Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-28 @ 6:56 AM
Study NCT ID:
NCT00275392
Status:
COMPLETED
Last Update Posted:
2014-12-09
First Post:
2006-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vestibular Rehabilitation and Dizziness in Geriatric Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004244', 'term': 'Dizziness'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'courtney.hall@va.gov', 'phone': '423-926-1171', 'title': 'Courtney D. Hall, PhD', 'phoneExt': '7518', 'organization': 'James H. Quillen VAMC'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Vestibular Rehabilitation', 'description': 'vestibular exercises plus standard balance and gait exercises\n\nVestibular rehabilitation: vestibular adaptation and substitution exercises', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'placebo exercises plus standard balance and gait exercises\n\nPlacebo Vestibular rehabilitation: placebo vestibular exercises', 'otherNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Dynamic Gait Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vestibular Rehabilitation', 'description': 'vestibular exercises plus standard balance and gait exercises\n\nVestibular rehabilitation: vestibular adaptation and substitution exercises'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo exercises plus standard balance and gait exercises\n\nPlacebo Vestibular rehabilitation: placebo vestibular exercises'}], 'classes': [{'title': 'Discharge (6 weeks)', 'categories': [{'measurements': [{'value': '18.9', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '18.9', 'spread': '3.0', 'groupId': 'OG001'}]}]}, {'title': 'Baseline', 'categories': [{'measurements': [{'value': '14.2', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '16.1', 'spread': '2.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.026', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Interaction effect', 'statisticalMethod': 'RM ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<.001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'main effect of time', 'statisticalMethod': 'RM ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '>.05', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'main effect of group', 'statisticalMethod': 'RM ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Fall risk was determined using the Dynamic Gait Index (DGI). A maximum total score of 24 is possible and a total score of \\< 20 indicates risk for falling.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol analyses (i.e., only subjects who completed the intervention were included).'}, {'type': 'SECONDARY', 'title': 'Dynamic Visual Acuity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vestibular Rehabilitation', 'description': 'vestibular exercises plus standard balance and gait exercises\n\nVestibular rehabilitation: vestibular adaptation and substitution exercises'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo exercises plus standard balance and gait exercises\n\nPlacebo Vestibular rehabilitation: placebo vestibular exercises'}], 'classes': [{'title': 'Discharge (6 weeks)', 'categories': [{'measurements': [{'value': '0.14', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '0.19', 'spread': '0.08', 'groupId': 'OG001'}]}]}, {'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.20', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '0.21', 'spread': '0.10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '> 0.05', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Interaction effect', 'statisticalMethod': 'RM ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '.016', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'main effect of time', 'statisticalMethod': 'RM ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '>.05', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'Main effect of Group', 'statisticalMethod': 'RM ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'description': 'Visual acuity during head movement (dynamic visual acuity, DVA) was measured using customized computerized software. DVA is measured in Logarithm of the Minimum Angle of Resolution (LogMAR). Participants identified letters while turning the head from side to side between 120 and 180 deg/s. DVA, the difference in acuity between head stationary and moving, is reported as the average of rightward and leftward scores; higher scores indicate worse visual acuity.', 'unitOfMeasure': 'LogMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vestibular Rehabilitation', 'description': 'vestibular exercises plus standard balance and gait exercises\n\nVestibular rehabilitation: vestibular adaptation and substitution exercises'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'placebo exercises plus standard balance and gait exercises\n\nPlacebo Vestibular rehabilitation: placebo vestibular exercises'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Vestibular Rehabilitation', 'description': 'vestibular exercises plus standard balance and gait exercises\n\nVestibular rehabilitation: vestibular adaptation and substitution exercises'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'placebo exercises plus standard balance and gait exercises\n\nPlacebo Vestibular rehabilitation: placebo vestibular exercises'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.6', 'spread': '6.5', 'groupId': 'BG000'}, {'value': '74.5', 'spread': '8.5', 'groupId': 'BG001'}, {'value': '73.8', 'spread': '7.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Dynamic Gait Index', 'classes': [{'categories': [{'measurements': [{'value': '14.2', 'spread': '3.1', 'groupId': 'BG000'}, {'value': '16.1', 'spread': '2.6', 'groupId': 'BG001'}, {'value': '15.1', 'spread': '3.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Dynamic Gait Index (DGI) measures the ability to adapt gait to external demands and also is used to assess fall risk while walking. The eight items of the DGI include walking while changing speed and turning the head, walking over and around obstacles, and stair climbing. Scoring of the DGI is based on a 4-point scale from 0 to 3 with 0 indicating severe impairment and 3 indicating normal ability. A maximum total score of 24 is possible and scores of \\< 20 indicate risk for falling.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Dynamic Visual Acuity', 'classes': [{'categories': [{'measurements': [{'value': '0.20', 'spread': '0.08', 'groupId': 'BG000'}, {'value': '0.14', 'spread': '0.07', 'groupId': 'BG001'}, {'value': '0.16', 'spread': '0.08', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Visual acuity during head movement (dynamic visual acuity, DVA) was measured using customized computerized software. Participants identified letters while turning the head from side to side between 120 and 180 deg/s. DVA, the difference in acuity between head stationary and moving, is reported as the average of rightward and leftward scores; higher scores indicate worse visual acuity (0.00 LogMAR = 20/20).', 'unitOfMeasure': 'LogMAR', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-05', 'studyFirstSubmitDate': '2006-01-10', 'resultsFirstSubmitDate': '2014-09-17', 'studyFirstSubmitQcDate': '2006-01-10', 'lastUpdatePostDateStruct': {'date': '2014-12-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-10-09', 'studyFirstPostDateStruct': {'date': '2006-01-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dynamic Gait Index', 'timeFrame': '6 weeks', 'description': 'Fall risk was determined using the Dynamic Gait Index (DGI). A maximum total score of 24 is possible and a total score of \\< 20 indicates risk for falling.'}], 'secondaryOutcomes': [{'measure': 'Dynamic Visual Acuity', 'timeFrame': '6 weeks', 'description': 'Visual acuity during head movement (dynamic visual acuity, DVA) was measured using customized computerized software. DVA is measured in Logarithm of the Minimum Angle of Resolution (LogMAR). Participants identified letters while turning the head from side to side between 120 and 180 deg/s. DVA, the difference in acuity between head stationary and moving, is reported as the average of rightward and leftward scores; higher scores indicate worse visual acuity.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dizziness', 'Geriatrics', 'Rehabilitation', 'Vestibular rehabilitation'], 'conditions': ['Dizziness']}, 'referencesModule': {'references': [{'pmid': '20588090', 'type': 'RESULT', 'citation': 'Hall CD, Heusel-Gillig L, Tusa RJ, Herdman SJ. Efficacy of gaze stability exercises in older adults with dizziness. J Neurol Phys Ther. 2010 Jun;34(2):64-9. doi: 10.1097/NPT.0b013e3181dde6d8.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to develop effective exercise intervention to reduce dizziness and fall risk in older adults with non-specific dizziness. We hypothesize that the use of vestibular exercises can reduce dizziness and improve gaze and postural stability in older persons.', 'detailedDescription': 'Community dwelling older individuals who present to a specialty dizziness clinic (Atlanta VAMC or Emory University) with a primary complaint of dizziness will be recruited to participate in this study. Before beginning the study, the presence of normal vestibular function will be measured directly using standard vestibular function tests. Individuals will be randomly assigned to the vestibular exercise group (VR) or to the control group (CON). Data will be collected prior to the initiation of physical therapy and at the completion of the 6-week intervention period.\n\nThe VR group will perform vestibular exercises plus balance and gait exercises. The CON group will perform saccadic eye movements without targets against a blank wall, as well as balance and gait exercises. The balance and gait exercises for each group will be based on identified impairments and functional limitations, as is the standard of care in physical therapy. All subjects within a group will follow the same exercise progression for the vestibular or eye movement exercises. Subjects will be seen in the clinic on a weekly basis to review and modify the exercises according to a standard protocol and to reinforce compliance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients must be at least 60 years of age, seeking medical care due to dizziness and have normal vestibular function based on results of the clinical examination, rotary chair and/or caloric tests.\n\nExclusion Criteria:\n\nAbnormal vestibular function based on results of clinical examination, rotary chair and/or caloric tests.'}, 'identificationModule': {'nctId': 'NCT00275392', 'briefTitle': 'Vestibular Rehabilitation and Dizziness in Geriatric Patients', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Vestibular Rehabilitation and Dizziness in Geriatric Patients', 'orgStudyIdInfo': {'id': 'C4168-P'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vestibular Rehabilitation', 'description': 'vestibular exercises plus standard balance and gait exercises', 'interventionNames': ['Behavioral: Vestibular rehabilitation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'placebo exercises plus standard balance and gait exercises', 'interventionNames': ['Behavioral: Placebo']}], 'interventions': [{'name': 'Vestibular rehabilitation', 'type': 'BEHAVIORAL', 'description': 'vestibular adaptation and substitution exercises', 'armGroupLabels': ['Vestibular Rehabilitation']}, {'name': 'Placebo', 'type': 'BEHAVIORAL', 'description': 'placebo vestibular exercises', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30033', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta VA Medical and Rehab Center, Decatur', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}], 'overallOfficials': [{'name': 'Courtney D. Hall, PhD PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}