POSTURODYN: Proof of Concept Study Concerning Vestibular Stimulation Using a New Method of Dynamic Posturography.

Sponsor

Centre Hospitalier Universitaire Dijon (Other)

Overall Status

Completed

CT.gov ID

NCT02851524

Collaborator

(none)

Enrollment

Location

Arm

9.9

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vestibular Stimulation	Other: posturography	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Proof of Concept Study Concerning Vestibular Stimulation Using a New Method of Dynamic Posturography.

Actual Study Start Date :

Jun 23, 2016

Actual Primary Completion Date :

Apr 21, 2017

Actual Study Completion Date :

Apr 21, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: posturography	Other: posturography

Arm

Intervention/Treatment

Experimental: posturography

Other: posturography

Outcome Measures

Primary Outcome Measures

Cinematics of eye movements (amplitude and direction) evaluated by videonystagmography (VNG). [At Day 0]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Older than 18 years
National health insurance cover
Written consent
Subjects able to understand simple instructions and packaging information and to provide informed consent

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Dijon Bourgogne	Dijon		France	21079

Sponsors and Collaborators

Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire Dijon

ClinicalTrials.gov Identifier:

NCT02851524

Other Study ID Numbers:

REVERCHON AOI 2015

First Posted:

Aug 1, 2016

Last Update Posted:

May 3, 2019

Last Verified:

May 1, 2019

Study Results

No Results Posted as of May 3, 2019