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

NCT05403606 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2026-04-20

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • MARC LE FORT · Nantes University Hospital

  • GAELLE AUDAT · CRRF l'Arche

  • RECH CELIA · Raymond Poincaré Hospital

  • KERDRAON Jacques · CRRF Kerpape

  • GELIS ANTHONY · Centre Mutualiste Neurologique Propora

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2026-02-03
Completion
2026-02-03

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05403606 on ClinicalTrials.gov