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Completed

NCT Number: NCT02716389

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Sports Medicine, Goethe University Frankfurt/Main

Frankfurt am Main, Hesse, 60487, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subscribing informed consent
  • Healthy

Exclusion criteria

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

Treatment and study plan

Zebris CMS 70

Other

3-D Bulls Eye Spirit Meter

Other

Primary outcomes

  1. Maximal cervical range of motion in flexion/extension

    Time frame: 2 min.

Secondary outcomes

  1. Maximal cervical range of motion in lateral flexion

    Time frame: 2 min.

  2. Maximal cervical range of motion in rotation

    Time frame: 2 min.

Sponsors and collaborators

Lead sponsor

Goethe University

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 23, 2016
Registry last updated
Apr 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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