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)

NCT01834417 | Completed

• 1 other identifier: RC11_0009
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Pressure Ulcer

Keywords

Pressure ulcer, spinal cord injury, on-board device

Outcome Measures

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

  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 Outcomes (1)

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

  4 weeks

Interventions

TexiMat DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU Nantes

Nantes, 44093, France

Location

MeSH Terms

Conditions

Pressure Ulcer; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• Brigitte PERROUIN-VERBE, PU-PH

  CHU de Nantes- Hôpital Saint Jacques

  PRINCIPAL INVESTIGATOR

• Marc Le Fort, PH

  CHU de Nantes-Hôpital Saint Jacques

  STUDY CHAIR

• Guy Egon

  Centre de l'Arche

  STUDY CHAIR

• Djamel Bensmail, PU-PH

  CH Raymond Poincaré

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2013
• First Posted: April 17, 2013
• Study Start: April 18, 2013
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: February 6, 2020

Record last verified: 2020-02

Locations

FR (1)