NCT06300840

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

Use of a Vibrotactile Feedback Belt in People With Chronic Disabling Unilateral Vestibular Hypofunction: a Single-case Experiment

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: Hanna van Eijsden · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Vestibular Disorder

Interventions

Type	Name	Description
DEVICE	BalanceBelt	The vibrotactile belt (i.e., Elitac BalanceBelt®) supports patients with severe balance disorders by substituting the missing balance information with vibrations (haptic feedback).

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-04-01
• Completion: 2025-04-01
• First posted: 2024-03-08
• Last updated: 2024-03-08

Locations

1 site across 1 country: Netherlands