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)

Pressure Ulcer Clinical Trial

— PRESDIE  

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) Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01834417
• Other study ID #: RC11_0009
• Status: Completed
• Phase: N/A
• Start date: April 18, 2013
• Est. completion date: January 2020

Study information

• Verified date: February 2020
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria :

• Patient is male or female, aged = 18

• Patient accepting the initial assessment and the following visits during the protocol

• Written informed consent has been obtained

• Patient having a social assurance

• Spinal cord injury = C6 stable Spinal cord trauma > 1 an

• Main mode of ambulation : own manual wheelchair

Exclusion criteria :

• Aged = 18

• Adults under guardianship

• Patients do not speak French, refusing or unable to be followed

• Pregnant or lactating women

• Person deprived of their liberty by judicial or administrative decision

• Person hospitalised without consent

• Pelvic pressure ulcer ongoing

• Cognitive disorder incompatible with the use of the device, understanding and conduct of the study

Related Conditions & MeSH terms

• Pressure Ulcer
• Ulcer

Intervention

Device:
• TexiMat

Locations

Country	Name	City	State
France	CHU Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	4 weeks
Secondary	Intra- and inter-patients variability of stored pressures for subpopulations	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	4 weeks