Clinical Trials Directory

Trials / Completed

CompletedNCT01976897

Effect of the Physiological Angular Position of the Resting Knee on Pressure at the Heel/Surface Interface

Status
Completed
Phase
Study type
Observational
Enrollment
65 (actual)
Sponsor
Centre Hospitalier Universitaire de Nīmes · Academic / Other
Sex
All
Age
50 Years
Healthy volunteers
Not accepted

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).

Detailed description

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).

Conditions

Interventions

TypeNameDescription
OTHERKnee flexion measurement 1The angle of knee flexion during resting, supine position is measured by a first person.
OTHERKnee flexion measurement 2The angle of knee flexion during resting, supine position is measured by a second person.
OTHERHeel - 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.

Timeline

Start date
2014-03-01
Primary completion
2014-05-01
Completion
2014-05-01
First posted
2013-11-06
Last updated
2015-03-26

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT01976897. Inclusion in this directory is not an endorsement.