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Completed

NCT Number: NCT01834417

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)

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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Key information

Conditions

Pressure Ulcer Central Nervous System Diseases Nervous System Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Nantes

Nantes, 44093, France

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TexiMat

Device

Primary outcomes

  1. 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

    Time frame: 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 outcomes

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study 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

Acronym: PRESDIE

Important dates

Study start
2013
Primary completion
2020
Study completion
2020
First posted
Apr 17, 2013
Registry last updated
Feb 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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