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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01976897
Acronym
FlessCare
Enrollment
65
Registered
2013-11-06
Start date
2014-03-31
Completion date
2014-05-31
Last updated
2015-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult, Hospitalized

Keywords

heel - mattress pressure interface, flexion, knee angular position

Brief 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).

Interventions

OTHERKnee flexion measurement 1

The angle of knee flexion during resting, supine position is measured by a first person.

OTHERKnee flexion measurement 2

The angle of knee flexion during resting, supine position is measured by a second person.

OTHERHeel - 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.

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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

MeasureTime frameDescription
Concordance for skin marks for knee flexion angles between 2 operators for 30 knees.Day 0relaxed, decubitus dorsal position
Intra-operator concordance for skin marks used for measuring knee flexion angle for 30 kneesDay 1Relaxed decubitus dorsal position
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 mmHgDay 0
Concordance for measurements 1 & 2 for knee flexion angle in a relaxed supine position (via photos)Day 0

Other

MeasureTime frame
AgeDay 0
SexDay 0
Weight (kg)Day 0
Height (cm)Day 0
Braden risk scaleDay 0

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026