Clinical trial NCT04126798: 2BALANCE: Cognitive-motor Dual-tasking in Persons with Vestibular Disorders
Official title: 2BALANCE: the Impact of a Vestibular Dysfunction on Cognitive and Motor Performance in Adults in Single and Dual-task Condition
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vestibular Diseases
Keywords: Cognition
Motor performance
Dual-task
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: University Ghent
name: Universiteit Antwerpen
name: Maastricht University Medical Center
First posted: 2019-10-15
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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).

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).

Eligibility 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)

Primary outcomes:
measure: Stride length measured on the GAITRite Walkway (ProCare)
timeFrame: 4 years
measure: Step length measured on the GAITRite Walkway (ProCare)
timeFrame: 4 years
measure: Stride width measured on the GAITRite Walkway (ProCare)
timeFrame: 4 years
measure: Step width measured on the GAITRite Walkway (ProCare)
timeFrame: 4 years
measure: Step time measured on the GAITRite Walkway (ProCare)
timeFrame: 4 years
measure: Stride time measured on the GAITRite Walkway (ProCare)
timeFrame: 4 years
measure: Velocity measured on the GAITRite Walkway (ProCare)
timeFrame: 4 years
measure: Surface (mm²) of the confidence ellipse which contains 90% of the center of pressure (COP) measured on the GymPlate (TechnoConcepts)
timeFrame: 4 years
measure: Length covered by the consecutive center of pressure (COP) positions measured on the GymPlate (TechnoConcepts)
timeFrame: 4 years
measure: Mean velocity of the oscillations of the center of pressure (COP) measured on the GymPlate (TechnoConcepts)
timeFrame: 4 years
measure: Velocity variance measured on the GymPlate (TechnoConcepts)
timeFrame: 4 years
measure: Percent accuracy on the Corsi Block Test
timeFrame: 4 years
measure: Response time on the Corsi Block Test
timeFrame: 4 years
measure: Percentage of accuracy on the mental rotation task
timeFrame: 4 years
measure: Response time on the mental rotation task
timeFrame: 4 years
measure: Percentage of accuracy on the backward digit recall test
timeFrame: 4 years
measure: Response time on the backward digit recall test
timeFrame: 4 years
measure: Percentage of accuracy on the symbol digit modalities test
timeFrame: 4 years
measure: Response time on the symbol digit modalities test
timeFrame: 4 years
measure: Percentage of accuracy on the auditory Stroop task
timeFrame: 4 years
measure: Response time on the auditory Stroop task
timeFrame: 4 years
measure: Percentage of accuracy on the visual Stroop task
timeFrame: 4 years
measure: Response time on the visual Stroop task
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent, departement otorhinolaryngology
Study officials:
affiliation: Ghent University Hospital, Ghent University
name: Leen Maes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.