Effect of Vestibular Rehabilitation - a Randomized Controlled Trial

This study has been completed.
Sponsor:
Collaborators:
Haukeland University Hospital
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00702832
First received: June 19, 2008
Last updated: April 10, 2012
Last verified: April 2012
  Purpose

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 Intervention
Dizziness
Nausea
Nystagmus
Vestibular Diseases
Behavioral: Vestibular rehabilitation
Other: standard treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Vestibular Rehabilitation in the Treatment of Patients With Acute Vestibular Loss. - A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • vertigo [ Time Frame: at inclusion, 10-12 weeks, 12 months ] [ Designated as safety issue: No ]
    Vertigo symptom scale (VSS)


Secondary Outcome Measures:
  • Dizziness [ Time Frame: At inclusion, 10-12 weeks, 12 months ] [ Designated as safety issue: No ]
    Dizziness Handicap Inventory (DHI), University of California Los Angeles Dizziness Questionnaire (UCLA-DQ), Three questions regarding dizziness on VAS-scale,

  • Movement provoked dizziness [ Time Frame: at inclusion, 10-12 weeks, 12 months ] [ Designated as safety issue: No ]
    Rombergs test and advanced Rombergs test

  • return of symptoms [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • sick leave [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: January 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

Exclusion Criteria:

  • chronic dizziness
  • psychiatric diagnosis that might interfere with participation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00702832

Locations
Norway
St. Olavs Hospital
Trondheim, Norway, 7489
Sponsors and Collaborators
Norwegian University of Science and Technology
Haukeland University Hospital
St. Olavs Hospital
Investigators
Principal Investigator: Siv Mørkved, PhD Associate professor / senior researcher
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00702832     History of Changes
Other Study ID Numbers: REK 4.2007.1802
Study First Received: June 19, 2008
Last Updated: April 10, 2012
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:
Vestibular rehabilitation
acute vestibular injury
Dizziness
Nausea
Nystagmus
Daily life activities
Balance
physiotherapy

Additional relevant MeSH terms:
Dizziness
Vertigo
Nausea
Nystagmus, Pathologic
Vestibular Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Signs and Symptoms, Digestive
Ocular Motility Disorders
Cranial Nerve Diseases
Eye Diseases

ClinicalTrials.gov processed this record on August 21, 2014