Vestibular Rehabilitation for Unsteadiness After Intratympanic Gentamicin in Patients With Meniere's Disease
NCT ID: NCT06143462
Last Updated: 2023-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
48 participants
INTERVENTIONAL
2024-01-01
2024-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group A: usual care (UC)
Group A (UC) will receive conventional medications.
Usual care
Include anti-dizziness medications, diuretics, or hormone therapy.
Health Education
Include comprehensive health education, fall prevention and lifestyle adjustments.
Group B: vestibular rehabilitation treatment (VRT)
Group B (VRT) will receive outpatient VRT in combination with home practice based on conventional treatment.
vestibular 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.
Interventions
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Usual care
Include anti-dizziness medications, diuretics, or hormone therapy.
Health Education
Include comprehensive health education, fall prevention and lifestyle adjustments.
vestibular 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.
Eligibility Criteria
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Inclusion Criteria
2. Complained of persistent unsteadiness 1 month after intratympanic gentamicin treatment;
3. Be willing to sign the informed consent of the study.
Exclusion Criteria
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.
18 Years
75 Years
ALL
No
Sponsors
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Eye & ENT Hospital of Fudan University
OTHER
Responsible Party
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Principal Investigators
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Huiqian Yu
Role: PRINCIPAL_INVESTIGATOR
Eye and ENT Hospital of Fudan University
Locations
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Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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References
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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.
Other Identifiers
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202311-MD-ITG-VRT
Identifier Type: -
Identifier Source: org_study_id