Wheelchair UsersMECMISANCT05650671
Measurement of Multiphysical Fields at the Subject-sitting Interface
An observational study of Wheelchair Users, run by Université de Reims Champagne-Ardenne.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wheelchair Users
- What is being tested?
- instrumented wheelchair
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2023to 1 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Healthy subjects
Who may be able to join
- Healthy subjects
- aged of 18 and more
- agreeing to participate in the study
Who cannot join
- under 18 years old
- pregnant women
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Wheelchair Users
- Being tested
- instrumented wheelchair
- Keywords
- Wheelchair, Pressure ulcers, Pressure measurement, Temperature measurement, Humidity measurement
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
instrumented wheelchairDevice
Measurements of pressure, temperature and humidity at the subject/cushion interface
| Study group | Role | What they receive |
|---|---|---|
| "wheelchair user-seat" group | healthy subjects agreeing to participate in the study Receives: Device: instrumented wheelchair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start1 Mar 2023 (estimated)
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wheelchair UsersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Reims Champagne-Ardenne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05650671
- Sponsor's protocol ID
- 2022_RIPH_006_MECMISA
- Acronym
- MECMISA
- Status last verified
- Dec 2022
- First submitted
- 6 Dec 2022
- Last updated
- 14 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Multiphysical Fields at the Subject-sitting Interface
- ClinicalTrials.gov ID
- NCT05650671
- Acronym / sponsor ID
- MECMISA / 2022_RIPH_006_MECMISA
- Conditions
- Wheelchair Users
- Keywords
- Wheelchair, Pressure ulcers, Pressure measurement, Temperature measurement, Humidity measurement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Université de Reims Champagne-ArdenneUniversity, hospital or other
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 14 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| "wheelchair user-seat" group | – | Device: instrumented wheelchairhealthy subjects agreeing to participate in the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects
Key inclusion criteria (3 listed)
- Healthy subjects
- aged of 18 and more
- agreeing to participate in the study
Key exclusion criteria (2 listed)
- under 18 years old
- pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| instrumented wheelchairMeasurements of pressure, temperature and humidity at the subject/cushion interface | Device | "wheelchair user-seat" group |
Primary outcome
pressure
Time frame: Day 0
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
temperature
Time frame: Day 0
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
humidity
Time frame: Day 0
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
Related trials for Wheelchair Users
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Recruiting
Comparison Between Objective Biomechanical Cost and Perceived Physical Demand in Manual Wheelchair Users During Propulsion Tasks
Manual Wheelchair Use, Spinal Cord Injury
Not yet recruiting
Efficacy of Seated Physical Activity INtervention(SPIN) for Wheelchair Users With Multiple Sclerosis
Multiple Sclerosis
Not yet recruiting
User Evaluation of Advanced Personalized Modular Pressure Relief Seating Cushion Systems
Mobility Impairment
Recruiting
Fast In-Bed Tracking (FIT) System Lifestyle Intervention is a Clinical Trial of a Bed Scale Device. Overweight Wheelchair Users Will Complete a Weight Loss Program, Half Get Scales at Baseline, Half at Month 6 Those Who Receive the Bed Scales at Baseline Are Expected to Have Increased Weight Loss
Disability Physical, Wheelchair
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Wheelchair Users, run by Université de Reims Champagne-Ardenne.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sébastien Murer (03 26 91 81 20 ext. +33, sebastien.murer@univ-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pressure (time frame: Day 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2022.