Clinical trial NCT06300840: Vibrotactile Feedback Belt in Patients With Unilateral Vestibular Hypofunction (UVH)
Official title: Use of a Vibrotactile Feedback Belt in People With Chronic Disabling Unilateral Vestibular Hypofunction: a Single-case Experiment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Vestibular Disorder
Keywords: vibrotactile feedback
Lead sponsor: Gelre Hospitals
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Single-case-experiment (SCE) with a reversal design and with randomization of phases.
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Mobility and Balance Score (MBS)
timeFrame: Daily for 7 weeks
Secondary outcomes:
measure: General functioning
timeFrame: Daily for 7 weeks
measure: physical activity_NRS
timeFrame: Daily for 7 weeks
measure: physical activity_steps
timeFrame: Daily for 7 weeks
measure: Fear of falling
timeFrame: Daily for 7 weeks
measure: fatigue
timeFrame: Daily for 7 weeks
measure: falls
timeFrame: Daily for 7 weeks
measure: structured interview on compliance on wearing the Balancebelt(R)
timeFrame: Daily for 7 weeks
measure: Questionnaire: vestibular activity avoiding instrument (VAAI)
timeFrame: At baseline and at the end of the study (8 weeks)
measure: Questionnaire: Dizziness handicap inventory (DHI)
timeFrame: At baseline and at the end of the study (8 weeks)
measure: modified Clinical Test of Sensory Interaction on Balance (mCTSIB)
timeFrame: At baseline and at the end of the study (8 weeks)
measure: Dynamic Gait Index (DGI)
timeFrame: At the baseline and at the end of the study (8 weeks)
measure: Timed up and Go test (TUG)
timeFrame: At baseline and at the end of the study (8 weeks)
Other outcomes:
measure: age
timeFrame: Baseline
measure: time since onset of the vestibular hypofunction
timeFrame: Baseline
measure: cause of vestibular hypofunction
timeFrame: Baseline
measure: Structured interview on vestibular rehabilitation
timeFrame: Baseline
measure: outcome of the vestibular function tests
timeFrame: Baseline
measure: Structured interview on participating in the research
timeFrame: At the end of the study (8 weeks)
measure: Structured interview on the overall experience with the Balancebelt(R)
timeFrame: At the end of the study (8 weeks)
Locations:
city: Apeldoorn
country: Netherlands
facility: Gelre Hospitals
state: Gelderland
Study officials:
affiliation: Gelre Hop
name: Tjasse Bruintjes, PhD
role: PRINCIPAL_INVESTIGATOR
References: