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

NCT01976897 | Completed

• 2 other identifiers: LOCAL/2013/EVFN-012013-A01063-42
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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).

Conditions

Adult, Hospitalized

Keywords

heel - mattress pressure interface; flexion; knee angular position

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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

Other Outcomes (5)

• Age

  Day 0

• Sex

  Day 0

• Weight (kg)

  Day 0

Study Arms (1)

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; Other: Knee flexion measurement 2; Other: Heel - interface pressure measurements

Interventions

Knee flexion measurement 1 OTHER

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

The study population

Knee flexion measurement 2 OTHER

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

The study population

Heel - interface pressure measurements OTHER

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.

The study population

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• The patient is participating in another 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 a bed-sore or bandages on his/her heels
• The patient has had a lower-limb amputation

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Study Officials

• Emilie Viollet, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2013
• First Posted: November 6, 2013
• Study Start: March 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: March 26, 2015

Record last verified: 2015-03

Locations

FR (1)