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

Spinal Cord Injury Clinical Trial

— GASPARD-SCI  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05403606
• Other study ID #: RC21_0044
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2022
• Est. completion date: June 2025

Study information

• Verified date: May 2022
• Source: Nantes University Hospital
• Contact: MARC LE FORT
• Phone: 02 40 84 62 17
• Email: marc.lefort[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 242
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Device:
• GASPARD®
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients per group for whom a pressure ulcer occurred.		1 year
Secondary	Incremental cost-utility ratio of a connected electronic seat pressure measurement device (GASPARD®) compared to traditional management (= without device)		1 year
Secondary	Skin Risk Knowledge Questionnaire Revised-SMNAC (Skin Management Needs Assessment Checklist)		1 year
Secondary	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.		1 year
Secondary	Frequency of pelvic location of pressure ulcer (sacrum, ischium, trochanters). Frequency of pressure ulcer stages (1 to 4)		1 year
Secondary	Number of pressure sores per patient		1 year
Secondary	Analysis of Hospital Anxiety and Depression Scale (HADS) scores and International Pain Data Set variables.		1 year