Measurement of Multiphysical Fields at the Subject-sitting Interface (MECMISA)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Wheelchair Users
• Intervention / Treatment: Device: instrumented wheelchair

Detailed Description

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

• Study Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

• Study Contact: Name: Sébastien Murer; Phone Number: +33 03 26 91 81 20; Email: sebastien.murer@univ-reims.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy subjects

Description

Inclusion Criteria:

• Healthy subjects
• aged of 18 and more
• agreeing to participate in the study

Exclusion Criteria:

• under 18 years old
• pregnant women

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
"wheelchair user-seat" group; healthy subjects agreeing to participate in the study	Device: instrumented wheelchair; Measurements of pressure, temperature and humidity at the subject/cushion interface

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Université de Reims Champagne-Ardenne

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: December 6, 2022
• First Submitted That Met QC Criteria: December 6, 2022
• First Posted (Actual): December 14, 2022

Study Record Updates

• Last Update Posted (Actual): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 6, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Wheelchair; Pressure ulcers; Pressure measurement; Temperature measurement; Humidity measurement
• Other Study ID Numbers: 2022_RIPH_006_MECMISA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No