NCT01976897|Completed
Effect of the Physiological Angular Position of the Resting Knee on Pressure at the Heel/Surface Interface
FlessCare
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FlessCare
Sponsor study identifier
Secondary identifiers
OTHER · RCB number
observational
65
1 country
1
Study Start
March 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2014
Actual (reported)Study Completion
May 2014
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 30, 2013
Actual (reported)November 6, 2013
Actual (reported)March 2014
Date type not reportedThis date has not been verified as actual or estimated.
May 2014
Actual (reported)May 2014
Actual (reported)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
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
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.
Day 0
Intra-operator concordance for skin marks used for measuring knee flexion angle for 30 knees
Day 1
Age
Day 0
Sex
Day 0
Weight (kg)
Day 0
Only one group is included. See inclusion/exclusion criteria. Intervention: Knee flexion measurement 1 Intervention: Knee flexion measurement 2 Intervention: Heel - interface pressure measurements
The angle of knee flexion during resting, supine position is measured by a first person.
The angle of knee flexion during resting, supine position is measured by a second person.
The study population consists of consecutive patients admitted in the functional rehabilitation unit of the Nîmes University Hospital.
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029, France
Emilie Viollet, MD
Centre Hospitalier Universitaire de Nīmes
65 participants (actual enrollment reported by the registry).
First Submitted
October 30, 2013
First Posted
November 6, 2013
Study Start
March 2014
Date type not reportedThis date has not been verified as actual or estimated.
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.
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Primary Completion
May 2014
Actual (reported)Study Completion
May 2014
Actual (reported)Last Updated
March 26, 2015
Record last verified: 2015-03
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Source: ClinicalTrials.gov.
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