Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-31 @ 3:54 AM
Study NCT ID:
NCT06945133
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-19
First Post:
2025-04-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Study Between the Classification of Arthrogenic Motor Inhibition (AMI) and Clinical Assessment After ACL Rupture
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2025-04-18', 'studyFirstSubmitQcDate': '2025-04-18', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle Surface EMG and AMI correlation', 'timeFrame': 'From enrollment to Day 30', 'description': 'Electrical signal amplitude, expressed in mV, is evaluated at the level of the VM. This electrical signal amplitude is correlated with the level of muscle activation. It is measured with a surface EMG, which measures the activation of the VM during a voluntary attempt to contract the knee extensors. The ratio: Amplitude of the electrical signal from the injured side of the VM / Amplitude of the electrical signal from the non-injured side of the VM is used to determine the inhibition of the VM.\n\nAMI is assessed using the Sonnery-Cottet classification (Sonnery-Cottet et al, 2022)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ACL - Anterior Cruciate Ligament Rupture']}, 'descriptionModule': {'briefSummary': 'The goal of this interventional study is to measure medial vastus inhibition and associate it with AMI classification in patients with ACL rupture. The main question it aims to answer is:\n\nIs there a correlation between AMI classification and clinical assessment after ACL rupture ? Participants will undergo surface EMG and Myotonometry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient, male or female, aged ≥ 18 years and \\< 45 years\n* Patient with an ACL rupture confirmed by MRI\n* Patient with an ACL rupture ≤ 30 days old\n* French speaking patient who does not object to the use of his/her data\n\nExclusion Criteria:\n\n* Patient with previous ipsi or contralateral knee injury/surgery\n* Patient with multi-ligament injury\n* Pregnant or breastfeeding woman'}, 'identificationModule': {'nctId': 'NCT06945133', 'acronym': 'AMIVAL', 'briefTitle': 'Correlation Study Between the Classification of Arthrogenic Motor Inhibition (AMI) and Clinical Assessment After ACL Rupture', 'organization': {'class': 'OTHER', 'fullName': "GCS Ramsay Santé pour l'Enseignement et la Recherche"}, 'officialTitle': 'Correlation Study Between the Classification of Arthrogenic Motor Inhibition (AMI) and Clinical Assessment After ACL Rupture', 'orgStudyIdInfo': {'id': '2025-A00125-44'}, 'secondaryIdInfos': [{'id': '2025-A00125-44', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AMI testing group', 'description': 'Interventions administered are the following :\n\n* Surface EMG to measure inhibition of the VM and the RF on the injured and non-injured sides during attempts at voluntary contractions of the knee extensor muscles.\n* Myotonometry to measure the stiffness of the semi-membranosus and biceps femoris (long head) on the injured and non-injured sides under resting conditions', 'interventionNames': ['Other: Clinical testing']}], 'interventions': [{'name': 'Clinical testing', 'type': 'OTHER', 'description': 'Intervention includes :\n\n* Surface EMG to measure inhibition of the VM and the rectus femoris (RF) on the injured and non-injured sides during attempts at voluntary contractions of the knee extensor muscles.\n* Myotonometry to measure the stiffness of the semimembranosus and biceps femoris (long head) on the injured and non-injured sides under resting conditions', 'armGroupLabels': ['AMI testing group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69008', 'city': 'Lyon', 'country': 'France', 'contacts': [{'name': 'Bertrand SONNERY-COTTET, MD, PhD', 'role': 'CONTACT', 'email': 'sonnerycottet@aol.com', 'phone': '+33 4 37 53 00 22'}], 'facility': 'Hôpital Privé Jean Mermoz', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'centralContacts': [{'name': 'Bertrand SONNERY-COTTET, MD,PhD', 'role': 'CONTACT', 'email': 'sonnerycottet@aol.com', 'phone': '+33 4 37 53 00 22'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "GCS Ramsay Santé pour l'Enseignement et la Recherche", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}