Vestibular DiseasesNCT04126798
2BALANCE: Cognitive-motor Dual-tasking in Persons with Vestibular Disorders
An observational study of Vestibular Diseases, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vestibular Diseases
- What is being tested?
- Behavioural
- How many people
- 130 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Aug 2019to 15 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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)
Who cannot join
- 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):
Trial locations and contacts
1 site in 1 country.
Belgium1 site
University Hospital Ghent, departement otorhinolaryngology
Ghent, 9000
About this study
Official title: 2BALANCE: the Impact of a Vestibular Dysfunction on Cognitive and Motor Performance in Adults in Single and Dual-task Condition
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.
Read the 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).
- Conditions
- Vestibular Diseases
- Being tested
- Behavioural
- Keywords
- Cognition, Motor performance, Dual-task
- Medical subject headings
- Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BehaviouralOther
Assessment of the 2BALANCE protocol: dual-task protocol consisting of a motor task, cognitive task, and motor-cognitive dual-tasks
| Study group | Role | What they receive |
|---|---|---|
| Healthy adults | Standardization and collecting normative age-related data for cognitive and motor single tasks, as well as cognitive-motor dual-tasks Receives: Other: Behavioural | |
| Bilateral vestibulopathy | Validation of cognitive and motor single tasks, as well as cognitive-motor dual-tasks Receives: 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 Receives: Other: Behavioural |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stride length measured on the GAITRite Walkway (ProCare)
Stride length measured in centimeters on pressure sensitive mat
Measured: 4 years
Step length measured on the GAITRite Walkway (ProCare)
Step length measured in centimeters on pressure sensitive mat
Measured: 4 years
Stride width measured on the GAITRite Walkway (ProCare)
Stride width measured in centimeters on pressure sensitive mat
Measured: 4 years
Step width measured on the GAITRite Walkway (ProCare)
Step width measured in centimeters on pressure sensitive mat
Measured: 4 years
Step time measured on the GAITRite Walkway (ProCare)
Step time measured in seconds on pressure sensitive mat
Measured: 4 years
Stride time measured on the GAITRite Walkway (ProCare)
Stride time measured in seconds on pressure sensitive mat
Measured: 4 years
Velocity measured on the GAITRite Walkway (ProCare)
Velocity measured in centimeters per second on pressure sensitive mat
Measured: 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
Measured: 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
Measured: 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
Measured: 4 years
Velocity variance measured on the GymPlate (TechnoConcepts)
Length of the COP measured in millimeter² per second² on force platform
Measured: 4 years
Percent accuracy on the Corsi Block Test
Measure of visuospatial memory
Measured: 4 years
Response time on the Corsi Block Test
Measure of visuospatial memory in milliseconds
Measured: 4 years
Percentage of accuracy on the mental rotation task
Measure of mental rotation (visuospatial cognition)
Measured: 4 years
Response time on the mental rotation task
Measure of mental rotation (visuospatial cognition) in milliseconds
Measured: 4 years
Percentage of accuracy on the backward digit recall test
Measure of working memory
Measured: 4 years
Response time on the backward digit recall test
Measure of working memory in milliseconds
Measured: 4 years
Percentage of accuracy on the symbol digit modalities test
Measure of processing speed
Measured: 4 years
Response time on the symbol digit modalities test
Measure of processing speed in milliseconds
Measured: 4 years
Percentage of accuracy on the auditory Stroop task
Measure of response inhibition
Measured: 4 years
Response time on the auditory Stroop task
Measure of response inhibition
Measured: 4 years
Percentage of accuracy on the visual Stroop task
Measure of response inhibition
Measured: 4 years
Response time on the visual Stroop task
Measure of response inhibition
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start12 Aug 2019
- Primary completion15 Apr 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vestibular DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent, Universiteit Antwerpen, Maastricht University Medical Center
- Responsible party
- Sponsor
- Investigators
- Leen Maes, PhD, Principal investigator, Ghent University Hospital, Ghent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04126798
- Sponsor's protocol ID
- BC-7935
- Status last verified
- Sep 2024
- First submitted
- 25 Feb 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32665391
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 2BALANCE: the Impact of a Vestibular Dysfunction on Cognitive and Motor Performance in Adults in Single and Dual-task Condition
- ClinicalTrials.gov ID
- NCT04126798
- Acronym / sponsor ID
- BC-7935
- Conditions
- Vestibular Diseases
- Keywords
- Cognition, Motor performance, Dual-task
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent, Universiteit Antwerpen, Maastricht University Medical Center
- Study start
- 12 Aug 2019 (actual)
- Primary completion
- 15 Apr 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 15 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy adults | – | Other: BehaviouralStandardization and collecting normative age-related data for cognitive and motor single tasks, as well as cognitive-motor dual-tasks |
| Bilateral vestibulopathy | – | Other: BehaviouralValidation of cognitive and motor single tasks, as well as cognitive-motor dual-tasks |
| Unilateral vestibular impairment | – | Other: BehaviouralCross-sectional study on cognitive and motor single tasks, as well as cognitive-motor dual-tasks, in persons with unilateral vestibular impairment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (7 listed)
- 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
- the horizontal VOR gain should be <0.6 unilaterally and/or
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BehaviouralAssessment of the 2BALANCE protocol: dual-task protocol consisting of a motor task, cognitive task, and motor-cognitive dual-tasks | Other | Bilateral vestibulopathy, Healthy adults, Unilateral vestibular impairment |
Primary outcome
Stride length measured on the GAITRite Walkway (ProCare)
Time frame: 4 years
Stride length measured in centimeters on pressure sensitive mat
Step length measured on the GAITRite Walkway (ProCare)
Time frame: 4 years
Step length measured in centimeters on pressure sensitive mat
Stride width measured on the GAITRite Walkway (ProCare)
Time frame: 4 years
Stride width measured in centimeters on pressure sensitive mat
Step width measured on the GAITRite Walkway (ProCare)
Time frame: 4 years
Step width measured in centimeters on pressure sensitive mat
Step time measured on the GAITRite Walkway (ProCare)
Time frame: 4 years
Step time measured in seconds 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
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
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
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
Velocity variance measured on the GymPlate (TechnoConcepts)
Time frame: 4 years
Length of the COP measured in millimeter² per second² on force platform
Percent accuracy on the Corsi Block Test
Time frame: 4 years
Measure of visuospatial memory
Response time on the Corsi Block Test
Time frame: 4 years
Measure of visuospatial memory in milliseconds
Percentage of accuracy on the mental rotation task
Time frame: 4 years
Measure of mental rotation (visuospatial cognition)
Response time on the mental rotation task
Time frame: 4 years
Measure of mental rotation (visuospatial cognition) in milliseconds
Percentage of accuracy on the backward digit recall test
Time frame: 4 years
Measure of working memory
Response time on the backward digit recall test
Time frame: 4 years
Measure of working memory in milliseconds
Percentage of accuracy on the symbol digit modalities test
Time frame: 4 years
Measure of processing speed
Response time on the symbol digit modalities test
Time frame: 4 years
Measure of processing speed in milliseconds
Percentage of accuracy on the auditory Stroop task
Time frame: 4 years
Measure of response inhibition
Response time on the auditory Stroop task
Time frame: 4 years
Measure of response inhibition
Percentage of accuracy on the visual Stroop task
Time frame: 4 years
Measure of response inhibition
Response time on the visual Stroop task
Time frame: 4 years
Measure of response inhibition
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 32665391Danneels 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.
Related trials for Vestibular Diseases
RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Comparison of Vestibular Stimulation and Core Stability Training on Sitting Balance in Hypotonic CP
Hypotonic Cerebral Palsy
Enrolling by invitationObservational study
Long Term Follow-up Study of AAVAnc80-antiVEGF Gene Therapy
Vestibular Schwannoma
RecruitingPhase 1/2
Anti-VEGF Gene Therapy Trial for Vestibular Schwannoma
Vestibular Schwannoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leen Maes, PhD principal investigator
Ghent University Hospital, Ghent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vestibular Diseases, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stride length measured on the GAITRite Walkway (ProCare) (time frame: 4 years). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04126798, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.