Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To investigate the efficacy of vestibular rehabilitation treatment on unsteadiness after intratympanic gentamicin in patients with Meniere's disease.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: usual care (UC) | Active Comparator | Group A (UC) will receive conventional medications. |
|
| Group B: vestibular rehabilitation treatment (VRT) | Experimental | Group B (VRT) will receive outpatient VRT in combination with home practice based on conventional treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual care | Drug | Include anti-dizziness medications, diuretics, or hormone therapy. |
|
| 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 |
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huiqian Yu | Contact | 13636423139 | yhq925@163.com | |
| Qiling Tong | Contact | 13816520179 | 23211260026@m.fudan.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Huiqian Yu | Eye and ENT Hospital of Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University | Shanghai | Shanghai Municipality | 200031 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39987011 | Derived | Tong Q, Zhou Y, Wu P, Yu H. Effect of vestibular rehabilitation treatment (VRT) on patients with unsteadiness after intratympanic gentamicin in Meniere's disease: protocol for a randomised controlled trial. BMJ Open. 2025 Feb 22;15(2):e088722. doi: 10.1136/bmjopen-2024-088722. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015837 | Vestibular Diseases |
| ID | Term |
|---|---|
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Health Education | Other | Include comprehensive health education, fall prevention and lifestyle adjustments. |
|
| vestibular rehabilitation | Behavioral | 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. |
|
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 |