25 and minute 55))

研究者

发起方
University Children's Hospital, Zurich
申办方类型
Other
责任方
Sponsor

研究点 (2)

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