Does Vestibular Rehabilitation Significantly Improve the Level of Vestibular Function Following Vestibular Neuritis?

July 28, 2022 updated by: Dan Dupont Hougaard, Aalborg University Hospital

Which Treatment is Most Effective When Treating Vestibular Neuritis: Corticosteroid Treatment Alone or Combined Corticosteroid Treatment and Vestibular Rehabilitation?

To investigate which treatment option (corticosteroid treatment alone or combined corticosteroid treatment and vestibular rehabilitation) is the most effective in patients diagnosed with vestibular neuritis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients diagnosed with vestibular neuritis will we consider for enrollment. Each patient will undergo randomization for a specific treatment.

Study Type

Interventional

Enrollment (Actual)

50

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 Locations

  • Denmark
    • North Denmark Region
      • Aalborg, North Denmark Region, Denmark, 9000
        • Department of Otolaryngology, Head & Neck Surgery and Audiology

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age above 18 years of age
  2. Medical history compatible with vestibular neuritis
  3. Verification of vestibular neuritis with positive romberg test, pathological v-HIT and horizontal nystagmus with a rotatory component.

Exclusion Criteria:

  1. Former medical history with vestibular dysfunction
  2. Medical history or objective signs of cochlear dysfunction before, during or after onset of vestibular neuritis
  3. Onset of symptoms 14 days before recruitment to the study
  4. Focal neurological symptoms/signs
  5. Contraindication to prednisolone treatment
  6. Problem with participating in vestibular rehabilitation due to muscular-skeletal disease ect.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Neuritis vestibularis (group 1)
Corticosteroid ("prednisolone")
Drug: Corticosteroid
Prednisolone
Experimental: Neuritis vestibularis (group 2)
Corticosteroid ("prednisolone") + vestibular rehabilitation
Drug: Corticosteroid
Prednisolone
Other: Vestibular rehabilitation
Specialized physical therapy aimed at restoring balance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Suppressing head impulse paradigm (SHIMP)
Time Frame: 6 month
SHIMP equipment will objectively quantify change of vestibular function.
6 month
Subjective visual vertical (SVV)
Time Frame: 6 month
SVV test will objectively quantify the experienced spatial orientation as an indicator of visual and vestibular otolithic function
6 month
Video head impulse test (v-HIT)
Time Frame: 6 month
v-HIT equipment will objectively quantify change of vestibular function.
6 month
Dizziness handicap inventory (DHI) questionnaire
Time Frame: 6 month
Fulfillment of the questionnaire "Dizziness Handicap Inventory" (DHI) will quantify the level of experienced vertigo.
6 month

Collaborators and Investigators

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

Sponsor

Aalborg University Hospital

Investigators

  • Principal Investigator: Dan D Hougaard, MD, Aalborg University Hospital
  • Principal Investigator: Martin H Wolder, MS, Aalborg University Hospital

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 (Actual)

February 1, 2019

Primary Completion (Actual)

July 1, 2021

Study Completion (Actual)

January 1, 2022

Study Registration Dates

First Submitted

January 21, 2019

First Submitted That Met QC Criteria

January 27, 2019

First Posted (Actual)

January 29, 2019

Study Record Updates

Last Update Posted (Actual)

July 29, 2022

Last Update Submitted That Met QC Criteria

July 28, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-166

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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