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临床试验/NCT02716389
NCT02716389已完成不适用

Cervical Kinematics' Reliability: Zero Positioning Using a 3-D-bulls Eye Spirit Level

Goethe University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年3月1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
20
试验地点
2
主要终点
Maximal cervical range of motion in flexion/extension

研究概览

简要总结

The measurement of cervical spine range of motion (ROM) figures among the most common aspects of clinical diagnosis. Good reliability has been demonstrated for assessments using ultrasonic movement analysis systems, such as Zebris CMS 70 (Isny, Germany). However, in contrast to combined measurements of movement amplitudes (e.g., flexion plus extension in the sagittal plane), separating the respective components provides less reliable results. Current research suggest that this is due to the participants' determination of the zero position. This position is influenced by possible disposed treatments and, in particular, by the subject in case of subjective determination. The present study therefore aims to examine the test-retest reliability of separate ROM assessments using a bulls eye spirit meter.

Twenty healthy participants will be included in the trial that adopts a two-armed randomized, crossover design. With a washout-period of one week in between, each subject participates in two sessions in a randomised order. In both sessions, cervical ROM (flexion/extension, rotation, lateral flexion) will be measured twice (with a five-minute wait period). In all measurements, the zero position will be determined by means of a bulls eye spirit level. The difference of the two sessions consists in the design of the waiting period. In one session, the subjects will keep the mask carrying the ultrasound markers on their head. In the other session, the mask will be removed during the break.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subscribing informed consent

排除标准

  • Severe orthopedic, cardiovascular, neurological, psychiatric or endocrine diseases
  • Not completely healed traumata
  • Drug intake in the past 48 hours
  • Pregnancy
  • Muscle soreness

结局指标

主要结局

Maximal cervical range of motion in flexion/extension

时间窗: 2 min.

次要结局

  • Maximal cervical range of motion in lateral flexion(2 min.)
  • Maximal cervical range of motion in rotation(2 min.)

研究者

发起方
Goethe University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. Dr. Winfried Banzer

Head of Department

Goethe University

研究点 (2)

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