Vestibular Rehabilitation for Unsteadiness After Intratympanic Gentamicin in Patients With Meniere's Disease

Not Applicable

Not yet recruiting

• Conditions: Vestibular Disorder
• Interventions: Drug: Usual care; Behavioral: vestibular rehabilitation; Other: Health Education

• Registration Number: NCT06143462
• Lead Sponsor: Eye & ENT Hospital of Fudan University

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.

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-16
• Study First Submitted QC: 2023-11-16
• Last Update Submitted: 2023-11-16
• Study First Posted: 2023-11-22
• Last Update Posted: 2023-11-22
• Study Start: 2024-01-01
• Primary Completion: 2024-06-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A: usual care (UC)	Usual care	Group A (UC) will receive conventional medications.
Group A: usual care (UC)	Health Education	Group A (UC) will receive conventional medications.
Group B: vestibular rehabilitation treatment (VRT)	vestibular rehabilitation	Group B (VRT) will receive outpatient VRT in combination with home practice based on conventional treatment.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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.

Trial Locations

Locations (1)

Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China