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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014