CHU Montpellier
Montpellier, France
Location status: Recruiting
NCT Number: NCT07028723
Among young athletes involved in pivot and pivot-contact sports (soccer, handball, rugby, etc.), lateral ankle sprains and lesions of the anterior cruciate ligament (ACL) are the most frequent ligament injuries. Despite existing prevention programs, these injuries lead to prolonged downtime, risk of recurrence and long-term sequelae.
A little-studied risk factor is proprioceptive rigidity, defined as the central nervous system's difficulty in adapting the use of sensory information (proprioception) according to environment and motor context. This deficit could limit the ability to maintain balance in high-risk situations, thereby increasing the likelihood of injury.
To our knowledge, there is no evidence of a direct link between proprioceptive profile (flexible/rigid) and the incidence of lower-limb ligament injury. If such a link is established, preventive strategies focusing on the recovery of an optimal proprioceptive profile could be developed in an attempt to limit the occurrence of ligament injuries in young elite and sub-elite athletes, and thus limit the medical, financial and personal repercussions for these athletes.
Interested in participating?
Request Info14 year–25 year
All sexes
Interventional
Not applicable
Montpellier, France
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Proprioceptive profile is measured by assessing static bipodal balance on a force platform. The patient is asked to stand motionless in bipodal support on a stable and then unstable floor, with vision masked by an eye mask. The investigators randomly apply a tendon vibration (80Hz) to the subjects' Achilles tendons or paravertebral muscles.
This vibration alters proprioceptive information in the vibrated zone, leading to a disturbance in postural balance and an increased displacement of the center of pressure, whose position is continuously calculated from the force platform's sensors.
Thus, depending on the amount of displacement of the center of pressure, the investigator calculates a proprioceptive weighting ratio (PWR) to deduce the weight assigned by the Central Nervous System to the various proprioceptive inputs during the postural task.
An PWR of 1 indicates 100% use of information from the ankle, while an PWR of 0 means 100% use of information from the hip.
Time frame: During 1 year after inclusion
Data collection on the occurrence of injuries will be carried out by club doctors, who will complete a questionnaire sent to them by e-mail by the investigator. They will then be contacted once a month by a single person to centralize the data.
Time frame: During 1 year after inclusion
Data collection on the occurrence of injuries will be carried out by club doctors, who will complete a questionnaire sent to them by e-mail by the investigator. They will then be contacted once a month by a single person to centralize the data.
Time frame: During 1 year after inclusion
Time frame: During 1 year after inclusion
Period of injury (1st, 2nd, 3rd or 4th quarter of training/match)
Time frame: During 1 year after inclusion
Period of season (1st, 2nd, 3rd or 4th quarter of season)
Time frame: During 1 year after inclusion
Number of hours of practice (training and match)
Time frame: During 1 year after inclusion
Direct (contact) or indirect (non-contact) injury mechanism
Time frame: During 1 year after inclusion
Action of injury (attack or defense)
Time frame: During 1 year after inclusion
First episode or recurrence
Time frame: During 1 year after inclusion
Time to return to sport at same level
Contact information is provided by the study sponsor or research team.
University Hospital, Montpellier
Other
Acronym: FlexiPro
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.