NCT00702832

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 20, 2008

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

December 9, 2019

Status Verified

December 1, 2019

Enrollment Period

3.9 years

First QC Date

June 19, 2008

Last Update Submit

December 4, 2019

Conditions

Keywords

Vestibular rehabilitationacute vestibular injuryDizzinessNauseaNystagmusDaily life activitiesBalancephysiotherapy

Outcome Measures

Primary Outcomes (1)

  • vertigo

    Vertigo symptom scale (VSS)

    at inclusion, 10-12 weeks, 12 months

Secondary Outcomes (4)

  • Dizziness

    At inclusion, 10-12 weeks, 12 months

  • Movement provoked dizziness

    at inclusion, 10-12 weeks, 12 months

  • return of symptoms

    12 months

  • sick leave

    12 months

Study Arms (2)

Vestibular rehabilitation

EXPERIMENTAL

early supported vestibular rehabilitation

Behavioral: Vestibular rehabilitation

standard

ACTIVE COMPARATOR

standard treatment

Other: standard treatment

Interventions

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.

Vestibular rehabilitation

treatment as usual

standard

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • acute symptoms of dizziness, nausea and nystagmus
  • diagnosed by videonystagmography (at least 25% reduced caloric response in one ear)
  • age 18-70 years

You may not qualify if:

  • chronic dizziness
  • psychiatric diagnosis that might interfere with participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Olavs Hospital

Trondheim, 7489, Norway

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

DizzinessNauseaNystagmus, PathologicVestibular Diseases

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveOcular Motility DisordersCranial Nerve DiseasesNervous System DiseasesEye DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Siv Mørkved, PhD

    Associate professor / senior researcher

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2008

First Posted

June 20, 2008

Study Start

January 1, 2008

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

December 9, 2019

Record last verified: 2019-12

Locations