Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2026-02-24 @ 2:29 PM
Study NCT ID:
NCT02905292
Status:
UNKNOWN
Last Update Posted:
2016-09-19
First Post:
2016-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inactivity, Balance Problems and Fall Risk in Institutionalized Frail Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-16', 'studyFirstSubmitDate': '2016-09-14', 'studyFirstSubmitQcDate': '2016-09-16', 'lastUpdatePostDateStruct': {'date': '2016-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'outcome of the vestibular bedside testing', 'timeFrame': 'baseline', 'description': 'outcome of the vestibular bedside testing (i.e. Dix-Hallpike-, side lying- or roll-test)'}, {'measure': 'outcome of the vestibular bedside testing', 'timeFrame': 'month 1', 'description': 'outcome of the vestibular bedside testing (i.e. Dix-Hallpike-, side lying- or roll-test)'}, {'measure': 'outcome of the vestibular bedside testing', 'timeFrame': 'month 2', 'description': 'outcome of the vestibular bedside testing (i.e. Dix-Hallpike-, side lying- or roll-test)'}, {'measure': 'outcome of the vestibular bedside testing', 'timeFrame': 'month 3', 'description': 'outcome of the vestibular bedside testing (i.e. Dix-Hallpike-, side lying- or roll-test)'}, {'measure': 'outcome of the vestibular bedside testing', 'timeFrame': 'month 4', 'description': 'outcome of the vestibular bedside testing (i.e. Dix-Hallpike-, side lying- or roll-test)'}, {'measure': 'outcome of the vestibular bedside testing', 'timeFrame': 'month 5', 'description': 'outcome of the vestibular bedside testing (i.e. Dix-Hallpike-, side lying- or roll-test)'}, {'measure': 'outcome of the vestibular bedside testing', 'timeFrame': 'month 6', 'description': 'outcome of the vestibular bedside testing (i.e. Dix-Hallpike-, side lying- or roll-test)'}, {'measure': 'static and dynamic balance using the Mobility lab (APDM-sensors)', 'timeFrame': 'baseline', 'description': 'static and dynamic balance using the Mobility lab (APDM-sensors): iSway (COP sway area and velocity with and without vision), iTUG'}, {'measure': 'static and dynamic balance using the Mobility lab (APDM-sensors)', 'timeFrame': 'month 3', 'description': 'static and dynamic balance using the Mobility lab (APDM-sensors): iSway (COP sway area and velocity with and without vision), iTUG'}, {'measure': 'Four Test Balance Scale (4TBS)', 'timeFrame': 'baseline'}, {'measure': 'Four Test Balance Scale (4TBS)', 'timeFrame': 'month 1'}, {'measure': 'Four Test Balance Scale (4TBS)', 'timeFrame': 'month 2'}, {'measure': 'Four Test Balance Scale (4TBS)', 'timeFrame': 'month 3'}, {'measure': 'Four Test Balance Scale (4TBS)', 'timeFrame': 'month 4'}, {'measure': 'Four Test Balance Scale (4TBS)', 'timeFrame': 'month 5'}, {'measure': 'Four Test Balance Scale (4TBS)', 'timeFrame': 'month 6'}, {'measure': 'Functional Ambulation categories (FAC)', 'timeFrame': 'baseline'}, {'measure': 'Functional Ambulation categories (FAC)', 'timeFrame': 'month 1'}, {'measure': 'Functional Ambulation categories (FAC)', 'timeFrame': 'month 2'}, {'measure': 'Functional Ambulation categories (FAC)', 'timeFrame': 'month 3'}, {'measure': 'Functional Ambulation categories (FAC)', 'timeFrame': 'month 4'}, {'measure': 'Functional Ambulation categories (FAC)', 'timeFrame': 'month 5'}, {'measure': 'Functional Ambulation categories (FAC)', 'timeFrame': 'month 6'}, {'measure': 'Dizziness Handicap Inventory (DHI)', 'timeFrame': 'baseline'}, {'measure': 'Dizziness Handicap Inventory (DHI)', 'timeFrame': 'month 3'}], 'secondaryOutcomes': [{'measure': 'Fall incidents', 'timeFrame': 'baseline'}, {'measure': 'Fall incidents', 'timeFrame': 'month 1'}, {'measure': 'Fall incidents', 'timeFrame': 'month 2'}, {'measure': 'Fall incidents', 'timeFrame': 'month 3'}, {'measure': 'Fall incidents', 'timeFrame': 'month 4'}, {'measure': 'Fall incidents', 'timeFrame': 'month 5'}, {'measure': 'Fall incidents', 'timeFrame': 'month 6'}, {'measure': 'fear of falling', 'timeFrame': 'baseline', 'description': 'fear of falling: Falls Efficacy Scale'}, {'measure': 'fear of falling', 'timeFrame': 'month 3', 'description': 'fear of falling: Falls Efficacy Scale'}, {'measure': 'depression', 'timeFrame': 'baseline', 'description': 'depression: Geriatric depression scale'}, {'measure': 'depression', 'timeFrame': 'month 3', 'description': 'depression: Geriatric depression scale'}, {'measure': 'ambulatory activity level', 'timeFrame': 'baseline', 'description': 'ambulatory activity level: the StepWatch Activity Monitor (SAM)'}, {'measure': 'ambulatory activity level', 'timeFrame': 'month 3', 'description': 'ambulatory activity level: the StepWatch Activity Monitor (SAM)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Institutional Frail Elderly']}, 'descriptionModule': {'briefSummary': 'The overall objective of the research is to identify the prevalence and incidence of BPPV and the impact on balance problems, fall risk and inactivity in frail elderly. The investigators will demonstrate the importance of early diagnosis and treatment in this patient group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'institutionalized frail elderly', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Institutionalized in a nursing home for at least 3 months\n* Able to understand and follow simple instructions\n* Able to stand independently for 30 seconds\n* Willing to participate in the study\n\nExclusion Criteria:\n\n* diagnosis of progressive neurological diseases (such as Amyotrophic Lateral Sclerosis) resulting in a fast decline within 3 months\n* Rehabilitating for a neurological or orthopaedic incident such as knee prosthesis, stroke,… )\n* Contra-indication for Hallpike and Epley maneuver'}, 'identificationModule': {'nctId': 'NCT02905292', 'briefTitle': 'Inactivity, Balance Problems and Fall Risk in Institutionalized Frail Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Hasselt University'}, 'officialTitle': 'Inactivity, Balance Problems and Fall Risk in Institutionalized Frail Elderly: What is the Impact of Benign Paroxysmal Positional Vertigo (BPPV) and Treatment Effectiveness?', 'orgStudyIdInfo': {'id': 'BPPV-ELDERLY-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'evaluation and treatment maneuver for BPPV', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3500', 'city': 'Hasselt', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Joke Spildooren, dr.', 'role': 'CONTACT'}], 'facility': 'Hasselt University', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}], 'centralContacts': [{'name': 'Joke Spildooren, dr.', 'role': 'CONTACT', 'email': 'joke.spildooren@uhasselt.be'}], 'overallOfficials': [{'name': 'Joke spildooren, dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hasselt University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hasselt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'dr.', 'investigatorFullName': 'JSpildooren', 'investigatorAffiliation': 'Hasselt University'}}}}