Ignite Creation Date:
2025-12-24 @ 2:34 PM
Ignite Modification Date:
2026-01-02 @ 8:18 AM
Study NCT ID:
NCT03589859
Status:
COMPLETED
Last Update Posted:
2024-11-26
First Post:
2018-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Computerized Vestibular Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015837', 'term': 'Vestibular Diseases'}], 'ancestors': [{'id': 'D007759', 'term': 'Labyrinth Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mark.walker5@va.gov', 'phone': '216-791-3800', 'title': 'Dr. Mark Walker', 'phoneExt': '65229', 'organization': 'VA Northeast Ohio Healthcare System'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': "No conclusions can be made regarding the therapeutic efficacy of the computer game for treatment of vestibular hypofunction, because the study was not designed to test that. Instead, its objectives were, first, to test the game's ability to induce motor learning, to establish a physiological basis for therapeutic use, and, second, to test feasibility and playability by individuals with vestibular disorders."}}, 'adverseEventsModule': {'timeFrame': 'For the full duration of the study (4 years).', 'description': 'The procedure was to report adverse events to the local IRB.', 'eventGroups': [{'id': 'EG000', 'title': 'Normal Volunteers', 'description': 'Testing motor learning\n\nVOR Test: Video-oculography is used to record the vestibulo-ocular reflex during active and passive turns of the head.\n\nComputer Game: Participants play a custom computer game that is designed to produce motor learning in the vestibulo-ocular reflex', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Vestibular Hypofunction', 'description': 'Testing feasibility of rehabilitation game\n\nVOR Test: Video-oculography is used to record the vestibulo-ocular reflex during active and passive turns of the head.\n\nComputer Game: Participants play a custom computer game that is designed to produce motor learning in the vestibulo-ocular reflex\n\nNausea Scale: Participants asked to rate their subjective nausea on a numeric scale after playing units of the computer game', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Vestibulo-ocular Reflex Gain Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Volunteers', 'description': 'Healthy individuals with intact vestibular function\n\nVOR Test: Video-oculography is used to record the vestibulo-ocular reflex during active and passive turns of the head.\n\nComputer Game: Participants play a custom computer game that is designed to produce motor learning in the vestibulo-ocular reflex'}, {'id': 'OG001', 'title': 'Vestibular Hypofunction', 'description': 'Veterans with vestibular hypofunction'}], 'classes': [{'categories': [{'measurements': [{'value': '1.15', 'groupId': 'OG000', 'lowerLimit': '1.10', 'upperLimit': '1.20'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'groupDescription': 'A linear mixed effects model was used to compare pre- and post-training VOR gains', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'This was a physiology study, not a treatment trial. The test was for a change in VOR gain.'}], 'paramType': 'MEAN', 'timeFrame': 'VOR measurements to determine gain were performed immediately before and after each approximately 30 minute training session. Pre- and post-training gains were then combined in the VOR gain ratio to determine the training effect.', 'description': 'The vestibulo-ocular reflex gain is the relationship between a rotation of the head and the evoked eye movement. The outcome measure is the ratio of the VOR gain after training to that before training. VOR gain is determined by a scaled fit of eye speed to evoking head speed (normal gain is 1). Note that this experiment was not a treatment of impairment but a test of the ability of the vestibular game to elicit motor learning (away from normal) in individuals with intact motor learning. In that context, an increase in the gain to a value greater than unity (faster eye movement relative to the head movement) is "better" with respect to the training goal, but it is not "better" with respect to real-world visual function, for which a gain of one is the goal. There is no threshold value for this type of motor learning experiment. Instead, the question is whether the gain is increased after training, and if so, by what percentage relative to the training goal.', 'unitOfMeasure': 'unitless gain ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'This measure applied only to Group 1: healthy individuals with intact vestibular function'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Nausea Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Normal Volunteers', 'description': 'Healthy individuals with intact vestibular function\n\nVOR Test: Video-oculography is used to record the vestibulo-ocular reflex during active and passive turns of the head.\n\nComputer Game: Participants play a custom computer game that is designed to produce motor learning in the vestibulo-ocular reflex'}, {'id': 'OG001', 'title': 'Vestibular Hypofunction', 'description': 'Veterans with vestibular hypofunction'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '4.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Immediately after each 10-minute game block, median value calculated for each participant', 'description': 'Participants with vestibular hypofunction rated their nausea after each game block on a scale of 1 to 10. For each visit, there were up to 3 game-blocks, each of 10-minutes duration. The number of blocks was determined by the participant. A higher score is a worse outcome (more nausea). The average nausea scale rating was determined for each participant. The final result is the median of these averaged scores.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This measure applied only to Group 2: participants with vestibular dysfunction. Of the 6 enrolled participants in this group, one chose not to complete the game playing after consenting, and a second was found to have recovery of his vestibular function before game playing. The reported data are from the remaining four participants.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Normal Volunteers', 'description': 'Healthy individuals with intact vestibular function\n\nVOR Test: Video-oculography is used to record the vestibulo-ocular reflex during active and passive turns of the head.\n\nComputer Game: Participants play a custom computer game that is designed to produce motor learning in the vestibulo-ocular reflex'}, {'id': 'FG001', 'title': 'Vestibular Hypofunction', 'description': 'Veterans with peripheral vestibular hypofunction\n\nVOR Test: Video-oculography is used to record the vestibulo-ocular reflex during active and passive turns of the head.\n\nComputer Game: Participants play a custom computer game that is designed to produce motor learning in the vestibulo-ocular reflex'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Normal Volunteers', 'description': 'Healthy individuals with intact vestibular function\n\nVOR Test: Video-oculography is used to record the vestibulo-ocular reflex during active and passive turns of the head.\n\nComputer Game: Participants play a custom computer game that is designed to produce motor learning in the vestibulo-ocular reflex'}, {'id': 'BG001', 'title': 'Vestibular Hypofunction', 'description': 'Veterans with peripheral vestibular hypofunction\n\nVOR Test: Video-oculography is used to record the vestibulo-ocular reflex during active and passive turns of the head.\n\nComputer Game: Participants play a custom computer game that is designed to produce motor learning in the vestibulo-ocular reflex'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '35', 'spread': '13', 'groupId': 'BG000'}, {'value': '61', 'spread': '15', 'groupId': 'BG001'}, {'value': '42', 'spread': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Dizziness Handicap Inventory', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '31.6', 'spread': '16.7', 'groupId': 'BG001'}, {'value': '31.6', 'spread': '16.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Dizziness Handicap Inventory is a 25-item questionnaire that has a score range of 0-100. Higher scores mean worse dizziness.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Assessed only in participants with vestibular dysfunction'}, {'title': 'Activities-specific Balance Confidence scale', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '79.5', 'spread': '14.0', 'groupId': 'BG001'}, {'value': '79.5', 'spread': '14.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The Activities-Balance Confidence Scale is a 16-item questionnaire that assesses an individual's confidence in doing various activities that require balance. Each is given a percentage from 0% to 100% confidence in performing that activity. The number reported is the mean of these individual percentages. Higher numbers mean more confidence (better).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Assessed only in participants with vestibular dysfunction'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-10-04', 'size': 960541, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-11-30T15:38', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'No biological specimens will be retained.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-31', 'studyFirstSubmitDate': '2018-07-06', 'resultsFirstSubmitDate': '2023-12-13', 'studyFirstSubmitQcDate': '2018-07-06', 'lastUpdatePostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-31', 'studyFirstPostDateStruct': {'date': '2018-07-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Nausea Scale', 'timeFrame': 'Immediately after each 10-minute game block, median value calculated for each participant', 'description': 'Participants with vestibular hypofunction rated their nausea after each game block on a scale of 1 to 10. For each visit, there were up to 3 game-blocks, each of 10-minutes duration. The number of blocks was determined by the participant. A higher score is a worse outcome (more nausea). The average nausea scale rating was determined for each participant. The final result is the median of these averaged scores.'}], 'primaryOutcomes': [{'measure': 'Vestibulo-ocular Reflex Gain Ratio', 'timeFrame': 'VOR measurements to determine gain were performed immediately before and after each approximately 30 minute training session. Pre- and post-training gains were then combined in the VOR gain ratio to determine the training effect.', 'description': 'The vestibulo-ocular reflex gain is the relationship between a rotation of the head and the evoked eye movement. The outcome measure is the ratio of the VOR gain after training to that before training. VOR gain is determined by a scaled fit of eye speed to evoking head speed (normal gain is 1). Note that this experiment was not a treatment of impairment but a test of the ability of the vestibular game to elicit motor learning (away from normal) in individuals with intact motor learning. In that context, an increase in the gain to a value greater than unity (faster eye movement relative to the head movement) is "better" with respect to the training goal, but it is not "better" with respect to real-world visual function, for which a gain of one is the goal. There is no threshold value for this type of motor learning experiment. Instead, the question is whether the gain is increased after training, and if so, by what percentage relative to the training goal.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neurologic rehabilitation', 'computer games'], 'conditions': ['Vestibular Diseases']}, 'descriptionModule': {'briefSummary': "Disorders of vestibular function and balance are an important component of many conditions that commonly affect veterans, such as inner ear diseases, diabetes, and traumatic brain injury. Veterans with vestibular impairment have reduced quality of life, limitations on work and physical activities, and an increased risk of falls. The goal of this research is to develop a more engaging and effective interactive tool for vestibular rehabilitation to improve the lives of affected veterans. The first steps in this process will be to test the ability of the application to facilitate vestibular learning and to test its feasibility in vestibular patients. The hypothesis is that computer-game-based adaptation will induce robust VOR motor learning and will provide an engaging platform for vestibular rehabilitation. Ultimately, our application has the potential to provide more flexible vestibular exercises that will allow therapy to be customized for each patient. It will also have the ability to track a patient's progress over time and to advance exercises as function improves."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Normal volunteers and patients with vestibular hypofunction', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* GROUP 1: Healthy volunteers: Static visual acuity of at least 20/30 at testing distance\n* GROUP 2: Vestibular patients: Unilateral or bilateral vestibular hypofunction, No central vestibular disorder, Static Visual Acuity of at least 20/30 at testing distance\n\nExclusion Criteria:\n\n* GROUP 1: Peripheral or central vestibular disorder\n* GROUP 2: Central vestibular disorder'}, 'identificationModule': {'nctId': 'NCT03589859', 'briefTitle': 'Computerized Vestibular Rehabilitation', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Computerized Game-based Vestibular Rehabilitation: Assessment of Feasibility and Motor Learning', 'orgStudyIdInfo': {'id': 'C2892-P'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Normal Volunteers', 'description': 'Testing motor learning', 'interventionNames': ['Diagnostic Test: VOR Test', 'Other: Computer Game']}, {'label': 'Vestibular hypofunction', 'description': 'Testing feasibility of rehabilitation game', 'interventionNames': ['Diagnostic Test: VOR Test', 'Other: Computer Game', 'Other: Nausea Scale']}], 'interventions': [{'name': 'VOR Test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Video-oculography is used to record the vestibulo-ocular reflex during active and passive turns of the head.', 'armGroupLabels': ['Normal Volunteers', 'Vestibular hypofunction']}, {'name': 'Computer Game', 'type': 'OTHER', 'description': 'Participants play a custom computer game that is designed to produce motor learning in the vestibulo-ocular reflex', 'armGroupLabels': ['Normal Volunteers', 'Vestibular hypofunction']}, {'name': 'Nausea Scale', 'type': 'OTHER', 'description': 'Participants asked to rate their subjective nausea on a numeric scale after playing units of the computer game', 'armGroupLabels': ['Vestibular hypofunction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Louis Stokes VA Medical Center, Cleveland, OH', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Mark F. Walker, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Louis Stokes VA Medical Center, Cleveland, OH'}]}, 'ipdSharingStatementModule': {'timeFrame': 'Pursuant to Data Use Agreement', 'ipdSharing': 'YES', 'description': 'A limited set of de-identified data supporting published results will be made available on request, pursuant to a Data Use Agreement.', 'accessCriteria': 'Pursuant to Data Use Agreement'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}