NCT01857089

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 20, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

April 11, 2014

Status Verified

April 1, 2014

Enrollment Period

3 months

First QC Date

February 1, 2013

Last Update Submit

April 10, 2014

Conditions

Keywords

Pressure Ulcerprevention

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Correlation between interface pressure measurements and postural data.

    2 hours

Other Outcomes (1)

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

    2 hours

Study Arms (1)

Pressure Measurement

EXPERIMENTAL
Device: Orthotest CE

Interventions

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

Also known as: Orthotest CE mark, Vista-Medical, Mapping system
Pressure Measurement

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • more or equal than 18 years old
  • age between 20 and 30 years old
  • affiliation to social security or similarly regime

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CIC-IT GrenobleUniversityHospital

Grenoble, France

Location

Related Links

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Alexandre MOREAU-GAUDRY, MD,PhD

    INSERM-CIC-IT

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2013

First Posted

May 20, 2013

Study Start

May 1, 2013

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

April 11, 2014

Record last verified: 2014-04

Locations