Ignite Creation Date:
2025-12-25 @ 4:37 AM
Ignite Modification Date:
2025-12-26 @ 3:39 AM
Study NCT ID:
NCT04737018
Status:
COMPLETED
Last Update Posted:
2023-12-27
First Post:
2021-01-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of a Focal Muscle Vibration Protocol in Front of the the Anterior Tibial Muscle in the Subacute Post-stroke Period on Motor Recovery in Hemiplegic Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-26', 'studyFirstSubmitDate': '2021-01-28', 'studyFirstSubmitQcDate': '2021-02-02', 'lastUpdatePostDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'score of Fugl Meyer Assessment (lower limbs)', 'timeFrame': 'day 30', 'description': 'score from 0 to 34 Stroke-specific performance-based disability index that quantitatively assesses analytical motor skills in the lower limb.'}], 'secondaryOutcomes': [{'measure': 'score of Fugl Meyer Assessment (lower limbs)', 'timeFrame': 'day 0, day 15, day 30 and month 2', 'description': 'score from 0 to 34 Stroke-specific performance-based disability index that quantitatively assesses analytical motor skills in the lower limb.'}, {'measure': 'score of Medical Research Concil', 'timeFrame': 'day 0, day 15, day 30 and month 2', 'description': 'score of 0 (absence of contraction) to 5 (normal force)'}, {'measure': 'assess functional walking ability', 'timeFrame': 'day 0, day 15, day 30 and month 2', 'description': 'measured with 2 Minute Walk Test'}, {'measure': 'score of postural assessment scale for stroke', 'timeFrame': 'day 0, day 15, day 30 and month 2', 'description': "measures the patient's ability to maintain stable postures, as well as balance in changes of position score of 0 (cannot perform the activity) to 36 (can perform the activity)"}, {'measure': 'analysis of static equilibrium', 'timeFrame': 'day 0, day 15, day 30 and month 2', 'description': 'with Winposturo platform'}, {'measure': 'positional measurement of the center of gravity', 'timeFrame': 'day 0, day 15, day 30 and month 2', 'description': 'with Winposturo platform'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['muscle vibration protocol', 'anterior tibia muscle', 'hemiplegic patient'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'In about 40 percent of cases, after a stroke, neuromotor impairment leads to activity limitations and the development of chronic functional disorders, which have a significant impact on patient autonomy.\n\nIn the early subacute phase, motor deficit in foot lifters is one of the factors limiting standing posture and ambulation, which is ultimately difficult to rehabilitate due to the lack of available techniques for obtaining early onset of useful active voluntary contraction.\n\nThe use of muscular focal vibration therapy, applied to relaxed muscle, may be of interest due to the portability and availability of the system and the neuromotor benefits demonstrated in healthy subjects and in acute and chronic post-stroke patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having had a stroke (with or without previous stroke) and being in the early subacute phase (between 14 days and 3 months of stroke).\n* Responsible for a motor deficit in the right or left lower limb.\n* No neurological history other than stroke.\n\nExclusion Criteria:\n\n* Multifocal stroke\n* Patient having received a botulinum toxin injection to the lower limb to be vibrated'}, 'identificationModule': {'nctId': 'NCT04737018', 'acronym': 'VIBRATAC', 'briefTitle': 'Impact of a Focal Muscle Vibration Protocol in Front of the the Anterior Tibial Muscle in the Subacute Post-stroke Period on Motor Recovery in Hemiplegic Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Impact of a Focal Muscle Vibration Protocol in Front of the the Anterior Tibial Muscle in the Subacute Post-stroke Period on Motor Recovery in Hemiplegic Patients.', 'orgStudyIdInfo': {'id': '20CH152'}, 'secondaryIdInfos': [{'id': '2020-A03189-30', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'vibration program', 'description': 'a 4-week program of muscular focal vibrations, at the rate of 5 sessions of 30 minutes per week, in addition to conventional rehabilitation. The program will apply a frequency of 100 Hz, with an amplitude of 1 mm', 'interventionNames': ['Other: Fugl-Meyer Assessment (FMA)', 'Other: Medical Research Concil (MRC)', 'Other: 2 Minute Walk Test (2MWT)', 'Other: Timed Up & Go Test', 'Other: Modified Ashworth Scale', 'Other: Postural Assessment Scale for Stroke', 'Device: posturographic recording', 'Other: vibration program']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham program', 'description': 'a 4-week program of muscular focal vibrations, at the rate of 5 sessions of 30 minutes per week, in addition to conventional rehabilitation.', 'interventionNames': ['Other: Fugl-Meyer Assessment (FMA)', 'Other: Medical Research Concil (MRC)', 'Other: 2 Minute Walk Test (2MWT)', 'Other: Timed Up & Go Test', 'Other: Modified Ashworth Scale', 'Other: Postural Assessment Scale for Stroke', 'Device: posturographic recording', 'Other: sham program']}], 'interventions': [{'name': 'Fugl-Meyer Assessment (FMA)', 'type': 'OTHER', 'description': 'assessment of motor skills : measurement of the intensity of reflexes, as well as an assessment of voluntary movements and motor coordination Score from 0 to 34', 'armGroupLabels': ['sham program', 'vibration program']}, {'name': 'Medical Research Concil (MRC)', 'type': 'OTHER', 'description': 'evaluation of muscular strength score from 0 to 5', 'armGroupLabels': ['sham program', 'vibration program']}, {'name': '2 Minute Walk Test (2MWT)', 'type': 'OTHER', 'description': 'Assess functional walking and aerobic abilities', 'armGroupLabels': ['sham program', 'vibration program']}, {'name': 'Timed Up & Go Test', 'type': 'OTHER', 'description': 'measures the time it takes to get up from a chair, walk 10 feet, turn around, return to the seat and sit down', 'armGroupLabels': ['sham program', 'vibration program']}, {'name': 'Modified Ashworth Scale', 'type': 'OTHER', 'description': 'score from 0 to 4 evaluation of spasticity', 'armGroupLabels': ['sham program', 'vibration program']}, {'name': 'Postural Assessment Scale for Stroke', 'type': 'OTHER', 'description': "score from 0 to 36 measures the patient's ability to maintain stable postures and balance in changes of position", 'armGroupLabels': ['sham program', 'vibration program']}, {'name': 'posturographic recording', 'type': 'DEVICE', 'description': 'analysis of static equilibrium parameters and positional measurement of the center of gravity on the Winposturo platform', 'armGroupLabels': ['sham program', 'vibration program']}, {'name': 'vibration program', 'type': 'OTHER', 'description': 'a 4-week program of muscular focal vibrations, at the rate of 5 sessions of 30 minutes per week, in addition to conventional rehabilitation. The program will apply a frequency of 100 Hz, with an amplitude of 1 mm', 'armGroupLabels': ['vibration program']}, {'name': 'sham program', 'type': 'OTHER', 'description': 'a 4-week program of muscular focal vibrations, at the rate of 5 sessions of 30 minutes per week, in addition to conventional rehabilitation.', 'armGroupLabels': ['sham program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'city': 'Saint-Priest-en-Jarez', 'country': 'France', 'facility': 'Le Clos Champirol - Service de Médecine Physique et de Réadaptation', 'geoPoint': {'lat': 45.4739, 'lon': 4.37678}}], 'overallOfficials': [{'name': 'Bruno FERNANDEZ, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU SAINT-ETIENNE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}