Clinical trial NCT01976897: Effect of the Physiological Angular Position of the Resting Knee on Pressure at the Heel/Surface Interface
Official title: Effect of the Physiological Angular Position of the Resting Knee on Pressure at the Heel/Surface Interface
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adult, Hospitalized
Keywords: heel - mattress pressure interface
flexion
knee angular position
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2013-11-06
Enrollment: 65
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consists of consecutive patients admitted in the functional rehabilitation unit of the Nîmes University Hospital.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Measurement 1: Measurement of the knee joint angle (degrees °) in a physiological relaxed position (supine)(via photos of first skin marks).
timeFrame: Day 0
measure: Measurement 2: Measurement of the knee joint angle (degrees °) in a physiological relaxed position (supine)(via photos of first skin marks)
timeFrame: Day 0
measure: Maximum pressure on the heel area (Ptal)
timeFrame: Day 0
Secondary outcomes:
measure: Mean pressure over the entire heel area (P mean)
timeFrame: Day 0
measure: Measurement of the contact surface of the heel zone (Stal) having a pressure greater than 60 mmHg
timeFrame: Day 0
measure: Concordance for measurements 1 & 2 for knee flexion angle in a relaxed supine position (via photos)
timeFrame: Day 0
measure: Concordance for skin marks for knee flexion angles between 2 operators for 30 knees.
timeFrame: Day 0
measure: Intra-operator concordance for skin marks used for measuring knee flexion angle for 30 knees
timeFrame: Day 1
Other outcomes:
measure: Age
timeFrame: Day 0
measure: Sex
timeFrame: Day 0
measure: Weight (kg)
timeFrame: Day 0
measure: Height (cm)
timeFrame: Day 0
measure: Braden risk scale
timeFrame: Day 0
Locations:
city: Nîmes Cedex 9
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Emilie Viollet, MD
role: PRINCIPAL_INVESTIGATOR
References: