Proof of Concept Study Concerning Vestibular Stimulation Using a New Method of Dynamic Posturography.
POSTURODYN
1 other identifier
interventional
30
1 country
1
Brief Summary
Falls in the elderly population are a major public health problem because of their frequency and their consequences, notably in terms of dependence their cost to society. In most cases, balance disorders related to an impaired vestibular system are blamed, even though there is no formal evidence that this is the case. Vestibular tests in routine otoneurological practice are based on the exploration of vestibulo-ocular or even vestibulo-cortical reflexes. They are not particularly suitable to screen for vestibular disorders in falls. A prototype rocking chair has been developed to test psycho-vestibular pathways, defined as the pathways via which vestibular afferents are transported to the subject's conscience. Thanks to this apparatus, a stimulus of body movement will be generated, but with limited tactile, visual and proprioceptive afferents, in such a way that the vestibular system alone is able to indicate to subjects their position in space. The subject will be required to detect oscillatory movement, and then to distinguish between a vestibular stimulus and a pulsed auditory stimulus. The study hypothesis is that the movement stimulation generated by our prototype will be sufficient to stimulate the vestibular system, which will manifest itself as a conscious sensation of movement and by a vestibulo-ocular reflex causing oculomotor manifestations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 23, 2016
CompletedFirst Submitted
Initial submission to the registry
July 28, 2016
CompletedFirst Posted
Study publicly available on registry
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 21, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 21, 2017
CompletedFebruary 6, 2026
February 1, 2026
10 months
July 28, 2016
February 4, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Cinematics of eye movements (amplitude and direction) evaluated by videonystagmography (VNG).
At Day 0
Study Arms (1)
posturography
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Older than 18 years
- National health insurance cover
- Written consent
- Subjects able to understand simple instructions and packaging information and to provide informed consent
You may not qualify if:
- Vertigo, consciousness disorders, nausea or pain before the tests
- Bilateral deafness
- History of neurological, rheumatic or orthopaedic disease likely by itself to trigger a fall
- Psychiatric disorder likely to compromise participation.
- Personal history of falls of undetermined cause.
- Présence de saccades et/ou nystagmus en position statique
- Femme enceinte
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Dijon Bourgogne
Dijon, 21079, France
Related Publications (1)
Guyon M, Chea C, Laroche D, Fournel I, Baudet A, Toupet M, Bozorg Grayeli A. Measuring threshold and latency of motion perception on a swinging bed. PLoS One. 2021 Jul 9;16(7):e0252914. doi: 10.1371/journal.pone.0252914. eCollection 2021.
PMID: 34242212RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2016
First Posted
August 1, 2016
Study Start
June 23, 2016
Primary Completion
April 21, 2017
Study Completion
April 21, 2017
Last Updated
February 6, 2026
Record last verified: 2026-02