KinematicsNCT02716389
Cervical Kinematics' Reliability: Zero Positioning Using a 3-D-bulls Eye Spirit Level
A study testing Zebris CMS 70 and 3-D Bulls Eye Spirit Meter in people with Kinematics and Reliability, run by Goethe University at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Kinematics, Reliability, Cervical
- What is being tested?
- Zebris CMS 70 and 3-D Bulls Eye Spirit Meter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2016to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subscribing informed consent
- Healthy
Who cannot join
- Severe orthopedic, cardiovascular, neurological, psychiatric or endocrine diseases
- Not completely healed traumata
- Drug intake in the past 48 hours
- Pregnancy
- Muscle soreness
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Sports Medicine, Goethe University Frankfurt/Main
Frankfurt am Main, Hesse, 60487
About this study
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
- Being tested
- Zebris CMS 70, 3-D Bulls Eye Spirit Meter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zebris CMS 70Other
3-D Bulls Eye Spirit MeterOther
| Study group | Role | What they receive |
|---|---|---|
| Mask on | Other | Not described Receives: Other: Zebris CMS 70; Other: 3-D Bulls Eye Spirit Meter |
| Mask off | Other | Not described Receives: Other: Zebris CMS 70; Other: 3-D Bulls Eye Spirit Meter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal cervical range of motion in flexion/extension
Measured: 2 min.
Secondary outcomes (2)
Maximal cervical range of motion in lateral flexion
Measured: 2 min.
Maximal cervical range of motion in rotation
Measured: 2 min.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for KinematicsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Dr. Winfried Banzer, Goethe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02716389
- Sponsor's protocol ID
- SpM2016-001
- Status last verified
- Apr 2016
- First submitted
- 4 Mar 2016
- Last updated
- 19 Apr 2016
- Results posted
- No
Publications
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.
PubMed 17693335
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Kinematics' Reliability: Zero Positioning Using a 3-D-bulls Eye Spirit Level
- ClinicalTrials.gov ID
- NCT02716389
- Acronym / sponsor ID
- SpM2016-001
- Conditions
- Kinematics, Reliability, Cervical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 23 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subscribing informed consent
- Healthy
Key exclusion criteria (5 listed)
- Severe orthopedic, cardiovascular, neurological, psychiatric or endocrine diseases
- Not completely healed traumata
- Drug intake in the past 48 hours
- Pregnancy
- Muscle soreness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zebris CMS 70 | Other | Mask off, Mask on |
| 3-D Bulls Eye Spirit Meter | Other | Mask off, Mask on |
Primary outcome
Maximal cervical range of motion in flexion/extension
Time frame: 2 min.
2 secondary outcomes
Maximal cervical range of motion in lateral flexion
Time frame: 2 min.
Maximal cervical range of motion in rotation
Time frame: 2 min.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2016.
- Background: PubMed 17693335Cagnie 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zebris CMS 70 and 3-D Bulls Eye Spirit Meter in people with Kinematics and Reliability, run by Goethe University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal cervical range of motion in flexion/extension (time frame: 2 min.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02716389, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2016.