Status:
COMPLETED
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)
Lead Sponsor:
Nantes University Hospital
Conditions:
Pressure Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
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 thei...
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 * ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 18 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2020
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01834417
Start Date
April 18 2013
End Date
January 1 2020
Last Update
February 6 2020
Active Locations (1)
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1
CHU Nantes
Nantes, France, 44093