"Guarantee Assessment in Skin Prevention Adapted to Real Life With a Connected Device After a Spinal Cord Injury." (GASPARD-SCI)

Nantes University Hospital (NUH)

Status: Not yet enrolling

Conditions: Spinal Cord Injury

Treatments: Device: GASPARD®

Study type: Interventional

Funder types: Other

Identifiers

NCT05403606

RC21_0044

Details and patient eligibility

About

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

Enrollment: 242 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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242 participants in 2 patient groups

Experimental Group (GASPARD®)

Experimental group

Description:

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

Treatment:

Device: GASPARD®

Control group:

No Intervention group

Description:

Spinal cord injured patient with traditional follow-up with therapeutic education at discharge from initial care