Effect of the Physiological Angular Position of the Resting Knee on Pressure at the Heel/Surface Interface
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- Measurement 1: Measurement of the knee joint angle (degrees °) in a physiological relaxed position (supine)(via photos of first skin marks).
Study Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Measurement 1: Measurement of the knee joint angle (degrees °) in a physiological relaxed position (supine)(via photos of first skin marks).
Time Frame: Day 0
Measurement 2: Measurement of the knee joint angle (degrees °) in a physiological relaxed position (supine)(via photos of first skin marks)
Time Frame: Day 0
Maximum pressure on the heel area (Ptal)
Time Frame: Day 0
Secondary Outcomes
- 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)