Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:27 AM
Study NCT ID:
NCT07389850
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-05
First Post:
2026-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Evolution of Proprioceptive Reweighting Abilities Following Anterior Cruciate Ligament Reconstruction Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'ReproEVO is a multicenter prospective interventional study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2028-05-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-28', 'studyFirstSubmitDate': '2026-01-28', 'studyFirstSubmitQcDate': '2026-01-28', 'lastUpdatePostDateStruct': {'date': '2026-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-05-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of progress in proprioceptive reweighting after knee ligament reconstruction', 'timeFrame': 'Baseline, 3 months after surgery and 9 months after surgery', 'description': 'Difference between the mean proprioceptive reweighting coefficient (RPw) preoperatively and 3 months postoperatively'}], 'secondaryOutcomes': [{'measure': 'Assesment of the variation in weighting between before and after the operation', 'timeFrame': 'Baseline and 3 months postoperatively', 'description': 'Difference between the mean proprioceptive reweighting coefficient (RPw) preoperatively and 3 months postoperatively'}, {'measure': 'Assess postural control', 'timeFrame': 'Baseline, at 3 months postoperatively and at 9 months postoperatively', 'description': 'Difference in the size of the shift in the center of pressure in a static standing position, with eyes open and closed'}, {'measure': 'Assess your Anterior Cruciate Ligament - Return to Sport and Injury (ACL-RSI) perception score', 'timeFrame': 'Baseline, at 3 months postoperatively and at 9 months postoperatively', 'description': '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'}, {'measure': 'Assess the subjective IKDC activity score', 'timeFrame': 'Baseline, at 3 months postoperatively and at 9 months postoperatively', 'description': 'Assess the subjective IKDC activity score (0: Never; 10: Always) at the inclusion visit (preoperative); at 3 months postoperatively and at 9 months postoperatively.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anterior Cruciate Ligament', 'Anterior Cruciate Ligament Reconstruction', 'Central Nervous System', 'Proprioceptive reweighting', 'Pivot-contact sport', 'Plastic patient', 'Athletes'], 'conditions': ['Anterior Cruciate Ligament Rupture With Ligamentoplasty']}, 'descriptionModule': {'briefSummary': '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%.\n\nDuring rehabilitation and sports practice, proprioceptive information is essential for adjusting the muscle sensorimotor loop and enabling optimal movement.\n\nAthletes 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.', 'detailedDescription': '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.\n\nDuring rehabilitation and sports practice, proprioceptive information is essential for adjusting the muscle sensorimotor loop and enabling optimal movement.\n\nWe have demonstrated that athletes and athletes after ACL reconstruction show variability in the integration of proprioceptive information during a complex balance task.\n\nAthletes can thus be classified as plastic (able to vary the source of proprioceptive information depending on conditions) or rigid (unable to do so).\n\nOur 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged between 15 and 40;\n* Patients with ACL rupture scheduled for ACL reconstruction surgery;\n* Patients able to maintain a stable bipedal standing position without technical assistance and with their eyes closed;\n* Consent of the patient, parents, legal guardians, or guardians to the recording (for minor patients) of data for research and publication purposes.\n\nExclusion Criteria:\n\n* Recent osteoarticular pathology (i.e., less than three months) of the lower limbs, whether traumatic or not, other than ACL rupture;\n* Proven disabling neurological pathology;\n* Pain in the musculoskeletal system during exercise (excluding the operated knee);\n* Fatigue assessed using the Borg scale \\> 6;\n* Skin allergy to an adhesive product.'}, 'identificationModule': {'nctId': 'NCT07389850', 'acronym': 'ReproEVO', 'briefTitle': 'Evaluation of the Evolution of Proprioceptive Reweighting Abilities Following Anterior Cruciate Ligament Reconstruction Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Evaluation of the Evolution of Proprioceptive Reweighting Abilities Following Anterior Cruciate Ligament Reconstruction Surgery - ReproEVO', 'orgStudyIdInfo': {'id': '29BRC25.0312'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with Anterior Cruciate Ligament', 'description': 'Patients with Anterior Cruciate Ligament (ACL) rupture scheduled for ACL reconstruction surgery', 'interventionNames': ['Procedure: ReproEVO intervention']}], 'interventions': [{'name': 'ReproEVO intervention', 'type': 'PROCEDURE', 'description': "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.\n\nSubjects 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.\n\nFinally, 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.", 'armGroupLabels': ['Patients with Anterior Cruciate Ligament']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29609', 'city': 'Brest', 'country': 'France', 'contacts': [{'name': 'Olivier REMY-NERIS, Professor', 'role': 'CONTACT', 'email': 'olivier.remyneris@chu-brest.fr', 'phone': '+33298223152'}, {'name': 'Olivier REMY-NERIS, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Brest University Hospital', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '34000', 'city': 'Montpellier', 'country': 'France', 'contacts': [{'name': 'Benoît ATTALIN, Doctor', 'role': 'CONTACT', 'email': 'benoit.attalin@gmail.com', 'phone': '+33687643336'}, {'name': 'Benoît ATTALIN, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Montpellier University Hospital', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '34980', 'city': 'Saint-Clément-de-Rivière', 'country': 'France', 'contacts': [{'name': 'François FEUVRIER, Doctor', 'role': 'CONTACT', 'email': 'francois.feuvrier@cliniques-ster.fr', 'phone': '+33626467428'}, {'name': 'François FEUVRIER, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dr. STER Clinic, Saint Clément de Rivière', 'geoPoint': {'lat': 43.68333, 'lon': 3.83333}}], 'centralContacts': [{'name': 'Olivier REMY-NERIS, Professor', 'role': 'CONTACT', 'email': 'olivier.remyneris@chu-brest.fr', 'phone': '+33298223152'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be available after the publication of result and ending fifteen years following the last visit of the last patient', 'ipdSharing': 'YES', 'description': 'All collected data that underlie results in a publication', 'accessCriteria': 'Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}