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"Guarantee Assessment in Skin Prevention Adapted to Real Life With a Connected Device After a Spinal Cord Injury." (GASPARD-SCI)

Primary Purpose

Spinal Cord Injury

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
GASPARD®
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spinal Cord Injury focused on measuring spinal cord injury, pressure ulcer, prevention, medical advice, visual feedback

Eligibility Criteria

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

Inclusion Criteria:

  • Patients of both sexes with acquired spinal cord injury Traumatic or non-traumatic origin of the spinal cord injury

    • Motor level < C6
    • Complete or incomplete injury (AIS A, B and C impairment scale)
    • Primarily using a manual wheelchair (with or without electric propulsion assistance) as a means of mobility
    • At least 18 years of age
    • At any time after the occurrence of the spinal cord injury
    • Patients discharged from the center, with a first post-injury rehabilitation completed
    • Having participated in a specific therapeutic patient education on pressure ulcer prevention
    • No pelvic pressure sores under medical or surgical treatment at the time of inclusion
    • No aorto-iliac arterial disease that may promote pelvic ischemia (arterial Doppler <6 months)
    • Patient using a cushion approved by the HAS
    • Patients with a smartphone

Exclusion Criteria:

  • Congenital spinal cord injury
  • Motor level of the lesion > or = C6
  • Incomplete motor lesion (AIS D and E)
  • Patients who walk as their primary mode of ambulation
  • Use of an electric wheelchair
  • Minors

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Experimental Group (GASPARD®)

    Control group:

    Arm Description

    Spinal cord injured patient with the connected electronic seat pressure measurement device (GASPARD®), a traditional follow-up and having received therapeutic education at the end of the treatment

    Spinal cord injured patient with traditional follow-up with therapeutic education at discharge from initial care

    Outcomes

    Primary Outcome Measures

    Percentage of patients per group for whom a pressure ulcer occurred.

    Secondary Outcome Measures

    Incremental cost-utility ratio of a connected electronic seat pressure measurement device (GASPARD®) compared to traditional management (= without device)
    Skin Risk Knowledge Questionnaire Revised-SMNAC (Skin Management Needs Assessment Checklist)
    Cross-analysis and thematic analysis of the comments made during the focus groups, particularly with regard to the perception of one's ability to take charge of one's health and the connected dimension of the device.
    Frequency of pelvic location of pressure ulcer (sacrum, ischium, trochanters). Frequency of pressure ulcer stages (1 to 4)
    Number of pressure sores per patient
    Analysis of Hospital Anxiety and Depression Scale (HADS) scores and International Pain Data Set variables.

    Full Information

    First Posted
    May 19, 2022
    Last Updated
    May 31, 2022
    Sponsor
    Nantes University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05403606
    Brief Title
    "Guarantee Assessment in Skin Prevention Adapted to Real Life With a Connected Device After a Spinal Cord Injury."
    Acronym
    GASPARD-SCI
    Official Title
    "Guarantee Assessment in Skin Prevention Adapted to Real Life With a Connected Device After a Spinal Cord Injury."
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2022 (Anticipated)
    Primary Completion Date
    June 2025 (Anticipated)
    Study Completion Date
    June 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Nantes University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The investigators propose to test an embedded device on the seat of the wheelchair of paraplegic or tetraplegic patients (Gaspard), allowing on the one hand the continuous measurement of the pressures of seat, on the other hand a retro-control connected to the cell phone of the participants to inform them on these variables of seat (bad positioning, prolonged supports etc...) This study will be carried out over a long period of time (1 year), in an ergonomic situation of integration in the daily life of the participants. The main objective of this randomized controlled study is to study the difference in the incidence of pressure sores according to the use or not of this device. A qualitative study of the experience and perceived benefit of its use and a medico-economic study are associated to judge the expected interest in making this type of embedded device more systematically integrated into the classic movement equipment (wheelchair and seat cushion) of people with a spinal cord injury

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spinal Cord Injury
    Keywords
    spinal cord injury, pressure ulcer, prevention, medical advice, visual feedback

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    242 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental Group (GASPARD®)
    Arm Type
    Experimental
    Arm Description
    Spinal cord injured patient with the connected electronic seat pressure measurement device (GASPARD®), a traditional follow-up and having received therapeutic education at the end of the treatment
    Arm Title
    Control group:
    Arm Type
    No Intervention
    Arm Description
    Spinal cord injured patient with traditional follow-up with therapeutic education at discharge from initial care
    Intervention Type
    Device
    Intervention Name(s)
    GASPARD®
    Intervention Description
    Spinal cord injured patient with the connected electronic seat pressure measurement device (GASPARD®), a traditional follow-up and having received therapeutic education at the end of the treatment
    Primary Outcome Measure Information:
    Title
    Percentage of patients per group for whom a pressure ulcer occurred.
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Incremental cost-utility ratio of a connected electronic seat pressure measurement device (GASPARD®) compared to traditional management (= without device)
    Time Frame
    1 year
    Title
    Skin Risk Knowledge Questionnaire Revised-SMNAC (Skin Management Needs Assessment Checklist)
    Time Frame
    1 year
    Title
    Cross-analysis and thematic analysis of the comments made during the focus groups, particularly with regard to the perception of one's ability to take charge of one's health and the connected dimension of the device.
    Time Frame
    1 year
    Title
    Frequency of pelvic location of pressure ulcer (sacrum, ischium, trochanters). Frequency of pressure ulcer stages (1 to 4)
    Time Frame
    1 year
    Title
    Number of pressure sores per patient
    Time Frame
    1 year
    Title
    Analysis of Hospital Anxiety and Depression Scale (HADS) scores and International Pain Data Set variables.
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients of both sexes with acquired spinal cord injury Traumatic or non-traumatic origin of the spinal cord injury Motor level < C6 Complete or incomplete injury (AIS A, B and C impairment scale) Primarily using a manual wheelchair (with or without electric propulsion assistance) as a means of mobility At least 18 years of age At any time after the occurrence of the spinal cord injury Patients discharged from the center, with a first post-injury rehabilitation completed Having participated in a specific therapeutic patient education on pressure ulcer prevention No pelvic pressure sores under medical or surgical treatment at the time of inclusion No aorto-iliac arterial disease that may promote pelvic ischemia (arterial Doppler <6 months) Patient using a cushion approved by the HAS Patients with a smartphone Exclusion Criteria: Congenital spinal cord injury Motor level of the lesion > or = C6 Incomplete motor lesion (AIS D and E) Patients who walk as their primary mode of ambulation Use of an electric wheelchair Minors
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    MARC LE FORT
    Phone
    02 40 84 62 17
    Email
    marc.lefort@chu-nantes.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    MARC LE FORT
    Organizational Affiliation
    Nantes University Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    GAELLE AUDAT
    Organizational Affiliation
    CRRF l'Arche
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    RECH CELIA
    Organizational Affiliation
    Raymond Poincaré Hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    KERDRAON Jacques
    Organizational Affiliation
    CRRF Kerpape
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    GELIS ANTHONY
    Organizational Affiliation
    Centre Mutualiste Neurologique Propora
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    "Guarantee Assessment in Skin Prevention Adapted to Real Life With a Connected Device After a Spinal Cord Injury."

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