Vibrotactile Feedback Belt in Patients With Unilateral Vestibular Hypofunction (UVH) (VIBE)

Hanna van Eijsden

Status: Not yet enrolling

Conditions: Vestibular Disorder

Treatments: Device: BalanceBelt

Study type: Interventional

Funder types: Other

Identifiers

NCT06300840

NL84562.075.23 (Other Identifier)

2023_49

Details and patient eligibility

About

The goal of this clinical trial is to study the impact of a continuous vibrotactile feedback belt on balance, (fear of) falling, fatigue and overall functioning in participants with chronic disabling unilateral vestibular hypofunction.

The main questions it aims to answer are: • does wearing a vibrotactile feedback belt during waking hours for a week improve sense of balance and mobility, fear of falling, fatigue and overall functioning • does wearing a vibrotactile feedback belt influence static and dynamic balance and gait performance during balance and gait testing.

Participants will goes through different phases in an randomized order; a baseline phase, a sham phase (i.e., wearing the BalanceBelt while it is switched off) and an intervention phase (i.e., wearing the BalanceBelt while it is switched on).

It is expected that, just as with patients with bilateral loss of the balance organ, patients with a unilateral loss will also benefit from the BalanceBelt.

Enrollment: 8 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with severe unilateral vestibular dysfunction (i.e., a gain below 0.6 of the affected side and a gain between 0.8 and 1.1 of the contralateral side measured by the video-Head Impulse Test (vHIIT)).
• Duration of dizziness complaints >3 months (i.e. chronic dizziness).
• Self-reported imbalance with a fear of falling and/or actual falls.
• Is able to walk (with or without a walking aid).
• Self-reported overall Mobility and Balance Score (MBS) of 3-5 points
• Motivated to try the BalanceBelt.
• Provides written informed consent.

Exclusion criteria

• Age < 18 years
• Presence of neurological, psychiatric or orthopaedic disorders, Persistent postural-perceptual dizziness (PPPD), reduced proprioceptive sensitivity or impaired vision which influences the postural stability.
• Not able to understand instructions and questionnaires in Dutch
• Not able/willing to visit Gelre Hospital Apeldoorn for necessary visits.
• Wheelchair bound at home

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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8 participants in 3 patient groups

Baseline

No Intervention group

Description:

Wearing no Balancebelt.

Sham condition

Sham Comparator group

Description:

Wearing the BalanceBelt while it is switched off

Treatment:

Device: BalanceBelt

Intervention

Experimental group

Description:

Wearing the BalanceBelt while it is switched on

Treatment:

Device: BalanceBelt