Vestibular Rehabilitation for Unsteadiness After Intratympanic Gentamicin in Patients With Meniere's Disease

Study Overview
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Brief Summary
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To investigate the efficacy of vestibular rehabilitation treatment on unsteadiness after intratympanic gentamicin in patients with Meniere's disease.

Detailed Description
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Previous studies have generally focused on the efficacy of VRT for Meniere's disease, with little attention paid to the effect of VRT on MD patients who still have vestibular dysfunction even after intratympanic gentamicin treatment. The aim of this study is to compare the efficacy of VRT with usual care in MD patients who experience persistence of unsteadiness 1 month after intratympanic gentamicin treatment, in order to understand whether VR has a positive impact on balance maintenance and vertigo control in MD patients.

Official Title
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The Effect of Vestibular Rehabilitation Treatment (VRT) on Patients With Unsteadiness After Intratympanic Gentamicin in Meniere's Disease: Protocol for a Randomized Controlled Trial

Conditions
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Vestibular Disorder

Intervention / Treatment
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* Drug: Usual care
* Other: Health Education
* Behavioral: vestibular rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged between 18 and 75 years old; Complained of persistent unsteadiness 1 month after intratympanic gentamicin treatment; Be willing to sign the informed consent of the study. Exclusion Criteria: Conformed to neuromuscular disease; Conformed to severe cervical spine disease; Conformed to congenital inner ear disease (except vestibular migraine(VM)) Concurrent manifestation of psychiatric or psychological disorders.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A: usual care (UC)<br>Group A (UC) will receive conventional medications. | Drug: Usual care<br>* Include anti-dizziness medications, diuretics, or hormone therapy.<br>Other: Health Education<br>* Include comprehensive health education, fall prevention and lifestyle adjustments.<br>|
| Experimental: Group B: vestibular rehabilitation treatment (VRT)<br>Group B (VRT) will receive outpatient VRT in combination with home practice based on conventional treatment. | Behavioral: vestibular rehabilitation<br>* Encompass office-based sessions of vestibular rehabilitation treatment once weekly, supplemented by home-based exercises conducted two or three times daily for the remaining duration of the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Gait Assessment (FGA) | FGA is a semi-quantitative measure of walking balance ability. | Change from baseline, at 8 weeks and 6 months post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensory Organization Test (SOT) | SOT is a form of posturography, aiming to distinguish and assess the weight of vestibular, visual, and proprioceptive sensations in maintaining balance. | Change from baseline, at 8 weeks and 6 months post-randomization | 
| Meniere's Disease Outcomes Questionnaire (MDOQ) | MDOQ is a comprehensive assessment of MD patients' quality of life (QOL) in three dimensions: physical, emotional, and social. | Change from baseline, at 8 weeks and 6 months post-randomization | 
| Visual Vertigo Analogue Scale (VVAS) | In VVAS, patients estimate the intensity of their symptoms related to dizziness, vertigo, and imbalance. | Change from baseline, at 8 weeks and 6 months post-randomization | 
| Vestibular Activities and Participation Measure (VAP) | VAP is a 34-item self-report questionnaire, aiming to evaluate the extent of activity limitations and participation restrictions created by vestibular disorders. | Change from baseline, at 8 weeks and 6 months post-randomization |