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

NCT04126798 | Completed DMC

• 1 other identifier: BC-7935
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Vestibular Diseases

Keywords

Cognition; Motor performance; Dual-task

Outcome Measures

Primary Outcomes (23)

• Stride length measured on the GAITRite Walkway (ProCare)

  Stride length measured in centimeters on pressure sensitive mat

  4 years

• Step length measured on the GAITRite Walkway (ProCare)

  Step length measured in centimeters on pressure sensitive mat

  4 years

• Stride width measured on the GAITRite Walkway (ProCare)

  Stride width measured in centimeters on pressure sensitive mat

  4 years

• Step width measured on the GAITRite Walkway (ProCare)

  Step width measured in centimeters on pressure sensitive mat

  4 years

• Step time measured on the GAITRite Walkway (ProCare)

  Step time measured in seconds on pressure sensitive mat

  4 years

• Stride time measured on the GAITRite Walkway (ProCare)

  Stride time measured in seconds on pressure sensitive mat

  4 years

• Velocity measured on the GAITRite Walkway (ProCare)

  Velocity measured in centimeters per second on pressure sensitive mat

  4 years

• Surface (mm²) of the confidence ellipse which contains 90% of the center of pressure (COP) measured on the GymPlate (TechnoConcepts)

  Confidence ellipse measured in millimeter² on force platform

  4 years

• Length covered by the consecutive center of pressure (COP) positions measured on the GymPlate (TechnoConcepts)

  Length of the COP measured in millimeter on force platform

  4 years

• Mean velocity of the oscillations of the center of pressure (COP) measured on the GymPlate (TechnoConcepts)

  Length of the COP measured in millimeter per second on force platform

  4 years

• Velocity variance measured on the GymPlate (TechnoConcepts)

  Length of the COP measured in millimeter² per second² on force platform

  4 years

• Percent accuracy on the Corsi Block Test

  Measure of visuospatial memory

  4 years

• Response time on the Corsi Block Test

  Measure of visuospatial memory in milliseconds

  4 years

• Percentage of accuracy on the mental rotation task

  Measure of mental rotation (visuospatial cognition)

  4 years

• Response time on the mental rotation task

  Measure of mental rotation (visuospatial cognition) in milliseconds

  4 years

• Percentage of accuracy on the backward digit recall test

  Measure of working memory

  4 years

• Response time on the backward digit recall test

  Measure of working memory in milliseconds

  4 years

• Percentage of accuracy on the symbol digit modalities test

  Measure of processing speed

  4 years

• Response time on the symbol digit modalities test

  Measure of processing speed in milliseconds

  4 years

• Percentage of accuracy on the auditory Stroop task

  Measure of response inhibition

  4 years

• Response time on the auditory Stroop task

  Measure of response inhibition

  4 years

• Percentage of accuracy on the visual Stroop task

  Measure of response inhibition

  4 years

• Response time on the visual Stroop task

  Measure of response inhibition

  4 years

Study Arms (3)

Healthy adults

Standardization and collecting normative age-related data for cognitive and motor single tasks, as well as cognitive-motor dual-tasks

Other: Behavioural

Bilateral vestibulopathy

Validation of cognitive and motor single tasks, as well as cognitive-motor dual-tasks

Other: Behavioural

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

Interventions

Behavioural OTHER

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

Bilateral vestibulopathy; Healthy adults; Unilateral vestibular impairment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may not qualify if:

• 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):
• 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:
• 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)

Sponsors & Collaborators

• University Hospital, Ghent: lead
• University Ghent: collaborator
• Universiteit Antwerpen: collaborator
• Maastricht University Medical Center: collaborator

Study Sites (1)

University Hospital Ghent, departement otorhinolaryngology

Ghent, 9000, Belgium

Location

Related Publications (1)

• 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.

  PMID: 32665391 DERIVED

MeSH Terms

Conditions

Vestibular Diseases

Interventions

Memory and Learning Tests

Condition Hierarchy (Ancestors)

Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Leen Maes, PhD

  Ghent University Hospital, Ghent University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2019
• First Posted: October 15, 2019
• Study Start: August 12, 2019
• Primary Completion: April 15, 2023
• Study Completion: June 15, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

BE (1)