Effectiveness of a Quick Release Dynamic Muscle-strengthening Program on Dynamic Stabilization of the Cervical Spine

NCT06545006 | Enrolling By Invitation

• 1 other identifier: RECHMPL24_0006
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 (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.

Conditions

Rugby; Craniocerebral Trauma; Cervical Spine Injury; Stabilization

Keywords

Cervical Muscle; Dynamic Strengthening; Stabilization; Cervical Spine; Head Impact; Rugby

Outcome Measures

Primary Outcomes (1)

• Comparison of the activation delay

  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.

  Baseline and at end (week 6)

Secondary Outcomes (3)

• Rate of Reflex Force Production

  Baseline and at end (week 6)

• Maximum Reactive Force

  Baseline and at end (week 6)

• Workload

  Baseline and at end (week 6)

Study Arms (2)

Quick Release Strengthening

EXPERIMENTAL

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

Other: isometric contractions; Other: Quick Release

Stroboscopic Glasses Tasks

SHAM COMPARATOR

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.

Other: isometric contractions; Other: stroboscopic glasses

Interventions

isometric contractions OTHER

Participants will perform 20 minutes of isometric contractions in different positions, with contraction durations of 10 seconds and a number of repetitions between 4 and 10, depending on their progress in the training program.

Quick Release Strengthening; Stroboscopic Glasses Tasks

stroboscopic glasses OTHER

This training involves performing skill exercises with a rugby ball while wearing stroboscopic glasses. The glasses have alternating opaque and clear sections, causing multiple and/or fragmented vision. The goal is to improve the processing of visual information at the level of higher functions. This aids in decision-making. It does not involve the same structures and functions implicated in reflexive muscle recruitment strategies as the Quick Release, so it should not be a confounding factor. However, it provides a beneficial, stimulating, and enjoyable training session, increasing subject adherence as they work on a skill useful in their sport.

Stroboscopic Glasses Tasks

Quick Release OTHER

The distance (in mm) of the anterior head translation will be measured using a linear displacement sensor. The subject will be instructed to recruit their extensor muscles as quickly and as strongly as possible to minimise the head displacement distance. They will be aware of their score after each repetition (real-time feedback). Subjects must react to a rapid forward displacement of the cervical spine, without impact. To generate this forward displacement without impact, subjects are positioned with support in front of the forehead, holding their head and neck. The subject must exert an isometric flexion effort against this frontal support (energy storage), with the intensity set by the examiner based on the Maximum Isometric Force measured during a prior maximal isometric test. The frontal resistance will suddenly release, and the head displacement in the sagittal plane will be measured until the recruitment of the cervical spine extensor muscles stops this displacement

Quick Release Strengthening

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 or older
• Possess a valid rugby practice licence
• 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
• Refusal of consent after information
• Participant not fluent in French and without a support person able to read.
• People who practice other contact sports.

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Université Montpellier: collaborator

Study Sites (1)

EuroMov Université de Montpellier

Montpellier, Herault, 34 090, France

Location

Related Publications (6)

• Bohu Y, Julia M, Bagate C, Peyrin JC, Colonna JP, Thoreux P, Pascal-Moussellard H. Declining incidence of catastrophic cervical spine injuries in French rugby: 1996-2006. Am J Sports Med. 2009 Feb;37(2):319-23. doi: 10.1177/0363546508325926.

  PMID: 19182111 RESULT

• Eckner JT, Oh YK, Joshi MS, Richardson JK, Ashton-Miller JA. Effect of neck muscle strength and anticipatory cervical muscle activation on the kinematic response of the head to impulsive loads. Am J Sports Med. 2014 Mar;42(3):566-76. doi: 10.1177/0363546513517869. Epub 2014 Jan 31.

  PMID: 24488820 RESULT

• Pedersen MT, Essendrop M, Skotte JH, Jorgensen K, Fallentin N. Training can modify back muscle response to sudden trunk loading. Eur Spine J. 2004 Oct;13(6):548-52. doi: 10.1007/s00586-004-0679-3. Epub 2004 Feb 25.

  PMID: 14986074 RESULT

• Garrett JM, Mastrorocco M, Peek K, van den Hoek DJ, McGuckian TB. The Relationship Between Neck Strength and Sports-Related Concussion in Team Sports: A Systematic Review With Meta-analysis. J Orthop Sports Phys Ther. 2023 Oct;53(10):585-593. doi: 10.2519/jospt.2023.11727.

  PMID: 37428807 RESULT

• Tognella F, Mainar A, Vanhoutte C, Goubel F. A mechanical device for studying mechanical properties of human muscles in vivo. J Biomech. 1997 Oct;30(10):1077-80. doi: 10.1016/s0021-9290(97)00067-5.

  PMID: 9391877 RESULT

• Daneshvar DH, Goldstein LE, Kiernan PT, Stein TD, McKee AC. Post-traumatic neurodegeneration and chronic traumatic encephalopathy. Mol Cell Neurosci. 2015 May;66(Pt B):81-90. doi: 10.1016/j.mcn.2015.03.007. Epub 2015 Mar 7.

  PMID: 25758552 RESULT

MeSH Terms

Conditions

Craniocerebral Trauma

Interventions

Isometric Contraction

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Muscle Contraction; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Marc Julia, MD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Main Investigator will be be blinded from the group intervention. The Main Investigator will record the outcomes.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center, controlled, randomized, stratified on time to activation of cervical spine extensor muscles, open-label study with blinded evaluation.

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 9, 2024
• Study Start: August 5, 2024
• Primary Completion: May 5, 2025
• Study Completion: May 5, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

FR (1)