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

Completed

• Conditions: Vestibular Diseases
• Interventions: Other: Behavioural

• Registration Number: NCT04126798
• Lead Sponsor: University Hospital, Ghent

Brief 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.

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 Timeline

• Study First Submitted: 2019-02-25
• Study Start: 2019-08-12
• Study First Submitted QC: 2019-10-14
• Study First Posted: 2019-10-15
• Primary Completion: 2023-04-15
• Study Completion: 2023-06-15
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-25
• Last Update Posted: 2023-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Not provided

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Ghent, departement otorhinolaryngology; 🇧🇪 Ghent, Belgium