Preliminary 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 ( PRESDIE)

Nantes University Hospital90 enrolled

Overview

Analysis of stored seat-pressures in SCI patients during a 4-week use of an on-board device. During this period, patients write in an agenda noteworthy events that could occur while they're using their wheelchair. A control is done every week and the device can be changed until it is returned at the end of the study period.

* 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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Pressure Ulcer

Interventions

TexiMatDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria : * Patient is male or female, aged ≥ 18 * Patient accepting the initial assessment and the following visits during the protocol * Written informed consent has been obtained * Patient having a social assurance * Spinal cord injury ≤ C6 stable Spinal cord trauma \> 1 an * Main mode of ambulation : own manual wheelchair Exclusion criteria : * Aged ≤ 18 * Adults under guardianship * Patients do not speak French, refusing or unable to be followed * Pregnant or lactating women * Person deprived of their liberty by judicial or administrative decision * Person hospitalised without consent * Pelvic pressure ulcer ongoing * Cognitive disorder incompatible with the use of the device, understanding and conduct of the study

Locations (1)

CHU Nantes

Nantes, France

Outcomes

Primary Outcomes

Intra- and inter-patients variability of stored pressures for the whole included population Intra- and inter-patients variability of stored pressures for the whole included population

Intra- and inter-patients variability of stored pressures for the whole included population Measured at the end of the study Each topic will be equipped with a layer of pressure sensors 32x32. The pressure maps are stored every second rule, which will be of the order of 30 000 maps daily. For each topic, we will be able to calculate the frequency and location of peak pressure

Time frame: 4 weeks

Secondary Outcomes

Intra- and inter-patients variability of stored pressures for subpopulations

Intra- and inter-patients variability of stored pressures for subpopulations : * quadriplegic vs paraplegic * according to high-risk areas for pressure ulcers * according to noteworthy events Each topic will be equipped with a layer of pressure sensors 32x32. The pressure maps are stored every second rule, which will be of the order of 30 000 maps daily. For each topic, we will be able to calculate the frequency and location of peak pressure Measured at the end of the study

Time frame: 4 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.