Lower Limb Ligament InjuryFlexiProNCT07028723
Relationship Between Proprioceptive Flexibility and the Occurrence of Lower Limb Ligament Injury in Pivot-contact Sports
A study testing proprioceptive profile measurement in people with Lower Limb Ligament Injury, run by University Hospital, Montpellier at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Limb Ligament Injury
- What is being tested?
- proprioceptive profile measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jun 2025to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Athlete practicing in a high-level program
- Aged between 14 and 25
- Practicing a pivot-contact sport (rugby, soccer, handball)
Who cannot join
- Lower limb injury <6 weeks prior to inclusion
- Concussion <6 weeks prior to inclusion
- Known neurological or vestibular disorder
- Lack of consent from athlete or legal guardians
- Non-affiliation with a social security scheme
- Persons under court protection
- Participant in another study with an ongoing exclusion period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Montpellier
Montpellier
ATTALIN Benoît, MD, b-attalin@chu-montpellier.fr
About this study
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.
- Conditions
- Lower Limb Ligament Injury
- Being tested
- proprioceptive profile measurement
- Keywords
- Anterior Cruciate Ligament (ACL), Laterale Ankle Sprain (LAS), Inferior Tibio-fibular syndesmosis, Proprioception, Postural control, Injury Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proprioceptive profile measurementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| proprioceptive profile measurement | Experimental | Not described Receives: Other: proprioceptive profile measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of occurrence of lower limb ligament injuries in groups of athletes with rigid proprioceptive profiles
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.
Measured: During 1 year after inclusion
Rate of occurrence of lower limb ligament injuries in groups of athletes with flexible proprioceptive profiles
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.
Measured: During 1 year after inclusion
Secondary outcomes (8)
Describe the prevalence of rigid and flexible profiles in this population and according to the sport played (rugby, soccer, handball).
Measured: During 1 year after inclusion
Describe the relationship between proprioceptive stiffness and the period of training or match during which the injury occurred (training or match divided into 4)
Period of injury (1st, 2nd, 3rd or 4th quarter of training/match)
Measured: During 1 year after inclusion
Describe the relationship between proprioceptive stiffness and the period of the season
Period of season (1st, 2nd, 3rd or 4th quarter of season)
Measured: During 1 year after inclusion
Describe the relationship between proprioceptive stiffness and exposure time during training and matches
Number of hours of practice (training and match)
Measured: During 1 year after inclusion
Describe the relationship between proprioceptive stiffness and injury mechanism (contact/non-contact)
Direct (contact) or indirect (non-contact) injury mechanism
Measured: During 1 year after inclusion
Describe the relationship between proprioceptive stiffness and action during which injury occurs (attack/defense)
Action of injury (attack or defense)
Measured: During 1 year after inclusion
Describe the relationship between proprioceptive stiffness and occurrence of a first or recurrent injury
First episode or recurrence
Measured: During 1 year after inclusion
Describe the relationship between proprioceptive stiffness and time to return to sport at the same level
Time to return to sport at same level
Measured: During 1 year after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start30 Jun 2025
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb Ligament InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07028723
- Sponsor's protocol ID
- RECHMPL25_0121
- Other IDs
- 2025-A00797-42
- Acronym
- FlexiPro
- Status last verified
- Jul 2025
- First submitted
- 11 Jun 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Proprioceptive Flexibility and the Occurrence of Lower Limb Ligament Injury in Pivot-contact Sports
- ClinicalTrials.gov ID
- NCT07028723
- Acronym / sponsor ID
- FlexiPro / RECHMPL25_0121
- Conditions
- Lower Limb Ligament Injury
- Keywords
- Anterior Cruciate Ligament (ACL), Laterale Ankle Sprain (LAS), Inferior Tibio-fibular syndesmosis, Proprioception, Postural control, Injury Prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| proprioceptive profile measurement | Experimental | Other: proprioceptive profile measurement |
Who may qualify
- Ages
- 14 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Athlete practicing in a high-level program
- Aged between 14 and 25
- Practicing a pivot-contact sport (rugby, soccer, handball)
Key exclusion criteria (7 listed)
- Lower limb injury <6 weeks prior to inclusion
- Concussion <6 weeks prior to inclusion
- Known neurological or vestibular disorder
- Lack of consent from athlete or legal guardians
- Non-affiliation with a social security scheme
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| proprioceptive profile measurementProprioceptive 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. | Other | proprioceptive profile measurement |
Primary outcome
Rate of occurrence of lower limb ligament injuries in groups of athletes with rigid proprioceptive profiles
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.
Rate of occurrence of lower limb ligament injuries in groups of athletes with flexible proprioceptive profiles
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.
8 secondary outcomes
Describe the prevalence of rigid and flexible profiles in this population and according to the sport played (rugby, soccer, handball).
Time frame: During 1 year after inclusion
Describe the relationship between proprioceptive stiffness and the period of training or match during which the injury occurred (training or match divided into 4)
Time frame: During 1 year after inclusion
Describe the relationship between proprioceptive stiffness and the period of the season
Time frame: During 1 year after inclusion
Describe the relationship between proprioceptive stiffness and exposure time during training and matches
Time frame: During 1 year after inclusion
Describe the relationship between proprioceptive stiffness and injury mechanism (contact/non-contact)
Time frame: During 1 year after inclusion
Describe the relationship between proprioceptive stiffness and action during which injury occurs (attack/defense)
Time frame: During 1 year after inclusion
Describe the relationship between proprioceptive stiffness and occurrence of a first or recurrent injury
Time frame: During 1 year after inclusion
Describe the relationship between proprioceptive stiffness and time to return to sport at the same level
Time frame: During 1 year after inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
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Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing proprioceptive profile measurement in people with Lower Limb Ligament Injury, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benoit ATTALIN, MD (+33467330565, fed-medecinedusport@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of occurrence of lower limb ligament injuries in groups of athletes with rigid proprioceptive profiles (time frame: During 1 year after inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.