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Characterization of Sitting Postures in Healthy Subjects (CaPAS)

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ClinicalTrials.gov Identifier: NCT01857089
Recruitment Status : Completed
First Posted : May 20, 2013
Last Update Posted : April 11, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief 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.

Condition or disease Intervention/treatment Phase
Pressure Ulcer Device: Orthotest CE Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Characterization of Sitting Postures in Healthy Subjects
Study Start Date : May 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pressure Measurement Device: Orthotest 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

Other Names:
  • Orthotest CE mark
  • Vista-Medical
  • Mapping system




Primary Outcome Measures :
  1. Assessment of intra and inter-subjects variability of the pressure measurements for the whole population included. [ Time Frame: 2 hours ]
    Sit pressure measurements of all subjects of the study


Secondary Outcome Measures :
  1. Correlation between interface pressure measurements and postural data. [ Time Frame: 2 hours ]
    • Sit pressure measurements
    • Video recording


Other Outcome Measures:
  1. Correlation between interface pressure measurements and the response to micro electrical stimulation of the buttock. [ Time Frame: 2 hours ]
    • Sit pressure measurements
    • Body composition: body fat mass, lean body mass, water body, bone mineral content etc.



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Ages Eligible for Study:   20 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01857089


Locations
France
CIC-IT GrenobleUniversityHospital
Grenoble, France
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Alexandre MOREAU-GAUDRY, MD,PhD INSERM-CIC-IT

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01857089     History of Changes
Other Study ID Numbers: CaPAS-DCIC-1204
First Posted: May 20, 2013    Key Record Dates
Last Update Posted: April 11, 2014
Last Verified: April 2014

Keywords provided by University Hospital, Grenoble:
Pressure Ulcer
prevention

Additional relevant MeSH terms:
Pressure Ulcer
Skin Ulcer
Skin Diseases