Balance disorders Vestibular Disorders
Conditions
Interventions
Patients will be randomised for participation of one of three patients groups:
the device group (1), the rehabilitation therapy by exercises group (2) or a
control group (3) in which an expectative
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Our main outcome will be the Dizziness Handicap Inventory (DHI), our power calculations are based on this psychometric test. Further, physiological and psychological evaluation of the treatment will be performed with various other tests: Electronystagmography (ENG), Vestibular Evoked Myogenic Potentials (VEMPs) and the questionnaire: Activities-specific Balance Confidence (ABC) Scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome is the safety of the BrainPort Balance Device in clinical use. This will be measured by the frequency, type and severity of adverse events. Telephone contacts will provide such information. In the in home use period patients will be called 1 time a week for the first six weeks and one time a month after that. | — |
Countries
Netherlands
Outcome results
None listed