Vestibular DisorderVIBENCT06300840
Vibrotactile Feedback Belt in Patients With Unilateral Vestibular Hypofunction (UVH)
A study testing BalanceBelt in people with Vestibular Disorder, run by Hanna van Eijsden at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vestibular Disorder
- What is being tested?
- BalanceBelt
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2024to Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Tjard Schermer, PhD contact
About this study
Official title: Use of a Vibrotactile Feedback Belt in People With Chronic Disabling Unilateral Vestibular Hypofunction: a Single-case Experiment
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.
Read more
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.
- Conditions
- Vestibular Disorder
- Being tested
- BalanceBelt
- Keywords
- vibrotactile feedback
- Medical subject headings
- Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BalanceBeltDevice
The vibrotactile belt (i.e., Elitac BalanceBelt®) supports patients with severe balance disorders by substituting the missing balance information with vibrations (haptic feedback).
| Study group | Role | What they receive |
|---|---|---|
| Baseline | No intervention | Wearing no Balancebelt. |
| Sham condition | Sham comparator | Wearing the BalanceBelt while it is switched off Receives: Device: BalanceBelt |
| Intervention | Experimental | Wearing the BalanceBelt while it is switched on Receives: Device: BalanceBelt |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Daily for 7 weeks
Secondary outcomes (12)
General functioning
Numeric rating scale (NRS), rang 0-10, where a higher score means a better outcome.
Measured: Daily for 7 weeks
physical activity_NRS
Numeric rating scale, rang 0-10, where a higher score means a better outcome.
Measured: Daily for 7 weeks
physical activity_steps
Number of steps a day
Measured: Daily for 7 weeks
Fear of falling
Numeric rating scale, rang 0-10, where a higher score means a better outcome.
Measured: Daily for 7 weeks
fatigue
Numeric rating scale, rang 0-10, where a higher score means a better outcome.
Measured: Daily for 7 weeks
falls
number of actual falls and near falls
Measured: Daily for 7 weeks
structured interview on compliance on wearing the Balancebelt(R)
compliance on wearing the Balancebelt(R)
Measured: Daily for 7 weeks
Questionnaire: vestibular activity avoiding instrument (VAAI)
vestibular activity avoiding instrument, score range 0-54, higher score means worse outcome.
Measured: 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.
Measured: 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
Measured: 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
Measured: At the baseline and at the end of the study (8 weeks)
Timed up and Go test (TUG)
Timed up and Go test
Measured: At baseline and at the end of the study (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study startMar 2024 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single-case-experiment (SCE) with a reversal design and with randomization of phases.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanna van Eijsden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hanna van Eijsden, Gelre Hospitals
- Investigators
- Tjasse Bruintjes, PhD, Principal investigator, Gelre Hop
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300840
- Sponsor's protocol ID
- 2023_49
- Other IDs
- NL84562.075.23
- Acronym
- VIBE
- Status last verified
- Mar 2024
- First submitted
- 13 Feb 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Vibrotactile Feedback Belt in People With Chronic Disabling Unilateral Vestibular Hypofunction: a Single-case Experiment
- ClinicalTrials.gov ID
- NCT06300840
- Acronym / sponsor ID
- VIBE / 2023_49
- Conditions
- Vestibular Disorder
- Keywords
- vibrotactile feedback
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Hanna van EijsdenUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Single-case-experiment (SCE) with a reversal design and with randomization of phases.
| Arm | Type | Receives |
|---|---|---|
| Baseline | No intervention | –Wearing no Balancebelt. |
| Sham condition | Sham comparator | Device: BalanceBeltWearing the BalanceBelt while it is switched off |
| Intervention | Experimental | Device: BalanceBeltWearing the BalanceBelt while it is switched on |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BalanceBeltThe vibrotactile belt (i.e., Elitac BalanceBelt®) supports patients with severe balance disorders by substituting the missing balance information with vibrations (haptic feedback). | Device | Intervention, Sham condition |
Primary outcome
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.
12 secondary outcomes
General functioning
Time frame: Daily for 7 weeks
physical activity_NRS
Time frame: Daily for 7 weeks
physical activity_steps
Time frame: Daily for 7 weeks
Fear of falling
Time frame: Daily for 7 weeks
fatigue
Time frame: Daily for 7 weeks
falls
Time frame: Daily for 7 weeks
structured interview on compliance on wearing the Balancebelt(R)
Time frame: Daily for 7 weeks
Questionnaire: vestibular activity avoiding instrument (VAAI)
Time frame: At baseline and at the end of the study (8 weeks)
Questionnaire: Dizziness handicap inventory (DHI)
Time frame: At baseline and at the end of the study (8 weeks)
modified Clinical Test of Sensory Interaction on Balance (mCTSIB)
Time frame: At baseline and at the end of the study (8 weeks)
Dynamic Gait Index (DGI)
Time frame: At the baseline and at the end of the study (8 weeks)
Timed up and Go test (TUG)
Time frame: At baseline and at the end of the study (8 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tjard Schermer, PhD contact
Tjasse Bruintjes, PhD principal investigator
Gelre Hop
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BalanceBelt in people with Vestibular Disorder, run by Hanna van Eijsden at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanna Koppelaar - van Eijsden, MSc (+31555818470, h.van.eijsden@gelre.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mobility and Balance Score (MBS) (time frame: Daily for 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.