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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00917228
Other study ID # prevesc0001
Secondary ID
Status Completed
Phase N/A
First received June 8, 2009
Last updated June 9, 2009

Study information

Verified date June 2009
Source TIMC-IMAG
Contact n/a
Is FDA regulated No
Health authority France: Centre National de Recherche ScientifiqueFrance: Université Joseph Fourier
Study type Observational

Clinical Trial Summary

This study evaluates the feasibility of a biofeedback system aimed at reducing overpressures during seated posture. The system consists of (1) a pressure sensors map, (2) a laptop that couples sensors with actuators, (3) a Tongue Display Unit (TDU) consisting of a wireless circuit embedded in a dental retainer with a matrix of electrodes. The principle of this biofeedback system consists in (1) detecting overpressures in people who are seated over long periods of time, (2) estimating a postural change that could reduce these overpressures and (3) communicating this change through directional information transmitted by the TDU.

It is hypothesized that overpressures are diminished after biofeedback.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- young healthy subjects

Exclusion Criteria:

- motor or sensory disabilities

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Intervention

Device:
recordings with device equipped

Control
Recording without device equipped

Locations

Country Name City State
France Timc-Imag La tronche

Sponsors (5)

Lead Sponsor Collaborator
TIMC-IMAG Jacques Demongeot, Nicolas Vuillerme, Olivier Chenu, Yohan Payan

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ability to reach a target posture 10 seconds Yes
Primary Decrease of the overpressures at the seat/body interface 10 seconds Yes
Primary Decrease of overpressures bigger for higher pressures 10 seconds Yes