Vestibular Disorder
Conditions
Keywords
vibrotactile feedback
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.
Interventions
DEVICEBalanceBelt
The vibrotactile belt (i.e., Elitac BalanceBelt®) supports patients with severe balance disorders by substituting the missing balance information with vibrations (haptic feedback).
Sponsors
Hanna van Eijsden
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Data-analyst and test-observer are masked
Intervention model description
Single-case-experiment (SCE) with a reversal design and with randomization of phases.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mobility and Balance Score (MBS) | Daily for 7 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fear of falling | Daily for 7 weeks | Numeric rating scale, rang 0-10, where a higher score means a better outcome. |
| falls | Daily for 7 weeks | number of actual falls and near falls |
| structured interview on compliance on wearing the Balancebelt(R) | Daily for 7 weeks | compliance on wearing the Balancebelt(R) |
| Questionnaire: vestibular activity avoiding instrument (VAAI) | At baseline and at the end of the study (8 weeks) | vestibular activity avoiding instrument, score range 0-54, higher score means worse outcome. |
| Questionnaire: Dizziness handicap inventory (DHI) | At baseline and at the end of the study (8 weeks) | Dizziness handicap inventory, score range 0-100, higher score means worse outcome. |
| modified Clinical Test of Sensory Interaction on Balance (mCTSIB) | At baseline and at the end of the study (8 weeks) | modified Clinical Test of Sensory Interaction on Balance |
| Dynamic Gait Index (DGI) | At the baseline and at the end of the study (8 weeks) | Dynamic Gait Index, score 0-24, higher score means better outcome |
| Timed up and Go test (TUG) | At baseline and at the end of the study (8 weeks) | Timed up and Go test |
| General functioning | Daily for 7 weeks | Numeric rating scale (NRS), rang 0-10, where a higher score means a better outcome. |
| physical activity_NRS | Daily for 7 weeks | Numeric rating scale, rang 0-10, where a higher score means a better outcome. |
| physical activity_steps | Daily for 7 weeks | Number of steps a day |
| fatigue | Daily for 7 weeks | Numeric rating scale, rang 0-10, where a higher score means a better outcome. |
Other
| Measure | Time frame | Description |
|---|---|---|
| cause of vestibular hypofunction | Baseline | etiology |
| Structured interview on vestibular rehabilitation | Baseline | previous experience with vestibular rehabilitation (types of intervention, number of therapie sessions, benefit) |
| outcome of the vestibular function tests | Baseline | results of available video-Head Impulse Test (vHIT) or caloric testing |
| Structured interview on participating in the research | At the end of the study (8 weeks) | experience of the research |
| Structured interview on the overall experience with the Balancebelt(R) | At the end of the study (8 weeks) | evaluation of the Balancebelt(R) |
| time since onset of the vestibular hypofunction | Baseline | in months or years |
| age | Baseline | in years |
Countries
Netherlands
Contacts
Primary ContactHanna Koppelaar - van Eijsden, MSc
Backup ContactTjard Schermer, PhD
Outcome results
None listed