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

Sponsor

Aalborg University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03821155

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Vestibular Neuritis	Other: Vestibular rehabilitation Drug: Corticosteroid	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patients randomized to two different treatments: corticosteroid treatment ("prednisolone") combined corticosteroid treatment ("prednisolone") and vestibular rehabilitationPatients randomized to two different treatments:corticosteroid treatment ("prednisolone") combined corticosteroid treatment ("prednisolone") and vestibular rehabilitation

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 1, 2019

Actual Primary Completion Date :

Jul 1, 2021

Actual Study Completion Date :

Jan 1, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Neuritis vestibularis (group 1)

Corticosteroid ("prednisolone")

Drug: Corticosteroid

Prednisolone

Experimental: Neuritis vestibularis (group 2)

Corticosteroid ("prednisolone") + vestibular rehabilitation

Other: Vestibular rehabilitation

Specialized physical therapy aimed at restoring balance

Drug: Corticosteroid

Prednisolone

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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