Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-01-01 @ 3:32 PM
Study NCT ID:
NCT06524869
Status:
RECRUITING
Last Update Posted:
2024-07-29
First Post:
2024-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association Between Neuromuscular Parameters and Functional Assessment After ACL Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}], 'ancestors': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-24', 'studyFirstSubmitDate': '2024-07-24', 'studyFirstSubmitQcDate': '2024-07-24', 'lastUpdatePostDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Passive proprioceptive evaluation', 'timeFrame': 'One measurement during the visit at 6 to 12 months after surgery', 'description': 'Measurement of knee proprioception by the passive repositioning technique (JPS, in degrees) on isokinetic dynamometer.'}, {'measure': 'Strength', 'timeFrame': 'One measurement during the visit at 6 to 12 months after surgery', 'description': 'Measurement of knee extensors and flexors peak strength (in newton.meter, Nm) on isokinetic dynamometer.'}, {'measure': 'Single Hop test', 'timeFrame': 'One measurement during the visit at 6 to 12 months after surgery', 'description': 'Measurement of knee position during landing from a single leg hop task'}, {'measure': 'Single-leg landing task', 'timeFrame': 'One measurement during the visit at 6 to 12 months after surgery', 'description': 'Measurement of knee position during landing from a 30-cm box'}], 'secondaryOutcomes': [{'measure': 'Single Hop for Distance', 'timeFrame': 'One measurement during the visit at 6 to 12 months after surgery', 'description': 'The total distance is recorded (in cm)'}, {'measure': 'ACL-RSI questionnaire (Anterior Cruciate Ligament-Return to Sport after Injury)', 'timeFrame': 'One measurement during the visit at 6 to 12 months after surgery', 'description': "The ACL-RSI measures the patient's understanding of his knee. It comprises 12 questions with a score of 1 to 10 for each"}, {'measure': 'Landing Error Scoring System (LESS)', 'timeFrame': 'One measurement during the visit at 6 to 12 months after surgery', 'description': 'The LESS (Landing Error Scoring System) scale is a 13-item tool used to assess landing technique during a hop task.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ACL Injury']}, 'referencesModule': {'references': [{'pmid': '40194659', 'type': 'DERIVED', 'citation': 'Faivre O, Prum G, Hulet C, Drigny J. Improved hamstring strength and knee position sense are associated with enhanced landing mechanics after anterior cruciate ligament reconstruction. J ISAKOS. 2025 Jun;12:100858. doi: 10.1016/j.jisako.2025.100858. Epub 2025 Apr 5.'}]}, 'descriptionModule': {'briefSummary': 'The anterior cruciate ligament (ACL) injury is common in athletes aged 18 to 35. ACL reconstruction (ACLR) aims to restore knee stability in the process of returning to sports. Post-surgical rehabilitation focuses on optimizing biomechanical parameters, with neuromuscular and functional tests assessing muscle strength, proprioception, and dynamic stability. Isokinetic allows the measurement of muscle strength symmetry and proprioception, while the single-leg hop and landing tasks assess functional stability and are predictive of sports resumption and injury prevention. Despite progress, concerns remain about neuromuscular factors impacting knee stability, especially during landings, which can increase the risk of secondary ACL injuries.\n\nThis study proposes examining knee strength and proprioception using isokinetic dynamometry, alongside biomechanical assessments from functional tests, to explore their relationship to biomechanical features during landings, at 6-to-12 months post-ACL reconstruction. The hypothesis is that better muscle strength and proprioception correlate with improved knee control during landing tasks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All sports patients included in the sport medicine follow-up protocole with isokinetic muscular assessment at 6-12 months after ACL reconstruction surgery since March 2024 in the sports medicine department (Return To Sport Process)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, aged 18-40, who have undergone a first ACL reconstruction more than 6 months ago and are being followed in a sports medicine care pathway\n* Affiliated with a health insurance plan\n* Information form: Non-objection to the use of data for research purposes\n\nExclusion Criteria:\n\n* Previous ligament surgery of the lower limbs prior to ACL reconstruction\n* Complex ligament injury (lateral ligaments, posterior cruciate ligament)\n* Recent muscle injuries\n* History of injury to the uninjured knee\n* Pregnant woman\n* Neurological history with residual effects or taking medication that affects balance/coordination\n* Inability to perform a muscular assessment\n* Postoperative complications (deep vein thrombosis, sepsis, stiffness/arthrofibrosis)'}, 'identificationModule': {'nctId': 'NCT06524869', 'acronym': 'KASTLAB', 'briefTitle': 'Association Between Neuromuscular Parameters and Functional Assessment After ACL Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'officialTitle': 'Association of Strength and Proprioception Parameters With Qualitative Assessment of Functional Tasks After ACL Reconstruction', 'orgStudyIdInfo': {'id': 'KASTLAB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ACL reconstruction group', 'description': 'All sports patients who had a muscle evaluation at 6 to 12 months after ACLR since March 2024', 'interventionNames': ['Diagnostic Test: Isokinetic neuromuscular assessment']}], 'interventions': [{'name': 'Isokinetic neuromuscular assessment', 'type': 'DIAGNOSTIC_TEST', 'description': 'All sports patients who had a muscle evaluation in addition to functional testing at 6-12 months after ACLR since March 2024', 'armGroupLabels': ['ACL reconstruction group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14000', 'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Joffrey Drigny, MD MSC', 'role': 'CONTACT', 'email': 'drigny-j@chu-caen.fr', 'phone': '+33231064533'}], 'facility': 'CHU Caen Normandie', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Joffrey DRIGNY', 'investigatorAffiliation': 'University Hospital, Caen'}}}}