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CompletedNCT01857089CaPASUpdated Apr 11, 2014

Characterization of Sitting Postures in Healthy Subjects

An interventional study of Orthotest CE in Pressure Ulcer, sponsored by University Hospital, Grenoble. Completed at 1 site in France. Open to participants aged 20 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-04-11.

Sponsored by University Hospital, Grenoble · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
20 Years to 30 Years
Sex
All
01

Study summary

The aim of this study is to assess the intra and inter-subjects variability of the pressure measurement cartography in healthy and well and able volunteers, sitting on a rigid base during two hours.

Read the detailed description
  • The purpose of this study is to understand the formation of pressure sore, to improve the care of paraplegic patients.
  • This pilot study is going to help to establish a model in healthy volunteers in the prevention of pressure sores.
02

Conditions studied

  • Pressure Ulcer

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Keywords

  • Pressure Ulcer
  • prevention
03

In context

Pressure Ulcer

518 studies on the registry are indexed under Pressure Ulcer; 117 are open to participants now.

This study's enrollment of 30 is below the median of 70 across 395 interventional studies indexed under Pressure Ulcer.

Browse Pressure Ulcer studies →

Lead sponsor

University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • more or equal than 18 years old
  • age between 20 and 30 years old
  • affiliation to social security or similarly regime

Exclusion criteria

Exclusion Criteria:

  • Person with pacemaker
  • Person with a history of lumbar pain, chest or/and cervical pain.
  • Person with an history of lumbar, chest or/and cervical muscular disorders,
  • Person with history of circulatory problems,
  • Person with history of skin pathologies at the seat area,
  • Protected person referred to in Articles L1121-5 to L1121-8 of the Code of Public Health
  • Person having a total annual compensation for the participation in biomedical research higher than €4460.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Pressure Measurement

    Device: Orthotest CE

Interventions

  • DeviceOrthotest CE

    Orthotest CE is a rigid base mapping system composed by 1024 pressure transducers uniformly distributed in a 35x35 cm surface. Orthotest CE is a product manufactured by Vista-Medical. The patient sit on the rigid base during 2 hours to record the pressure and all the data needed for the pilot study. Pressure measurement

    Also known as: Orthotest CE mark, Vista-Medical, Mapping system

06

What researchers measure

Primary outcomes

  1. Assessment of intra and inter-subjects variability of the pressure measurements for the whole population included.

    Sit pressure measurements of all subjects of the study

    Time frame: 2 hours

Secondary outcomes

  1. Correlation between interface pressure measurements and postural data.

    * Sit pressure measurements * Video recording

    Time frame: 2 hours

Other outcomes

  1. Correlation between interface pressure measurements and the response to micro electrical stimulation of the buttock.

    * Sit pressure measurements * Body composition: body fat mass, lean body mass, water body, bone mineral content etc.

    Time frame: 2 hours

07

Study locations

1 site
  • CIC-IT GrenobleUniversityHospital
    Grenoble, France
08

References and documents

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01857089
Lead sponsor
University Hospital, Grenoble
Responsible party
Sponsor
First posted
May 20, 2013
Start date
May 2013
Primary completion
Aug 2013
Completion
Aug 2013
Last update
Apr 11, 2014

Study contacts

Alexandre MOREAU-GAUDRY, MD,PhD
principal investigator · INSERM-CIC-IT

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

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