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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vestibular Disorder
• Intervention / Treatment: Device: BalanceBelt

• Study Type: Interventional
• Enrollment (Estimated): 8
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hanna Koppelaar - van Eijsden, MSc; Phone Number: +31555818470; Email: h.van.eijsden@gelre.nl
• Study Contact Backup: Name: Tjard Schermer, PhD; Email: t.schermer@gelre.nl

Study Locations

• Netherlands
  • Gelderland
    • Apeldoorn, Gelderland, Netherlands, 7334 DZ
      • Gelre Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Baseline; Wearing no Balancebelt.
Sham Comparator: Sham condition; Wearing the BalanceBelt while it is switched off	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).
Experimental: Intervention; Wearing the BalanceBelt while it is switched on	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mobility and Balance Score (MBS)	The MBS is a rating given by the patient on a scale ranging from 0 to 10, as a subjective grading of his or her overall mobility and balance in daily life. Where a higher score means a better score.	Daily for 7 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General functioning	Numeric rating scale (NRS), rang 0-10, where a higher score means a better outcome.	Daily for 7 weeks
physical activity_NRS	Numeric rating scale, rang 0-10, where a higher score means a better outcome.	Daily for 7 weeks
physical activity_steps	Number of steps a day	Daily for 7 weeks
Fear of falling	Numeric rating scale, rang 0-10, where a higher score means a better outcome.	Daily for 7 weeks
fatigue	Numeric rating scale, rang 0-10, where a higher score means a better outcome.	Daily for 7 weeks
falls	number of actual falls and near falls	Daily for 7 weeks
structured interview on compliance on wearing the Balancebelt(R)	compliance on wearing the Balancebelt(R)	Daily for 7 weeks
Questionnaire: vestibular activity avoiding instrument (VAAI)	vestibular activity avoiding instrument, score range 0-54, higher score means worse outcome.	At baseline and at the end of the study (8 weeks)
Questionnaire: Dizziness handicap inventory (DHI)	Dizziness handicap inventory, score range 0-100, higher score means worse outcome.	At baseline and at the end of the study (8 weeks)
modified Clinical Test of Sensory Interaction on Balance (mCTSIB)	modified Clinical Test of Sensory Interaction on Balance	At baseline and at the end of the study (8 weeks)
Dynamic Gait Index (DGI)	Dynamic Gait Index, score 0-24, higher score means better outcome	At the baseline and at the end of the study (8 weeks)
Timed up and Go test (TUG)	Timed up and Go test	At baseline and at the end of the study (8 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
age	in years	Baseline
time since onset of the vestibular hypofunction	in months or years	Baseline
cause of vestibular hypofunction	etiology	Baseline
Structured interview on vestibular rehabilitation	previous experience with vestibular rehabilitation (types of intervention, number of therapie sessions, benefit)	Baseline
outcome of the vestibular function tests	results of available video-Head Impulse Test (vHIT) or caloric testing	Baseline
Structured interview on participating in the research	experience of the research	At the end of the study (8 weeks)
Structured interview on the overall experience with the Balancebelt(R)	evaluation of the Balancebelt(R)	At the end of the study (8 weeks)

Collaborators and Investigators

• Sponsor: Hanna van Eijsden
• Investigators: Principal Investigator: Tjasse Bruintjes, PhD, Gelre Hop

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: February 13, 2024
• First Submitted That Met QC Criteria: March 7, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: vibrotactile feedback
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Vestibular Diseases
• Other Study ID Numbers: 2023_49; NL84562.075.23 (Other Identifier: METC ISALA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No