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临床试验/NCT04086069
NCT04086069撤回不适用

Effect of Sit-to-stand Trainer in Patients With Unilateral Lower Limb Amputation on the Ability of Independent Standing up

University Rehabilitation Institute, Republic of Slovenia2 个研究点 分布在 1 个国家开始时间: 2019年2月6日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Change in 30-Second Chair Stand Test

研究概览

简要总结

The study will include rehabilitation inpatients after unilateral lower limb amputation who are candidates for walking with a prosthesis. Those in the experimental group will receive training using a sit-to-stand trainer device in addition to standard training of standing-up with the help of a physiotherapist. Those in the control group will only receive the standard training. The effects of the rehabilitation programme will be assessed using the 30-Second Chair Stand Test before the start of the training and after 10 days of training. For the first five patients from each group who will be able to stand up with the use of hands, detailed kinesiological analysis of standing-up pattern will be performed.

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
None

入排标准

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

入选标准

  • unilateral lower-limb amputation
  • candidate for walking with a prosthesis
  • Montreal Cognitive Assessment (MoCA) test score 26 or more

排除标准

  • associated neurological or orthopaedic disease
  • amputation caused by cancer or injury
  • BMI below 18.5 or above 30

结局指标

主要结局

Change in 30-Second Chair Stand Test

时间窗: Change from day 0 to day 10

The test measures the number of times the participant is able to stand and return to a seated position in a chair in 30 seconds.

次要结局

  • Standing-up pattern(On day 10 after the last training session)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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