An observational study in Vestibular Disease and Vestibular Function Disorder, sponsored by Université Catholique de Louvain. Completed at 1 site in Belgium. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-18.
Sponsored by Université Catholique de Louvain · Observational
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.
175 studies on the registry are indexed under Vestibular Diseases; 41 are open to participants now.
This study's enrollment of 100 is above the median of 59 across 36 observational studies indexed under Vestibular Diseases.
Browse Vestibular Diseases studies →Université Catholique de Louvain is the lead sponsor of 151 studies on the registry; 57 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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).
For patients :
Inclusion Criteria:
Exclusion Criteria:
For healthy controls :
Inclusion criteria :
- Age between 18 and 90 years old.
Exclusion criteria:
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)
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
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.
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.
Also known as: Neuropsychological assesment
Neuropsychological evaluation assess attention (Test for Attentional Performance -TAP-) and quality-of-life (DHI, HADS, and NVI).
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Through the entire study, approximately 24 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2021 to primary completion in Jul 2023, 22 months.
Of 18 observational studies under Vestibular Diseases, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 35. This study's 22 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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