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Characterization of Sitting Postures in Healthy Subjects (CaPAS)

Primary Purpose

Pressure Ulcer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Orthotest CE
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pressure Ulcer focused on measuring Pressure Ulcer, prevention

Eligibility Criteria

20 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • CIC-IT GrenobleUniversityHospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pressure Measurement

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Correlation between interface pressure measurements and postural data.
Sit pressure measurements Video recording

Full Information

First Posted
February 1, 2013
Last Updated
April 10, 2014
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT01857089
Brief Title
Characterization of Sitting Postures in Healthy Subjects
Acronym
CaPAS
Official Title
Characterization of Sitting Postures in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer
Keywords
Pressure Ulcer, prevention

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pressure Measurement
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Orthotest CE
Other Intervention Name(s)
Orthotest CE mark, Vista-Medical, Mapping system
Intervention Description
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
Primary Outcome Measure Information:
Title
Assessment of intra and inter-subjects variability of the pressure measurements for the whole population included.
Description
Sit pressure measurements of all subjects of the study
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Correlation between interface pressure measurements and postural data.
Description
Sit pressure measurements Video recording
Time Frame
2 hours
Other Pre-specified Outcome Measures:
Title
Correlation between interface pressure measurements and the response to micro electrical stimulation of the buttock.
Description
Sit pressure measurements Body composition: body fat mass, lean body mass, water body, bone mineral content etc.
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre MOREAU-GAUDRY, MD,PhD
Organizational Affiliation
INSERM-CIC-IT
Official's Role
Principal Investigator
Facility Information:
Facility Name
CIC-IT GrenobleUniversityHospital
City
Grenoble
Country
France

12. IPD Sharing Statement

Links:
URL
http://www.cic-it-grenoble.fr/
Description
Related Info

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Characterization of Sitting Postures in Healthy Subjects

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