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Completed

NCT Number: NCT06739577

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

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.

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Key information

Conditions

Vestibular Disease Ear Diseases Labyrinth Diseases Otorhinolaryngologic Diseases Vestibular Diseases Vestibular Function Disorder

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cliniques universitaires Saint-Luc

Brussels, 1000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Other names: Neuropsychological assesment

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).

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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.

Sponsors and collaborators

Lead sponsor

Université Catholique de Louvain

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 18, 2024
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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