Effect of Vestibular Rehabilitation - a Randomized Controlled Trial

Nausea Clinical Trial

Official title:

Effects of Vestibular Rehabilitation in the Treatment of Patients With Acute Vestibular Loss. - A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00702832
• Other study ID #: REK 4.2007.1802
• Status: Completed
• Phase: N/A
• Start date: January 2008
• Est. completion date: December 2011

Study information

• Verified date: December 2019
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 compared to standard treatment?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Dizziness
• Nausea
• Nystagmus
• Vertigo
• Vestibular Diseases

Intervention

Behavioral:
• 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.

Other:
• standard treatment
treatment as usual

Locations

Country	Name	City	State
Norway	St. Olavs Hospital	Trondheim

Sponsors (3)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Haukeland University Hospital, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Tokle G, Mørkved S, Bråthen G, Goplen FK, Salvesen Ø, Arnesen H, Holmeslet B, Nordahl SHG, Wilhelmsen KT. Efficacy of Vestibular Rehabilitation Following Acute Vestibular Neuritis: A Randomized Controlled Trial. Otol Neurotol. 2019 Nov 1. doi: 10.1097/MAO — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vertigo	Vertigo symptom scale (VSS)	at inclusion, 10-12 weeks, 12 months
Secondary	Dizziness	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
Secondary	Movement provoked dizziness	Rombergs test and advanced Rombergs test	at inclusion, 10-12 weeks, 12 months
Secondary	return of symptoms		12 months
Secondary	sick leave		12 months