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

Vestibular Disorder Clinical Trial

Official title:

The Effect of Vestibular Rehabilitation Treatment (VRT) on Patients With Unsteadiness After Intratympanic Gentamicin in Meniere's Disease: Protocol for a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06143462
• Other study ID #: 202311-MD-ITG-VRT
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Eye & ENT Hospital of Fudan University
• Contact: Huiqian Yu
• Phone: 13636423139
• Email: yhq925[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate the efficacy of vestibular rehabilitation treatment on unsteadiness after intratympanic gentamicin in patients with Meniere's disease.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Meniere Disease
• Vestibular Diseases
• Vestibular Disorder

Intervention

Drug:
• Usual care
Include anti-dizziness medications, diuretics, or hormone therapy.

Other:
• Health Education
Include comprehensive health education, fall prevention and lifestyle adjustments.

Behavioral:
• 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.

Locations

Country	Name	City	State
China	Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Eye & ENT Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Meniere's Disease Outcomes Questionnaire (MDOQ)	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
Secondary	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
Secondary	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