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

Vestibular Disorder Clinical Trial

— VIBE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06300840
• Other study ID #: 2023_49
• Secondary ID: NL84562.075.23
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: April 2025

Study information

• Verified date: March 2024
• Source: Gelre Hospitals
• Contact: Hanna Koppelaar - van Eijsden, MSc
• Phone: +31555818470
• Email: h.van.eijsden[@]gelre.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 8
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vestibular Diseases
• Vestibular Disorder

Intervention

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).

Locations

Country	Name	City	State
Netherlands	Gelre Hospitals	Apeldoorn	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Hanna van Eijsden

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	age	in years	Baseline
Other	time since onset of the vestibular hypofunction	in months or years	Baseline
Other	cause of vestibular hypofunction	etiology	Baseline
Other	Structured interview on vestibular rehabilitation	previous experience with vestibular rehabilitation (types of intervention, number of therapie sessions, benefit)	Baseline
Other	outcome of the vestibular function tests	results of available video-Head Impulse Test (vHIT) or caloric testing	Baseline
Other	Structured interview on participating in the research	experience of the research	At the end of the study (8 weeks)
Other	Structured interview on the overall experience with the Balancebelt(R)	evaluation of the Balancebelt(R)	At the end of the study (8 weeks)
Primary	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	General functioning	Numeric rating scale (NRS), rang 0-10, where a higher score means a better outcome.	Daily for 7 weeks
Secondary	physical activity_NRS	Numeric rating scale, rang 0-10, where a higher score means a better outcome.	Daily for 7 weeks
Secondary	physical activity_steps	Number of steps a day	Daily for 7 weeks
Secondary	Fear of falling	Numeric rating scale, rang 0-10, where a higher score means a better outcome.	Daily for 7 weeks
Secondary	fatigue	Numeric rating scale, rang 0-10, where a higher score means a better outcome.	Daily for 7 weeks
Secondary	falls	number of actual falls and near falls	Daily for 7 weeks
Secondary	structured interview on compliance on wearing the Balancebelt(R)	compliance on wearing the Balancebelt(R)	Daily for 7 weeks
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Timed up and Go test (TUG)	Timed up and Go test	At baseline and at the end of the study (8 weeks)