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:
Ege University
Organization:
Study Overview
Official Title:
Evaluation of the Effectiveness of Virtual Reality-Based Vestibular Rehabilitation in Patients With Vestibular Migraine: A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VR-VM
Brief Summary:
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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 324S720 | OTHER_GRANT | The Scientific and Technological Research Council of Türkiye (TÜBİTAK) | View |