Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 3:22 PM
Study NCT ID:
NCT07493005
Status:
COMPLETED
Last Update Posted:
2026-03-25
First Post:
2026-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Virtual Reality-Based Vestibular Rehabilitation in Vestibular Migraine: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-19', 'studyFirstSubmitDate': '2026-03-19', 'studyFirstSubmitQcDate': '2026-03-19', 'lastUpdatePostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in balance performance measured by Sensory Organization Test (SOT)', 'timeFrame': 'Baseline and 4 weeks', 'description': "Postural control will be assessed using the Sensory Organization Test (SOT), which evaluates the participant's ability to maintain balance under different sensory conditions by integrating visual, vestibular, and somatosensory inputs."}, {'measure': 'Change in functional vestibulo-ocular reflex performance measured by the Functional Head Impulse Test (fHIT)', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Functional vestibulo-ocular reflex performance will be assessed using the Functional Head Impulse Test (fHIT), which evaluates gaze stabilization during rapid head movements.'}, {'measure': 'Change in dynamic balance measured by the Limits of Stability test (LOS)', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Dynamic balance will be assessed using the Limits of Stability (LOS) test, which measures the ability to voluntarily shift the center of gravity within the base of support without losing balance.'}], 'secondaryOutcomes': [{'measure': 'Change in dizziness severity measured by the Visual Analog Scale (VAS)', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Dizziness severity will be assessed using a Visual Analog Scale (VAS). Participants will rate the severity of dizziness experienced during the previous week on a 10-cm scale, with higher scores indicating greater symptom severity.'}, {'measure': 'Change in balance-related symptom severity measured by the Visual Analog Scale (VAS)', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Balance-related symptom severity will be assessed using a Visual Analog Scale (VAS). Participants will rate the severity of imbalance experienced during the previous week on a 10-cm scale, with higher scores indicating greater symptom severity.'}, {'measure': 'Change in dizziness-related disability measured by the Dizziness Handicap Inventory (DHI)', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Dizziness-related disability will be assessed using the Dizziness Handicap Inventory (DHI), a 25-item self-reported questionnaire evaluating the functional, emotional, and physical impact of dizziness. Higher scores indicate greater perceived disability.'}, {'measure': 'Change in activities of daily living measured by the Vestibular Disorders Activities of Daily Living Scale (VADL)', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Functional limitations in daily life will be assessed using the Vestibular Disorders Activities of Daily Living Scale (VADL), which evaluates the impact of vestibular symptoms on functional, ambulatory, and instrumental daily activities. Higher scores indicate greater limitation.'}, {'measure': 'Change in functional gait performance measured by the Functional Gait Assessment (FGA)', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Functional gait performance will be assessed using the Functional Gait Assessment (FGA), which evaluates postural stability during various walking tasks. Higher scores indicate better gait performance.'}, {'measure': 'Change in dynamic gait performance measured by the Dynamic Gait Index (DGI)', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Dynamic gait performance will be assessed using the Dynamic Gait Index (DGI), which evaluates gait, balance, and fall risk during functional walking tasks. Higher scores indicate better mobility and balance performance.'}, {'measure': 'Change in balance confidence measured by the Activities-specific Balance Confidence Scale (ABC Scale)', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Balance confidence will be assessed using the Activities-specific Balance Confidence (ABC) Scale, a self-reported measure of confidence in maintaining balance during daily activities. Higher scores indicate greater balance confidence.'}, {'measure': 'Change in anxiety and depression symptoms measured by the Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Psychological status will be assessed using the Hospital Anxiety and Depression Scale (HADS), a self-reported questionnaire evaluating symptoms of anxiety and depression. Higher scores indicate greater psychological distress.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vestibular Migraine', 'Virtual Reality', 'Vestibular Rehabilitation', 'Balance', 'Dizziness', 'Functional Outcomes', 'Randomized Controlled Trial'], 'conditions': ['Vestibular Migraine']}, 'descriptionModule': {'briefSummary': 'Vestibular migraine (VM) is a common neurological condition characterized by recurrent episodes of dizziness, vertigo, and balance problems, often accompanied by migraine symptoms. These symptoms can significantly impair daily functioning and quality of life. Vestibular rehabilitation (VR) is a non-pharmacological treatment approach aimed at improving balance, reducing dizziness, and promoting central compensation mechanisms.\n\nThis randomized controlled trial aims to evaluate the effectiveness of virtual reality (VR)-based vestibular rehabilitation in patients with vestibular migraine. Participants diagnosed with definite VM will be randomly assigned to two groups: one group will receive a conventional home-based vestibular rehabilitation program, while the other group will receive the same home-based program in addition to a clinic-based virtual reality rehabilitation program.\n\nThe intervention will last for four weeks. Clinical outcomes will be assessed before and after the intervention using both objective and subjective measures, including functional vestibulo-ocular reflex (VOR) performance, postural control, balance, dizziness severity, psychological status, and quality of life.\n\nThe study aims to determine whether adding virtual reality-based rehabilitation to conventional home exercises provides additional benefits in improving balance, reducing symptoms, and enhancing functional outcomes in patients with vestibular migraine.', 'detailedDescription': 'Vestibular migraine (VM) is one of the most common causes of recurrent vertigo and dizziness, characterized by episodic vestibular symptoms associated with migraine features. In addition to vertigo, patients frequently report imbalance, spatial disorientation, and functional limitations that significantly impair quality of life. Although pharmacological treatments are widely used, non-pharmacological approaches such as vestibular rehabilitation (VR) have gained increasing attention for managing persistent vestibular symptoms.\n\nVestibular rehabilitation is based on mechanisms of central neuroplasticity, including adaptation, habituation, and substitution, aiming to improve gaze stability, postural control, and functional mobility. Previous studies have demonstrated that conventional home-based VR programs can reduce dizziness severity and improve balance performance in patients with vestibular disorders, including VM. However, adherence, motivation, and the ability to systematically expose patients to controlled sensory conflicts remain challenging in traditional rehabilitation approaches.\n\nVirtual reality (VR)-based rehabilitation has emerged as an innovative tool that allows patients to interact with controlled, immersive environments that can systematically manipulate visual and proprioceptive inputs. By inducing sensory conflict in a safe and controlled setting, VR-based interventions may enhance vestibular compensation and improve postural control more effectively than conventional methods. Despite these advantages, the effectiveness of VR-based vestibular rehabilitation specifically in patients with vestibular migraine has not been sufficiently investigated.\n\nThe present study is designed as a prospective, randomized, single-blind controlled trial to evaluate the effectiveness of adding virtual reality-based vestibular rehabilitation to a conventional home-based VR program in patients with vestibular migraine. Participants diagnosed with definite VM according to the International Classification of Headache Disorders (ICHD-3) criteria will be recruited and randomly assigned to one of two groups: (1) a control group receiving only a home-based individualized vestibular rehabilitation program, and (2) an intervention group receiving both home-based VR and additional clinic-based virtual reality rehabilitation.\n\nThe rehabilitation program will be conducted over a four-week period. The home-based program will include adaptation (vestibulo-ocular reflex exercises), habituation, substitution, and balance training exercises tailored to individual symptom profiles. The virtual reality-based intervention will consist of structured tasks such as optokinetic stimulation, head-eye coordination training, target tracking, limits of stability exercises, optical flow exposure, spatial navigation, and simulated environmental challenges.\n\nOutcome measures will be assessed before and after the intervention using both objective and subjective tools. Objective assessments will include functional head impulse test (fHIT), sensory organization test (SOT), and limits of stability (LOS). Subjective and functional measures will include visual analog scale (VAS) for dizziness and balance, Dizziness Handicap Inventory (DHI), Vestibular Disorders Activities of Daily Living Scale (VADL), Functional Gait Assessment (FGA), Dynamic Gait Index (DGI), Activities-specific Balance Confidence Scale (ABC), and Hospital Anxiety and Depression Scale (HADS).\n\nThe primary aim of this study is to determine whether the addition of virtual reality-based vestibular rehabilitation provides superior improvements in balance, dizziness severity, and functional outcomes compared to conventional home-based rehabilitation alone. Secondary aims include evaluating changes in vestibulo-ocular reflex function, postural control, psychological status, and quality of life.\n\nThis study is expected to provide evidence for the clinical effectiveness of virtual reality-based vestibular rehabilitation in vestibular migraine and contribute to the development of more targeted and engaging rehabilitation strategies for this patient population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nDiagnosis of definite vestibular migraine according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria\n\nAge between 18 and 60 years\n\nConfirmation of vestibular migraine diagnosis using the vestibular migraine diagnostic scale\n\nNot receiving acute pharmacological treatment for vestibular migraine at the time of enrollment\n\nAbility to perform daily activities independently\n\nNo visual impairment or eye disease that would interfere with the evaluation or rehabilitation process\n\nAbility to understand and comply with study procedures\n\nProvision of written informed consent\n\nExclusion Criteria:\n\nPresence of medical contraindications to the head movements required during vestibular rehabilitation (e.g., severe cervical disorders)\n\nIntolerance to virtual reality equipment or the presence of visual or balance problems preventing virtual reality use\n\nPresence of severe comorbid conditions, such as life-threatening disease, severe cognitive impairment, neurological disorder, or severe psychiatric disorder\n\nPresence of a central nervous system disorder\n\nDiagnosis of any vestibular disorder other than vestibular migraine\n\nInability or unwillingness to regularly perform home-based vestibular rehabilitation exercises or virtual reality-based rehabilitation sessions\n\nFailure to complete the objective and subjective assessment tests\n\nPhysical disability preventing walking'}, 'identificationModule': {'nctId': 'NCT07493005', 'acronym': 'VR-VM', 'briefTitle': 'Virtual Reality-Based Vestibular Rehabilitation in Vestibular Migraine: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Ege University'}, 'officialTitle': 'Evaluation of the Effectiveness of Virtual Reality-Based Vestibular Rehabilitation in Patients With Vestibular Migraine: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '324S720'}, 'secondaryIdInfos': [{'id': '324S720', 'type': 'OTHER_GRANT', 'domain': 'The Scientific and Technological Research Council of Türkiye (TÜBİTAK)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Home-Based Vestibular Rehabilitation', 'description': "Participants in this group will receive an individualized home-based vestibular rehabilitation program. The program will include adaptation exercises (vestibulo-ocular reflex training), habituation exercises, substitution strategies, and balance training tailored to the patient's symptoms. Participants will be instructed to perform the exercises daily, three times per day, over a period of four weeks. Compliance will be monitored through regular follow-up and communication.", 'interventionNames': ['Behavioral: Home-Based Vestibular Rehabilitation']}, {'type': 'EXPERIMENTAL', 'label': 'Virtual Reality-Based Vestibular Rehabilitation + Home-Based Vestibular Rehabilitation', 'description': 'Participants in this group will receive the same individualized home-based vestibular rehabilitation program as the control group. In addition, they will undergo clinic-based virtual reality-based vestibular rehabilitation sessions twice per week for four weeks. The virtual reality program will include tasks such as optokinetic stimulation, head-eye coordination, target tracking, limits of stability training, optical flow exposure, spatial navigation, and simulated environments designed to induce controlled sensory conflict and improve balance and postural control.', 'interventionNames': ['Behavioral: Virtual Reality-Based Vestibular Rehabilitation']}], 'interventions': [{'name': 'Home-Based Vestibular Rehabilitation', 'type': 'BEHAVIORAL', 'description': "Intervention 1 - Home-Based Vestibular Rehabilitation\n\nThis intervention consists of an individualized home-based vestibular rehabilitation program designed according to each participant's symptom profile. The program includes adaptation exercises (vestibulo-ocular reflex training), habituation exercises targeting motion sensitivity, substitution strategies, and balance training. Participants will be instructed to perform the exercises three times daily, with multiple repetitions, over a four-week period. The program will be explained and demonstrated by a clinician, and participants will be provided with written and visual instructions. Adherence will be monitored through regular follow-up and weekly contact.", 'armGroupLabels': ['Home-Based Vestibular Rehabilitation']}, {'name': 'Virtual Reality-Based Vestibular Rehabilitation', 'type': 'BEHAVIORAL', 'description': 'This intervention consists of a clinic-based virtual reality-based vestibular rehabilitation program administered in addition to the home-based program. Participants will attend supervised sessions twice per week for four weeks, with each session lasting approximately 30 minutes. The virtual reality program includes structured tasks such as optokinetic stimulation, head-eye coordination training, target tracking, limits of stability exercises, optical flow exposure, spatial navigation, and simulated environments. These tasks are designed to induce controlled sensory conflict, enhance vestibular compensation, and improve postural control and functional balance in a safe and interactive environment.', 'armGroupLabels': ['Virtual Reality-Based Vestibular Rehabilitation + Home-Based Vestibular Rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Ege University', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'Gulce Kirazli, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ege University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ege University', 'class': 'OTHER'}, 'collaborators': [{'name': 'THE SCİENTİFİC AND TECHNOLOGİCAL RESEARCH COUNCİL OF TURKEY (TUBITAK)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc.Prof.', 'investigatorFullName': 'Gulce Kirazli', 'investigatorAffiliation': 'Ege University'}}}}