Using the Vestibular Labyrinthine Substitution system in daily life

Bilateral vestibular loss represents a major handicap with strong balance
disturbances, higher risk of fall, visual symptoms (oscillopsia) and a loss of
autonomy. There is still no therapy is available. At current, development of a
vestibular implant (VI) is our main goal. In order to achieve this goal, a so
called Vestibular Labyrinthine Substitution system (VLS) is developed. The VLS,
a fully ambulant system, contains a 3D sensor for linear accelerations, a
processor and a belt with actuators. It functions best with people who have
major balance problems. Studies show that in the majority of patients using the
VLS-system, significant improvements in balance during gait are obtained, as
well increased confidence, independence and a feeling of balance. Until now,
all tests were performed in a balance lab, but never during daily life. This
study investigates whether patient performance and quality of life indeed
increase by using biofeedback in a daily situation, for a longer period (12
weeks).

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To objectify the effect of the VLS-system during daily use regarding postural
stability and quality of life.

Single blinded, placebo-controlled intervention study

1. After returning written informed consent, selected patients will undergo an
extensive vestibular examination (about 4 hours) which is routinely done in our
ENT-Department to investigate patients with balance disorders.
2. Patients will undergo also a one-day-testing phase, as explained in the
protocol.
3. Patients are scheduled for extra visits to the outpatient department,
including questionnaires and vestibular examination.
4. Patients have to wear a non-invasive device (VLS-system) during the day for
twelve weeks.
No risks are associated with the use of the VLS-system.