"Guarantee Assessment in Skin Prevention Adapted to Real Life With a Connected Device After a Spinal Cord Injury."
Reason given: lack of inclusion
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Trial details
- Who runs it
- Nantes University Hospital
- Trial code
- NCT05403606
- Record updated
- 20 April 2026
- Original description
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 injuryRead full original descriptionShow less
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
Inclusion: Patients of both sexes with acquired spinal cord injury Traumatic or non-traumatic origin of the spinal cord injury; Motor level < C6; Complete or incomplete injury (AIS A, B and C impairment scale); Primarily using a manual wheelchair (with or without electric propulsion assistance) as a means of mobility; At least 18 years of age; At any time after the occurrence of the spinal cord injury; Patients discharged from the center, with a first post-injury rehabilitation completed; Having participated in a specific therapeutic patient education on pressure ulcer prevention; No pelvic pressure sores under medical or surgical treatment at the time of inclusion; No aorto-iliac arterial disease that may promote pelvic ischemia (arterial Doppler <6 months); Patient using a cushion approved by the HAS; Patients with a smartphone.
Exclusion: Congenital spinal cord injury; Motor level of the lesion > or = C6; Incomplete motor lesion (AIS D and E); Patients who walk as their primary mode of ambulation; Use of an electric wheelchair; Minors.