Clinical trial
The Effect of Vestibular Rehabilitation Treatment (VRT) on Patients With Unsteadiness After Intratympanic Gentamicin in Meniere's Disease: Protocol for a Randomized Controlled Trial
Name
202311-MD-ITG-VRT
Description
To investigate the efficacy of vestibular rehabilitation treatment on unsteadiness after intratympanic gentamicin in patients with Meniere's disease.
Trial arms
Trial start
2024-01-01
Estimated PCD
2024-06-30
Trial end
2024-12-31
Status
Not yet recruiting
Treatment
Usual care
Include anti-dizziness medications, diuretics, or hormone therapy.
Arms:
Group A: usual care (UC)
Health Education
Include comprehensive health education, fall prevention and lifestyle adjustments.
Arms:
Group A: usual care (UC)
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.
Arms:
Group B: vestibular rehabilitation treatment (VRT)
Size
48
Primary endpoint
Functional Gait Assessment (FGA)
Change from baseline, at 8 weeks and 6 months post-randomization
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 48, 'type': 'ESTIMATED'}}
Updated at
2023-11-22
1 organization
1 product
1 indication
Organization
Eye & ENT Hospital of Fudan UniversityProduct
Usual careIndication
Vestibular Disorder