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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-18

Study Completion Date

2020-01-31

Brief Summary

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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.

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Detailed Description

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* 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

Conditions

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Pressure Ulcer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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TexiMat

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No