protocolSection identificationModule nctId: NCT06300840, orgStudyIdInfo id: 2023_49, secondaryIdInfos id: NL84562.075.23, type: OTHER, domain: METC ISALA, briefTitle: Vibrotactile Feedback Belt in Patients With Unilateral Vestibular Hypofunction (UVH), acronym: VIBE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2025-04, completionDateStruct date: 2025-04, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Hanna van Eijsden, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Vestibular Disorder, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Single-case-experiment (SCE) with a reversal design and with randomization of phases., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Data-analyst and test-observer are masked, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 8, type: ESTIMATED, armsInterventionsModule interventions name: BalanceBelt, outcomesModule primaryOutcomes measure: Mobility and Balance Score (MBS), secondaryOutcomes measure: General functioning, secondaryOutcomes measure: physical activity_NRS, secondaryOutcomes measure: physical activity_steps, secondaryOutcomes measure: Fear of falling, secondaryOutcomes measure: fatigue, secondaryOutcomes measure: falls, secondaryOutcomes measure: structured interview on compliance on wearing the Balancebelt(R), secondaryOutcomes measure: Questionnaire: vestibular activity avoiding instrument (VAAI), secondaryOutcomes measure: Questionnaire: Dizziness handicap inventory (DHI), secondaryOutcomes measure: modified Clinical Test of Sensory Interaction on Balance (mCTSIB), secondaryOutcomes measure: Dynamic Gait Index (DGI), secondaryOutcomes measure: Timed up and Go test (TUG), otherOutcomes measure: age, otherOutcomes measure: time since onset of the vestibular hypofunction, otherOutcomes measure: cause of vestibular hypofunction, otherOutcomes measure: Structured interview on vestibular rehabilitation, otherOutcomes measure: outcome of the vestibular function tests, otherOutcomes measure: Structured interview on participating in the research, otherOutcomes measure: Structured interview on the overall experience with the Balancebelt(R), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Gelre Hospitals, city: Apeldoorn, state: Gelderland, zip: 7334 DZ, country: Netherlands, geoPoint lat: 52.21, lon: 5.96944, hasResults: False