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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) (PRESDIE)

Primary Purpose

Pressure Ulcer

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

TexiMat

About this trial

This is an interventional prevention trial for Pressure Ulcer focused on measuring Pressure ulcer, spinal cord injury, on-board device

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CHU Nantes

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01834417

First Posted

April 8, 2013

Last Updated

February 5, 2020

Sponsor

Nantes University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01834417

Brief 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 ( PRESDIE)

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

April 18, 2013 (Actual)

Primary Completion Date

January 2020 (Actual)

Study Completion Date

January 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nantes University Hospital

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pressure Ulcer

Keywords

Pressure ulcer, spinal cord injury, on-board device

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

TexiMat

Primary Outcome Measure Information:

Title

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

Description

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brigitte PERROUIN-VERBE, PU-PH

Organizational Affiliation

CHU de Nantes- Hôpital Saint Jacques

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Marc Le Fort, PH

Organizational Affiliation

CHU de Nantes-Hôpital Saint Jacques

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Guy Egon

Organizational Affiliation

Centre de l'Arche

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Djamel Bensmail, PU-PH

Organizational Affiliation

CH Raymond Poincaré

Official's Role

Study Chair

Facility Information:

Facility Name

CHU Nantes

City

Nantes

ZIP/Postal Code

44093

Country

France

12. IPD Sharing Statement

Learn more about this 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)

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