Guarantee Assessment in Skin Prevention Adapted to Real Life With a Connected Device After a Spinal Cord Injury. - Trial NCT05403606
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Study Focus
Sponsor & Location
Nantes University Hospital
Timeline & Enrollment
N/A
Jun 01, 2022
Jun 01, 2025
Primary Outcome
Percentage of patients per group for whom a pressure ulcer occurred.
Summary
The investigators propose to test an embedded device on the seat of the wheelchair of
 paraplegic or tetraplegic patients (Gaspard), allowing on the one hand the continuous
 measurement of the pressures of seat, on the other hand a retro-control connected to the cell
 phone of the participants to inform them on these variables of seat (bad positioning,
 prolonged supports etc...) This study will be carried out over a long period of time (1
 year), in an ergonomic situation of integration in the daily life of the participants. The
 main objective of this randomized controlled study is to study the difference in the
 incidence of pressure sores according to the use or not of this device. A qualitative study
 of the experience and perceived benefit of its use and a medico-economic study are associated
 to judge the expected interest in making this type of embedded device more systematically
 integrated into the classic movement equipment (wheelchair and seat cushion) of people with a
 spinal cord injury
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05403606
Device Trial