Effectiveness of a Quick Release Dynamic Muscle-strengthening Program on Dynamic Stabilization of the Cervical Spine
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Comparison of the activation delay
研究概览
简要总结
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 (N/ms): slope of the force/time 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
Main Investigator will be be blinded from the group intervention. The Main Investigator will record the outcomes.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18 or older
- •Possess a valid rugby practice licence
- •Non Inclusion Criteria :
- •History of serious cervical trauma during his career with : Need for surgery (in case of arthrodesis at 2 or more levels) and/or Persistent after-effects (sensory or motor), any cervicobrachial symptomatology.
- •History of epileptic disease
- •Any concussion less than one month old
- •Population with special legal protection: Pregnant or breast-feeding woman (L. 1121-5), subject deprived of liberty (art.L. 1121-6), minors L. 1121-7, patient unable to give consent (1121-8), protected adults L. 1121-8, not affiliated to a social security scheme (L1121-8-1), vulnerable persons (L.1122-2), exclusion period (Article L1121-12).
- •Refusal of consent after information
- •Participant not fluent in French and without a support person able to read.
- •People who practice other contact sports.
排除标准
- 未提供
研究组 & 干预措施
Quick Release Strengthening
The rugby player participants will do 10 sessions of 40 minutes of muscle strengthening at a rate of 2 to 3 sessions per week. 20 minutes of isometric strengthening and 20 minutes of Quick release strengthening
干预措施: isometric contractions (Other)
Quick Release Strengthening
The rugby player participants will do 10 sessions of 40 minutes of muscle strengthening at a rate of 2 to 3 sessions per week. 20 minutes of isometric strengthening and 20 minutes of Quick release strengthening
干预措施: Quick Release (Other)
Stroboscopic Glasses Tasks
The rugby player participants will do 10 sessions of 40 minutes of muscle strengthening at a rate of 2 to 3 sessions per week. 20 minutes of exercises with a rugby ball while wearing stroboscopic glasses.
干预措施: isometric contractions (Other)
Stroboscopic Glasses Tasks
The rugby player participants will do 10 sessions of 40 minutes of muscle strengthening at a rate of 2 to 3 sessions per week. 20 minutes of exercises with a rugby ball while wearing stroboscopic glasses.
干预措施: stroboscopic glasses (Other)
结局指标
主要结局
Comparison of the activation delay
时间窗: Baseline and at end (week 6)
the time between the onset of impact application on the head and the onset of reactive muscle force production (in miliseconds) comparison between the intervention and control groups of the variation in muscle activation delay of the cervical spine extensors (in ms) between the start and the end of the strengthening program. The activation delay in ms corresponds to the time between the start of the application of impact to the head and the start of production of reactive muscle force during the test on the Cervistab© ergometer.
次要结局
- Maximum Reactive Force(Baseline and at end (week 6))
- Rate of Reflex Force Production(Baseline and at end (week 6))
- Workload(Baseline and at end (week 6))