Effect of Vestibular Rehabilitation - a Randomized Controlled Trial

NCT ID: NCT00702832

Last Updated: 2019-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2011-12-31

Brief Summary

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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?

Detailed Description

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Conditions

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Dizziness Nausea Nystagmus Vestibular Diseases

Keywords

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Vestibular rehabilitation acute vestibular injury Dizziness Nausea Nystagmus Daily life activities Balance physiotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vestibular rehabilitation

early supported vestibular rehabilitation

Group Type EXPERIMENTAL

Vestibular rehabilitation

Intervention Type BEHAVIORAL

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

standard treatment

Group Type ACTIVE_COMPARATOR

standard treatment

Intervention Type OTHER

treatment as usual

Interventions

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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.

Intervention Type BEHAVIORAL

standard treatment

treatment as usual

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Haukeland University Hospital

OTHER

Sponsor Role collaborator

St. Olavs Hospital

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Siv Mørkved, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate professor / senior researcher

Locations

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St. Olavs Hospital

Trondheim, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type RESULT
PMID: 31789800 (View on PubMed)

Other Identifiers

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REK 4.2007.1802

Identifier Type: -

Identifier Source: org_study_id