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lack of inclusion
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group (GASPARD®) | Experimental | 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 |
|
| Control group: | No Intervention | Spinal cord injured patient with traditional follow-up with therapeutic education at discharge from initial care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GASPARD® | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients per group for whom a pressure ulcer occurred. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Incremental cost-utility ratio of a connected electronic seat pressure measurement device (GASPARD®) compared to traditional management (= without device) | 1 year | |
| Skin Risk Knowledge Questionnaire Revised-SMNAC (Skin Management Needs Assessment Checklist) |
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Inclusion Criteria:
Patients of both sexes with acquired spinal cord injury Traumatic or non-traumatic origin of the spinal cord injury
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MARC LE FORT | Nantes University Hospital | Principal Investigator |
| GAELLE AUDAT | CRRF l'Arche | Principal Investigator |
| RECH CELIA | Raymond Poincaré Hospital | Principal Investigator |
| KERDRAON Jacques | CRRF Kerpape | Principal Investigator |
| GELIS ANTHONY | Centre Mutualiste Neurologique Propora | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Le FORT Marc | Nantes | France |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| 1 year |
| Cross-analysis and thematic analysis of the comments made during the focus groups, particularly with regard to the perception of one's ability to take charge of one's health and the connected dimension of the device. | 1 year |
| Frequency of pelvic location of pressure ulcer (sacrum, ischium, trochanters). Frequency of pressure ulcer stages (1 to 4) | 1 year |
| Number of pressure sores per patient | 1 year |
| Analysis of Hospital Anxiety and Depression Scale (HADS) scores and International Pain Data Set variables. | 1 year |
| D014947 | Wounds and Injuries |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |