Clinical trial NCT05403606: "Guarantee Assessment in Skin Prevention Adapted to Real Life With a Connected Device After a Spinal Cord Injury."
Official title: "Guarantee Assessment in Skin Prevention Adapted to Real Life With a Connected Device After a Spinal Cord Injury."
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injury
Keywords: spinal cord injury
pressure ulcer
prevention
medical advice
visual feedback
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2022-06-03
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients per group for whom a pressure ulcer occurred.
timeFrame: 1 year
Secondary outcomes:
measure: Incremental cost-utility ratio of a connected electronic seat pressure measurement device (GASPARD®) compared to traditional management (= without device)
timeFrame: 1 year
measure: Skin Risk Knowledge Questionnaire Revised-SMNAC (Skin Management Needs Assessment Checklist)
timeFrame: 1 year
measure: 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.
timeFrame: 1 year
measure: Frequency of pelvic location of pressure ulcer (sacrum, ischium, trochanters). Frequency of pressure ulcer stages (1 to 4)
timeFrame: 1 year
measure: Number of pressure sores per patient
timeFrame: 1 year
measure: Analysis of Hospital Anxiety and Depression Scale (HADS) scores and International Pain Data Set variables.
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Nantes University Hospital
name: MARC LE FORT
role: PRINCIPAL_INVESTIGATOR
affiliation: CRRF l'Arche
name: GAELLE AUDAT
role: PRINCIPAL_INVESTIGATOR
affiliation: Raymond Poincaré Hospital
name: RECH CELIA
role: PRINCIPAL_INVESTIGATOR
affiliation: CRRF Kerpape
name: KERDRAON Jacques
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Mutualiste Neurologique Propora
name: GELIS ANTHONY
role: PRINCIPAL_INVESTIGATOR
References: