Completed
PRESDIEPreliminary Study Leading to Prevention of Pressure Ulcers by the Use of an On-board Device : Ergonomic Assessment of Wheelchair-seat Pressures in Spinal Cord Injured (SCI) Patients
What is being tested
TexiMat
Device
Who is being recruted
Central Nervous System Diseases+7
+ Nervous System Diseases
+ Skin Diseases
Over 18 Years
+14 Eligibility Criteria
How is the trial designed
Prevention Study
Interventional
Study Start: April 2013
Summary
Principal SponsorNantes University Hospital
Last updated: February 6, 2020
Sourced from a government-validated database.Claim as a partner
Study start date: April 18, 2013
Actual date on which the first participant was enrolled.inclusion visit : recovery of the signed informed-consent form, clinical examination, skin control, seat-pressures control, device 9-position control, delivery of the agenda for noteworthy events 3 follow-up visits : noteworthy events check, skin control, cushioncloth control, device 9-position control return visit : device return, agenda return, skin control, seat-pressures control
Principal SponsorNantes University Hospital
Last updated: February 6, 2020
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
90 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Central Nervous System DiseasesNervous System DiseasesSkin DiseasesSkin UlcerSpinal Cord DiseasesWounds and InjuriesSkin and Connective Tissue DiseasesTrauma, Nervous SystemPressure UlcerSpinal Cord Injuries
Criteria
6 inclusion criteria required to participate
Main mode of ambulation : own manual wheelchair
Patient accepting the initial assessment and the following visits during the protocol
Patient having a social assurance
Patient is male or female, aged >= 18
Show More Criteria
8 exclusion criteria prevent from participating
Adults under guardianship
Aged <= 18
Cognitive disorder incompatible with the use of the device, understanding and conduct of the study
Patients do not speak French, refusing or unable to be followed
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center