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

U

University Hospital Center (CHU) Dijon Bourgogne

Status

Completed

Conditions

Vestibular Stimulation

Treatments

Other: posturography

Study type

Interventional

Funder types

Other

Identifiers

NCT02851524
REVERCHON AOI 2015

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

posturography
Experimental group
Treatment:
Other: posturography

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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