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临床试验/NCT03183856
NCT03183856已完成不适用

Comparison of Clinical Efficacy and Safety for Ambulatory and Functional Improvement in Patients After Total Knee Arthroplasty With Morning Walk

Ulsan University Hospital1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2017年9月15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
入组人数
9
试验地点
1
主要终点
Change of WOMAC index

研究概览

简要总结

The aim of this study is to determine the clinical efficacy and feasability of gait rehabilitation robot through approving functional improvement by an end-effector typed gait robot in patients underwent total knee arthroplasty.

详细描述

pre-interventional evaluation; within 1 day of initiation of the intervention; 5 days after initiation of the intervention; 10 days after intervention after initiation of the intervention; 42 days after intervention start

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Patients underwent Unilateral or both Total Knee Arthroplasty

排除标准

  • •brain disease, spinal cord injury, peripheral neuropathy, myopathy
  • •Inability to ambulate fully due to muscukoskeletal disorders
  • •history of arthroplasty surgery on either of legs
  • •Cardiac pacemaker
  • •Refusal of participation

研究组 & 干预措施

Morning walk

Experimental

200 steps of gait rehabilitation using an end-effector typed gait robot with 5 minute break, 3 times a day for 10 weekdays: the end-effector type gait robot (Morning Walk®, Hyundai Heavy Industry, Republic of Korea)

干预措施: Morning walk (Device)

No Morning walk

Active Comparator

200 steps by themselves or with a help of a walker on a even floor at a comfortable pace with 5 minute break, three times a day for 10 weekdays

干预措施: no Morning walk (Other)

结局指标

主要结局

Change of WOMAC index

时间窗: 1 day before the initiation of intervention), 5 day, 10 day, and 31 days after the initiation of intervention

Western Ontario and McMaster Universities Osteoarthritis Index

次要结局

  • Change of VAS(1 day before the initiation of intervention), 5 day, 10 day, and 31 days after the initiation of intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chang Ho Hwang

PhD and MD

Ulsan University Hospital

研究点 (1)

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