Measurement of Multiphysical Fields at the Subject-sitting Interface

Wheelchair Users Clinical Trial

— MECMISA  

Official title:

Measurement of Multiphysical Fields at the Subject-sitting Interface

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05650671
• Other study ID #: 2022_RIPH_006_MECMISA
• Status: Not yet recruiting
• Start date: March 1, 2023
• Est. completion date: July 1, 2023

Study information

• Verified date: December 2022
• Source: Université de Reims Champagne-Ardenne
• Contact: Sébastien Murer
• Phone: 03 26 91 81 20
• Email: sebastien.murer[@]univ-reims.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

With the population ageing and the increase in disabilities prevalence, demand for wheelchairs is increasing. Padding and shape of seat are important factors for comfort when sitting for long periods of time. Sustained mechanical loads induced by the seated stance can cause pressure ulcers in the ischial prominences. Temperature and humidity have also been shown to be important in the development of pressure ulcers.

Description:

The aim of this research is to measure the pressure, temperature and relative humidity fields at the user-seat interface of a wheelchair.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: July 1, 2023
• Est. primary completion date: April 1, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Healthy subjects

• aged of 18 and more

• agreeing to participate in the study

Exclusion Criteria:

• under 18 years old

• pregnant women

Related Conditions & MeSH terms

• Wheelchair Users

Intervention

Device:
• instrumented wheelchair
Measurements of pressure, temperature and humidity at the subject/cushion interface

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Université de Reims Champagne-Ardenne

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pressure	Pressures at the user-seat interface of a wheelchair will be measured by non-invasive method using a pressure pad positioned directly on the cushion, under the seated subject. No contact with the skin will take place	Day 0
Primary	temperature	Temperatures at the ischial tuberosities will be measured by a non-intrusive methods using sensors taped directly on the pants of the participants. No contact with the skin of the participants will take place	Day 0
Primary	humidity	Humidity at the ischial tuberosities will be measured by a non-intrusive methods using sensors taped directly on the pants of the participants. No contact with the skin of the participants will take place	Day 0