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NCT01857089 Clinical Trial

Characterization of Sitting Postures in Healthy Subjects

Pressure Ulcer Clinical Trial

— CaPAS  

Official title:
Characterization of Sitting Postures in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01857089
Other study ID # CaPAS-DCIC-1204
Secondary ID
Status Completed
Phase N/A
First received February 1, 2013
Last updated April 10, 2014
Start date May 2013
Est. completion date August 2013

Study information
Verified date April 2014
Source University Hospital, Grenoble
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date August 2013
Est. primary completion date August 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 30 Years
Eligibility 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France CIC-IT GrenobleUniversityHospital Grenoble

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Other 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.		 2 hours No
Primary 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 2 hours No
Secondary Correlation between interface pressure measurements and postural data. Sit pressure measurements
Video recording		 2 hours No
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