"Guarantee Assessment in Skin Prevention Adapted to Real Life With a Connected Device After a Spi… (NCT05403606) | Clinical Trial Compass
TerminatedNot Applicable
"Guarantee Assessment in Skin Prevention Adapted to Real Life With a Connected Device After a Spinal Cord Injury."
Stopped: lack of inclusion
France134 participantsStarted 2023-01-01
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of patients per group for whom a pressure ulcer occurred.