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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04126798
Recruitment Status : Recruiting
First Posted : October 15, 2019
Last Update Posted : October 15, 2019
Sponsor:
Collaborators:
University Ghent
Universiteit Antwerpen
Maastricht University Medical Center
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Vestibular Diseases Other: Behavioural

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).

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: 2BALANCE: The Impact of a Vestibular Dysfunction on Cognitive and Motor Performance in Adults in Single and Dual-task Condition
Actual Study Start Date : August 12, 2019
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : December 2022

Group/Cohort Intervention/treatment
Healthy adults
Standardization and collecting normative age-related data for cognitive and motor single tasks, as well as cognitive-motor dual-tasks
Other: Behavioural
Assessment of the 2BALANCE protocol: dual-task protocol consisting of a motor task, cognitive task, and motor-cognitive dual-tasks

Bilateral vestibulopathy
Validation of cognitive and motor single tasks, as well as cognitive-motor dual-tasks
Other: Behavioural
Assessment of the 2BALANCE protocol: dual-task protocol consisting of a motor task, cognitive task, and motor-cognitive dual-tasks

Unilateral vestibular impairment
Cross-sectional study on cognitive and motor single tasks, as well as cognitive-motor dual-tasks, in persons with unilateral vestibular impairment
Other: Behavioural
Assessment of the 2BALANCE protocol: dual-task protocol consisting of a motor task, cognitive task, and motor-cognitive dual-tasks




Primary Outcome Measures :
  1. Stride length measured on the GAITRite Walkway (ProCare) [ Time Frame: 4 years ]
    Stride length measured in centimeters on pressure sensitive mat

  2. Step length measured on the GAITRite Walkway (ProCare) [ Time Frame: 4 years ]
    Step length measured in centimeters on pressure sensitive mat

  3. Stride width measured on the GAITRite Walkway (ProCare) [ Time Frame: 4 years ]
    Stride width measured in centimeters on pressure sensitive mat

  4. Step width measured on the GAITRite Walkway (ProCare) [ Time Frame: 4 years ]
    Step width measured in centimeters on pressure sensitive mat

  5. Step time measured on the GAITRite Walkway (ProCare) [ Time Frame: 4 years ]
    Step time measured in seconds on pressure sensitive mat

  6. Stride time measured on the GAITRite Walkway (ProCare) [ Time Frame: 4 years ]
    Stride time measured in seconds on pressure sensitive mat

  7. Velocity measured on the GAITRite Walkway (ProCare) [ Time Frame: 4 years ]
    Velocity measured in centimeters per second on pressure sensitive mat

  8. Surface (mm²) of the confidence ellipse which contains 90% of the center of pressure (COP) measured on the GymPlate (TechnoConcepts) [ Time Frame: 4 years ]
    Confidence ellipse measured in millimeter² on force platform

  9. Length covered by the consecutive center of pressure (COP) positions measured on the GymPlate (TechnoConcepts) [ Time Frame: 4 years ]
    Length of the COP measured in millimeter on force platform

  10. Mean velocity of the oscillations of the center of pressure (COP) measured on the GymPlate (TechnoConcepts) [ Time Frame: 4 years ]
    Length of the COP measured in millimeter per second on force platform

  11. Velocity variance measured on the GymPlate (TechnoConcepts) [ Time Frame: 4 years ]
    Length of the COP measured in millimeter² per second² on force platform

  12. Percent accuracy on the Corsi Block Test [ Time Frame: 4 years ]
    Measure of visuospatial memory

  13. Response time on the Corsi Block Test [ Time Frame: 4 years ]
    Measure of visuospatial memory in milliseconds

  14. Percentage of accuracy on the mental rotation task [ Time Frame: 4 years ]
    Measure of mental rotation (visuospatial cognition)

  15. Response time on the mental rotation task [ Time Frame: 4 years ]
    Measure of mental rotation (visuospatial cognition) in milliseconds

  16. Percentage of accuracy on the backward digit recall test [ Time Frame: 4 years ]
    Measure of working memory

  17. Response time on the backward digit recall test [ Time Frame: 4 years ]
    Measure of working memory in milliseconds

  18. Percentage of accuracy on the symbol digit modalities test [ Time Frame: 4 years ]
    Measure of processing speed

  19. Response time on the symbol digit modalities test [ Time Frame: 4 years ]
    Measure of processing speed in milliseconds

  20. Percentage of accuracy on the auditory Stroop task [ Time Frame: 4 years ]
    Measure of response inhibition

  21. Response time on the auditory Stroop task [ Time Frame: 4 years ]
    Measure of response inhibition

  22. Percentage of accuracy on the visual Stroop task [ Time Frame: 4 years ]
    Measure of response inhibition

  23. Response time on the visual Stroop task [ Time Frame: 4 years ]
    Measure of response inhibition



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04126798


Contacts
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Contact: Maya Danneels, MSc +329 332 08 63 maya.danneels@ugent.be

Locations
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Belgium
University Hospital Ghent, departement otorhinolaryngology Recruiting
Ghent, Belgium, 9000
Contact: Lara Derycke, phD    003293321246      
Sponsors and Collaborators
University Hospital, Ghent
University Ghent
Universiteit Antwerpen
Maastricht University Medical Center
Investigators
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Principal Investigator: Leen Maes, PhD Ghent University Hospital, Ghent University

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Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT04126798    
Other Study ID Numbers: 01N05218
First Posted: October 15, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Ghent:
Cognition
Motor performance
Dual-task
Additional relevant MeSH terms:
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Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases