NCT05403606

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 242 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Spinal Cord Injury

Interventions

Type	Name	Description
DEVICE	GASPARD®	Spinal cord injured patient with the connected electronic seat pressure measurement device (GASPARD®), a traditional follow-up and having received therapeutic education at the end of the treatment

Timeline

• Start date: 2022-06-01
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2022-06-03
• Last updated: 2022-06-03