- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06739577
Show Me How You Move and I Will Tell You Who You Are
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Brussels, Belgium, 1000
- Cliniques Universitaires Saint-Luc
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
For patients :
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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 :
Inclusion criteria :
- Age between 18 and 90 years old.
Exclusion criteria:
- Previous neurological disorders (stroke, dementia, …)
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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)
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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.
Other Names:
Neuropsychological evaluation assess attention (Test for Attentional Performance -TAP-) and quality-of-life (DHI, HADS, and NVI).
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Healthy controls
People with no vestibular loss
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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.
Other Names:
Neuropsychological evaluation assess attention (Test for Attentional Performance -TAP-) and quality-of-life (DHI, HADS, and NVI).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Neuropsychological measures
Time Frame: Through the entire study, approximately 24 months
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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.
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Through the entire study, approximately 24 months
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Neuropsychological measures
Time Frame: Through the entire study, approximately 24 months
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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 |
Through the entire study, approximately 24 months
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Neuropsychological measures
Time Frame: Through the entire study, approximately 24 months
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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 |
Through the entire study, approximately 24 months
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Neuropsychological measures
Time Frame: Through the entire study, approximately 24 months
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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 |
Through the entire study, approximately 24 months
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Walking activity
Time Frame: Through the entire study, approximately 24 months
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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.
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Through the entire study, approximately 24 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ABMA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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