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| ID | Type | Description | Link |
|---|---|---|---|
| 324S720 | Other Grant/Funding Number | The Scientific and Technological Research Council of Türkiye (TÜBİTAK) |
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| Name | Class |
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| The Scientific and Technological Research Council of Turkey | OTHER |
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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.
This 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.
The 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.
The 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.
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.
Vestibular 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.
Virtual 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.
The 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.
The 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.
Outcome 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).
The 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.
This 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home-Based Vestibular Rehabilitation | Active Comparator | 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. |
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| Virtual Reality-Based Vestibular Rehabilitation + Home-Based Vestibular Rehabilitation | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home-Based Vestibular Rehabilitation | Behavioral | Intervention 1 - Home-Based Vestibular Rehabilitation This 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in balance performance measured by Sensory Organization Test (SOT) | 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. | Baseline and 4 weeks |
| Change in functional vestibulo-ocular reflex performance measured by the Functional Head Impulse Test (fHIT) | Functional vestibulo-ocular reflex performance will be assessed using the Functional Head Impulse Test (fHIT), which evaluates gaze stabilization during rapid head movements. | Baseline and 4 weeks |
| Change in dynamic balance measured by the Limits of Stability test (LOS) | 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. | Baseline and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in dizziness severity measured by the Visual Analog Scale (VAS) | 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 ranging from 0 to 10, where 0 indicates no dizziness and 10 indicates the worst possible dizziness. Higher scores indicate greater symptom severity. | Baseline and 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gulce Kirazli, PhD | Ege University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ege University | Izmir | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D004244 | Dizziness |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Virtual Reality-Based Vestibular Rehabilitation | Behavioral | 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. |
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| Change in balance-related symptom severity measured by the Visual Analog Scale (VAS) | 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 ranging from 0 to 10, where 0 indicates no imbalance and 10 indicates the worst possible imbalance. Higher scores indicate greater symptom severity. | Baseline and 4 weeks |
| Change in dizziness-related disability measured by the Dizziness Handicap Inventory (DHI) | 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. The total score ranges from 0 to 100, with higher scores indicating greater perceived disability. | Baseline and 4 weeks |
| Change in activities of daily living measured by the Vestibular Disorders Activities of Daily Living Scale (VADL) | 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. The scale ranges from 1 to 10, with higher scores indicating greater functional limitation. | Baseline and 4 weeks |
| Change in functional gait performance measured by the Functional Gait Assessment (FGA) | Functional gait performance will be assessed using the Functional Gait Assessment (FGA), which evaluates postural stability during various walking tasks. The total score ranges from 0 to 30, with higher scores indicating better gait performance. | Baseline and 4 weeks |
| Change in dynamic gait performance measured by the Dynamic Gait Index (DGI) | Dynamic gait performance will be assessed using the Dynamic Gait Index (DGI), which evaluates gait, balance, and fall risk during functional walking tasks. The total score ranges from 0 to 24, with higher scores indicating better mobility and balance performance. | Baseline and 4 weeks |
| Change in balance confidence measured by the Activities-specific Balance Confidence Scale (ABC Scale) | Balance confidence will be assessed using the Activities-specific Balance Confidence Scale (ABC), a self-reported measure of confidence in maintaining balance during daily activities. The total score ranges from 0 to 100%, with higher scores indicating greater balance confidence. | Baseline and 4 weeks |
| Change in anxiety and depression symptoms measured by the Hospital Anxiety and Depression Scale (HADS) | Psychological status will be assessed using the Hospital Anxiety and Depression Scale (HADS), a self-reported questionnaire evaluating symptoms of anxiety and depression. The total score ranges from 0 to 42, with higher scores indicating greater psychological distress. The scale also includes anxiety (HADS-A) and depression (HADS-D) subscales, each ranging from 0 to 21. | Baseline and 4 weeks |