Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2026-02-22 @ 7:01 AM
Study NCT ID:
NCT02929004
Status:
COMPLETED
Last Update Posted:
2022-12-15
First Post:
2016-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chronic Effects of Local Vibration on Neuromuscular Reconditioning After Anterior Cruciate Ligament Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2020-04-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-13', 'studyFirstSubmitDate': '2016-10-07', 'studyFirstSubmitQcDate': '2016-10-07', 'lastUpdatePostDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-02-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximal voluntary force', 'timeFrame': '60 days', 'description': 'Maximal voluntary strength in dorsal flexion of the ankle'}], 'secondaryOutcomes': [{'measure': '6 minutes walking test', 'timeFrame': '60 days', 'description': 'The patients will have to realize round trips by walking on a distance of 30 meters during 6 minutes. The total distance traveled by the patient will be calculated (in meters)'}, {'measure': 'Get up and Go test', 'timeFrame': '60 days', 'description': 'The patient, sat on a seat placed in 3 meters of the wall, is invited:\n\n* to get up\n* to walk up to the wall\n* to turn back\n* to return up to their seat and\n* to sit down there again The results will be expressed according to a highly-rated scale from 1 to 5'}, {'measure': 'The cortical level of activation (%)', 'timeFrame': '60 days', 'description': 'It is determined by the increment of strength obtained further to a magnetic cortical stimulation realized during a condition of muscle in state of maximal contraction'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anterior Cruciate Ligament Reconstruction', 'Local vibration training', 'Ligamentoplasty', 'Anterior cruciate ligament', 'Corticospinal excitability', 'Elastography', 'Knee extensor muscles', 'Readaptation'], 'conditions': ['Anterior Cruciate Ligament Reconstruction']}, 'referencesModule': {'references': [{'pmid': '33059096', 'type': 'RESULT', 'citation': 'Coulondre C, Souron R, Rambaud A, Dalmais E, Espeit L, Neri T, Pinaroli A, Estour G, Millet GY, Rupp T, Feasson L, Edouard P, Lapole T. Local vibration training improves the recovery of quadriceps strength in early rehabilitation after anterior cruciate ligament reconstruction: A feasibility randomised controlled trial. Ann Phys Rehabil Med. 2022 Jun;65(4):101441. doi: 10.1016/j.rehab.2020.08.005. Epub 2021 Nov 13.'}]}, 'descriptionModule': {'briefSummary': 'These last years, it has been proven that the solicitation of a muscle using vibration may lead to positive effects on the neuromuscular function. Thus, the aim of the current study is to assess if the addition of local vibration training sessions on the quadriceps muscle to the classic readaptation program (i.e. physiotherapist sessions) may allow a better recuperation 2 months after the surgery and the reconstruction of the anterior cruciate ligament.\n\nThe aim of the vibration training proposed in the current study is to allow a better recuperation 2 months after the anterior cruciate ligament reconstruction when compared with conventional physiotherapy alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing to surgery (i.e. ligamentoplasty) of the anterior cruciate ligament\n\nExclusion Criteria:\n\n* Taking neuro-active substances which can lead to alteration of the corticospinal excitability\n* Contra indications for using magnetic stimulation\n* Participating in another study in the same time'}, 'identificationModule': {'nctId': 'NCT02929004', 'acronym': 'VIB_LCA', 'briefTitle': 'Chronic Effects of Local Vibration on Neuromuscular Reconditioning After Anterior Cruciate Ligament Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Chronic Effects of Local Vibration on Neuromuscular Reconditioning After Anterior Cruciate Ligament Reconstruction', 'orgStudyIdInfo': {'id': '1608114'}, 'secondaryIdInfos': [{'id': '2016-A01358-43', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vibrasens', 'description': 'In addition of classical physiotherapist sessions for the readaptation following anterior cruciate ligament reconstruction, this group will follow a local vibration training, using small and portable vibrator device.\n\nTraining programme: vibration training 3/week from Day 1 to Day 60', 'interventionNames': ['Device: Vibrasens']}, {'type': 'NO_INTERVENTION', 'label': 'Usual activities', 'description': 'Usual activities from day 1 to Day 60 during their classical physiotherapist sessions for the readaptation following anterior cruciate ligament reconstruction.'}], 'interventions': [{'name': 'Vibrasens', 'type': 'DEVICE', 'otherNames': ['Vibrasens (TECHNO CONCEPT, France).'], 'description': 'Transcutaneous vibrations are used. This device allows vibrations from 25 to 150 Hz with an amplitude of 1 mm. In our study the frequency used is 50 Hz.', 'armGroupLabels': ['Vibrasens']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Challes-les-Eaux', 'country': 'France', 'facility': 'CEPART', 'geoPoint': {'lat': 45.54685, 'lon': 5.98098}}, {'zip': '42000', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU de SAINT-ETIENNE', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Pascal EDOUARD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de SAINT-ETIENNE'}, {'name': 'Thomas LAPOLE, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Jean Monnet University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}