Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 11:54 PM
Study NCT ID:
NCT06271694
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2024-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Activity and Participation in Vestibular Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015837', 'term': 'Vestibular Diseases'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D007759', 'term': 'Labyrinth Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2024-01-11', 'studyFirstSubmitQcDate': '2024-02-20', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Late-life Function and Disability Instrument', 'timeFrame': '8-weeks', 'description': 'Activity and Participation (raw 16-80; scale 0-100 min-max scores); higher is better'}, {'measure': 'Dizziness Handicap Inventory', 'timeFrame': '8-weeks', 'description': 'Dizziness disability; 0-100 (min-max score); higher is greater disability.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vestibular Rehabilitation', 'Activity and Participation'], 'conditions': ['Vestibular Disorder']}, 'descriptionModule': {'briefSummary': 'This study will examine whether impairments and personal factors are associated with activity and participation in people with vestibulopathy. Data collection will occur prior to starting vestibular rehabilitation and after completing vestibular rehabilitation.', 'detailedDescription': 'Adults aged 18-years and older with symptomatic complaints of dizziness and/or imbalance and a medical diagnosis of unilateral vestibular hypofunction will be recruited at the time of their entry into vestibular rehabilitation. The investigators will analyze what factors (impairments and personal factors) are related to activity and participation in people with vestibular disorders and see if change in activity and participation is related to recovery from vestibulopathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- 18-years and older with symptomatic complaints of dizziness and/or imbalance and a medical diagnosis of unilateral vestibular hypofunction\n\nExclusion Criteria:\n\n* 1\\. Cognition \\<18 on Montreal Cognitive Assessment (MoCA)\n* 2\\. Visual acuity worse than 20/40 with corrected lenses\n* 3\\. Loss of protective distal sensation (defined as the inability to feel a 4.31 size monofilament on the plantar surface of the foot)\n* 4\\. Inability to engage in community mobility'}, 'identificationModule': {'nctId': 'NCT06271694', 'acronym': 'APV', 'briefTitle': 'Activity and Participation in Vestibular Disorders', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Impairments and Personal Factors Associated With Activity and Participation in Vestibular Rehabilitation', 'orgStudyIdInfo': {'id': 'STUDY22020027'}, 'secondaryIdInfos': [{'id': '1K23DC020215-01', 'link': 'https://reporter.nih.gov/quickSearch/1K23DC020215-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Standard Vestibular Rehabilitation', 'description': 'All participants will receive standard vestibular rehabilitation', 'interventionNames': ['Other: Vestibular Rehabilitation']}], 'interventions': [{'name': 'Vestibular Rehabilitation', 'type': 'OTHER', 'description': 'Standard vestibular rehabilitation', 'armGroupLabels': ['Standard Vestibular Rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15206', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Chelsea Behling', 'role': 'CONTACT', 'email': 'chb317@pitt.edu', 'phone': '412-624-8811'}], 'facility': 'UPMC-Rehab Institute', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'centralContacts': [{'name': 'Chelsea Behling', 'role': 'CONTACT', 'email': 'chb317@pitt.edu', 'phone': '412-624-8811'}], 'overallOfficials': [{'name': 'Brooke Klatt, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Professor'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Immediately following article publication. No end date.', 'ipdSharing': 'YES', 'description': 'De-identified participant data that underlie the results reported in the article could be shared with researchers who provide a methodologically sound proposal.', 'accessCriteria': 'To gain access to data requestors will need to sign a data access agreement and proposals should be directed at klattresearch@pitt.edu'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Deafness and Other Communication Disorders (NIDCD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Brooke Klatt', 'investigatorAffiliation': 'University of Pittsburgh'}}}}