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临床试验/NCT04191759
NCT04191759已完成不适用

Reliability of the Passive Properties of the Calf Muscles in Healthy Subjects Assessed Using Isokinetic Device

University Hospital, Caen2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2018年6月12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
16
试验地点
2
主要终点
Change from Baseline stiffness parameters at 15 days to assess the reproducibility of stiffness parameters

研究概览

简要总结

The investigators designed this study to determine the test-retest reliability of the viscoelastic passive properties of the calf muscles assessed using isokinetic device in flexed and extended knee position. The second objective is to determine the clinical viability of the parameters using the coefficient of repeatability and to investigate the individual characteristics associated with increased calf stiffness or altered viscoelasticity

详细描述

Recordings using an isokinetic dynamometer make it possible to quantify the resisting force during passive muscle stretch for a constant speed movement in dorsal flexion (flexion) and its release in plantar flexion (extension). The surface electromyography (EMG) makes it possible to measure voluntary contraction and the movement is considered passive if the corrected and normalized EMG signal, using root-mean-square (RMS), is less than 10% RMS during the Maximal Voluntary Muscle Contraction (MVMC).

Stiffness is calculated from the slope of the rise of the curve during the passive dorsiflexion phase of the joint. The elastic potential energy can be measured and corresponds to the area under the curve during elongation.

During the plantar flexion return phase, there is a hysteresis phenomenon resulting in behavior that differs from the curve. This difference between the two curves corresponds to the behavior related to viscoelastic relaxation. Viscoelasticity has a thixotropic behavior, i.e. it varies over time, for example, with heating. These parameters have been studied together or separately to evaluate the effect of age or stretching on the passive mechanical properties of the calf.

However, the test-retest reliability of the viscoelastic passive properties of the calf muscles assessed using isokinetic device has not been demonstrated.

The investigators designed this study to determine the test-retest reliability of the viscoelastic passive properties of the calf muscles assessed using isokinetic device in flexed and extended knee position. The second objective is to determine the clinical viability of the parameters using the coefficient of repeatability and to investigate the individual characteristics associated with increased calf stiffness or altered viscoelasticity

研究设计

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

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patient who signed the research information form
  • Patient affiliated to a social security system
  • An active patient, under 45 years of age, who participates in at least 4 hours of physical activity per week

排除标准

  • Individuals unable to perform an isokinetic muscle testing
  • Individuals with a current or recent lower limb injury with time loss from sport participation within the previous month.

结局指标

主要结局

Change from Baseline stiffness parameters at 15 days to assess the reproducibility of stiffness parameters

时间窗: Two evaluations on both dominant and non dominant knees: one evaluation at the first visit, and a second evaluation at the second visit at 15 days after the first visit

Change from Baseline stiffness parameters at 15 days, measurement of passive peak torque at 0 and 10° and slope of curve during the passive ankle flexion using an isokinetic device

Change from Baseline viscoelastic parameters at 15 days to assess the reproducibility of viscoelastic parameters

时间窗: Two evaluations on both dominant and non dominant knees: one evaluation at the first visit, and a second evaluation at the second visit at 15 days after the first visit

Change from Baseline viscoelasticity parameters at 15 days, measurement of hysterisis (AUC release/AUC storage) during the passive ankle flexion/extension using an isokinetic device

次要结局

  • Patient characteristics(One evaluation only, at the first visit after inclusion)
  • Physical characteristics, popliteal angle(One evaluation only, at the first visit after inclusion)
  • Physical characteristics, Calf Circumference(One evaluationsonly, at the first visit after inclusion (T1))
  • Physical characteristics, ROM(One evaluation only, at the first visit after inclusion)
  • Physical characteristics, Fingertip-to-Floor (FTF) Test(One evaluation only, at the first visit after inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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