Effect of Vestibular Rehabilitation - a Randomized Controlled Trial

Sponsor

Norwegian University of Science and Technology (Other)

Overall Status

Completed

CT.gov ID

NCT00702832

Collaborator

Haukeland University Hospital (Other), St. Olavs Hospital (Other)

Enrollment

Location

Arms

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to assess if early supported vestibular rehabilitation can reduce dizziness and improve daily life activities in patients with acute vestibular injury.

The study question is: Does early supported vestibular rehabilitation have an additional effect on dizziness symptoms and daily life functions compared to standard treatment?

Condition or Disease	Intervention/Treatment	Phase
Dizziness Nausea Nystagmus Vestibular Diseases	Behavioral: Vestibular rehabilitation Other: standard treatment	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effects of Vestibular Rehabilitation in the Treatment of Patients With Acute Vestibular Loss. - A Randomized Controlled Trial

Actual Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vestibular rehabilitation early supported vestibular rehabilitation	Behavioral: Vestibular rehabilitation Daily home training (4-6 specific exercises) 2-3 times per day. Group training led by a physiotherapist twice per week during the first 10 weeks and once per week from 10 weeks to 12 months or to symptoms are cured.
Active Comparator: standard standard treatment	Other: standard treatment treatment as usual

Arm

Intervention/Treatment

Experimental: Vestibular rehabilitation

early supported vestibular rehabilitation

Behavioral: Vestibular rehabilitation

Daily home training (4-6 specific exercises) 2-3 times per day. Group training led by a physiotherapist twice per week during the first 10 weeks and once per week from 10 weeks to 12 months or to symptoms are cured.

Active Comparator: standard

standard treatment

Other: standard treatment

treatment as usual

Outcome Measures

Primary Outcome Measures

vertigo [at inclusion, 10-12 weeks, 12 months]
Vertigo symptom scale (VSS)

Secondary Outcome Measures

Dizziness [At inclusion, 10-12 weeks, 12 months]
Dizziness Handicap Inventory (DHI), University of California Los Angeles Dizziness Questionnaire (UCLA-DQ), Three questions regarding dizziness on VAS-scale,
Movement provoked dizziness [at inclusion, 10-12 weeks, 12 months]
Rombergs test and advanced Rombergs test
return of symptoms [12 months]
sick leave [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

acute symptoms of dizziness, nausea and nystagmus
diagnosed by videonystagmography (at least 25% reduced caloric response in one ear)
age 18-70 years
inclusion within one week after symptom debut