2BALANCE: The Impact of a Vestibular Dysfunction on Cognitive and Motor Performance in Adults in Single and Dual-task Condition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Stride length measured on the GAITRite Walkway (ProCare)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •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)
结局指标
主要结局
Stride length measured on the GAITRite Walkway (ProCare)
时间窗: 4 years
Stride length measured in centimeters on pressure sensitive mat
Response time on the symbol digit modalities test
时间窗: 4 years
Measure of processing speed in milliseconds
Response time on the mental rotation task
时间窗: 4 years
Measure of mental rotation (visuospatial cognition) in milliseconds
Response time on the backward digit recall test
时间窗: 4 years
Measure of working memory in milliseconds
Step length measured on the GAITRite Walkway (ProCare)
时间窗: 4 years
Step length measured in centimeters on pressure sensitive mat
Percentage of accuracy on the mental rotation task
时间窗: 4 years
Measure of mental rotation (visuospatial cognition)
Percentage of accuracy on the visual Stroop task
时间窗: 4 years
Measure of response inhibition
Step width measured on the GAITRite Walkway (ProCare)
时间窗: 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)
时间窗: 4 years
Length of the COP measured in millimeter on force platform
Percentage of accuracy on the backward digit recall test
时间窗: 4 years
Measure of working memory
Percentage of accuracy on the symbol digit modalities test
时间窗: 4 years
Measure of processing speed
Percentage of accuracy on the auditory Stroop task
时间窗: 4 years
Measure of response inhibition
Mean velocity of the oscillations of the center of pressure (COP) measured on the GymPlate (TechnoConcepts)
时间窗: 4 years
Length of the COP measured in millimeter per second on force platform
Response time on the Corsi Block Test
时间窗: 4 years
Measure of visuospatial memory in milliseconds
Response time on the auditory Stroop task
时间窗: 4 years
Measure of response inhibition
Step time measured on the GAITRite Walkway (ProCare)
时间窗: 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)
时间窗: 4 years
Confidence ellipse measured in millimeter² on force platform
Velocity variance measured on the GymPlate (TechnoConcepts)
时间窗: 4 years
Length of the COP measured in millimeter² per second² on force platform
Stride width measured on the GAITRite Walkway (ProCare)
时间窗: 4 years
Stride width measured in centimeters on pressure sensitive mat
Stride time measured on the GAITRite Walkway (ProCare)
时间窗: 4 years
Stride time measured in seconds on pressure sensitive mat
Velocity measured on the GAITRite Walkway (ProCare)
时间窗: 4 years
Velocity measured in centimeters per second on pressure sensitive mat
Percent accuracy on the Corsi Block Test
时间窗: 4 years
Measure of visuospatial memory
Response time on the visual Stroop task
时间窗: 4 years
Measure of response inhibition
次要结局
未报告次要终点