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

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.

Study Overview

• Status: Terminated
• Conditions: Cervical Spine Destabilization
• Intervention / Treatment: Other: Destabilization of the upper cervical spine by Cervistab

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34090
    • Montpellier University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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
Other: Healthy 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reproducibility of head movement amplitude measurements on healthy volunteers	Measurement in millimetres by "Cervistab" ergometer	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	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	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	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	Week 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of biomechanical behaviour of upper cervical spine dynamic stabilization capacities between healthy volunteers and rugby players	Measurement by "Cervistab" ergometer	Week 1
Comparison of neuromuscular behaviour of upper cervical spine dynamic stabilization capacities between healthy volunteers and rugby players	Measurement by "Cervistab" ergometer	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	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	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	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	Week 1

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2017
• Primary Completion (Actual): September 23, 2021
• Study Completion (Actual): September 23, 2021

Study Registration Dates

• First Submitted: April 27, 2018
• First Submitted That Met QC Criteria: October 16, 2018
• First Posted (Actual): October 19, 2018

Study Record Updates

• Last Update Posted (Actual): December 27, 2021
• Last Update Submitted That Met QC Criteria: December 21, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: UF 9536

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No