NCT05403606

Guarantee Assessment in Skin Prevention Adapted to Real Life With a Connected Device After a Spinal Cord Injury.

Nantes University Hospital·ClinicalTrials.gov·device·Device trialNot yet recruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Spinal Cord Injury
Drug/Device/Intervention
GASPARD®
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Nantes University Hospital
Timeline & enrollment
Phase
N/A
Start date
Jun 01, 2022
End date
Jun 01, 2025
Enrollment
242 participants
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
Sequelae of injury of spinal cordOther injury of lumbar spinal cordInjury of spinal cord, level unspecifiedOther and unspecified injuries of thoracic spinal cordOther and unspecified injuries of cervical spinal cord
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05403606
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT05403606 through Pure Global AI's free database. This phase not specified trial is sponsored by Nantes University Hospital and is currently Not yet recruiting. The study focuses on Spinal Cord Injury. Target enrollment is 242 participants.

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