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 Hospital (NUH)

Status

Completed

Conditions

Pressure Ulcer

Treatments

Device: TexiMat

Study type

Interventional

Funder types

Other

Identifiers

NCT01834417

RC11_0009

Details and patient eligibility

About

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.

Full description

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

Enrollment

90 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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