Back to resultsEffect of Vestibular Rehabilitation - a Randomized Controlled Trial
Primary Purpose
Dizziness, Nausea, Nystagmus
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Vestibular rehabilitation
standard treatment
Sponsored by
About this trial
This is an interventional treatment trial for Dizziness focused on measuring Vestibular rehabilitation, acute vestibular injury, Dizziness, Nausea, Nystagmus, Daily life activities, Balance, physiotherapy
Eligibility 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
Sites / Locations
- St. Olavs Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Vestibular rehabilitation
standard
Arm Description
early supported vestibular rehabilitation
standard treatment
Outcomes
Primary Outcome Measures
vertigo
Vertigo symptom scale (VSS)
Secondary Outcome Measures
Dizziness
Dizziness Handicap Inventory (DHI), University of California Los Angeles Dizziness Questionnaire (UCLA-DQ), Three questions regarding dizziness on VAS-scale,
Movement provoked dizziness
Rombergs test and advanced Rombergs test
return of symptoms
sick leave
Full Information
NCT ID
NCT00702832
First Posted
June 19, 2008
Last Updated
December 4, 2019
Sponsor
Norwegian University of Science and Technology
Collaborators
Haukeland University Hospital, St. Olavs Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00702832
Brief Title
Effect of Vestibular Rehabilitation - a Randomized Controlled Trial
Official Title
Effects of Vestibular Rehabilitation in the Treatment of Patients With Acute Vestibular Loss. - A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
January 2008 (Actual)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
Haukeland University Hospital, St. Olavs Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dizziness, Nausea, Nystagmus, Vestibular Diseases
Keywords
Vestibular rehabilitation, acute vestibular injury, Dizziness, Nausea, Nystagmus, Daily life activities, Balance, physiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vestibular rehabilitation
Arm Type
Experimental
Arm Description
early supported vestibular rehabilitation
Arm Title
standard
Arm Type
Active Comparator
Arm Description
standard treatment
Intervention Type
Behavioral
Intervention Name(s)
Vestibular rehabilitation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
standard treatment
Intervention Description
treatment as usual
Primary Outcome Measure Information:
Title
vertigo
Description
Vertigo symptom scale (VSS)
Time Frame
at inclusion, 10-12 weeks, 12 months
Secondary Outcome Measure Information:
Title
Dizziness
Description
Dizziness Handicap Inventory (DHI), University of California Los Angeles Dizziness Questionnaire (UCLA-DQ), Three questions regarding dizziness on VAS-scale,
Time Frame
At inclusion, 10-12 weeks, 12 months
Title
Movement provoked dizziness
Description
Rombergs test and advanced Rombergs test
Time Frame
at inclusion, 10-12 weeks, 12 months
Title
return of symptoms
Time Frame
12 months
Title
sick leave
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siv Mørkved, PhD
Organizational Affiliation
Associate professor / senior researcher
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Olavs Hospital
City
Trondheim
ZIP/Postal Code
7489
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31789800
Citation
Tokle G, Morkved S, Brathen G, Goplen FK, Salvesen O, Arnesen H, Holmeslet B, Nordahl SHG, Wilhelmsen KT. Efficacy of Vestibular Rehabilitation Following Acute Vestibular Neuritis: A Randomized Controlled Trial. Otol Neurotol. 2020 Jan;41(1):78-85. doi: 10.1097/MAO.0000000000002443.
Results Reference
result
Learn more about this trial
Effect of Vestibular Rehabilitation - a Randomized Controlled Trial
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