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

NCT ID: NCT03821155

Last Updated: 2022-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2022-01-01

Brief Summary

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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.

Detailed Description

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

Conditions

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Vestibular Neuritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients randomized to two different treatments:

1. corticosteroid treatment ("prednisolone")
2. combined corticosteroid treatment ("prednisolone") and vestibular rehabilitation
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Neuritis vestibularis (group 1)

Corticosteroid ("prednisolone")

Group Type ACTIVE_COMPARATOR

Corticosteroid

Intervention Type DRUG

Prednisolone

Neuritis vestibularis (group 2)

Corticosteroid ("prednisolone") + vestibular rehabilitation

Group Type EXPERIMENTAL

Vestibular rehabilitation

Intervention Type OTHER

Specialized physical therapy aimed at restoring balance

Corticosteroid

Intervention Type DRUG

Prednisolone

Interventions

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Vestibular rehabilitation

Specialized physical therapy aimed at restoring balance

Intervention Type OTHER

Corticosteroid

Prednisolone

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aalborg University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dan Dupont Hougaard

MD, Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dan D Hougaard, MD

Role: PRINCIPAL_INVESTIGATOR

Aalborg University Hospital

Martin H Wolder, MS

Role: PRINCIPAL_INVESTIGATOR

Aalborg University Hospital

Locations

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Department of Otolaryngology, Head & Neck Surgery and Audiology

Aalborg, North Denmark, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2018-166

Identifier Type: -

Identifier Source: org_study_id

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