Adult, HospitalizedFlessCareNCT01976897
Effect of the Physiological Angular Position of the Resting Knee on Pressure at the Heel/Surface Interface
An observational study of Adult, Hospitalized, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The main objective of this study is to evaluate the relationship between the angle of knee flexion in a supine position with joint relaxation (DDPD) and the maximum interface pressure at the heel area (PtAl). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Adult, Hospitalized
- What is being tested?
- Knee flexion measurement 1, Knee flexion measurement 2 and Heel - interface pressure measurements
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2014to May 2014
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of consecutive patients admitted in the functional rehabilitation unit of the Nîmes University Hospital.
Who may be able to join
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient is in a stable medical state (no complications within the past 10 days)
Who cannot join
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- The patient has had medical complications within the ten days preceding study inclusion
- The patient has a bed-sore or bandages on his/her heels
- The patient has had a lower-limb amputation
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of this study is to evaluate the relationship between the angle of knee flexion in a supine position with joint relaxation (DDPD) and the maximum interface pressure at the heel area (PtAl).
Read the detailed description
The secondary objectives of this study are:
- To evaluate the relationship between the angle of flexion of the knee in DDPD and the average pressure throughout the heel area (Pmean).
- To evaluate the relationship between the angle of flexion of the knee in DDPD and the contact surface of the heel area (Stal) where the pressure is greater than 60 mm Hg.
- To evaluate the inter-operator concordance for the knee flexion angle measurement in DDPD via photos.
- To evaluate the inter-operator concordance for skin marks used to measure knee flexion angles in DDPD via photos (only one knee for 30 patients).
- To evaluate the inta-operator concordance (measures on 2 consecutive days) for skin marks used to measure knee flexion angles in DDPD via photos (for 30 patients).
- Conditions
- Adult, Hospitalized
- Being tested
- Knee flexion measurement 1, Knee flexion measurement 2, Heel - interface pressure measurements
- Keywords
- heel - mattress pressure interface, flexion, knee angular position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knee flexion measurement 1Other
The angle of knee flexion during resting, supine position is measured by a first person.
Knee flexion measurement 2Other
The angle of knee flexion during resting, supine position is measured by a second person.
Heel - interface pressure measurementsOther
The pressure analysis system used is the X Sensor X3 model (Xsensor Technology Corporation, Calgary, Canada). The sensor mat is made up of transducer cells, each measuring 1.6 cm^2. The digital signal is transmitted to a PC via a USB port at a sampling frequency of 10Hz. Before each measurement, the sensor mat is calibrated from 10 to 220 mm Hg, according to the manufacturer's recommendations.
The sheet of pressure sensors is disposed on the dedicated bed. The patient is then asked to take his/her usual position in the supine position and a latency of 5 minutes is observed. The recording time pressure is then performed for 90 seconds in the optical observing time to adapt to changes in media.
| Study group | Role | What they receive |
|---|---|---|
| The study population | Only one group is included. See inclusion/exclusion criteria.
Intervention: Knee flexion measurement 1
Intervention: Knee flexion measurement 2
Intervention: Heel - interface pressure measurements Receives: Other: Knee flexion measurement 1; Other: Knee flexion measurement 2; Other: Heel - interface pressure measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement 1: Measurement of the knee joint angle (degrees °) in a physiological relaxed position (supine)(via photos of first skin marks).
Measured: Day 0
Measurement 2: Measurement of the knee joint angle (degrees °) in a physiological relaxed position (supine)(via photos of first skin marks)
Measured: Day 0
Maximum pressure on the heel area (Ptal)
Measured: Day 0
Secondary outcomes (5)
Mean pressure over the entire heel area (P mean)
Measured: Day 0
Measurement of the contact surface of the heel zone (Stal) having a pressure greater than 60 mmHg
Measured: Day 0
Concordance for measurements 1 & 2 for knee flexion angle in a relaxed supine position (via photos)
Measured: Day 0
Concordance for skin marks for knee flexion angles between 2 operators for 30 knees.
relaxed, decubitus dorsal position
Measured: Day 0
Intra-operator concordance for skin marks used for measuring knee flexion angle for 30 knees
Relaxed decubitus dorsal position
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study startMar 2014
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult, HospitalizedStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie Viollet, MD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01976897
- Sponsor's protocol ID
- LOCAL/2013/EVFN-01
- Other IDs
- 2013-A01063-42
- Acronym
- FlessCare
- Status last verified
- Mar 2015
- First submitted
- 30 Oct 2013
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Physiological Angular Position of the Resting Knee on Pressure at the Heel/Surface Interface
- ClinicalTrials.gov ID
- NCT01976897
- Acronym / sponsor ID
- FlessCare / LOCAL/2013/EVFN-01
- Conditions
- Adult, Hospitalized
- Keywords
- heel - mattress pressure interface, flexion, knee angular position
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 6 Nov 2013 (estimated)
- 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.
The main objective of this study is to evaluate the relationship between the angle of knee flexion in a supine position with joint relaxation (DDPD) and the maximum interface pressure at the heel area (PtAl).
Detailed description
The secondary objectives of this study are:
- To evaluate the relationship between the angle of flexion of the knee in DDPD and the average pressure throughout the heel area (Pmean).
- To evaluate the relationship between the angle of flexion of the knee in DDPD and the contact surface of the heel area (Stal) where the pressure is greater than 60 mm Hg.
- To evaluate the inter-operator concordance for the knee flexion angle measurement in DDPD via photos.
- To evaluate the inter-operator concordance for skin marks used to measure knee flexion angles in DDPD via photos (only one knee for 30 patients).
- To evaluate the inta-operator concordance (measures on 2 consecutive days) for skin marks used to measure knee flexion angles in DDPD via photos (for 30 patients).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study population | – | Other: Knee flexion measurement 1, Other: Knee flexion measurement 2, Other: Heel - interface pressure measurementsOnly one group is included. See inclusion/exclusion criteria. Intervention: Knee flexion measurement 1 Intervention: Knee flexion measurement 2 Intervention: Heel - interface pressure measurements |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of consecutive patients admitted in the functional rehabilitation unit of the Nîmes University Hospital.
Key inclusion criteria (3 listed)
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient is in a stable medical state (no complications within the past 10 days)
Key exclusion criteria (8 listed)
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
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 |
|---|---|---|
| Knee flexion measurement 1The angle of knee flexion during resting, supine position is measured by a first person. | Other | The study population |
| Knee flexion measurement 2The angle of knee flexion during resting, supine position is measured by a second person. | Other | The study population |
| Heel - interface pressure measurementsThe pressure analysis system used is the X Sensor X3 model (Xsensor Technology Corporation, Calgary, Canada). The sensor mat is made up of transducer cells, each measuring 1.6 cm^2. The digital signal is transmitted to a PC via a USB port at a sampling frequency of 10Hz. Before each measurement, the sensor mat is calibrated from 10 to 220 mm Hg, according to the manufacturer's recommendations. The sheet of pressure sensors is disposed on the dedicated bed. The patient is then asked to take his/her usual position in the supine position and a latency of 5 minutes is observed. The recording time pressure is then performed for 90 seconds in the optical observing time to adapt to changes in media. | Other | The study population |
Primary outcome
Measurement 1: Measurement of the knee joint angle (degrees °) in a physiological relaxed position (supine)(via photos of first skin marks).
Time frame: Day 0
Measurement 2: Measurement of the knee joint angle (degrees °) in a physiological relaxed position (supine)(via photos of first skin marks)
Time frame: Day 0
Maximum pressure on the heel area (Ptal)
Time frame: Day 0
5 secondary outcomes
Mean pressure over the entire heel area (P mean)
Time frame: Day 0
Measurement of the contact surface of the heel zone (Stal) having a pressure greater than 60 mmHg
Time frame: Day 0
Concordance for measurements 1 & 2 for knee flexion angle in a relaxed supine position (via photos)
Time frame: Day 0
Concordance for skin marks for knee flexion angles between 2 operators for 30 knees.
Time frame: Day 0
Intra-operator concordance for skin marks used for measuring knee flexion angle for 30 knees
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2015.
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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.
Emilie Viollet, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adult, Hospitalized, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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 8 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: finished, as of the sponsor's last update on 26 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement 1: Measurement of the knee joint angle (degrees °) in a physiological relaxed position (supine)(via photos of first skin marks). (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 26 Mar 2015; AzTrials last refreshed its copy on 6 Nov 2026.