Clinical evaluation of the effectiveness and safety of the BrainPort Balance Device in the rehabilitation of patients with unilateral vestibular disorders with different etiology. The effectiveness of the device will be compared to natural…
ID
Source
Brief title
Condition
- Inner ear and VIIIth cranial nerve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Loss of vestibular function leads to severe impairment and reduced quality of
life. At this time no causative treatment of vestibular loss is available and
an expectative approach is the most common one, which is understandable because
an effective spontaneous mechanism of vestibular compensation exists.
Rehabilitation therapy through exercises is an alternative for this expectative
approach. In recent years sensory substitution of the vestibular apparatus has
been developed as yet another alternative. The goal of vestibular therapy
through sensory substitution is a greater awareness of postural balance, more
adequate reactions to environmental changes, quicker rehabilitation and
improved quality of life.
Study objective
Clinical evaluation of the effectiveness and safety of the BrainPort Balance
Device in the rehabilitation of patients with unilateral vestibular disorders
with different etiology. The effectiveness of the device will be compared to
natural compensation in relation to the expectative approach and accelerated
compensation in relation to conventional vestibular rehabilitation therapy.
Study design
Randomised, prospective monocentre trial performed in a tertiary medical
centre.
Intervention
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 approach is adopted. Patients in the
device group will be trained to perform specific postural exercises. Patients
will continue for 26 weeks of in home use of the device after the clinical
training phase of the study. Patients in the exercise group will perform the
same specific exercises as the groups with the provided devices for 6 months.
After 4 and 12 weeks and after 6 months, patient groups will be compared to
each other.
Study burden and risks
The specific patient group continuously requests attention from clinical
professionals but hardly ever gets it. Therefore, participants will probably
not consider their participation in the study as an unbearable burden. The
potential risks arising from use of the BrainPort Balance Device are minor and
can be managed, after mandatory training, by setting the stimulus level
according to the preferred intensity, adhering to the instructions in the user
manual. As mentioned before, at this moment an expectative approach is the
regular treatment. When the BrainPort Balance Device and/or the Rehabilitation
therapy through exercises show an added effect compared to an expectative
approach, this could be beneficial for all patients with vestibular loss.
Heidelberglaan 100
3584 CX Utrecht
Nederland
Heidelberglaan 100
3584 CX Utrecht
Nederland
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL11375.041.06 |