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

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ClinicalTrials.gov Identifier: NCT02716389
Recruitment Status : Completed
First Posted : March 23, 2016
Last Update Posted : April 19, 2016
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Dr. Winfried Banzer, Goethe University

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.


Condition or disease Intervention/treatment Phase
Kinematics Reliability Cervical Other: Zebris CMS 70 Other: 3-D Bulls Eye Spirit Meter Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : March 2016
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Arm Intervention/treatment
Mask on Other: Zebris CMS 70
Other: 3-D Bulls Eye Spirit Meter
Mask off Other: Zebris CMS 70
Other: 3-D Bulls Eye Spirit Meter



Primary Outcome Measures :
  1. Maximal cervical range of motion in flexion/extension [ Time Frame: 2 min. ]

Secondary Outcome Measures :
  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. ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02716389


Locations
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Germany
Department of Sports Medicine, Goethe University Frankfurt/Main
Frankfurt am Main, Hessen, Germany, 60487
Sponsors and Collaborators
Goethe University

Publications:
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Responsible Party: Prof. Dr. Dr. Winfried Banzer, Head of Department, Goethe University
ClinicalTrials.gov Identifier: NCT02716389     History of Changes
Other Study ID Numbers: SpM2016-001
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: April 2016