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

Overview

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.

Full Title of Study: “2BALANCE: The Impact of a Vestibular Dysfunction on Cognitive and Motor Performance in Adults in Single and Dual-task Condition”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: May 2022

Detailed Description

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).

Interventions

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

Arms, Groups and Cohorts

  • Healthy adults
    • Standardization and collecting normative age-related data for cognitive and motor single tasks, as well as cognitive-motor dual-tasks
  • Bilateral vestibulopathy
    • Validation of cognitive and motor single tasks, as well as cognitive-motor dual-tasks
  • Unilateral vestibular impairment
    • Cross-sectional study on cognitive and motor single tasks, as well as cognitive-motor dual-tasks, in persons with unilateral vestibular impairment

Clinical Trial Outcome Measures

Primary Measures

  • Stride length measured on the GAITRite Walkway (ProCare)
    • Time Frame: 4 years
    • Stride length measured in centimeters on pressure sensitive mat
  • Step length measured on the GAITRite Walkway (ProCare)
    • Time Frame: 4 years
    • Step length measured in centimeters on pressure sensitive mat
  • Stride width measured on the GAITRite Walkway (ProCare)
    • Time Frame: 4 years
    • Stride width measured in centimeters on pressure sensitive mat
  • Step width measured on the GAITRite Walkway (ProCare)
    • Time Frame: 4 years
    • Step width measured in centimeters on pressure sensitive mat
  • Step time measured on the GAITRite Walkway (ProCare)
    • Time Frame: 4 years
    • Step time measured in seconds on pressure sensitive mat
  • Stride time measured on the GAITRite Walkway (ProCare)
    • Time Frame: 4 years
    • Stride time measured in seconds on pressure sensitive mat
  • Velocity measured on the GAITRite Walkway (ProCare)
    • Time Frame: 4 years
    • Velocity measured in centimeters per second on pressure sensitive mat
  • 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
  • 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
  • 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
  • Velocity variance measured on the GymPlate (TechnoConcepts)
    • Time Frame: 4 years
    • Length of the COP measured in millimeter² per second² on force platform
  • Percent accuracy on the Corsi Block Test
    • Time Frame: 4 years
    • Measure of visuospatial memory
  • Response time on the Corsi Block Test
    • Time Frame: 4 years
    • Measure of visuospatial memory in milliseconds
  • Percentage of accuracy on the mental rotation task
    • Time Frame: 4 years
    • Measure of mental rotation (visuospatial cognition)
  • Response time on the mental rotation task
    • Time Frame: 4 years
    • Measure of mental rotation (visuospatial cognition) in milliseconds
  • Percentage of accuracy on the backward digit recall test
    • Time Frame: 4 years
    • Measure of working memory
  • Response time on the backward digit recall test
    • Time Frame: 4 years
    • Measure of working memory in milliseconds
  • Percentage of accuracy on the symbol digit modalities test
    • Time Frame: 4 years
    • Measure of processing speed
  • Response time on the symbol digit modalities test
    • Time Frame: 4 years
    • Measure of processing speed in milliseconds
  • Percentage of accuracy on the auditory Stroop task
    • Time Frame: 4 years
    • Measure of response inhibition
  • Response time on the auditory Stroop task
    • Time Frame: 4 years
    • Measure of response inhibition
  • Percentage of accuracy on the visual Stroop task
    • Time Frame: 4 years
    • Measure of response inhibition
  • Response time on the visual Stroop task
    • Time Frame: 4 years
    • Measure of response inhibition

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University Hospital, Ghent
  • Collaborator
    • University Ghent
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Leen Maes, PhD, Principal Investigator, Ghent University Hospital, Ghent University
  • Overall Contact(s)
    • Maya Danneels, MSc, +329 332 08 63, maya.danneels@ugent.be

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