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临床试验/NCT03321357
NCT03321357已完成不适用

Test-retest-reliability and At-home-assessment Feasibility of the Five-repetition Sit-to-stand Test (5R-STS)

Bergman Clinics1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年12月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
5R-STS

研究概览

简要总结

The five-repetition sit-to-stand test has been validated and is used primarily in pulmonary medicine and cardiology, and has recently been shown to be a useful tool for the objective assessment of functional impairment in patients with degenerative diseases of the lumbar spine.

The goal of this study is to assess the possibility of supervised and unsupervised at-home-assessment. Validation of at-home-assessment would allow the 5R-STS to be easily used as a follow-up tool in clinical trials, for example.

详细描述

Patients will perform three 5R-STS measurements:

  1. During outpatient clinics, time measured by the physician
  2. At home, time measured by partner/family
  3. At home, and assessed by producing a video recording of the 5R-STS performance that is subsequently sent and analyzed (time measured digitally)

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Degenerative diseases of the lumbar spine (Herniated disc, lumbar stenosis, spondylolisthesis, degenerative disc disease)
  • Symptoms of lower back pain, neurogenic claudication, or radiculopathy

排除标准

  • Hip or Knee prosthetics
  • Walking aides

结局指标

主要结局

5R-STS

时间窗: 0 months

Objective functional test measuring the amount of functional impairment.

次要结局

  • VAS leg pain severity(0 months)
  • Oswestry Disability Index(0 months)
  • EQ-5D-3L(0 months)
  • VAS back pain severity(0 months)
  • Roland Morris Disability Questionnaire(0 months)

研究者

发起方
Bergman Clinics
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marc Schröder

MD, PhD

Bergman Clinics

研究点 (1)

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