Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT01541020
Status:
COMPLETED
Last Update Posted:
2013-12-05
First Post:
2012-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Inspiratory Resistive Loading and Proprioceptive Postural Control
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-04', 'studyFirstSubmitDate': '2012-01-04', 'studyFirstSubmitQcDate': '2012-02-23', 'lastUpdatePostDateStruct': {'date': '2013-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proprioceptive postural control', 'timeFrame': '1 year', 'description': 'Center of pressure displacement (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.'}], 'secondaryOutcomes': [{'measure': 'Back muscle oxygenation', 'timeFrame': '1 year', 'description': 'Near infrared spectroscopy: tissue oxygenation index (TOI) and haemoglobin'}, {'measure': 'Kinematics', 'timeFrame': '1 year', 'description': 'piezoresistive accelerometers'}, {'measure': 'Respiratory muscle force', 'timeFrame': '1 year', 'description': 'maximal inspiratory pressure - maximal expiratory pressure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Low Back Pain', 'Respiratory Loading', 'Proprioceptive Impairment']}, 'referencesModule': {'references': [{'pmid': '20393397', 'type': 'BACKGROUND', 'citation': 'Janssens L, Brumagne S, Polspoel K, Troosters T, McConnell A. The effect of inspiratory muscles fatigue on postural control in people with and without recurrent low back pain. Spine (Phila Pa 1976). 2010 May 1;35(10):1088-94. doi: 10.1097/BRS.0b013e3181bee5c3.'}]}, 'descriptionModule': {'briefSummary': 'Proprioceptive weighting changes may explain differences in postural control performance. In addition, the respiratory movement has a disturbing effect on postural balance. Postural balance seems to be impaired in individuals with respiratory disorders. Besides the essential role of respiration, the diaphragm may also play an important role in the control of the trunk and postural balance. Deficits in proprioception are found in a subgroup of patients with low back pain. In addition, disorders of respiration have been identified as strongly related to low back pain.\n\nThe aim of the study is to clarify whether loading of the inspiratory muscles has a negative effect upon proprioceptive postural control in healthy individuals and individuals with recurrent low back pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'young flemish volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria individuals with low back pain:\n\n* Age: 18-45 years old\n* At least 1 year of low back pain with/without referred pain in buttock/thigh\n* At least 3 episodes of disabling low back pain\n* At least a score of 20% on the Oswestry Disability Index\n* Willingness to sign the informed consent\n\nInclusion Criteria healthy individuals:\n\n* Age: 18-45 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, the pelvis or the lower quadrant\n* One of the following conditions: Parkinson, multiple sclerosis, stroke, history of vestibular disorder, respiratory disease, pregnancy\n* Radicular symptoms\n* Not Dutch-speaking\n* Strong opioids\n* Neck pain\n* Smoking history'}, 'identificationModule': {'nctId': 'NCT01541020', 'briefTitle': 'Inspiratory Resistive Loading and Proprioceptive Postural Control', 'organization': {'class': 'OTHER', 'fullName': 'KU Leuven'}, 'officialTitle': 'Inspiratory Resistive Loading and Proprioceptive Postural Control in Healthy Individuals and Individuals With Recurrent Low Back Pain', 'orgStudyIdInfo': {'id': '2011_SBrumagne_HealthyLBP'}, 'secondaryIdInfos': [{'id': '1.5.104.03, G.0674.09', 'type': 'OTHER_GRANT', 'domain': 'Research Foundation Flanders (FWO)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy individuals'}, {'label': 'Individuals with low back pain'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams-Brabant', 'country': 'Belgium', 'facility': 'Katholieke Universiteit Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Simon Brumagne, PhD', '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': 'Prof. dr. Simon Brumagne', 'investigatorFullName': 'Simon Brumagne', 'investigatorAffiliation': 'KU Leuven'}}}}