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)

Not Applicable

Completed

• Conditions: Pressure Ulcer

• Registration Number: NCT01834417
• Lead Sponsor: Nantes University Hospital

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 Description

* 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

Study Timeline

• Study First Submitted: 2013-04-08
• Study First Submitted QC: 2013-04-15
• Study First Posted: 2013-04-17
• Study Start: 2013-04-18
• Primary Completion: 2020-01
• Study Completion: 2020-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-05
• Last Update Posted: 2020-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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	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

Secondary Outcome Measures

Name	Time	Method
Intra- and inter-patients variability of stored pressures for subpopulations	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

Trial Locations

Locations (1)

CHU Nantes; 🇫🇷 Nantes, France