The Effect of Vestibular Rehabilitation Treatment (VRT) on Patients With Unsteadiness After Intratympanic Gentamicin in Meniere's Disease: Protocol for a Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- Health Education
- Conditions
- Vestibular Disorder
- Sponsor
- Eye & ENT Hospital of Fudan University
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Functional Gait Assessment (FGA)
- Status
- Not Yet Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Group A: usual care (UC)
Group A (UC) will receive conventional medications.
Intervention: Health Education
Group B: vestibular rehabilitation treatment (VRT)
Group B (VRT) will receive outpatient VRT in combination with home practice based on conventional treatment.
Intervention: vestibular rehabilitation
Group A: usual care (UC)
Group A (UC) will receive conventional medications.
Intervention: Usual care
Outcomes
Primary Outcomes
Functional Gait Assessment (FGA)
Time Frame: Change from baseline, at 8 weeks and 6 months post-randomization
FGA is a semi-quantitative measure of walking balance ability.
Secondary Outcomes
- Vestibular Activities and Participation Measure (VAP)(Change from baseline, at 8 weeks and 6 months post-randomization)
- Sensory Organization Test (SOT)(Change from baseline, at 8 weeks and 6 months post-randomization)
- Visual Vertigo Analogue Scale (VVAS)(Change from baseline, at 8 weeks and 6 months post-randomization)
- Meniere's Disease Outcomes Questionnaire (MDOQ)(Change from baseline, at 8 weeks and 6 months post-randomization)