Postural Behaviourprevesc0001NCT00917228
A Wireless Lingual Feedback Device to Reduce Overpressures in Seated Posture: A Feasibility Study
An observational study of Postural Behaviour and Overpressures Reductions, run by TIMC-IMAG at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Postural Behaviour, Overpressures Reductions
- What is being tested?
- recordings with device equipped
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteFrance
- Study dates
- Start not givento not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Young healthy subjects
Who may be able to join
- young healthy subjects
Who cannot join
- motor or sensory disabilities
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Postural Behaviour, Overpressures Reductions
- Being tested
- recordings with device equipped, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recordings with device equippedDevice
ControlDevice
Recording without device equipped
| Study group | Role | What they receive |
|---|---|---|
| Feedback | Subjects of this group are equipped with the biofeedback system Receives: Device: recordings with device equipped | |
| Control | Subjects of this group are not equipped with the biofeedback system Receives: Device: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to reach a target posture
Measured: 10 seconds
Decrease of the overpressures at the seat/body interface
Measured: 10 seconds
Decrease of overpressures bigger for higher pressures
Measured: 10 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural BehaviourStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Sponsor and investigators
- Lead sponsor
- TIMC-IMAG
- Sponsor type
- University, hospital or other
- Collaborators
- Olivier Chenu, Nicolas Vuillerme, Jacques Demongeot, Yohan Payan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00917228
- Sponsor's protocol ID
- prevesc0001
- Acronym
- prevesc0001
- Status last verified
- Jun 2009
- First submitted
- 8 Jun 2009
- Last updated
- 10 Jun 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Wireless Lingual Feedback Device to Reduce Overpressures in Seated Posture: A Feasibility Study
- ClinicalTrials.gov ID
- NCT00917228
- Acronym / sponsor ID
- prevesc0001 / prevesc0001
- Conditions
- Postural Behaviour, Overpressures Reductions
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- TIMC-IMAGUniversity, hospital or other
- Collaborators
- Olivier Chenu, Nicolas Vuillerme, Jacques Demongeot, Yohan Payan
- First posted
- 10 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Feedback | – | Device: recordings with device equippedSubjects of this group are equipped with the biofeedback system |
| Control | – | Device: ControlSubjects of this group are not equipped with the biofeedback system |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Young healthy subjects
Key inclusion criteria (1 listed)
- young healthy subjects
Key exclusion criteria (1 listed)
- motor or sensory disabilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| recordings with device equipped | Device | Feedback |
| ControlRecording without device equipped | Device | Control |
Primary outcome
Ability to reach a target posture
Time frame: 10 seconds
Decrease of the overpressures at the seat/body interface
Time frame: 10 seconds
Decrease of overpressures bigger for higher pressures
Time frame: 10 seconds
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postural Behaviour and Overpressures Reductions, run by TIMC-IMAG at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to reach a target posture (time frame: 10 seconds). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2009.