Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-25 @ 7:36 PM
Study NCT ID:
NCT00702832
Status:
COMPLETED
Last Update Posted:
2019-12-09
First Post:
2008-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Vestibular Rehabilitation - a Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004244', 'term': 'Dizziness'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D009759', 'term': 'Nystagmus, Pathologic'}, {'id': 'D015837', 'term': 'Vestibular Diseases'}], 'ancestors': [{'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D015835', 'term': 'Ocular Motility Disorders'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D007759', 'term': 'Labyrinth Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-04', 'studyFirstSubmitDate': '2008-06-19', 'studyFirstSubmitQcDate': '2008-06-19', 'lastUpdatePostDateStruct': {'date': '2019-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'vertigo', 'timeFrame': 'at inclusion, 10-12 weeks, 12 months', 'description': 'Vertigo symptom scale (VSS)'}], 'secondaryOutcomes': [{'measure': 'Dizziness', 'timeFrame': 'At inclusion, 10-12 weeks, 12 months', 'description': 'Dizziness Handicap Inventory (DHI), University of California Los Angeles Dizziness Questionnaire (UCLA-DQ), Three questions regarding dizziness on VAS-scale,'}, {'measure': 'Movement provoked dizziness', 'timeFrame': 'at inclusion, 10-12 weeks, 12 months', 'description': 'Rombergs test and advanced Rombergs test'}, {'measure': 'return of symptoms', 'timeFrame': '12 months'}, {'measure': 'sick leave', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vestibular rehabilitation', 'acute vestibular injury', 'Dizziness', 'Nausea', 'Nystagmus', 'Daily life activities', 'Balance', 'physiotherapy'], 'conditions': ['Dizziness', 'Nausea', 'Nystagmus', 'Vestibular Diseases']}, 'referencesModule': {'references': [{'pmid': '31789800', 'type': 'RESULT', 'citation': 'Tokle G, Morkved S, Brathen G, Goplen FK, Salvesen O, Arnesen H, Holmeslet B, Nordahl SHG, Wilhelmsen KT. Efficacy of Vestibular Rehabilitation Following Acute Vestibular Neuritis: A Randomized Controlled Trial. Otol Neurotol. 2020 Jan;41(1):78-85. doi: 10.1097/MAO.0000000000002443.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess if early supported vestibular rehabilitation can reduce dizziness and improve daily life activities in patients with acute vestibular injury.\n\nThe study question is: Does early supported vestibular rehabilitation have an additional effect on dizziness symptoms and daily life functions compared to standard treatment?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* acute symptoms of dizziness, nausea and nystagmus\n* diagnosed by videonystagmography (at least 25% reduced caloric response in one ear)\n* age 18-70 years\n* inclusion within one week after symptom debut\n\nExclusion Criteria:\n\n* chronic dizziness\n* psychiatric diagnosis that might interfere with participation'}, 'identificationModule': {'nctId': 'NCT00702832', 'briefTitle': 'Effect of Vestibular Rehabilitation - a Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'Effects of Vestibular Rehabilitation in the Treatment of Patients With Acute Vestibular Loss. - A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'REK 4.2007.1802'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vestibular rehabilitation', 'description': 'early supported vestibular rehabilitation', 'interventionNames': ['Behavioral: Vestibular rehabilitation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'standard', 'description': 'standard treatment', 'interventionNames': ['Other: standard treatment']}], 'interventions': [{'name': 'Vestibular rehabilitation', 'type': 'BEHAVIORAL', 'description': 'Daily home training (4-6 specific exercises) 2-3 times per day. Group training led by a physiotherapist twice per week during the first 10 weeks and once per week from 10 weeks to 12 months or to symptoms are cured.', 'armGroupLabels': ['Vestibular rehabilitation']}, {'name': 'standard treatment', 'type': 'OTHER', 'description': 'treatment as usual', 'armGroupLabels': ['standard']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7489', 'city': 'Trondheim', 'country': 'Norway', 'facility': 'St. Olavs Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Siv Mørkved, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate professor / senior researcher'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Haukeland University Hospital', 'class': 'OTHER'}, {'name': 'St. Olavs Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}