DizzinessNCT00702832
Effect of Vestibular Rehabilitation - a Randomized Controlled Trial
A study testing Vestibular rehabilitation and standard treatment in people with Dizziness and Nausea, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- What is being tested?
- Vestibular rehabilitation and standard treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2008to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute symptoms of dizziness, nausea and nystagmus
- diagnosed by videonystagmography (at least 25% reduced caloric response in one ear)
- age 18-70 years
Who cannot join
- chronic dizziness
- psychiatric diagnosis that might interfere with participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
- Conditions
- Dizziness, Nausea, Nystagmus, Vestibular Diseases
- Being tested
- Vestibular rehabilitation, standard treatment
- Keywords
- Vestibular rehabilitation, acute vestibular injury, Dizziness, Nausea, Nystagmus, Daily life activities, Balance, physiotherapy
- Medical subject headings
- Dizziness, Nausea, Nystagmus, Pathologic, Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular rehabilitationBehavioural
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.
standard treatmentOther
treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| Vestibular rehabilitation | Experimental | early supported vestibular rehabilitation Receives: Behavioral: Vestibular rehabilitation |
| standard | Active comparator | standard treatment Receives: Other: standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
vertigo
Vertigo symptom scale (VSS)
Measured: at inclusion, 10-12 weeks, 12 months
Secondary outcomes (4)
Dizziness
Dizziness Handicap Inventory (DHI), University of California Los Angeles Dizziness Questionnaire (UCLA-DQ), Three questions regarding dizziness on VAS-scale,
Measured: At inclusion, 10-12 weeks, 12 months
Movement provoked dizziness
Rombergs test and advanced Rombergs test
Measured: at inclusion, 10-12 weeks, 12 months
return of symptoms
Measured: 12 months
sick leave
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DizzinessStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital, St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Siv Mørkved, PhD, Principal investigator, Associate professor / senior researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00702832
- Sponsor's protocol ID
- REK 4.2007.1802
- Status last verified
- Dec 2019
- First submitted
- 19 Jun 2008
- Last updated
- 9 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31789800
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vestibular Rehabilitation in the Treatment of Patients With Acute Vestibular Loss. - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00702832
- Acronym / sponsor ID
- REK 4.2007.1802
- Conditions
- Dizziness, Nausea, Nystagmus, Vestibular Diseases
- Keywords
- Vestibular rehabilitation, acute vestibular injury, Dizziness, Nausea, Nystagmus, Daily life activities, Balance, physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Haukeland University Hospital, St. Olavs Hospital
- Study start
- Jan 2008 (actual)
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 20 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vestibular rehabilitation | Experimental | Behavioral: Vestibular rehabilitationearly supported vestibular rehabilitation |
| standard | Active comparator | Other: standard treatmentstandard treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- acute symptoms of dizziness, nausea and nystagmus
- diagnosed by videonystagmography (at least 25% reduced caloric response in one ear)
- age 18-70 years
Key exclusion criteria (2 listed)
- chronic dizziness
- psychiatric diagnosis that might interfere with participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vestibular rehabilitationDaily 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. | Behavioural | Vestibular rehabilitation |
| standard treatmenttreatment as usual | Other | standard |
Primary outcome
vertigo
Time frame: at inclusion, 10-12 weeks, 12 months
Vertigo symptom scale (VSS)
4 secondary outcomes
Dizziness
Time frame: At inclusion, 10-12 weeks, 12 months
Movement provoked dizziness
Time frame: at inclusion, 10-12 weeks, 12 months
return of symptoms
Time frame: 12 months
sick leave
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
- Results publication: PubMed 31789800Tokle 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siv Mørkved, PhD principal investigator
Associate professor / senior researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular rehabilitation and standard treatment in people with Dizziness and Nausea, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vertigo (time frame: at inclusion, 10-12 weeks, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00702832, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2019.