Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06545006
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
Effectiveness of a Quick Release Dynamic Muscle-strengthening Program on Dynamic Stabilization of the Cervical Spine
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness of a Quick Release Dynamic Muscle-strengthening Program on Dynamic Stabilization of the Cervical Spine
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CERVITRAIN
Brief Summary:
The goal of this clinical trial is to learn if Quick Release dynamic strengthening of the cervical spine extensor muscles reflex could improve dynamic stabilisation capacities of the cervical spine by reducing muscle activation delay in amateurs rugby players The main questions it aims to answer are described as follows
The primary outcome measure is the comparison between the intervention and control groups of the variation in activation delay of the cervical spine extensor muscles in milliseconds ms between the beginning and the end of the strengthening program The activation delay in milliseconds corresponds to the time between the onset of impact application on the head and the onset of reactive muscle force production measured by the Cervistab ergometer
The secondary outcomes are also a comparison between the two groups of the variations from the beginning to the end of the strengthening program for the followings parameters measured during with the Cervistab machine
Reflex Force Production Rate Nms slope of the forcetime graph
Maximum Reactive Force N maximum force value produced within 300 ms following impact
In both intervention groups measurement of the variation in head displacement in mm during quick release strengthening protocol
In each subgroup 10 participants will be equipped with Instrumented Mouthguards Researchers will compare the variation in workload measured by these mouthguards during Cervistab evaluations conducted before and after the training protocol
Researchers will compare the intervention group to a distractor control arm to see if our training protocol has an impact on the activation delay
The primary outcome measure is the comparison between the intervention and control groups of the variation in activation delay of the cervical spine extensor muscles in milliseconds ms between the beginning and the end of the strengthening program The activation delay in milliseconds corresponds to the time between the onset of impact application on the head and the onset of reactive muscle force production measured by the Cervistab ergometer
The secondary outcomes are also a comparison between the two groups of the variations from the beginning to the end of the strengthening program for the followings parameters measured during with the Cervistab machine
Reflex Force Production Rate Nms slope of the forcetime graph
Maximum Reactive Force N maximum force value produced within 300 ms following impact
In both intervention groups measurement of the variation in head displacement in mm during quick release strengthening protocol
In each subgroup 10 participants will be equipped with Instrumented Mouthguards Researchers will compare the variation in workload measured by these mouthguards during Cervistab evaluations conducted before and after the training protocol
Researchers will compare the intervention group to a distractor control arm to see if our training protocol has an impact on the activation delay
Detailed Description:
Rugby authorities are seeking preventive measures to reduce cranio-cervical injuries Literature suggests that early and strong contraction of cervical spine muscles could decrease this risk The Quick Release principle using maximal isometric contractions and non-impact disturbances might improve the dynamic stabilization of the cervical spine No study has yet evaluated the effect of muscle strengthening programs on this stabilization
It is hypothesized that specific training of the cervical spine extensor muscles could reduce activation delay and increase reflexive force
This study is a single-centre controlled randomised and stratified based on activation delay
It is an open study with blind evaluation Randomization will be stratified based on the activation delay of the cervical spine extensor muscles into two sub-groups slow and fast measured during the Cervistab test at the inclusion visit
Researchers propose an open-label study with blind evaluation The principal investigator who will conduct the pre- and post-training protocol tests will not be involved in the training protocol conducted by the associated investigator and will therefore not know which program the tested subject completed
Both groups will undergo a foundational cervical muscle strengthening regimen which includes classic isometric contraction strengthening duration 20 minutes at the beginning of their training session
The second part of each training session will depend on the group to which they have been randomised also 20 minutes
Either 20 minutes of dynamic strengthening through Quick Release tested arm
Or 20 minutes of decision-making aid with Stroboscopic Glasses control arm with distractor
Both groups will do 10 trainings of 40 minutes dispatched on one month
Cervistab ergometer is a machine developped by the main investigator and engineers that records force in newton as a function of time It delivers impacts over the head of the subject Each subject puts himself in scrum position and take small impacts over the head and we can measure the reflex force production rate after the activation delay
Distractor arm The comparison group will have to do useful tasks for their rugby practice that does not have an impact on the primary outcome Here researchers will ask the comparison group to use stroboscopic glasses to train their decision skills in catching and throwing rugby balls The stroboscopic glasses switch from bright to dark at a certain frequency and hence reduce the amount of visual information
It is hypothesized that specific training of the cervical spine extensor muscles could reduce activation delay and increase reflexive force
This study is a single-centre controlled randomised and stratified based on activation delay
It is an open study with blind evaluation Randomization will be stratified based on the activation delay of the cervical spine extensor muscles into two sub-groups slow and fast measured during the Cervistab test at the inclusion visit
Researchers propose an open-label study with blind evaluation The principal investigator who will conduct the pre- and post-training protocol tests will not be involved in the training protocol conducted by the associated investigator and will therefore not know which program the tested subject completed
Both groups will undergo a foundational cervical muscle strengthening regimen which includes classic isometric contraction strengthening duration 20 minutes at the beginning of their training session
The second part of each training session will depend on the group to which they have been randomised also 20 minutes
Either 20 minutes of dynamic strengthening through Quick Release tested arm
Or 20 minutes of decision-making aid with Stroboscopic Glasses control arm with distractor
Both groups will do 10 trainings of 40 minutes dispatched on one month
Cervistab ergometer is a machine developped by the main investigator and engineers that records force in newton as a function of time It delivers impacts over the head of the subject Each subject puts himself in scrum position and take small impacts over the head and we can measure the reflex force production rate after the activation delay
Distractor arm The comparison group will have to do useful tasks for their rugby practice that does not have an impact on the primary outcome Here researchers will ask the comparison group to use stroboscopic glasses to train their decision skills in catching and throwing rugby balls The stroboscopic glasses switch from bright to dark at a certain frequency and hence reduce the amount of visual information
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None