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

Study Overview
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Brief Summary
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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

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

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Device: GASPARD®


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group (GASPARD®)<br>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 | Device: GASPARD®<br>* 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<br>|
| No Intervention: Control group:<br>Spinal cord injured patient with traditional follow-up with therapeutic education at discharge from initial care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients per group for whom a pressure ulcer occurred. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal cord injury, pressure ulcer, prevention, medical advice, visual feedback