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

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

Study Overview

• Status: Terminated
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Device: GASPARD®

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France
    • Le FORT Marc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): February 3, 2026
• Study Completion (Actual): February 3, 2026

Study Registration Dates

• First Submitted: May 19, 2022
• First Submitted That Met QC Criteria: May 31, 2022
• First Posted (Actual): June 3, 2022

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: prevention; spinal cord injury; visual feedback; pressure ulcer; medical advice
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Skin Diseases; Skin Ulcer; Trauma, Nervous System; Spinal Cord Diseases; Skin and Connective Tissue Diseases; Spinal Cord Injuries; Pressure Ulcer
• Other Study ID Numbers: RC21_0044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No