Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-01-01 @ 4:28 AM
Study NCT ID:
NCT01505556
Status:
WITHDRAWN
Last Update Posted:
2019-02-08
First Post:
2012-01-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Proprioceptive Postural Control and Diaphragm Paresis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Problems to recruit individuals with diaphragm paresis.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2015-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-07', 'studyFirstSubmitDate': '2012-01-04', 'studyFirstSubmitQcDate': '2012-01-05', 'lastUpdatePostDateStruct': {'date': '2019-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}}, '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Proprioceptive Postural Control', 'Respiratory Disorders', 'Chronic Obstructive Pulmonary Disease']}, '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. Increased risk of falling is reported in individuals with chronic obstructive pulmonary disease. Besides the essential role of respiration, the diaphragm may also play an important role in the control of the trunk and postural balance.\n\nThe aim of the study is to clarify whether proprioceptive postural control is impaired in individuals with diaphragm paresis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients from the University Hospital Leuven - Respiratory Disvision', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria individuals with diaphragm paresis:\n\n* Age: 18-70 years old\n* Unilateral or bilateral diaphragm paresis following paresis of phrenic nerve\n* Willingness to sign the informed consent\n\nInclusion Criteria healthy controls:\n\n* Age: 18-70 years old\n* Spirometry: FEV1/FVC ≥ 0.7 and FEV1 \\> 80%\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\n* Respiratory disorder other than diaphragm paresis\n* Recent diagnosis of cancer\n* Significant cardiovascular comorbidity'}, 'identificationModule': {'nctId': 'NCT01505556', 'briefTitle': 'Proprioceptive Postural Control and Diaphragm Paresis', 'organization': {'class': 'OTHER', 'fullName': 'KU Leuven'}, 'orgStudyIdInfo': {'id': '2012_SBrumagne_DiaphParesis'}, 'secondaryIdInfos': [{'id': '1.5.104.03, G.0674.09', 'type': 'OTHER_GRANT', 'domain': 'Research Foundation Flanders (FWO)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diaphragm paresis'}, {'label': 'Healthy controls'}]}, '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'}, {'name': 'Thierry Troosters, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KU Leuven'}, {'name': 'Wim Janssens, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KU Leuven'}, {'name': 'Marc Decramer, MD, 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'}}}}