Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 7:50 PM
Study NCT ID:
NCT07424066
Status:
RECRUITING
Last Update Posted:
2026-02-20
First Post:
2026-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-invasive Vibratory Stimulation of the Knee Muscles for the Improvement of the Somatosensory Input and Motor Performance
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': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-13', 'studyFirstSubmitDate': '2026-02-06', 'studyFirstSubmitQcDate': '2026-02-13', 'lastUpdatePostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knee angle', 'timeFrame': 'Day 1.', 'description': 'Maximum distance (in degrees) between the knee trajectory obtained with and without vibratory stimulation.'}, {'measure': 'Surface electromyography (sEMG)', 'timeFrame': 'Day 1.', 'description': 'Difference in sEMG between the muscle activity with and without vibratory stimulation, for each muscle (i.e., Quadriceps, Hamstrings, and Plantarflexor muscles).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vibratory stimulation', 'muscle spindle', 'muscle contraction', 'spinal reflex', 'somatosensory system'], 'conditions': ['Vibration']}, 'descriptionModule': {'briefSummary': 'The goal of this interventional cross-sectional study is to evaluate motor responses to non-invasive vibratory stimulation applied to the hamstring muscle tendons in healthy individuals. Knee flexion and extension efforts, in both isometric and concentric contractions, will be tested.\n\nThe investigators hypothesize that vibratory stimulation causes an increase in activity in the flexor muscles (hamstrings) and a decrease in the extensor muscles (quadriceps) of the knee in all motor tasks. It follows that during knee flexion (both concentric and isometric), vibratory stimulation should cause an increase in the distance between the angular trajectories of the knee obtained with and without vibratory stimulation (with a positive sign). The increased activity of the hamstring muscles would, in fact, contribute to increasing the velocity of the flexor movement. Conversely, during extensor movements (both concentric and isometric), vibratory stimulation should reduce the instantaneous velocity of the movement, therefore causing an increase in distance (with a negative sign) between the trajectories obtained with and without stimulation.\n\nParticipants will be tested using an isokinetic dynamometer and they will be asked to perform the following motor tasks in a random order: concentric knee flexion, concentric knee extension, isometric knee flexion, and isometric knee extension. The dominant limb will be tested, only. The assessment will be performed one time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age equal to or greater than 18 years.\n\nExclusion Criteria:\n\n* Neurological disorders.\n* Musculoskeletal injuries, including previous ones, that may compromise the execution of required movements.\n* Cardiorespiratory disorders.'}, 'identificationModule': {'nctId': 'NCT07424066', 'acronym': 'VIBMOT', 'briefTitle': 'Non-invasive Vibratory Stimulation of the Knee Muscles for the Improvement of the Somatosensory Input and Motor Performance', 'organization': {'class': 'OTHER', 'fullName': 'University of Milano Bicocca'}, 'officialTitle': 'Stimolazione Vibratoria Non-invasiva Per il Miglioramento Del Ritorno Sensoriale e Della Performance Motoria in Atleti Con Lesione al Legamento Crociato Anteriore', 'orgStudyIdInfo': {'id': 'Prot. Nr. 138/25'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy participants', 'description': 'Healthy participants will perform motor tasks with the dominant lower limb, consisting in knee flexion and extension movements in isometric and concentric conditions. The motor tasks will be performed while a vibratory stimulation is applied to hamstring tendons (treatment) and without vibratory stimulation (control) to assess motor responses.', 'interventionNames': ['Device: Vibratory stimulation']}], 'interventions': [{'name': 'Vibratory stimulation', 'type': 'DEVICE', 'description': 'A vibratory stimulator will be applied to the back of the dominant leg, at the level of the hamstring muscle tendons. The stimulator consists of two small vibrating boxes fixed to the leg by means of an elastic band.', 'armGroupLabels': ['Healthy participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20122', 'city': 'Milan', 'state': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Stefano Scarano, Medical doctor', 'role': 'CONTACT', 'email': 's.scarano@auxologico.it', 'phone': '+3902619116717'}, {'name': 'Cristiano Alessandro, Engineer', 'role': 'CONTACT', 'email': 'cristiano.alessandro@unimib.it'}, {'name': 'Stefano Scarano, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Kevin Soter, M.Sc.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Istituto Auxologico Italiano, Clinica Capitanio', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Stefano Scarano, Medical Doctor', 'role': 'CONTACT', 'email': 's.scarano@auxologico.it', 'phone': '+3902619116717'}], 'overallOfficials': [{'name': 'Cristiano Alessandro, Engineering', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Milano Bicocca'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Milano Bicocca', 'class': 'OTHER'}, 'collaborators': [{'name': 'Istituto Auxologico Italiano', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}