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

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).

Study Overview

• Status: Completed
• Conditions: Adult, Hospitalized
• Intervention / Treatment: Other: Knee flexion measurement 1; Other: Knee flexion measurement 2; Other: Heel - interface pressure measurements

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).

• Study Type: Observational
• Enrollment (Actual): 65

Contacts and Locations

Study Locations

• France
  • Nîmes Cedex 9, France, 30029
    • CHRU de Nîmes - Hôpital Universitaire Carémeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population consists of consecutive patients admitted in the functional rehabilitation unit of the Nîmes University Hospital.

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Other: Knee flexion measurement 1; The angle of knee flexion during resting, supine position is measured by a first person.; Other: Knee flexion measurement 2; The angle of knee flexion during resting, supine position is measured by a second person.; Other: Heel - interface pressure measurements; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Other Outcome Measures

Outcome Measure	Time Frame
Age	Day 0
Sex	Day 0
Weight (kg)	Day 0
Height (cm)	Day 0
Braden risk scale	Day 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (ACTUAL): May 1, 2014
• Study Completion (ACTUAL): May 1, 2014

Study Registration Dates

• First Submitted: October 30, 2013
• First Submitted That Met QC Criteria: October 30, 2013
• First Posted (ESTIMATE): November 6, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): March 26, 2015
• Last Update Submitted That Met QC Criteria: March 25, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: flexion; heel - mattress pressure interface; knee angular position
• Other Study ID Numbers: LOCAL/2013/EVFN-01; 2013-A01063-42 (OTHER: RCB number)