Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-26 @ 1:01 AM
Study NCT ID:
NCT07156734
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-05
First Post:
2025-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Contralateral NMES on Quadriceps Activation After ACL Injury or Surgery
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-27', 'studyFirstSubmitDate': '2025-08-27', 'studyFirstSubmitQcDate': '2025-08-27', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EMG activity', 'timeFrame': 'Data will be collected at two time points: after ACL injury (within two weeks prior to surgery) and following ACL reconstruction (within three days post-surgery).', 'description': 'EMG data will be recorded from the vastus medialis, vastus lateralis and rectus femoris muscles.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ACL Injury']}, 'descriptionModule': {'briefSummary': "A major complication after cruciate ligament injury and surgery is arthrogenic muscle inhibition of the quadriceps, which is characterised by a deficit in voluntary muscle activation in the affected leg. This can hinder rehabilitation processes, lead to impaired knee function, and negatively impact the patients' quality of life. The primary objective of this study is to assess whether voluntary quadriceps activation on the injured side is facilitated by the concomitant application of neuromuscular electrical stimulation (NMES) on the contralateral quadriceps.", 'detailedDescription': 'The primary objective of this study is to assess whether injured-side voluntary quadriceps activation before and after ACL surgery is facilitated by the concomitant application of NMES on the contralateral quadriceps (uninjured side), in comparison to a control (CTRL) condition that does not involve any contralateral activity (passive rest) and to a voluntary (VOL) condition that involves a maximal voluntary contraction of the contralateral quadriceps.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing ACL surgery with semitendinosus tendon autograft in the Schulthess Clinic\n* Unilateral and primary ACL injury (with/without diagnoses of additional meniscus injury)\n\nExclusion Criteria:\n\n* Previous surgery/ligament rupture in injured or uninjured knee or hip\n* Severe pain in the uninjured-side quadriceps or knee joint\n* Ongoing pregnancy\n* BMI \\>30 kg/m²\n* Neuromuscular disease\n* Open wounds or tissue injuries on the anterior aspect of the thigh\n* Additional rupture of other knee ligaments (posterior cruciate ligament, medial collateral ligament, lateral collateral ligament)\n* Implanted metallic/electronic devices (cardiac pacemakers, defibrillators)\n* Patients getting a femoralis block (peripheral nerve block) after surgery will be excluded for the post-surgical appointment\n* Insufficient language comprehension'}, 'identificationModule': {'nctId': 'NCT07156734', 'acronym': 'ACLQuadAct', 'briefTitle': 'Effect of Contralateral NMES on Quadriceps Activation After ACL Injury or Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Schulthess Klinik'}, 'officialTitle': 'Does NMES Applied to the Contralateral Uninjured Side Facilitate Voluntary Quadriceps Activation Before and After ACL Surgery?', 'orgStudyIdInfo': {'id': '2025-00224'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Contralateral NMES', 'description': 'Participants receive neuromuscular electrical stimulation (NMES) applied to the quadriceps muscle of the contralateral leg while performing voluntary quadriceps contractions on the injured side. Each participant completes two sessions: one after ACL injury and one after ACL reconstruction surgery.', 'interventionNames': ['Device: Neuromuscular Electrical Stimulation']}], 'interventions': [{'name': 'Neuromuscular Electrical Stimulation', 'type': 'DEVICE', 'description': 'Studies in healthy individuals have demonstrated that NMES applied to the quadriceps of one limb induces short-term increases in strength and neural drive in the contralateral homologous muscle. Since these effects have only been observed in healthy individuals, it is essential to investigate whether similar responses occur in ACL patients.', 'armGroupLabels': ['Contralateral NMES']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Nicola Angelo Maffiuletti, PhD', 'role': 'CONTACT', 'email': 'nicola.maffiuletti@kws.ch', 'phone': '+41 44 385 75 79'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Schulthess Klinik', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head Research Group Human Performance Lab', 'investigatorFullName': 'Nicola Maffiuletti', 'investigatorAffiliation': 'Schulthess Klinik'}}}}