CompletedNot Applicable

2BALANCE: Cognitive-motor Dual-tasking in Persons with Vestibular Disorders

Belgium130 participantsStarted 2019-08-12

Plain-language summary

The overall aim of this study is to elucidate the impact of a vestibular dysfunction on the cognitive and motor performance by means of an extensive test protocol, evaluating the vestibular, cognitive and motor function using single as well as dual-task paradigms.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

For healthy controls: Exclusion Criteria: * Vestibular disorders or subjective dizziness complains (past or present) * Hearing loss * Mild Cognitive Impairment (Montreal Cognitive Assessment, MOCA) * Visual impairment (Snellen Chart) * Motor abnormalities (anamnestic questionnaire) For bilateral vestibulopathy (BV): Inclusion criteria: * Bilaterally reduced vestibular function, as defined by the Bárány Criteria for BV(Michael Strupp 2017): * the horizontal vestibulo-ocular reflex (VOR) gain should be \<0.6 bilaterally and/or * the sum of the maximal peak velocities of caloric response for stimulation with warm and cold water should be \<6◦/s bilaterally and/or * the horizontal angular VOR gain should be \<0.1 upon sinusoidal stimulation on the rotation test For unilateral vestibulopathy: Inclusion criteria: * the horizontal VOR gain should be \<0.6 unilaterally and/or * the slow component velocity of the caloric response should be below the age-dependent normative data unilaterally, established by Maes et al. (2010)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Stride length measured on the GAITRite Walkway (ProCare)

Timeframe: 4 years

Step length measured on the GAITRite Walkway (ProCare)

Timeframe: 4 years

Stride width measured on the GAITRite Walkway (ProCare)

Timeframe: 4 years

Step width measured on the GAITRite Walkway (ProCare)

Timeframe: 4 years

Step time measured on the GAITRite Walkway (ProCare)

Timeframe: 4 years

Stride time measured on the GAITRite Walkway (ProCare)

Timeframe: 4 years

Velocity measured on the GAITRite Walkway (ProCare)

Timeframe: 4 years

Surface (mm²) of the confidence ellipse which contains 90% of the center of pressure (COP) measured on the GymPlate (TechnoConcepts)

Trial details

NCT IDNCT04126798

SponsorUniversity Hospital, Ghent

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-04-15

View on ClinicalTrials.gov More Vestibular Diseases trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Stride length measured on the GAITRite Walkway (ProCare)

Timeframe: 4 years

Step length measured on the GAITRite Walkway (ProCare)

Timeframe: 4 years

Stride width measured on the GAITRite Walkway (ProCare)

Timeframe: 4 years

Step width measured on the GAITRite Walkway (ProCare)

Timeframe: 4 years

Step time measured on the GAITRite Walkway (ProCare)

Timeframe: 4 years

Stride time measured on the GAITRite Walkway (ProCare)

Timeframe: 4 years

Velocity measured on the GAITRite Walkway (ProCare)

Timeframe: 4 years

Surface (mm²) of the confidence ellipse which contains 90% of the center of pressure (COP) measured on the GymPlate (TechnoConcepts)