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临床试验/NCT03767205
NCT03767205已完成不适用

The Effect of a Ankle Assist Robot on Gait Function and Cardiopulmonary Metabolic Efficiency in Stroke Patients

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2018年12月17日最近更新:
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适应症

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
1
主要终点
Change on gait speed in different three conditions
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The aim of this study was to identify the assistance effect of Ankle Assist Robot v1 developed by Samsung Advanced Institute of Technology (Samsung Electronics Co, Ltd., Korea) by comparing

  1. gait function during overground gait in three conditions (with robot-assist torque on/with robot-assist torque off/without robot)
  2. the energy expenditure during treadmill gait in three conditions (with robot-assist torque on/with robot-assist torque off/without robot)

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
19 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Stroke patients with hemiplegia over 19 years old
  • •Ischemic or hemorrhagic stroke patients over 3 months of onset
  • •Functional Ambulation Category Scale with 3 or more scales

排除标准

  • •Stroke patients who have difficulty in walking independently regardless of assistive devices due to problems such as visual field defects or fractures
  • •Stroke patients with walking difficulty due to serious cognitive problems
  • •Patients with a foot size of 230 mm or less or a stroke of 280 mm or more that are not suitable for wearing ankle assist robot
  • •Stroke patients at risk of falling when walking with severe dizziness
  • •Modified ashworth scale (MAS) Stroke patients over 3
  • •Pregnant woman
  • •People with mental illness and psychiatric medication

结局指标

主要结局

Change on gait speed in different three conditions

时间窗: 20minutes

All participants perform overground walking in different three conditions (with robot-torque on/with robot-torque off/without robot) to assess the change of gait speed using a motion analysis.

次要结局

  • Change on gait function in different three conditions (kinetic)(20minutes)
  • Change on metabolic energy expenditure in different three conditions(1 hour)
  • Change on gait function in different three conditions (muscle activation)(20minutes)
  • Change on gait function in different three conditions (kinematic)(20minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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The Effect of a Ankle Assist Robot on Gait Function... | 临床试验