Vestibular Disorder
Conditions
Brief summary
To investigate the efficacy of vestibular rehabilitation treatment on unsteadiness after intratympanic gentamicin in patients with Meniere's disease.
Detailed description
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.
Interventions
DRUGUsual care
Include anti-dizziness medications, diuretics, or hormone therapy.
OTHERHealth Education
Include comprehensive health education, fall prevention and lifestyle adjustments.
BEHAVIORALvestibular rehabilitation
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.
Sponsors
Eye & ENT Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Adults aged between 18 and 75 years old; 2. Complained of persistent unsteadiness 1 month after intratympanic gentamicin treatment; 3. Be willing to sign the informed consent of the study.
Exclusion criteria
1. Conformed to neuromuscular disease; 2. Conformed to severe cervical spine disease; 3. Conformed to congenital inner ear disease (except vestibular migraine(VM)) 4. Concurrent manifestation of psychiatric or psychological disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Gait Assessment (FGA) | Change from baseline, at 8 weeks and 6 months post-randomization | FGA is a semi-quantitative measure of walking balance ability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensory Organization Test (SOT) | Change from baseline, at 8 weeks and 6 months post-randomization | SOT is a form of posturography, aiming to distinguish and assess the weight of vestibular, visual, and proprioceptive sensations in maintaining balance. |
| Meniere's Disease Outcomes Questionnaire (MDOQ) | Change from baseline, at 8 weeks and 6 months post-randomization | MDOQ is a comprehensive assessment of MD patients' quality of life (QOL) in three dimensions: physical, emotional, and social. |
| Visual Vertigo Analogue Scale (VVAS) | Change from baseline, at 8 weeks and 6 months post-randomization | In VVAS, patients estimate the intensity of their symptoms related to dizziness, vertigo, and imbalance. |
| Vestibular Activities and Participation Measure (VAP) | Change from baseline, at 8 weeks and 6 months post-randomization | VAP is a 34-item self-report questionnaire, aiming to evaluate the extent of activity limitations and participation restrictions created by vestibular disorders. |
Countries
China
Contacts
Primary ContactHuiqian Yu
Backup ContactQiling Tong
Outcome results
None listed