Use of a Vibrotactile Feedback Belt in People With Chronic Disabling Unilateral Vestibular Hypofunction: a Single-case Experiment
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Vestibular Disorder
- Sponsor
- Hanna van Eijsden
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Mobility and Balance Score (MBS)
- Status
- Not Yet Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Hanna van Eijsden
clinical investigator
Gelre Hospitals
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
Outcomes
Primary Outcomes
Mobility and Balance Score (MBS)
Time Frame: 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 Outcomes
- falls(Daily for 7 weeks)
- Dynamic Gait Index (DGI)(At the baseline and at the end of the study (8 weeks))
- Timed up and Go test (TUG)(At baseline and at the end of the study (8 weeks))
- Fear of falling(Daily for 7 weeks)
- fatigue(Daily for 7 weeks)
- structured interview on compliance on wearing the Balancebelt(R)(Daily for 7 weeks)
- Questionnaire: Dizziness handicap inventory (DHI)(At baseline and at the end of the study (8 weeks))
- General functioning(Daily for 7 weeks)
- physical activity_NRS(Daily for 7 weeks)
- physical activity_steps(Daily for 7 weeks)
- Questionnaire: vestibular activity avoiding instrument (VAAI)(At baseline and at the end of the study (8 weeks))
- modified Clinical Test of Sensory Interaction on Balance (mCTSIB)(At baseline and at the end of the study (8 weeks))