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Effect of Vestibular Rehabilitation - a Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT00702832
Recruitment Status : Completed
First Posted : June 20, 2008
Last Update Posted : February 13, 2017
Sponsor:
Collaborators:
Haukeland University Hospital
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
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 : January 2008
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011


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



Primary Outcome Measures :
  1. vertigo [ Time Frame: at inclusion, 10-12 weeks, 12 months ]
    Vertigo symptom scale (VSS)


Secondary Outcome Measures :
  1. Dizziness [ Time Frame: 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,

  2. Movement provoked dizziness [ Time Frame: at inclusion, 10-12 weeks, 12 months ]
    Rombergs test and advanced Rombergs test

  3. return of symptoms [ Time Frame: 12 months ]
  4. sick leave [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00702832     History of Changes
Other Study ID Numbers: REK 4.2007.1802
First Posted: June 20, 2008    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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