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Behavior of the Upper Cervical Spine in Rugby Players (Cervistab)

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ClinicalTrials.gov Identifier: NCT03712514
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief 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.

The aim of this study, is to evaluate the dynamic stabilization of the upper cervical spine in reaction to unexpected impact.


Condition or disease Intervention/treatment Phase
Cervical Spine Destabilization Other: Destabilization of the upper cervical spine by Cervistab Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Dynamic Stabilization of the Upper Cervical Spine in a Cohort of Rugby's Players Via Ergometer (Cervistab©)
Actual Study Start Date : February 23, 2017
Estimated Primary Completion Date : February 23, 2021
Estimated Study Completion Date : February 23, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Male rugby players
Destabilization of the upper cervical spine with Cervistab
Other: Destabilization of the upper cervical spine by Cervistab
Simulate a situation of destabilization of the cervical spine with Cervistab

Healthy males non rugby players
Destabilization of the upper cervical spine with Cervistab
Other: Destabilization of the upper cervical spine by Cervistab
Simulate a situation of destabilization of the cervical spine with Cervistab




Primary Outcome Measures :
  1. Reproducibility of head movement amplitude measurements on healthy volunteers [ Time Frame: Week 1 ]
    Measurement in millimetres by "Cervistab" ergometer

  2. 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

  3. 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

  4. 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

  5. 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


Secondary Outcome Measures :
  1. Comparison of biomechanical behaviour of upper cervical spine dynamic stabilization capacities between healthy volunteers and rugby players [ Time Frame: Week 1 ]
    Measurement by "Cervistab" ergometer

  2. Comparison of neuromuscular behaviour of upper cervical spine dynamic stabilization capacities between healthy volunteers and rugby players [ Time Frame: Week 1 ]
    Measurement by "Cervistab" ergometer

  3. 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 ]
    Measurement by "Cervistab" ergometer

  4. 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 ]
    Measurement by "Cervistab" ergometer



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Rugby players at least since 5 years
  • Amateurs or professionals players
  • Able to play in rugby competition

Exclusion Criteria:

  • Medical history of cervical spine injury requiring surgical intervention
  • Active cervical symptomatology
  • Medical history of migraine or epilepsy

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): NCT03712514


Contacts
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Contact: Marc Julia, MD, PhD 0467330565 ext 33 m-julia@chu-montpellier.fr

Locations
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France
Montpellier university Hospital Recruiting
Montpellier, France, 34090
Contact: Marc Julia, MD, PhD       m-julia@chu-montpellier.fr   
Principal Investigator: Marc Julia, MD, PhD         
Sponsors and Collaborators
University Hospital, Montpellier

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03712514     History of Changes
Other Study ID Numbers: UF 9536
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No