Vibrotactile Feedback Belt in Patients With Unilateral Vestibular Hypofunction (UVH)
- Conditions
- Vestibular Disorder
- Interventions
- Device: BalanceBelt
- Registration Number
- NCT06300840
- Lead Sponsor
- Hanna van Eijsden
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 8
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sham condition BalanceBelt Wearing the BalanceBelt while it is switched off Intervention BalanceBelt Wearing the BalanceBelt while it is switched on
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method physical activity_steps Daily for 7 weeks Number of steps a day
falls Daily for 7 weeks number of actual falls and near falls
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
Fear of falling Daily for 7 weeks Numeric rating scale, rang 0-10, where a higher score means a better outcome.
fatigue Daily for 7 weeks Numeric rating scale, rang 0-10, where a higher score means a better outcome.
structured interview on compliance on wearing the Balancebelt(R) Daily for 7 weeks compliance on wearing the Balancebelt(R)
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.
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.
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.
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
Trial Locations
- Locations (1)
Gelre Hospitals
🇳🇱Apeldoorn, Gelderland, Netherlands