- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00702832
Effect of Vestibular Rehabilitation - a Randomized Controlled Trial
December 4, 2019 updated by: Norwegian University of Science and Technology
Effects of Vestibular Rehabilitation in the Treatment of Patients With Acute Vestibular Loss. - A Randomized Controlled Trial
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?
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Trondheim, Norway, 7489
- St. Olavs Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vestibular rehabilitation
early supported 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
|
treatment as usual
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
vertigo
Time Frame: at inclusion, 10-12 weeks, 12 months
|
Vertigo symptom scale (VSS)
|
at inclusion, 10-12 weeks, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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,
|
At inclusion, 10-12 weeks, 12 months
|
Movement provoked dizziness
Time Frame: at inclusion, 10-12 weeks, 12 months
|
Rombergs test and advanced Rombergs test
|
at inclusion, 10-12 weeks, 12 months
|
return of symptoms
Time Frame: 12 months
|
12 months
|
|
sick leave
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Siv Mørkved, PhD, Associate professor / senior researcher
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2008
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
June 19, 2008
First Submitted That Met QC Criteria
June 19, 2008
First Posted (Estimate)
June 20, 2008
Study Record Updates
Last Update Posted (Actual)
December 9, 2019
Last Update Submitted That Met QC Criteria
December 4, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REK 4.2007.1802
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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