Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2026-02-23 @ 3:01 PM
Study NCT ID:
NCT02007135
Status:
COMPLETED
Last Update Posted:
2015-10-16
First Post:
2013-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Pneumatic and Electromagnetic Muscle Vibrators to Stimulate Muscle Proprioceptors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-14', 'studyFirstSubmitDate': '2013-12-05', 'studyFirstSubmitQcDate': '2013-12-05', 'lastUpdatePostDateStruct': {'date': '2015-10-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proprioceptive postural control', 'timeFrame': '6 months', 'description': 'Center of pressure displacement on a force plate in standing in response to local muscle vibration on ankle and back muscles to specifically detect the role of proprioception in postural control.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Proprioceptive Postural Control']}, 'referencesModule': {'references': [{'pmid': '20824281', 'type': 'BACKGROUND', 'citation': 'Claeys K, Brumagne S, Dankaerts W, Kiers H, Janssens L. Decreased variability in postural control strategies in young people with non-specific low back pain is associated with altered proprioceptive reweighting. Eur J Appl Physiol. 2011 Jan;111(1):115-23. doi: 10.1007/s00421-010-1637-x. Epub 2010 Sep 8.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the concurrent validity of a newly developed pneumatic, fMRI compatible muscle vibrator as compared to a electromagnetic muscle vibrator in the stimulation of muscle proprioceptors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Young Flemish Volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria for healthy individuals:\n\n* Age: 20-45 years old\n* No history of low back pain\n* A score of 0% on the Oswestry Disability Index\n* Willingness to sign the informed consent\n\nExclusion Criteria:\n\n* History of major trauma and/or major orthopedic surgery of the spine, pelvis or lower quadrant\n* One of the following conditions: Parkinson, MS, Stroke with sequels....\n* Radicular symptoms\n* Not Dutch-speaking\n* Strong opioids\n* Neck pain\n* Ankle problems\n* Smoking'}, 'identificationModule': {'nctId': 'NCT02007135', 'briefTitle': 'Comparison of Pneumatic and Electromagnetic Muscle Vibrators to Stimulate Muscle Proprioceptors', 'organization': {'class': 'OTHER', 'fullName': 'KU Leuven'}, 'officialTitle': 'Comparison of fMRI Compatible Pneumatic and Electromagnetic Muscle Vibrators to Stimulate Muscle Proprioceptors', 'orgStudyIdInfo': {'id': '2013_SBrumagne_pneumvibrators'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy', 'description': 'Healthy persons, without non-specific low back pain'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Katholieke Universiteit Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Simon Brumagne, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KU Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KU Leuven', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Simon Brumagne', 'investigatorFullName': 'Simon Brumagne', 'investigatorAffiliation': 'KU Leuven'}}}}