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

November 16, 2023 updated by: Eye & ENT Hospital of Fudan University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200031
        • Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A: usual care (UC)
Group A (UC) will receive conventional medications.
Drug: Usual care
Include anti-dizziness medications, diuretics, or hormone therapy.
Other: Health Education
Include comprehensive health education, fall prevention and lifestyle adjustments.
Experimental: Group B: vestibular rehabilitation treatment (VRT)
Group B (VRT) will receive outpatient VRT in combination with home practice based on conventional treatment.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline, at 8 weeks and 6 months post-randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensory Organization Test (SOT)
Time Frame: 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.
Change from baseline, at 8 weeks and 6 months post-randomization
Meniere's Disease Outcomes Questionnaire (MDOQ)
Time Frame: 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.
Change from baseline, at 8 weeks and 6 months post-randomization
Visual Vertigo Analogue Scale (VVAS)
Time Frame: 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.
Change from baseline, at 8 weeks and 6 months post-randomization
Vestibular Activities and Participation Measure (VAP)
Time Frame: 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.
Change from baseline, at 8 weeks and 6 months post-randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eye & ENT Hospital of Fudan University

Investigators

  • Principal Investigator: Huiqian Yu, Eye and ENT Hospital of Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

November 16, 2023

First Submitted That Met QC Criteria

November 16, 2023

First Posted (Actual)

November 22, 2023

Study Record Updates

Last Update Posted (Actual)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 16, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202311-MD-ITG-VRT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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