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Clinical Trials/NCT04126798
NCT04126798
Completed
Not Applicable

2BALANCE: The Impact of a Vestibular Dysfunction on Cognitive and Motor Performance in Adults in Single and Dual-task Condition

University Hospital, Ghent1 site in 1 country130 target enrollmentAugust 12, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Vestibular Diseases
Sponsor
University Hospital, Ghent
Enrollment
130
Locations
1
Primary Endpoint
Stride length measured on the GAITRite Walkway (ProCare)
Status
Completed
Last Updated
2 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
August 12, 2019
End Date
June 15, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

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

Outcomes

Primary Outcomes

Stride length measured on the GAITRite Walkway (ProCare)

Time Frame: 4 years

Stride length measured in centimeters on pressure sensitive mat

Response time on the symbol digit modalities test

Time Frame: 4 years

Measure of processing speed in milliseconds

Response time on the mental rotation task

Time Frame: 4 years

Measure of mental rotation (visuospatial cognition) in milliseconds

Response time on the backward digit recall test

Time Frame: 4 years

Measure of working memory in milliseconds

Step length measured on the GAITRite Walkway (ProCare)

Time Frame: 4 years

Step length measured in centimeters on pressure sensitive mat

Percentage of accuracy on the mental rotation task

Time Frame: 4 years

Measure of mental rotation (visuospatial cognition)

Percentage of accuracy on the visual Stroop task

Time Frame: 4 years

Measure of response inhibition

Step width measured on the GAITRite Walkway (ProCare)

Time Frame: 4 years

Step width measured in centimeters on pressure sensitive mat

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

Percentage of accuracy on the backward digit recall test

Time Frame: 4 years

Measure of working memory

Percentage of accuracy on the symbol digit modalities test

Time Frame: 4 years

Measure of processing speed

Percentage of accuracy on the auditory Stroop task

Time Frame: 4 years

Measure of response inhibition

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

Response time on the Corsi Block Test

Time Frame: 4 years

Measure of visuospatial memory in milliseconds

Response time on the auditory Stroop task

Time Frame: 4 years

Measure of response inhibition

Step time measured on the GAITRite Walkway (ProCare)

Time Frame: 4 years

Step time measured in seconds on pressure sensitive mat

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

Velocity variance measured on the GymPlate (TechnoConcepts)

Time Frame: 4 years

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

Stride width measured on the GAITRite Walkway (ProCare)

Time Frame: 4 years

Stride width measured in centimeters on pressure sensitive mat

Stride time measured on the GAITRite Walkway (ProCare)

Time Frame: 4 years

Stride time measured in seconds on pressure sensitive mat

Velocity measured on the GAITRite Walkway (ProCare)

Time Frame: 4 years

Velocity measured in centimeters per second on pressure sensitive mat

Percent accuracy on the Corsi Block Test

Time Frame: 4 years

Measure of visuospatial memory

Response time on the visual Stroop task

Time Frame: 4 years

Measure of response inhibition

Study Sites (1)

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