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Completed

NCT Number: NCT04126798

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

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.

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Key information

Conditions

Vestibular Diseases Ear Diseases Labyrinth Diseases Otorhinolaryngologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Ghent, departement otorhinolaryngology

Ghent, 9000, Belgium

About this study

The test protocol consists of five cognitive tasks, all assessing a different cognitive domain: executive function, working memory, processing speed, and visuospatial abilities (mental rotation and visuospatial memory). These cognitive tasks will be performed separately (in single task condition, while seated), as well as while performing different motor tasks (in dual-task condition). These motor tasks will also be performed in single task condition (without performing the cognitive tasks).

The study consists of the establishment of normative age-related data for the single as well as dual-task protocol in healthy adults, age ranging from 18 to 65 years old (objective 1). Subsequently, the test protocol will be validated in persons with bilateral vestibulopathy (objective 2). Finally, a cross-sectional study in persons with unilateral vestibular impairment will take place, and the results on the single as well as dual-task components will be compared to normative data, as well as to persons with bilateral vestibulopathy (objective 3).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Behavioural

Other

Assessment of the 2BALANCE protocol: dual-task protocol consisting of a motor task, cognitive task, and motor-cognitive dual-tasks

Primary outcomes

  1. Stride length measured on the GAITRite Walkway (ProCare)

    Time frame: 4 years

    Stride length measured in centimeters on pressure sensitive mat

  2. Step length measured on the GAITRite Walkway (ProCare)

    Time frame: 4 years

    Step length measured in centimeters on pressure sensitive mat

  3. Stride width measured on the GAITRite Walkway (ProCare)

    Time frame: 4 years

    Stride width measured in centimeters on pressure sensitive mat

  4. Step width measured on the GAITRite Walkway (ProCare)

    Time frame: 4 years

    Step width measured in centimeters on pressure sensitive mat

  5. Step time measured on the GAITRite Walkway (ProCare)

    Time frame: 4 years

    Step time measured in seconds on pressure sensitive mat

  6. Stride time measured on the GAITRite Walkway (ProCare)

    Time frame: 4 years

    Stride time measured in seconds on pressure sensitive mat

  7. Velocity measured on the GAITRite Walkway (ProCare)

    Time frame: 4 years

    Velocity measured in centimeters per second on pressure sensitive mat

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

    Time frame: 4 years

    Confidence ellipse measured in millimeter² on force platform

  9. Length covered by the consecutive center of pressure (COP) positions measured on the GymPlate (TechnoConcepts)

    Time frame: 4 years

    Length of the COP measured in millimeter on force platform

  10. Mean velocity of the oscillations of the center of pressure (COP) measured on the GymPlate (TechnoConcepts)

    Time frame: 4 years

    Length of the COP measured in millimeter per second on force platform

  11. Velocity variance measured on the GymPlate (TechnoConcepts)

    Time frame: 4 years

    Length of the COP measured in millimeter² per second² on force platform

  12. Percent accuracy on the Corsi Block Test

    Time frame: 4 years

    Measure of visuospatial memory

  13. Response time on the Corsi Block Test

    Time frame: 4 years

    Measure of visuospatial memory in milliseconds

  14. Percentage of accuracy on the mental rotation task

    Time frame: 4 years

    Measure of mental rotation (visuospatial cognition)

  15. Response time on the mental rotation task

    Time frame: 4 years

    Measure of mental rotation (visuospatial cognition) in milliseconds

  16. Percentage of accuracy on the backward digit recall test

    Time frame: 4 years

    Measure of working memory

  17. Response time on the backward digit recall test

    Time frame: 4 years

    Measure of working memory in milliseconds

  18. Percentage of accuracy on the symbol digit modalities test

    Time frame: 4 years

    Measure of processing speed

  19. Response time on the symbol digit modalities test

    Time frame: 4 years

    Measure of processing speed in milliseconds

  20. Percentage of accuracy on the auditory Stroop task

    Time frame: 4 years

    Measure of response inhibition

  21. Response time on the auditory Stroop task

    Time frame: 4 years

    Measure of response inhibition

  22. Percentage of accuracy on the visual Stroop task

    Time frame: 4 years

    Measure of response inhibition

  23. Response time on the visual Stroop task

    Time frame: 4 years

    Measure of response inhibition

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Maastricht University Medical Center
  • Universiteit Antwerpen
  • University Ghent

Registry information

Official study title

2BALANCE: the Impact of a Vestibular Dysfunction on Cognitive and Motor Performance in Adults in Single and Dual-task Condition

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Oct 15, 2019
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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