Characterization of Sitting Postures in Healthy Subjects

Not Applicable

Completed

• Conditions: Pressure Ulcer
• Interventions: Device: Orthotest CE

• Registration Number: NCT01857089
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2013-02-01
• Study Start: 2013-05
• Study First Submitted QC: 2013-05-17
• Study First Posted: 2013-05-20
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-10
• Last Update Posted: 2014-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pressure Measurement	Orthotest CE	-

Primary Outcome Measures

Name	Time	Method
Assessment of intra and inter-subjects variability of the pressure measurements for the whole population included.	2 hours	Sit pressure measurements of all subjects of the study

Secondary Outcome Measures

Name	Time	Method
Correlation between interface pressure measurements and postural data.	2 hours	* Sit pressure measurements; * Video recording

Trial Locations

Locations (1)

CIC-IT GrenobleUniversityHospital; 🇫🇷 Grenoble, France