- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07389850
Evaluation of the Evolution of Proprioceptive Reweighting Abilities Following Anterior Cruciate Ligament Reconstruction Surgery (ReproEVO)
Evaluation of the Evolution of Proprioceptive Reweighting Abilities Following Anterior Cruciate Ligament Reconstruction Surgery - ReproEVO
Anterior cruciate ligament (ACL) injury is the most common knee injury among athletes who play contact sports involving pivoting. ACL reconstruction (ACLR) combined with rehabilitation is the standard treatment for ACL tears in athletes, and rehabilitation is one of the keys to success. The overall return to sport rate is 80%, but the return to pre-injury level of sport is only 65% and the return to the same level of competition is only 55%. The recurrence rate is close to 20%.
During rehabilitation and sports practice, proprioceptive information is essential for adjusting the muscle sensorimotor loop and enabling optimal movement.
Athletes can thus be classified as plastic or rigid . Our hypothesis is to show that the proportion of "plastic" patients 9 months post-operative following ACL reconstruction is higher than that found in the same population 3 months post-operative, thus demonstrating the progression of proprioceptive integration abilities after ACL reconstruction surgery.
Study Overview
Status
Intervention / Treatment
Detailed Description
Anterior cruciate ligament (ACL) injury is the most common knee injury among athletes who play contact sports involving pivoting. ACL reconstruction (ACLR) combined with rehabilitation is the standard treatment for ACL tears in athletes, and rehabilitation is one of the keys to success. The overall return to sport rate is 80%, but the return to pre-injury level of sport is only 65% and the return to the same level of competition is only 55%. The recurrence rate is close to 20%. Although the number of studies on the subject is growing, there is currently no consensus on rehabilitation protocols.
During rehabilitation and sports practice, proprioceptive information is essential for adjusting the muscle sensorimotor loop and enabling optimal movement.
We have demonstrated that athletes and athletes after ACL reconstruction show variability in the integration of proprioceptive information during a complex balance task.
Athletes can thus be classified as plastic (able to vary the source of proprioceptive information depending on conditions) or rigid (unable to do so).
Our hypothesis is to show that the proportion of "plastic" patients 9 months post-operative following ACL reconstruction is higher than that found in the same population 3 months post-operative, thus demonstrating the progression of proprioceptive integration abilities after ACL reconstruction surgery.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Olivier REMY-NERIS, Professor
- Phone Number: +33298223152
- Email: olivier.remyneris@chu-brest.fr
Study Locations
-
-
-
Brest, France, 29609
- Brest University Hospital
-
Contact:
- Olivier REMY-NERIS, Professor
- Phone Number: +33298223152
- Email: olivier.remyneris@chu-brest.fr
-
Principal Investigator:
- Olivier REMY-NERIS, Professor
-
Montpellier, France, 34000
- Montpellier University Hospital
-
Contact:
- Benoît ATTALIN, Doctor
- Phone Number: +33687643336
- Email: benoit.attalin@gmail.com
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Principal Investigator:
- Benoît ATTALIN, Doctor
-
Saint-Clément-de-Rivière, France, 34980
- Dr. STER Clinic, Saint Clément de Rivière
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Contact:
- François FEUVRIER, Doctor
- Phone Number: +33626467428
- Email: francois.feuvrier@cliniques-ster.fr
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Principal Investigator:
- François FEUVRIER, Doctor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged between 15 and 40;
- Patients with ACL rupture scheduled for ACL reconstruction surgery;
- Patients able to maintain a stable bipedal standing position without technical assistance and with their eyes closed;
- Consent of the patient, parents, legal guardians, or guardians to the recording (for minor patients) of data for research and publication purposes.
Exclusion Criteria:
- Recent osteoarticular pathology (i.e., less than three months) of the lower limbs, whether traumatic or not, other than ACL rupture;
- Proven disabling neurological pathology;
- Pain in the musculoskeletal system during exercise (excluding the operated knee);
- Fatigue assessed using the Borg scale > 6;
- Skin allergy to an adhesive product.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patients with Anterior Cruciate Ligament
Patients with Anterior Cruciate Ligament (ACL) rupture scheduled for ACL reconstruction surgery
|
After the inclusion visit, each assessment will include an examination of standing balance in two support conditions: hard floor or soft floor and two conditions of vibration of the Achilles tendons or lumbar muscles, performed randomly over five trials for each condition. The subjects stand with their eyes covered by an opaque mask. Vibrators are positioned at both locations and vibrated randomly after a trial without recording to perceive the destabilizing effect induced by the vibration. The data is recorded using a force platform on the floor. Subjects will be seated and strapped into a rigid device attached to their leg. The device is connected to a motor that maintains a constant speed. Maximum strength will be measured at two different speeds. Finally, at each assessment, the subjects will complete questionnaires about their fear of pain, their assessment of their knee's capabilities, and the activities they engage in. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of progress in proprioceptive reweighting after knee ligament reconstruction
Time Frame: Baseline, 3 months after surgery and 9 months after surgery
|
Difference between the mean proprioceptive reweighting coefficient (RPw) preoperatively and 3 months postoperatively
|
Baseline, 3 months after surgery and 9 months after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assesment of the variation in weighting between before and after the operation
Time Frame: Baseline and 3 months postoperatively
|
Difference between the mean proprioceptive reweighting coefficient (RPw) preoperatively and 3 months postoperatively
|
Baseline and 3 months postoperatively
|
|
Assess postural control
Time Frame: Baseline, at 3 months postoperatively and at 9 months postoperatively
|
Difference in the size of the shift in the center of pressure in a static standing position, with eyes open and closed
|
Baseline, at 3 months postoperatively and at 9 months postoperatively
|
|
Assess your Anterior Cruciate Ligament - Return to Sport and Injury (ACL-RSI) perception score
Time Frame: Baseline, at 3 months postoperatively and at 9 months postoperatively
|
Assess your Anterior Cruciate Ligament - Return to Sport and Injury (ACL-RSI) perception score (0 : Not at all sure; 10: Completely safe) at the inclusion visit (preoperative); at 3 months postoperatively and at 9 months postoperatively
|
Baseline, at 3 months postoperatively and at 9 months postoperatively
|
|
Assess the subjective IKDC activity score
Time Frame: Baseline, at 3 months postoperatively and at 9 months postoperatively
|
Assess the subjective IKDC activity score (0: Never; 10: Always) at the inclusion visit (preoperative); at 3 months postoperatively and at 9 months postoperatively.
|
Baseline, at 3 months postoperatively and at 9 months postoperatively
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 29BRC25.0312
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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