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

Vestibular Neuritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03821155
• Other study ID #: 2018-166
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: January 1, 2022

Study information

• Verified date: July 2022
• Source: Aalborg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 1, 2022
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuritis
• Vestibular Neuritis
• Vestibular Neuronitis

Intervention

Other:
• Vestibular rehabilitation
Specialized physical therapy aimed at restoring balance

Drug:
• Corticosteroid
Prednisolone

Locations

Country	Name	City	State
Denmark	Department of Otolaryngology, Head & Neck Surgery and Audiology	Aalborg	North Denmark Region

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

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