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| ID | Type | Description | Link |
|---|---|---|---|
| NL84562.075.23 | Other Identifier | METC ISALA |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baseline | No Intervention | Wearing no Balancebelt. | |
| Sham condition | Sham Comparator | Wearing the BalanceBelt while it is switched off |
|
| Intervention | Experimental | Wearing the BalanceBelt while it is switched on |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BalanceBelt | Device | The vibrotactile belt (i.e., Elitac BalanceBelt®) supports patients with severe balance disorders by substituting the missing balance information with vibrations (haptic feedback). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Daily for 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| General functioning | Numeric rating scale (NRS), rang 0-10, where a higher score means a better outcome. | Daily for 7 weeks |
| physical activity_NRS | Numeric rating scale, rang 0-10, where a higher score means a better outcome. |
| Measure | Description | Time Frame |
|---|---|---|
| age | in years | Baseline |
| time since onset of the vestibular hypofunction | in months or years | Baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hanna Koppelaar - van Eijsden, MSc | Contact | +31555818470 | h.van.eijsden@gelre.nl | |
| Tjard Schermer, PhD | Contact | t.schermer@gelre.nl |
| Name | Affiliation | Role |
|---|---|---|
| Tjasse Bruintjes, PhD | Gelre Hop | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gelre Hospitals | Apeldoorn | Gelderland | 7334 DZ | Netherlands |
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| ID | Term |
|---|---|
| D015837 | Vestibular Diseases |
| ID | Term |
|---|---|
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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Single-case-experiment (SCE) with a reversal design and with randomization of phases.
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Data-analyst and test-observer are masked
| Daily for 7 weeks |
| physical activity_steps | Number of steps a day | Daily for 7 weeks |
| Fear of falling | Numeric rating scale, rang 0-10, where a higher score means a better outcome. | Daily for 7 weeks |
| fatigue | Numeric rating scale, rang 0-10, where a higher score means a better outcome. | Daily for 7 weeks |
| falls | number of actual falls and near falls | Daily for 7 weeks |
| structured interview on compliance on wearing the Balancebelt(R) | compliance on wearing the Balancebelt(R) | Daily for 7 weeks |
| Questionnaire: vestibular activity avoiding instrument (VAAI) | vestibular activity avoiding instrument, score range 0-54, higher score means worse outcome. | 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. | 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 | 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 | At the baseline and at the end of the study (8 weeks) |
| Timed up and Go test (TUG) | Timed up and Go test | At baseline and at the end of the study (8 weeks) |
| cause of vestibular hypofunction | etiology | Baseline |
| Structured interview on vestibular rehabilitation | previous experience with vestibular rehabilitation (types of intervention, number of therapie sessions, benefit) | Baseline |
| outcome of the vestibular function tests | results of available video-Head Impulse Test (vHIT) or caloric testing | Baseline |
| Structured interview on participating in the research | experience of the research | At the end of the study (8 weeks) |
| Structured interview on the overall experience with the Balancebelt(R) | evaluation of the Balancebelt(R) | At the end of the study (8 weeks) |