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Completed

NCT Number: NCT01857089

Characterization of Sitting Postures in Healthy Subjects

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.

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Key information

Conditions

Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

20 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CIC-IT GrenobleUniversityHospital

Grenoble, France

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Orthotest CE

Device

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

Primary outcomes

  1. Assessment of intra and inter-subjects variability of the pressure measurements for the whole population included.

    Time frame: 2 hours

    Sit pressure measurements of all subjects of the study

Secondary outcomes

  1. Correlation between interface pressure measurements and postural data.

    Time frame: 2 hours

    • Sit pressure measurements
    • Video recording

Other outcomes

  1. Correlation between interface pressure measurements and the response to micro electrical stimulation of the buttock.

    Time frame: 2 hours

    • Sit pressure measurements
    • Body composition: body fat mass, lean body mass, water body, bone mineral content etc.

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: CaPAS

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 20, 2013
Registry last updated
Apr 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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