Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-29 @ 9:58 PM
Study NCT ID:
NCT05115032
Status:
COMPLETED
Last Update Posted:
2025-04-10
First Post:
2021-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Posturography-assisted Vestibular Retraining for Stable Unilateral Vestibular Deficit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004244', 'term': 'Dizziness'}, {'id': 'D007759', 'term': 'Labyrinth 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': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized controlled interventional trial; single crossover; single-centre, open label'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-07', 'studyFirstSubmitDate': '2021-10-29', 'studyFirstSubmitQcDate': '2021-10-29', 'lastUpdatePostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SOT composite score', 'timeFrame': 'Through study completion, 12 rehabilitation sessions, an average of 7 weeks', 'description': 'Change in composite score of sensory organization test (Scores from 0-100; higher scores indicate better function)'}, {'measure': 'Dizziness Handicap Inventory', 'timeFrame': 'Through study completion, 12 rehabilitation sessions, an average of 7 weeks', 'description': 'Change in Dizziness Handicap Inventory (DHI); 16-30 Points (mild handicap), 32-52 Points (moderate handicap), 54+ Points (severe handicap)'}], 'secondaryOutcomes': [{'measure': 'ABC Score', 'timeFrame': 'Through study completion, 12 rehabilitation sessions, an average of 7 weeks', 'description': 'Change in Activity-specific Balance Confidence (ABC) score; (Scores from 0-100; higher scores indicate better function)'}, {'measure': 'FES-I score', 'timeFrame': 'Through study completion, 12 rehabilitation sessions, an average of 7 weeks', 'description': 'Change in Fall Efficacy Scale-International (FES-I); possible scores 16-64, higher score indicates greater impairment'}, {'measure': 'SOT condition scores', 'timeFrame': 'Through study completion, 12 rehabilitation sessions, an average of 7 weeks', 'description': 'Change in mean SOT scores for conditions 1 through 6; (Scores from 0-100; higher scores indicate better function)'}, {'measure': 'LOS directional control', 'timeFrame': 'Through study completion, 12 rehabilitation sessions, an average of 7 weeks', 'description': 'Limits of Stability test mean value of directional control of limits of stability; (Scores from 0-100; higher scores indicate better function)'}, {'measure': 'LOS excursion', 'timeFrame': 'Through study completion, 12 rehabilitation sessions, an average of 7 weeks', 'description': 'Limits of Stability test mean endpoint excursion value and maximum excursion point; (Scores from 0-100; higher scores indicate better function)'}, {'measure': 'DHI component scores', 'timeFrame': 'Through study completion, 12 rehabilitation sessions, an average of 7 weeks', 'description': 'Emotional, physical, and functional components of the DHI score'}, {'measure': 'SOT vestibular contribution', 'timeFrame': 'Through study completion, 12 rehabilitation sessions, an average of 7 weeks', 'description': 'Change in mean value of SOT condition 5/mean value of SOT conditions 1; measured as a ratio, higher scores indicate a greater vestibular contribution to balance deficit'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Dizziness', 'Equilibrium; Disorder, Labyrinth', 'Inner Ear Injury', 'Inner Ear Disease']}, 'referencesModule': {'references': [{'pmid': '40624853', 'type': 'DERIVED', 'citation': 'David EA, Shahnaz N, Wiseman I, David Y, Cochrane CL. Vestibular Rehabilitation Using Dynamic Posturography: Functional Stability and Fall Risk Outcomes From a Randomized Trial. Otolaryngol Head Neck Surg. 2025 Sep;173(3):713-723. doi: 10.1002/ohn.1302. Epub 2025 Jul 7.'}]}, 'descriptionModule': {'briefSummary': 'People that have difficulty with balance have a higher risk of falling and reduced quality of life. Some individuals can learn to compensate using their vision, their sense of where their limbs are in space, and balance organs that are still intact. Rehabilitation exercises, which typically involve shaking and nodding of the head, are often prescribed for dizzy patients but are not effective for everyone. Our study aims to determine if specific exercises performed on footplate sensors with visual feedback is superior to traditional rehabilitation exercises done at home for improving balance and quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Dizziness handicap inventory score at time of enrolment over 30\n* Unilateral vestibular weakness confirmed one or more of:\n\n * Videonystagmography showing unilateral weakness to bithermal testing of greater than 25%\n * VEMP: IAD asymmetry of greater than 40% for both cVEMP and oVEMP\n * VEMP: absence of both ocular and cervical vemp responses in one ear in the context of normal and replicable other ear\n * Or unilateral vestibular weakness idiopathic, not yet diagnosed (NYD)\n* Persistent imbalance following diagnosis of resolved benign paroxysmal positional vertigo (BPPV)\n* Symptomatic\n* Long-standing/persistent symptoms greater than six months\n\nExclusion Criteria:\n\n* Orthopedic deficit (eg. lower body joint dysfunction or lower joint replacement)\n* Neurological deficit or proprioception deficit\n* Diabetes\n* Poor vision or blindness\n* Fluctuating vestibular symptoms, or condition known to fluctuate eg. Menière's disease, perilymphatic fistula (PLF) or superior canal dehiscence (SDCS)\n* Active benign paroxysmal positional vertigo (BPPV)\n* Undergoing treatment which may affect balance or ability to stand\n* Cognitive impairment that prevents understanding and responding to instructions required to complete the study\n* Inability to provide informed consent"}, 'identificationModule': {'nctId': 'NCT05115032', 'briefTitle': 'Posturography-assisted Vestibular Retraining for Stable Unilateral Vestibular Deficit', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Randomized Controlled Trial of Computerized Dynamic Posturography-assisted Vestibular Retraining Compared With At-home Vestibular Rehabilitation Exercises for Stable Unilateral Vestibular Deficit', 'orgStudyIdInfo': {'id': 'H21-03343'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vestibular retraining with dynamic posturography', 'description': '12 sessions, twice per week, of rehabilitation exercises last about 20 minutes, using CDP and interactive visual feedback', 'interventionNames': ['Device: Vestibular retraining with dynamic posturography']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'At-home rehabilitation exercises', 'description': 'Daily rehabilitation exercises involving nodding and shaking of the head', 'interventionNames': ['Behavioral: At-home rehabilitation exercises']}], 'interventions': [{'name': 'Vestibular retraining with dynamic posturography', 'type': 'DEVICE', 'description': '12 sessions, twice per week, of rehabilitation exercises last about 20 minutes, using CDP and interactive visual feedback', 'armGroupLabels': ['Vestibular retraining with dynamic posturography']}, {'name': 'At-home rehabilitation exercises', 'type': 'BEHAVIORAL', 'description': '6 weeks of daily rehabilitation exercises involving nodding and shaking of the head', 'armGroupLabels': ['At-home rehabilitation exercises']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V7M 2H5', 'city': 'North Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Dr. EA David MD FRCSC', 'geoPoint': {'lat': 49.31636, 'lon': -123.06934}}], 'overallOfficials': [{'name': 'Eytan A David, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eytan A. David', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, FRCSC, Clinical Instructor, Dept. of Surgery', 'investigatorFullName': 'Eytan A. David', 'investigatorAffiliation': 'University of British Columbia'}}}}