Skip to content

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04126798
Enrollment
130
Registered
2019-10-15
Start date
2019-08-12
Completion date
2023-06-15
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vestibular Diseases

Keywords

Cognition, Motor performance, Dual-task

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).

Interventions

OTHERBehavioural

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

Sponsors

University Ghent
CollaboratorOTHER
Universiteit Antwerpen
CollaboratorOTHER
Maastricht University Medical Center
CollaboratorOTHER
University Hospital, Ghent
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

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)

Design outcomes

Primary

MeasureTime frameDescription
Stride length measured on the GAITRite Walkway (ProCare)4 yearsStride length measured in centimeters on pressure sensitive mat
Step length measured on the GAITRite Walkway (ProCare)4 yearsStep length measured in centimeters on pressure sensitive mat
Stride width measured on the GAITRite Walkway (ProCare)4 yearsStride width measured in centimeters on pressure sensitive mat
Step width measured on the GAITRite Walkway (ProCare)4 yearsStep width measured in centimeters on pressure sensitive mat
Step time measured on the GAITRite Walkway (ProCare)4 yearsStep time measured in seconds on pressure sensitive mat
Stride time measured on the GAITRite Walkway (ProCare)4 yearsStride time measured in seconds on pressure sensitive mat
Velocity measured on the GAITRite Walkway (ProCare)4 yearsVelocity 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)4 yearsConfidence ellipse measured in millimeter² on force platform
Length covered by the consecutive center of pressure (COP) positions measured on the GymPlate (TechnoConcepts)4 yearsLength 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)4 yearsLength of the COP measured in millimeter per second on force platform
Velocity variance measured on the GymPlate (TechnoConcepts)4 yearsLength of the COP measured in millimeter² per second² on force platform
Percent accuracy on the Corsi Block Test4 yearsMeasure of visuospatial memory
Response time on the Corsi Block Test4 yearsMeasure of visuospatial memory in milliseconds
Percentage of accuracy on the mental rotation task4 yearsMeasure of mental rotation (visuospatial cognition)
Response time on the mental rotation task4 yearsMeasure of mental rotation (visuospatial cognition) in milliseconds
Percentage of accuracy on the backward digit recall test4 yearsMeasure of working memory
Response time on the backward digit recall test4 yearsMeasure of working memory in milliseconds
Percentage of accuracy on the symbol digit modalities test4 yearsMeasure of processing speed
Response time on the symbol digit modalities test4 yearsMeasure of processing speed in milliseconds
Percentage of accuracy on the auditory Stroop task4 yearsMeasure of response inhibition
Response time on the auditory Stroop task4 yearsMeasure of response inhibition
Percentage of accuracy on the visual Stroop task4 yearsMeasure of response inhibition
Response time on the visual Stroop task4 yearsMeasure of response inhibition

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026