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

NCT02716389 | Completed

• 1 other identifier: SpM2016-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kinematics; Reliability; Cervical

Outcome Measures

Primary Outcomes (1)

• Maximal cervical range of motion in flexion/extension

  2 min.

Secondary Outcomes (2)

• Maximal cervical range of motion in lateral flexion

  2 min.

• Maximal cervical range of motion in rotation

  2 min.

Study Arms (2)

Mask on

OTHER

Other: Zebris CMS 70; Other: 3-D Bulls Eye Spirit Meter

Mask off

OTHER

Other: Zebris CMS 70; Other: 3-D Bulls Eye Spirit Meter

Interventions

Zebris CMS 70 OTHER

Mask off; Mask on

3-D Bulls Eye Spirit Meter OTHER

Mask off; Mask on

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subscribing informed consent
• Healthy

You may not qualify if:

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

Sponsors & Collaborators

• Goethe University: lead

Study Sites (1)

Department of Sports Medicine, Goethe University Frankfurt/Main

Frankfurt am Main, Hesse, 60487, Germany

Location

Related 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. doi: 10.1016/j.jmpt.2007.05.003.

  PMID: 17693335 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department

Study Record Dates

• First Submitted: March 4, 2016
• First Posted: March 23, 2016
• Study Start: March 1, 2016
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: April 19, 2016

Record last verified: 2016-04

Locations

DE (1)