Characterization of Sitting Postures in Healthy Subjects (CaPAS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01857089
First received: February 1, 2013
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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 Intervention
Pressure Ulcer
Device: Orthotest CE

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Characterization of Sitting Postures in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Assessment of intra and inter-subjects variability of the pressure measurements for the whole population included. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Sit pressure measurements of all subjects of the study


Secondary Outcome Measures:
  • Correlation between interface pressure measurements and postural data. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    • Sit pressure measurements
    • Video recording


Other Outcome Measures:
  • Correlation between interface pressure measurements and the response to micro electrical stimulation of the buttock. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    • Sit pressure measurements
    • Body composition: body fat mass, lean body mass, water body, bone mineral content etc.


Enrollment: 30
Study Start Date: May 2013
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   20 Years to 30 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01857089     History of Changes
Other Study ID Numbers: CaPAS-DCIC-1204
Study First Received: February 1, 2013
Last Updated: April 10, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by University Hospital, Grenoble:
Pressure Ulcer
prevention

Additional relevant MeSH terms:
Pressure Ulcer
Ulcer
Skin Ulcer
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014