Vestibular DiseaseNCT06739577
Show Me How You Move and I Will Tell You Who You Are
An observational study of Vestibular Disease and Vestibular Function Disorder, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The aim of this experiment is to gain a better understanding of the body movement patterns of patients with balance disorders (following damage to the vestibular system), as well as their cognitive performance profile. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Vestibular Disease, Vestibular Function Disorder
- What is being tested?
- Evaluation of walking abilities (manual Timed-Up & Go - TUG and automatic -OpenTUG)) and Neuropsychological assesment is provide to measure objective and subjective cognition/emotional aspects.
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Aug 2021to 1 Jul 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Vestibular loss diagnosed by senior ENT doctors with the gold standard ENT measures (caloric testing, head impulse test and/or vestibular evoked myogenic potential, ocular and cervical).
Who may be able to join
- Age between 18 and 90 years old.
- Vestibular loss diagnosed by senior ENT doctors with the gold standard ENT measures (caloric testing, head impulse test and/or vestibular evoked myogenic potential, ocular and cervical).
- Age between 18 and 90 years old.
Who cannot join
- Previous neurological disorders (stroke, dementia, …)
- Current medication interfering with the testing (reducing reaction time).
- Visual difficulties interfering with the testing (Visual field reduction,…)
- Age below 18 years old.
- For healthy controls :
- Previous neurological disorders (stroke, dementia, …)
Show all 11Show fewer
- Current medication interfering with the testing (reducing reaction time)
- Visual difficulties interfering with the testing (Visual field reduction,…)
- Vertigo or balance complains or an history of previous vestibular disorder.
- Age below 18 years old.
- Not being able to understand the consigns of the task.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Show Me How You Move and I Will Tell You Who You Are. Body Movement Analysis and Automatic Recognition of Associated Vestibular Impairment Patterns
The aim of this experiment is to gain a better understanding of the body movement patterns of patients with balance disorders (following damage to the vestibular system), as well as their cognitive performance profile. To achieve this, we will need to assess the performance of both patients and healthy subjects with no balance disorders. We will be using a newly-developed artificial intelligence tool to analyze body movement patterns on the basis of participants' videos, and we will also be evaluating participants' performance in a few simple tests of reaction times to image presentations on computer and/or tablet/smartphone.
If you agree to take part in this experiment, you will be asked to perform a simple walking exercise in a corridor (filmed and supervised by a physiotherapist) as well as a few objective cognitive measurement tests (reaction time to attentional and vigilance tasks on computer and/or tablet/smartphone) and subjective tests (self-reported questionnaires) requiring around 40 minutes of investigation in total.
In the long term, the results of this research will make it easier to assess balance disorders in patients with vestibular pathology, and better quantify any cognitive difficulties they may have.
- Conditions
- Vestibular Disease, Vestibular Function Disorder
- Being tested
- Evaluation of walking abilities (manual Timed-Up & Go - TUG and automatic -OpenTUG)), Neuropsychological assesment is provide to measure objective and subjective cognition/emotional aspects.
- Medical subject headings
- Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of walking abilities (manual Timed-Up & Go - TUG and automatic -OpenTUG))Diagnostic test
Also called Neuropsychological assesment
To evaluate walking abilities, participants performed the Timed-Up \& Go (TUG) f our times (practice trial, normal, slow and fast speed). Patient's performances are videorecorded with an Intel RealSense depth camera D435i to capture their movements, and manual time recording of time taken (in seconds) and number of steps are carried out by the experimenters.
Complementary to manual experimenter recording, a 2D human pose estimation method (OpenTUG) is applied to automatically extract the time and the number of steps taken by the participant during the TUG task.
Neuropsychological assesment is provide to measure objective and subjective cognition/emotional aspects.Diagnostic test
Neuropsychological evaluation assess attention (Test for Attentional Performance -TAP-) and quality-of-life (DHI, HADS, and NVI).
| Study group | Role | What they receive |
|---|---|---|
| Vestibular | Patients with vestibular loss diagnosed by senior ENT doctors with the gold standard ENT measures (caloric testing, head impulse test and/or vestibular evoked myogenic potential, ocular and cervical) Receives: Diagnostic Test: Evaluation of walking abilities (manual Timed-Up & Go - TUG and automatic -OpenTUG)); Diagnostic Test: Neuropsychological assesment is provide to measure objective and subjective cognition/emotional aspects. | |
| Healthy controls | People with no vestibular loss Receives: Diagnostic Test: Evaluation of walking abilities (manual Timed-Up & Go - TUG and automatic -OpenTUG)); Diagnostic Test: Neuropsychological assesment is provide to measure objective and subjective cognition/emotional aspects. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological measures
evaluation to assess attention (Test for Attentional Performance -TAP-) Alertness and Divided attention tasks. Median reaction time and standard deviation of the median (regularity) are record in milliseconds. Slow reaction times and large standard deviations indicate more difficulties.
Measured: Through the entire study, approximately 24 months
Neuropsychological measures
evaluation to assess quality-of-life (DHI -Dizziness Handicap Inventory, Jacobson \& Newman, 1990, Demanez 1991) 25-items, each scored on a 5-point Likert scale. Covering three main areas of difficulties: functional, physical, and emotional aspects related to dizziness and instability.
Higher scores = higher complains
Measured: Through the entire study, approximately 24 months
Neuropsychological measures
evaluation to assess quality-of-life (Anxiety and depression symptoms, measured with the French version of the Hospital Anxiety and Depression Scale (HADS) (Zigmond \& Snaith, 1983), using a 14-item self-assessed questionnaire, each with a 4-point response Likert scale.
Higher scores = higher complains
Measured: Through the entire study, approximately 24 months
Neuropsychological measures
evaluation to assess subjective perception of cognitive difficulties associated to vertigo with the Neuropsychological Vertigo Inventory - NVI (Lacroix et al., 2016), using 28-items, each scored on a 5-point Likert scale and divided into 7 distinct subscales measuring attention, memory, emotion, space perception, time perception, vision, and motor abilities.
Higher scores = higher complains
Measured: Through the entire study, approximately 24 months
Walking activity
Participants performed the Timed-Up \& Go (TUG) four times (practice trial, normal, slow and fast speed). They have to stand up from a chair, walk until a line on the ground marked at 3 meters, turn, go back to the chair, and sit down again. The time is recorded. There is no time limit to the task.
Measured: Through the entire study, approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start10 Aug 2021
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular DiseaseStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe 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
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06739577
- Sponsor's protocol ID
- ABMA
- Status last verified
- Dec 2024
- First submitted
- 10 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Show Me How You Move and I Will Tell You Who You Are. Body Movement Analysis and Automatic Recognition of Associated Vestibular Impairment Patterns
- ClinicalTrials.gov ID
- NCT06739577
- Acronym / sponsor ID
- ABMA
- Conditions
- Vestibular Disease, Vestibular Function Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 18 Dec 2024 (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 aim of this experiment is to gain a better understanding of the body movement patterns of patients with balance disorders (following damage to the vestibular system), as well as their cognitive performance profile. To achieve this, we will need to assess the performance of both patients and healthy subjects with no balance disorders. We will be using a newly-developed artificial intelligence tool to analyze body movement patterns on the basis of participants' videos, and we will also be evaluating participants' performance in a few simple tests of reaction times to image presentations on computer and/or tablet/smartphone.
If you agree to take part in this experiment, you will be asked to perform a simple walking exercise in a corridor (filmed and supervised by a physiotherapist) as well as a few objective cognitive measurement tests (reaction time to attentional and vigilance tasks on computer and/or tablet/smartphone) and subjective tests (self-reported questionnaires) requiring around 40 minutes of investigation in total.
In the long term, the results of this research will make it easier to assess balance disorders in patients with vestibular pathology, and better quantify any cognitive difficulties they may have.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vestibular | – | Diagnostic Test: Evaluation of walking abilities (manual Timed-Up & Go - TUG and automatic -OpenTUG)), Diagnostic Test: Neuropsychological assesment is provide to measure objective and subjective cognition/emotional aspects.Patients with vestibular loss diagnosed by senior ENT doctors with the gold standard ENT measures (caloric testing, head impulse test and/or vestibular evoked myogenic potential, ocular and cervical) |
| Healthy controls | – | Diagnostic Test: Evaluation of walking abilities (manual Timed-Up & Go - TUG and automatic -OpenTUG)), Diagnostic Test: Neuropsychological assesment is provide to measure objective and subjective cognition/emotional aspects.People with no vestibular loss |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Vestibular loss diagnosed by senior ENT doctors with the gold standard ENT measures (caloric testing, head impulse test and/or vestibular evoked myogenic potential, ocular and cervical).
Key inclusion criteria (3 listed)
- Age between 18 and 90 years old.
- Vestibular loss diagnosed by senior ENT doctors with the gold standard ENT measures (caloric testing, head impulse test and/or vestibular evoked myogenic potential, ocular and cervical).
- Age between 18 and 90 years old.
Key exclusion criteria (11 listed)
- Previous neurological disorders (stroke, dementia, …)
- Current medication interfering with the testing (reducing reaction time).
- Visual difficulties interfering with the testing (Visual field reduction,…)
- Age below 18 years old.
- Previous neurological disorders (stroke, dementia, …)
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 |
|---|---|---|
| Evaluation of walking abilities (manual Timed-Up & Go - TUG and automatic -OpenTUG))Also: Neuropsychological assesmentTo evaluate walking abilities, participants performed the Timed-Up \& Go (TUG) f our times (practice trial, normal, slow and fast speed). Patient's performances are videorecorded with an Intel RealSense depth camera D435i to capture their movements, and manual time recording of time taken (in seconds) and number of steps are carried out by the experimenters. Complementary to manual experimenter recording, a 2D human pose estimation method (OpenTUG) is applied to automatically extract the time and the number of steps taken by the participant during the TUG task. | Diagnostic test | Healthy controls, Vestibular |
| Neuropsychological assesment is provide to measure objective and subjective cognition/emotional aspects.Neuropsychological evaluation assess attention (Test for Attentional Performance -TAP-) and quality-of-life (DHI, HADS, and NVI). | Diagnostic test | Healthy controls, Vestibular |
Primary outcome
Neuropsychological measures
Time frame: Through the entire study, approximately 24 months
evaluation to assess attention (Test for Attentional Performance -TAP-) Alertness and Divided attention tasks. Median reaction time and standard deviation of the median (regularity) are record in milliseconds. Slow reaction times and large standard deviations indicate more difficulties.
Neuropsychological measures
Time frame: Through the entire study, approximately 24 months
evaluation to assess quality-of-life (DHI -Dizziness Handicap Inventory, Jacobson \& Newman, 1990, Demanez 1991) 25-items, each scored on a 5-point Likert scale. Covering three main areas of difficulties: functional, physical, and emotional aspects related to dizziness and instability. Higher scores = higher complains
Neuropsychological measures
Time frame: Through the entire study, approximately 24 months
evaluation to assess quality-of-life (Anxiety and depression symptoms, measured with the French version of the Hospital Anxiety and Depression Scale (HADS) (Zigmond \& Snaith, 1983), using a 14-item self-assessed questionnaire, each with a 4-point response Likert scale. Higher scores = higher complains
Neuropsychological measures
Time frame: Through the entire study, approximately 24 months
evaluation to assess subjective perception of cognitive difficulties associated to vertigo with the Neuropsychological Vertigo Inventory - NVI (Lacroix et al., 2016), using 28-items, each scored on a 5-point Likert scale and divided into 7 distinct subscales measuring attention, memory, emotion, space perception, time perception, vision, and motor abilities. Higher scores = higher complains
Walking activity
Time frame: Through the entire study, approximately 24 months
Participants performed the Timed-Up \& Go (TUG) four times (practice trial, normal, slow and fast speed). They have to stand up from a chair, walk until a line on the ground marked at 3 meters, turn, go back to the chair, and sit down again. The time is recorded. There is no time limit to the task.
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 18 Dec 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Disease and Vestibular Function Disorder, run by Université Catholique de Louvain 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 3 inclusion and 11 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 18 Dec 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?
Neuropsychological measures (time frame: Through the entire study, approximately 24 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Dec 2024.