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

Reliability Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02716389
• Other study ID #: SpM2016-001
• Status: Completed
• Phase: N/A
• First received: March 4, 2016
• Last updated: April 18, 2016
• Start date: March 2016
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Goethe University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cervical
• Kinematics
• Reliability

Intervention

Other:
• Zebris CMS 70

• 3-D Bulls Eye Spirit Meter

Locations

Country	Name	City	State
Germany	Department of Sports Medicine, Goethe University Frankfurt/Main	Frankfurt am Main	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Goethe University

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Cagnie B, Cools A, De Loose V, Cambier D, Danneels L. Reliability and normative database of the Zebris cervical range-of-motion system in healthy controls with preliminary validation in a group of patients with neck pain. J Manipulative Physiol Ther. 2007 Jul-Aug;30(6):450-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal cervical range of motion in flexion/extension		2 min.	No
Secondary	Maximal cervical range of motion in lateral flexion		2 min.	No
Secondary	Maximal cervical range of motion in rotation		2 min.	No