Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2026-02-25 @ 6:59 PM
Study NCT ID:
NCT02121093
Status:
UNKNOWN
Last Update Posted:
2014-04-23
First Post:
2014-04-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Vibration Stimulation Applied to Different Frequencies in Cortical Excitability and Muscular Function: Randomised Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014732', 'term': 'Vibration'}], 'ancestors': [{'id': 'D055595', 'term': 'Mechanical Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-04-21', 'studyFirstSubmitDate': '2014-04-07', 'studyFirstSubmitQcDate': '2014-04-21', 'lastUpdatePostDateStruct': {'date': '2014-04-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of vibration stimulation applied to different frequencies in cortical excitability and muscular function: randomised clinical trial', 'timeFrame': '1 month', 'description': 'We know that the vibration has multiple physiologic effects, promoting normal patterns of motor activity by changing motor-neuron excitability. Vibrations increase the final afferent influx of the primary muscular fuse, allowing the reflex contraction, the so-called tonic vibration reflex . This reflex is mediated by both segmental and supra-segmental spine path, and is supported by upper centres.'}, {'measure': 'Effect of vibration stimulation applied to different frequencies in cortical excitability and muscular function: randomised clinical trial', 'timeFrame': '1 month', 'description': 'The 80 volunteers will be randomly gathered in study groups by random computer-given numbers.\n\nFrom these 80 volunteers, 20 will be in the evaluation group (EG); 20 will participate in the group of low-frequency vibration stimulation (LFVS); 20 in the group of medium-frequency vibration stimulation (MFVS); and 20 will take part in the group of high-frequency vibration stimulation (HFVS).'}, {'measure': 'Effect of vibration stimulation applied to different frequencies in cortical excitability and muscular function: randomised clinical trial', 'timeFrame': '1 month', 'description': 'The 80 volunteers will be randomly gathered in study groups by random computer-given numbers.\n\nFrom these 80 volunteers, 20 will be in the evaluation group (EG); 20 will participate in the group of low-frequency vibration stimulation (LFVS); 20 in the group of medium-frequency vibration stimulation (MFVS); and 20 will take part in the group of high-frequency vibration stimulation (HFVS).\n\nThe three groups is intended to observe increased alpha band'}], 'secondaryOutcomes': [{'measure': 'Effect of vibration stimulation applied to different frequencies in cortical excitability and muscular function: randomised clinical trial', 'timeFrame': '1 month', 'description': 'The 80 volunteers will be randomly gathered in study groups by random computer-given numbers.\n\nFrom these 80 volunteers, 20 will be in the evaluation group (EG); 20 will participate in the group of low-frequency vibration stimulation (LFVS); 20 in the group of medium-frequency vibration stimulation (MFVS); and 20 will take part in the group of high-frequency vibration stimulation (HFVS).\n\nThe three groups is intended to observe increased electromyographic activity of the muscles'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['vibration', 'physiotherapy', 'cortex', 'muscles'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The vibration stimulation is regarded as a new method of training and therapy to change afferent parts and cortical projections, which are important for motor control. This study aims to check effects of different frequency parameters for electrical cortical potentials and electrical muscular potentials in healthy young adults. 80 volunteers will participate in the study, and they will be randomly subdivided in four groups for trials. The methodology consists of electroencephalographic and electromyographic assessment before and after 15-minute vibration application with a digital vibratory pad.', 'detailedDescription': 'The vibratory stimulation is regarded as a new training method and capable of modulating peripheral afferents and cortical projections therapy, which are important in motor control. This study aims to determine the effects of different parameters on cortical frequency electric potential and electric potential muscle in healthy young adults. Will participate in the study 80 volunteers, these randomly divided into four groups for the experimental procedures. The methodological approach consists of an electroencephalographic and electromyographic evaluation before and after 15 minutes of application of vibration through a digital vibrating pad.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physically and mentally healthy\n* Right-handed volunteers who are not using psychoactive or psychotropic substances,\n* Have nourished themselves up to three hours before the experiment.\n\nExclusion Criteria:\n\n* Under 18-year- and over-60-old volunteers\n* who do not fit into using data collection equipment,\n* individuals who have slept less than six to eight hours the night before the experiment,\n* who have already undergone vibration training and had problems with using it.'}, 'identificationModule': {'nctId': 'NCT02121093', 'briefTitle': 'Effect of Vibration Stimulation Applied to Different Frequencies in Cortical Excitability and Muscular Function: Randomised Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Universidade do Vale do Paraíba'}, 'officialTitle': 'Effect of Vibration Stimulation Applied to Different Frequencies in Cortical Excitability and Muscular Function: Randomised Clinical Trial', 'orgStudyIdInfo': {'id': 'janaina de moraes silva'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'alpha band of the EEG and electromyographic activity', 'description': '\\- 20 will be in the evaluation group (EG); then review the alpha band of EEG and EMG activity.'}, {'type': 'EXPERIMENTAL', 'label': 'Vibration', 'description': '* • 20 vai participar no grupo de baixa freqüência de vibração estimulação (LFVS);\n* 20 no grupo de estimulação da vibração de média freqüência (MFVS);\n* 20 vai participar no grupo de alta freqüência de vibração estimulação (HFVS). then review the alpha band of EEG and EMG activity.', 'interventionNames': ['Procedure: vibration']}], 'interventions': [{'name': 'vibration', 'type': 'PROCEDURE', 'armGroupLabels': ['Vibration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64020290', 'city': 'Teresina', 'state': 'Piauí', 'country': 'Brazil', 'contacts': [{'name': 'janaina silva', 'role': 'CONTACT', 'email': 'fisiojanainams@gmail.com', 'phone': '558699317552'}, {'name': 'janaina', 'role': 'CONTACT', 'email': 'fisiojanainams@gmail.com', 'phone': '558699317552'}], 'facility': 'Janaina de Moraes Silva', 'geoPoint': {'lat': -5.08917, 'lon': -42.80194}}], 'centralContacts': [{'name': 'janaina silva', 'role': 'CONTACT', 'email': 'fisiojanainams@gmail.com', 'phone': '558699317552'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade do Vale do Paraíba', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Effect of vibration stimulation applied to different frequencies in cortical excitability and muscular function: randomised clinical trial', 'investigatorFullName': 'Izabela dos Santos Mendes', 'investigatorAffiliation': 'Universidade do Vale do Paraíba'}}}}