Clinical Trial: Preliminary Study Leading to Prevention of Pressure Ulcers by the Use of an On-board Device : Ergonomic Assessment of Wheelchair-seat Pressures in Spinal Cord Injured (SCI) Patients ( PRESDIE)

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Preliminary Study Leading to Prevention of Pressure Ulcers by the Use of an On-board Device : Ergonomic Assessment of Wheelchair-seat Pressures in Spinal Cord Injured (SCI

Brief Summary: Analysis of stored seat-pressures in SCI patients during a 4-week use of an on-board device. During this period, patients write in an agenda noteworthy events that could occur while they're using their wheelchair. A control is done every week and the device can be changed until it is returned at the end of the study period.

Detailed Summary:

  • inclusion visit : recovery of the signed informed-consent form, clinical examination, skin control, seat-pressures control, device 9-position control, delivery of the agenda for noteworthy events
  • 3 follow-up visits : noteworthy events check, skin control, cushioncloth control, device 9-position control
  • return visit : device return, agenda return, skin control, seat-pressures control

Sponsor: Nantes University Hospital

Current Primary Outcome: Intra- and inter-patients variability of stored pressures for the whole included population Intra- and inter-patients variability of stored pressures for the whole included population [ Time Frame: 4 weeks ]

Intra- and inter-patients variability of stored pressures for the whole included population Measured at the end of the study

Each topic will be equipped with a layer of pressure sensors 32x32. The pressure maps are stored every second rule, which will be of the order of 30 000 maps daily. For each topic, we will be able to calculate the frequency and location of peak pressure



Original Primary Outcome: Same as current

Current Secondary Outcome: Intra- and inter-patients variability of stored pressures for subpopulations [ Time Frame: 4 weeks ]

Intra- and inter-patients variability of stored pressures for subpopulations :

  • quadriplegic vs paraplegic
  • according to high-risk areas for pressure ulcers
  • according to noteworthy events

Each topic will be equipped with a layer of pressure sensors 32x32. The pressure maps are stored every second rule, which will be of the order of 30 000 maps daily. For each topic, we will be able to calculate the frequency and location of peak pressure Measured at the end of the study



Original Secondary Outcome: Same as current

Information By: Nantes University Hospital

Dates:
Date Received: April 8, 2013
Date Started: April 2013
Date Completion: October 2016
Last Updated: March 22, 2016
Last Verified: March 2016