NCT05650671

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 14, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

December 14, 2022

Status Verified

December 1, 2022

Enrollment Period

1 month

First QC Date

December 6, 2022

Last Update Submit

December 6, 2022

Conditions

Wheelchair Users

Keywords

WheelchairPressure ulcersPressure measurementTemperature measurementHumidity measurement

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

"wheelchair user-seat" group

healthy subjects agreeing to participate in the study

Device: instrumented wheelchair

Interventions

instrumented wheelchairDEVICE

Measurements of pressure, temperature and humidity at the subject/cushion interface

"wheelchair user-seat" group

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy subjects

You may qualify if:

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

You may not qualify if:

  • under 18 years old
  • pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Sébastien Murer

CONTACT

03 26 91 81 20sebastien.murer@univ-reims.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2022

First Posted

December 14, 2022

Study Start

March 1, 2023

Primary Completion

April 1, 2023

Study Completion

July 1, 2023

Last Updated

December 14, 2022

Record last verified: 2022-12