Cervical Spine DestabilizationCervistabNCT03712514
Behavior of the Upper Cervical Spine in Rugby Players
A study testing Destabilization of the upper cervical spine by Cervistab in people with Cervical Spine Destabilization, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Rugby players are often exposed to destabilisation of the upper cervical spine.This kind of trauma may lead to dramatic injuries, due to lesion of spinal cord. CerviStab© is a device which evaluate the bio-mechanical and neuromuscular behavior of the upper cervical spine in rugby situation. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Spine Destabilization
- What is being tested?
- Destabilization of the upper cervical spine by Cervistab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteFrance
- Study dates
- 23 Feb 2017to 23 Sep 2021
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Rugby players at least since 5 years
- Amateurs or professionals players
- Able to play in rugby competition
Who cannot join
- Medical history of cervical spine injury requiring surgical intervention
- Active cervical symptomatology
- Medical history of migraine or epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dynamic Stabilization of the Upper Cervical Spine in a Cohort of Rugby's Players Via Ergometer (Cervistab©)
Rugby players are often exposed to destabilisation of the upper cervical spine.This kind of trauma may lead to dramatic injuries, due to lesion of spinal cord.
CerviStab© is a device which evaluate the bio-mechanical and neuromuscular behavior of the upper cervical spine in rugby situation.
The aim of this study, is to evaluate the dynamic stabilization of the upper cervical spine in reaction to unexpected impact.
- Conditions
- Cervical Spine Destabilization
- Being tested
- Destabilization of the upper cervical spine by Cervistab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Destabilization of the upper cervical spine by CervistabOther
Simulate a situation of destabilization of the cervical spine with Cervistab
| Study group | Role | What they receive |
|---|---|---|
| Rugby players | Other | Destabilization of the upper cervical spine with Cervistab Receives: Other: Destabilization of the upper cervical spine by Cervistab |
| Healthy non rugby players | Other | Destabilization of the upper cervical spine with Cervistab Receives: Other: Destabilization of the upper cervical spine by Cervistab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproducibility of head movement amplitude measurements on healthy volunteers
Measurement in millimetres by "Cervistab" ergometer
Measured: Week 1
Reproducibility of the measurement of mechanical resistance strength intensity produced by upper cervical spine muscles responding to destabilization on healthy volunteers
Measurement in decanewtons by "Cervistab" ergometer
Measured: Week 1
Reproducibility of time until appearance of mechanical resistance strength produced by upper cervical spine muscles responding to destabilization on healthy volunteers
Measurement in milliseconds by "Cervistab" ergometer
Measured: Week 1
Reproducibility of the time of response of upper cervical spine extensor muscles responding to destabilization on healthy volunteers
Measurement in milliseconds by "Cervistab" ergometer
Measured: Week 1
Reproducibility of the amplitude of the response of upper cervical spine extensor muscles responding to destabilization on healthy volunteers
Measurement in decanewtons by "Cervistab" ergometer
Measured: Week 1
Secondary outcomes (6)
Comparison of biomechanical behaviour of upper cervical spine dynamic stabilization capacities between healthy volunteers and rugby players
Measurement by "Cervistab" ergometer
Measured: Week 1
Comparison of neuromuscular behaviour of upper cervical spine dynamic stabilization capacities between healthy volunteers and rugby players
Measurement by "Cervistab" ergometer
Measured: Week 1
Comparison of biomechanical behaviour of upper cervical spine dynamic stabilization capacities between resting and acute fatigue situations in rugby players subjects
Measurement by "Cervistab" ergometer
Measured: Week 1
Comparison of neuromuscular behaviour of upper cervical spine dynamic stabilization capacities between resting and acute fatigue situations in rugby players subjects
Measurement by "Cervistab" ergometer
Measured: Week 1
Comparison of biomechanical behaviour of upper cervical spine dynamic stabilization capacities between male rugby players and female rugby players
Measurement by "Cervistab" ergometer
Measured: Week 1
Comparison of neuromuscular behaviour of upper cervical spine dynamic stabilization capacities between male rugby players and female rugby players
Measurement by "Cervistab" ergometer
Measured: Week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start23 Feb 2017
- Primary completion23 Sep 2021
- Study completion23 Sep 2021
Why it stopped: the inclusion period ended on 23/09/2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Spine DestabilizationStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712514
- Sponsor's protocol ID
- 9536
- Other IDs
- 2015-A00505-44
- Acronym
- Cervistab
- Status last verified
- Dec 2021
- First submitted
- 27 Apr 2018
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Stabilization of the Upper Cervical Spine in a Cohort of Rugby's Players Via Ergometer (Cervistab©)
- ClinicalTrials.gov ID
- NCT03712514
- Acronym / sponsor ID
- Cervistab / 9536
- Conditions
- Cervical Spine Destabilization
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the inclusion period ended on 23/09/2021
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 23 Feb 2017 (actual)
- Primary completion
- 23 Sep 2021 (actual)
- Study completion
- 23 Sep 2021 (actual)
- First posted
- 19 Oct 2018 (actual)
- 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.
Rugby players are often exposed to destabilisation of the upper cervical spine.This kind of trauma may lead to dramatic injuries, due to lesion of spinal cord.
CerviStab© is a device which evaluate the bio-mechanical and neuromuscular behavior of the upper cervical spine in rugby situation.
The aim of this study, is to evaluate the dynamic stabilization of the upper cervical spine in reaction to unexpected impact.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rugby players | Other | Other: Destabilization of the upper cervical spine by CervistabDestabilization of the upper cervical spine with Cervistab |
| Healthy non rugby players | Other | Other: Destabilization of the upper cervical spine by CervistabDestabilization of the upper cervical spine with Cervistab |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Rugby players at least since 5 years
- Amateurs or professionals players
- Able to play in rugby competition
Key exclusion criteria (3 listed)
- Medical history of cervical spine injury requiring surgical intervention
- Active cervical symptomatology
- Medical history of migraine or epilepsy
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 |
|---|---|---|
| Destabilization of the upper cervical spine by CervistabSimulate a situation of destabilization of the cervical spine with Cervistab | Other | Healthy non rugby players, Rugby players |
Primary outcome
Reproducibility of head movement amplitude measurements on healthy volunteers
Time frame: Week 1
Measurement in millimetres by "Cervistab" ergometer
Reproducibility of the measurement of mechanical resistance strength intensity produced by upper cervical spine muscles responding to destabilization on healthy volunteers
Time frame: Week 1
Measurement in decanewtons by "Cervistab" ergometer
Reproducibility of time until appearance of mechanical resistance strength produced by upper cervical spine muscles responding to destabilization on healthy volunteers
Time frame: Week 1
Measurement in milliseconds by "Cervistab" ergometer
Reproducibility of the time of response of upper cervical spine extensor muscles responding to destabilization on healthy volunteers
Time frame: Week 1
Measurement in milliseconds by "Cervistab" ergometer
Reproducibility of the amplitude of the response of upper cervical spine extensor muscles responding to destabilization on healthy volunteers
Time frame: Week 1
Measurement in decanewtons by "Cervistab" ergometer
6 secondary outcomes
Comparison of biomechanical behaviour of upper cervical spine dynamic stabilization capacities between healthy volunteers and rugby players
Time frame: Week 1
Comparison of neuromuscular behaviour of upper cervical spine dynamic stabilization capacities between healthy volunteers and rugby players
Time frame: Week 1
Comparison of biomechanical behaviour of upper cervical spine dynamic stabilization capacities between resting and acute fatigue situations in rugby players subjects
Time frame: Week 1
Comparison of neuromuscular behaviour of upper cervical spine dynamic stabilization capacities between resting and acute fatigue situations in rugby players subjects
Time frame: Week 1
Comparison of biomechanical behaviour of upper cervical spine dynamic stabilization capacities between male rugby players and female rugby players
Time frame: Week 1
Comparison of neuromuscular behaviour of upper cervical spine dynamic stabilization capacities between male rugby players and female rugby players
Time frame: Week 1
Results and safety
The study was stopped early (reason given: the inclusion period ended on 23/09/2021). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: No
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 Destabilization of the upper cervical spine by Cervistab in people with Cervical Spine Destabilization, run by University Hospital, Montpellier at 1 site in France.
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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 30 Sep 2025. 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 France. 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 was stopped early (reason given: the inclusion period ended on 23/09/2021). Results are not available in the source record.
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?
Reproducibility of head movement amplitude measurements on healthy volunteers (time frame: Week 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2025.