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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-A01063-42 | Other Identifier | RCB number |
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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).
The secondary objectives of this study are:
A. To evaluate the relationship between the angle of flexion of the knee in DDPD and the average pressure throughout the heel area (Pmean).
B. 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.
C. To evaluate the inter-operator concordance for the knee flexion angle measurement in DDPD via photos.
D. 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).
E. 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Knee flexion measurement 1 | Other | The angle of knee flexion during resting, supine position is measured by a first person. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurement 1: Measurement of the knee joint angle (degrees °) in a physiological relaxed position (supine)(via photos of first skin marks). | Day 0 | |
| Measurement 2: Measurement of the knee joint angle (degrees °) in a physiological relaxed position (supine)(via photos of first skin marks) | Day 0 | |
| Maximum pressure on the heel area (Ptal) | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean pressure over the entire heel area (P mean) | Day 0 | |
| Measurement of the contact surface of the heel zone (Stal) having a pressure greater than 60 mmHg | Day 0 | |
| Measure | Description | Time Frame |
|---|---|---|
| Age | Day 0 | |
| Sex | Day 0 | |
| Weight (kg) | Day 0 |
Inclusion Criteria:
Exclusion Criteria:
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The study population consists of consecutive patients admitted in the functional rehabilitation unit of the Nîmes University Hospital.
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| Name | Affiliation | Role |
|---|---|---|
| Emilie Viollet, MD | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | 30029 | France |
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| Knee flexion measurement 2 | Other | The angle of knee flexion during resting, supine position is measured by a second person. |
|
| Heel - interface pressure measurements | Other | 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. |
|
| Concordance for measurements 1 & 2 for knee flexion angle in a relaxed supine position (via photos) |
| Day 0 |
| Concordance for skin marks for knee flexion angles between 2 operators for 30 knees. | relaxed, decubitus dorsal position | Day 0 |
| Intra-operator concordance for skin marks used for measuring knee flexion angle for 30 knees | Relaxed decubitus dorsal position | Day 1 |
| Height (cm) | Day 0 |
| Braden risk scale | Day 0 |