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

Vestibular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04126798
• Other study ID #: BC-7935
• Status: Completed
• Start date: August 12, 2019
• Est. completion date: June 15, 2023

Study information

• Verified date: September 2023
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: June 15, 2023
• Est. primary completion date: April 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Vestibular Diseases

Intervention

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

Locations

Country	Name	City	State
Belgium	University Hospital Ghent, departement otorhinolaryngology	Ghent

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Ghent	Maastricht University Medical Center, Universiteit Antwerpen, University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

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