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

G

Ghent University Hospital (UZ)

Status

Completed

Conditions

Vestibular Diseases

Treatments

Other: Behavioural

Study type

Observational

Funder types

Other

Identifiers

NCT04126798
BC-7935

Details and patient eligibility

About

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.

Full 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).

Enrollment

130 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

130 participants in 3 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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