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临床试验/NCT06330129
NCT06330129已完成不适用

Validity and Reliability of Trunk Muscle Strength Assessements With Isometric Dynamometry

Schulthess Klinik2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年11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
30
试验地点
2
主要终点
maximal isometric trunk muscle strength

研究概览

简要总结

The study aims to evaluate the accuracy and consistency of assessing trunk muscle strength using an isometric device (Pegasus, Leipzig, Germany). Thirty healthy volunteers will undergo maximal isometric strength testing with the device, repeated one week later to assess repeatability. Surface electrodes will measure muscle activation, while MRI scans will assess structural condition.

详细描述

The aim of the study is to assess the validity and repeatability of trunk muscle strength evaluation using an isometric device (Pegasus, Leipzig, Germany) and to investigate it. Thirty healthy volunteer participants will undergo testing of maximal isometric (non-moving) strength using this device. The same strength measurement procedure will be repeated one week later for all participants to determine if the measurements are repeatable, i.e., if the device is capable of providing similar strength data in two closely timed measurements. To assess whether the device actually provides reliable strength data for the trunk muscles, surface electrodes will be additionally placed on the involved muscles to understand the extent of neural activation of these muscles during the test. Additionally, an MRI examination will be conducted for all study participants to assess the structural condition of the trunk muscles.

研究设计

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

入排标准

年龄范围
18 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • both male and female subjects
  • age between 18 and 59 years
  • BMI < 30 kg/m2
  • cognitively intact (self-reported)
  • autonomous walking

排除标准

  • age under 18 years or over 60 years
  • any prior spinal surgery or other musculoskeletal surgery having an impact on movement
  • acute or chronic back pain in the last 6 months(self-reported)
  • pregnancy (self-reported)
  • inability to perform the planned set of activities included in the study (e.g. maximal voluntary contraction torque test)
  • inability to give consent

研究组 & 干预措施

Healthy subjects

Experimental

30 healthy subjects undergo trunk muscle strength assessement using the Pegasus device, with repeated measurements to evaluate repeatability and correlation with both surface electromyography (EMG) and MRI scans of trunk muscles.

干预措施: CTT Pegasus (Device)

结局指标

主要结局

maximal isometric trunk muscle strength

时间窗: 1 hour

The computer-assisted test and trainig device (CTT) PEGASUS provides data on back muscle strength in isometric conditions, which constitutes the main endpoint of the present project.

次要结局

  • Electromyography (EMG) activity(1hour)
  • MRI muscle morphology(0.5-1hour)

研究者

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

Jacopo Vitale

Principal Investigator

Schulthess Klinik

研究点 (2)

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