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Search / Trial NCT06300840

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

Launched by HANNA VAN EIJSDEN · Mar 7, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Vibrotactile Feedback

ClinConnect Summary

This clinical trial is looking at how a special vibrotactile feedback belt can help people with a balance disorder called unilateral vestibular hypofunction (UVH). UVH often causes dizziness and a fear of falling, making it hard for people to feel steady on their feet. During the study, participants will wear this belt for a week, sometimes switched on and sometimes off, to see if it improves their balance, mobility, and overall daily functioning. Researchers want to find out if wearing the belt can make walking easier and reduce the fear of falling.

To join the study, participants need to be between 65 and 74 years old and have been diagnosed with severe unilateral vestibular dysfunction, which means they have been experiencing dizziness for more than three months. They should also be able to walk, even if they use a walking aid, and feel motivated to try the belt. People with certain other health conditions or who cannot visit the study location in Apeldoorn, Netherlands, will not be eligible. This trial is not yet recruiting participants, but it aims to provide valuable insights for those struggling with balance issues.

Gender

ALL

Eligibility criteria

  • 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

About Hanna Van Eijsden

Hanna van Eijsden is a dedicated clinical trial sponsor with a strong commitment to advancing medical research and improving patient outcomes. With expertise in designing and managing clinical studies across various therapeutic areas, she focuses on innovative approaches that ensure compliance with regulatory standards while prioritizing participant safety and integrity of data. Her collaborative approach fosters partnerships with research institutions and healthcare professionals, driving the successful execution of trials that contribute to the development of effective treatments and therapies.

Locations

Apeldoorn, Gelderland, Netherlands

Patients applied

0 patients applied

Trial Officials

Tjasse Bruintjes, PhD

Principal Investigator

Gelre Hop

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported