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

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

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.

Study Overview

• Status: Completed
• Conditions: Vestibular Diseases
• Intervention / Treatment: Other: Behavioural

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).

• Study Type: Observational
• Enrollment (Actual): 130

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • University Hospital Ghent, departement otorhinolaryngology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Healthy adults were used for establishing normative data of the dual-task protocol (convenience sampling).

Persons with bilateral vestibulopathy, established by vestibular assessment, were used for the validation of the study (recruited at the Ghent University Hospital, Antwerp University Hospital, and Maastricht University Medical Center).

Persons with unilateral vestibular impairment, established by vestibular assessment, were used for the cross-sectional study (recruited at the Ghent University Hospital).

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy adults; Standardization and collecting normative age-related data for cognitive and motor single tasks, as well as cognitive-motor dual-tasks	Other: Behavioural; Assessment of the 2BALANCE protocol: dual-task protocol consisting of a motor task, cognitive task, and motor-cognitive dual-tasks
Bilateral vestibulopathy; Validation of cognitive and motor single tasks, as well as cognitive-motor dual-tasks	Other: Behavioural; Assessment of the 2BALANCE protocol: dual-task protocol consisting of a motor task, cognitive task, and motor-cognitive 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	Other: Behavioural; Assessment of the 2BALANCE protocol: dual-task protocol consisting of a motor task, cognitive task, and motor-cognitive dual-tasks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stride length measured on the GAITRite Walkway (ProCare)	Stride length measured in centimeters on pressure sensitive mat	4 years
Step length measured on the GAITRite Walkway (ProCare)	Step length measured in centimeters on pressure sensitive mat	4 years
Stride width measured on the GAITRite Walkway (ProCare)	Stride width measured in centimeters on pressure sensitive mat	4 years
Step width measured on the GAITRite Walkway (ProCare)	Step width measured in centimeters on pressure sensitive mat	4 years
Step time measured on the GAITRite Walkway (ProCare)	Step time measured in seconds on pressure sensitive mat	4 years
Stride time measured on the GAITRite Walkway (ProCare)	Stride time measured in seconds on pressure sensitive mat	4 years
Velocity measured on the GAITRite Walkway (ProCare)	Velocity measured in centimeters per second on pressure sensitive mat	4 years
Surface (mm²) of the confidence ellipse which contains 90% of the center of pressure (COP) measured on the GymPlate (TechnoConcepts)	Confidence ellipse measured in millimeter² on force platform	4 years
Length covered by the consecutive center of pressure (COP) positions measured on the GymPlate (TechnoConcepts)	Length of the COP measured in millimeter on force platform	4 years
Mean velocity of the oscillations of the center of pressure (COP) measured on the GymPlate (TechnoConcepts)	Length of the COP measured in millimeter per second on force platform	4 years
Velocity variance measured on the GymPlate (TechnoConcepts)	Length of the COP measured in millimeter² per second² on force platform	4 years
Percent accuracy on the Corsi Block Test	Measure of visuospatial memory	4 years
Response time on the Corsi Block Test	Measure of visuospatial memory in milliseconds	4 years
Percentage of accuracy on the mental rotation task	Measure of mental rotation (visuospatial cognition)	4 years
Response time on the mental rotation task	Measure of mental rotation (visuospatial cognition) in milliseconds	4 years
Percentage of accuracy on the backward digit recall test	Measure of working memory	4 years
Response time on the backward digit recall test	Measure of working memory in milliseconds	4 years
Percentage of accuracy on the symbol digit modalities test	Measure of processing speed	4 years
Response time on the symbol digit modalities test	Measure of processing speed in milliseconds	4 years
Percentage of accuracy on the auditory Stroop task	Measure of response inhibition	4 years
Response time on the auditory Stroop task	Measure of response inhibition	4 years
Percentage of accuracy on the visual Stroop task	Measure of response inhibition	4 years
Response time on the visual Stroop task	Measure of response inhibition	4 years

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: Maastricht University Medical Center; University Ghent; Universiteit Antwerpen
• Investigators: Principal Investigator: Leen Maes, PhD, Ghent University Hospital, Ghent University

Publications and helpful links

General Publications

• Danneels M, Van Hecke R, Leyssens L, Degeest S, Cambier D, van de Berg R, Van Rompaey V, Maes L. 2BALANCE: a cognitive-motor dual-task protocol for individuals with vestibular dysfunction. BMJ Open. 2020 Jul 14;10(7):e037138. doi: 10.1136/bmjopen-2020-037138.

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2019
• Primary Completion (Actual): April 15, 2023
• Study Completion (Actual): June 15, 2023

Study Registration Dates

• First Submitted: February 25, 2019
• First Submitted That Met QC Criteria: October 14, 2019
• First Posted (Actual): October 15, 2019

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Cognition; Dual-task; Motor performance
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Vestibular Diseases
• Other Study ID Numbers: BC-7935

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No