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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
8
The vibrotactile belt (i.e., Elitac BalanceBelt®) supports patients with severe balance disorders by substituting the missing balance information with vibrations (haptic feedback).
Gelre Hospitals
Apeldoorn, Gelderland, Netherlands
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.
Time frame: Daily for 7 weeks
General functioning
Numeric rating scale (NRS), rang 0-10, where a higher score means a better outcome.
Time frame: Daily for 7 weeks
physical activity_NRS
Numeric rating scale, rang 0-10, where a higher score means a better outcome.
Time frame: Daily for 7 weeks
physical activity_steps
Number of steps a day
Time frame: Daily for 7 weeks
Fear of falling
Numeric rating scale, rang 0-10, where a higher score means a better outcome.
Time frame: Daily for 7 weeks
fatigue
Numeric rating scale, rang 0-10, where a higher score means a better outcome.
Time frame: Daily for 7 weeks
falls
number of actual falls and near falls
Time frame: Daily for 7 weeks
structured interview on compliance on wearing the Balancebelt(R)
compliance on wearing the Balancebelt(R)
Time frame: Daily for 7 weeks
Questionnaire: vestibular activity avoiding instrument (VAAI)
vestibular activity avoiding instrument, score range 0-54, higher score means worse outcome.
Time frame: At baseline and at the end of the study (8 weeks)
Questionnaire: Dizziness handicap inventory (DHI)
Dizziness handicap inventory, score range 0-100, higher score means worse outcome.
Time frame: At baseline and at the end of the study (8 weeks)
modified Clinical Test of Sensory Interaction on Balance (mCTSIB)
modified Clinical Test of Sensory Interaction on Balance
Time frame: At baseline and at the end of the study (8 weeks)
Dynamic Gait Index (DGI)
Dynamic Gait Index, score 0-24, higher score means better outcome
Time frame: At the baseline and at the end of the study (8 weeks)
Timed up and Go test (TUG)
Timed up and Go test
Time frame: At baseline and at the end of the study (8 weeks)
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