Show Me How You Move and I Will Tell You Who You Are

NCT ID: NCT06739577

Last Updated: 2024-12-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-08-10
• Study Completion Date: 2023-07-01

Brief 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. 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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

Evaluation of walking abilities (manual Timed-Up & Go - TUG and automatic -OpenTUG))

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: DIAGNOSTIC_TEST

Neuropsychological evaluation assess attention (Test for Attentional Performance -TAP-) and quality-of-life (DHI, HADS, and NVI).

Healthy controls

People with no vestibular loss

Evaluation of walking abilities (manual Timed-Up & Go - TUG and automatic -OpenTUG))

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: DIAGNOSTIC_TEST

Neuropsychological evaluation assess attention (Test for Attentional Performance -TAP-) and quality-of-life (DHI, HADS, and NVI).

Interventions

Evaluation of walking abilities (manual Timed-Up & Go - TUG and automatic -OpenTUG))

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.

Intervention Type: DIAGNOSTIC_TEST

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).

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Neuropsychological assesment

Eligibility Criteria

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).

• 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,…)
• Age below 18 years old.

For healthy controls :

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Université Catholique de Louvain

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cliniques universitaires Saint-Luc

Brussels, , Belgium

Countries

Belgium

Other Identifiers

ABMA

Identifier Type: -

Identifier Source: org_study_id