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临床试验/NCT04555759
NCT04555759已完成不适用

Validity and Reliability of the 2-minute Walk Test in Individuals With a Spinal Cord Injury

University of Zurich4 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年1月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
4
主要终点
2-minute walk test (meters an individual walks in 2 minutes)

研究概览

简要总结

There exist a variety of outcome measures to asses gait function in individuals with a spinal cord injury (SCI). The most established measures are the 10-meter walk test (10MWT) and the 6-minute walk test (6mWT). They are used to assess treatment efficacy and recovery of gait function in individuals with SCI. However, the 10MWT is appropriate for poor walkers but not sensitive in good walkers and the 6mWT can be time-consuming and is very demanding for severely impaired patients. Therefore the 2-minute walk test (2mWT) has gained more attention in the SCI field. The 2mWT has been established in numerous neurological diseases and has shown to correlate with the 6mWT in patients with neuromuscular disease, multiple sclerosis and stroke. Though the 2mWT has not yet been validated in individuals with SCI.

A limitation that affects all timed walking tests is that they suffer from limited information about gait quality (i.e. how walking function is achieved). Being able to receive information on the gait quality of a patient can help to understand the underlying mechanisms of walking improvements after an intervention (e.g. compensation vs recovery). The research in the field of inertia measuring units (IMU) develops and advances very rapidly at the moment resulting in the possibility to perform a gait analysis with a simple IMU setup. However, the reliability of such measurement setups has not yet been shown in individuals with SCI.

The primary aim of this study is to test the validity and reliability of the 2mWT in the SCI population.

Additionally, it will be investigated if a simple sensor setup can give additional reliable information about the gait pattern of individuals with SCI.

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

入选标准

  • Participants fulfilling all of the following inclusion criteria are eligible for the study:
  • Informed Consent as documented by signature (Appendix Informed Consent Form)
  • At least 18 years old
  • Spinal cord injury
  • Able to walk with a speed of at least 0.17m/s with or without walking devices and or bracing

排除标准

  • Current orthopaedic problems of lower limbs
  • History of severe cardiac condition
  • Premorbid major depression or psychosis
  • Unlikely to complete the intervention or return for second visit
  • Enrolment of the investigator, his/her family members, employees and other dependent persons

结局指标

主要结局

2-minute walk test (meters an individual walks in 2 minutes)

时间窗: 1-7 days

次要结局

  • Inertia Measuring Unit data(1-7 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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