Cervical Spine Destabilization Clinical Trial
— CervistabOfficial title:
Dynamic Stabilization of the Upper Cervical Spine in a Cohort of Rugby's Players Via Ergometer (Cervistab©)
| Verified date | December 2021 |
| Source | University Hospital, Montpellier |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 117 |
| Est. completion date | September 23, 2021 |
| Est. primary completion date | September 23, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 40 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Montpellier university Hospital | Montpellier |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Montpellier |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Reproducibility of head movement amplitude measurements on healthy volunteers | Measurement in millimetres by "Cervistab" ergometer | Week 1 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | Comparison of biomechanical behaviour of upper cervical spine dynamic stabilization capacities between healthy volunteers and rugby players | Measurement by "Cervistab" ergometer | Week 1 | |
| Secondary | Comparison of neuromuscular behaviour of upper cervical spine dynamic stabilization capacities between healthy volunteers and rugby players | Measurement by "Cervistab" ergometer | Week 1 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |