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

NCT05403606 | Terminated

• 1 other identifier: RC21_0044
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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

Conditions

Spinal Cord Injury

Keywords

spinal cord injury; pressure ulcer; prevention; medical advice; visual feedback

Outcome Measures

Primary Outcomes (1)

• Percentage of patients per group for whom a pressure ulcer occurred.

  1 year

Secondary Outcomes (6)

• 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

Study Arms (2)

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

Device: GASPARD®

Control group:

NO INTERVENTION

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

Interventions

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

Experimental Group (GASPARD®)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Le FORT Marc

Nantes, France

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Pressure Ulcer

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: June 3, 2022
• Study Start: January 1, 2023
• Primary Completion: February 3, 2026
• Study Completion: February 3, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)