- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00917228
A Wireless Lingual Feedback Device to Reduce Overpressures in Seated Posture: A Feasibility Study (prevesc0001)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Contacts and Locations
Study Locations
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-
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La tronche, France, 38710
- Timc-Imag
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- young healthy subjects
Exclusion Criteria:
- motor or sensory disabilities
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Feedback
Subjects of this group are equipped with the biofeedback system
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|
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Control
Subjects of this group are not equipped with the biofeedback system
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Recording without device equipped
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Ability to reach a target posture
Time Frame: 10 seconds
|
10 seconds
|
|
Decrease of the overpressures at the seat/body interface
Time Frame: 10 seconds
|
10 seconds
|
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Decrease of overpressures bigger for higher pressures
Time Frame: 10 seconds
|
10 seconds
|
Collaborators and Investigators
Sponsor
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- prevesc0001
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