Vestibular rehabilitation by sensory substitution.

Completed

Conditions: Balance disorders
Vestibular Disorders
10022396

Registration Number: NL-OMON30075

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 48

Inclusion Criteria

• Adults
• Complaints of persistent vertigo due to peripheral vestibular disorder of different etiology. (unilateral vestibular loss)
• Proven peripheral vestibular disease on calorisation, torsion test or VEMP test.

Exclusion Criteria

1) Additional neurological disorders (e.g. CNS malignancy)
2) Patients with severe vision defects
3) Patients with severe orthopaedic disease affecting the musculoskeletal system
4) Intra-oral pathologies
5) Patients with reduced propriocepsis (e.g. DM)
6) Low ability to communicate in Dutch language due to co-morbidity or impaired language competence.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Our main outcome will be the Dizziness Handicap Inventory (DHI), our power<br /><br>calculations are based on this psychometric test. Further, physiological and<br /><br>psychological evaluation of the treatment will be performed with various other<br /><br>tests: Electronystagmography (ENG), Vestibular Evoked Myogenic Potentials<br /><br>(VEMPs) and the questionnaire: Activities-specific Balance Confidence (ABC)<br /><br>Scale.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome is the safety of the BrainPort Balance Device in clinical use.<br /><br>This will be measured by the frequency, type and severity of adverse events.<br /><br>Telephone contacts will provide such information. In the in home use period<br /><br>patients will be called 1 time a week for the first six weeks and one time a<br /><br>month after that. </p><br>