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Perometer (400T) measurement of lower limb volume: development of a standardised protocol Fiona Coutts, Andrew Grainger, Dr Cathy Bulley Queen Margaret University, Edinburgh, UK Background • Various musculoskeletal, oncological or vascular conditions result in increased limb volume • Limb volume – outcome measures Fluid displacement Geometric calculations from limb circumferences using tape measure Perometer – optoelectronic imaging device; limb shape and volume (Pero-System GmbH, Wuppertal, Germany) Purpose • True repeatable measurement important in monitoring treatment efficacy. • Perometer (400T) optoelectronic imaging device used to assess limb volume. No protocol has been published to standardise its use. Study Design Rest Period (A) Phase 1 Diurnal Variation (A) Foot position on base plate (B) Leg position (Rotation) (B) Phase 2 Speed of frame Movement (C) Standardised protocol End point of limb measurement (C) Use of software (D) Phase 3 Phase 1A: Diurnal Variation • Issue: Does limb volume change through a day? • Results: Volumes averaged and % differences to initial volume were calculated. <2% volume change for each participant. • Design: n=2, healthy participants. 3 volume measurements @ 3 times per day, between 09.00 and 18.00. Tester Morning – Afternoon Morning – Evening 1 2 1.1% 1.6% 1.8% 1.2% Phase 1B: Foot position • Issue: Does the position of the limb on the base plate alter measurement data? • Results: Four centre squares (A,B,C,D) demonstrated the highest repeatability of measurement. Corner squares (1,2,3,4) lowest repeatability. • Design: Cylinder placed in each of the 16 squares marked on the base plate, measured 3 times. 1 4 2 A B D C 3 Phase 1C: End point of limb measurement • Issue: Standardised landmarks for measurement of volume? • Design: n=4, frame advanced to comfortable maximum vertical height, leg marked. Calculated as % of length Position 1 to 2 (see below) • Results: % leg length= 67.6, 69, 79.1, 81.7; 65% of leg length was max. height for vertical frame advancement Grt Trochanter (1) 65% Femur Lat Femoral Epicondyle (2) Lateral Malleolus Standardised Protocol 1 • Diurnal variation: keep standardised times for repeat visits • Foot position: maintain foot in the centre of the base plate at all times • End point of measurement: 65% of distance from lateral femoral Epicondyle to Greater Trochanter Repeatability after phase1 • n= 30 (22F: 8M) (25.9±3.48yrs, 171.02±6.77cm, 67.32±7.68Kg) Dominant leg – tested 9 times by a rater on 2 consecutive occasions ICC (p<0.001) 95% CI 0.99 0.996-0.999 Upper LOA 185.18 ml Lower LOA -193.81 ml Range % variation 378.99ml 4.07% LOA= Limits of Agreement (Bland & Altman, 1986) Concerns after phase 1 • Rest period prior to commencement of measurement • Axial rotation of the limb in the frame • Speed of Perometer frame movement = Phase 2 Phase 2A: Rest Period • Issue: Stasis of limb volume prior to assessment with perometer • Results: Volume change variable until 10 minutes of rest. After 10 mins. less variable. • Design: Pre and post rest limb volume at : 2.5, 5,10,12.5,15 mins., n=2 healthy participants % Difference from pre rest Participant 1 0.02 Participant 2 0.015 0.01 0.005 0 -0.005 2.5 5 10 -0.01 Minutes of rest 12.5 15 Phase 2B: Leg position • Design: Full size mannequin limb positioned 10 increments to internal and external axial rotation (0 - 50°), 3 times. • Issue: Does axial limb rotation cause measurement error? • Results: Mean of 3 tests on 2 occasions shows little variation, CoV <0.1% in all bar 1 position, <1.2% overall MeanCoefficient Volumne inofaxial rotation Variation (%)(mls) 8000 1.4 1.2 6000 1.0 0.8 4000 0.6 0.4 2000 0.2 0.00 50 50 40 40 30 30 20 20 10 10 00 10 10 20 20 Ext. Ext.Rot. Rot. Neutral Neutal Int. Int. Rot. Rot. 3030 40 40 5050 Phase 2C: Speed of frame • Design: mannequin limb measured 30 times Fast speed = 0.37m/s Slow speed = 0.022m/s Controlled by a motor • Issue: Does speed of movement affect Perometer measurement? Mean Perometer measures at Slow and Fast speeds (n=30) 6720 p<0.00001 6715 6710 mls • Results: Significant differences between slow and fast speeds , (p<0.00001) 6725 6705 6700 6695 6690 6685 Motor 1 0.022m/s Speeds 0.37m/s Reliability Intra- & inter-rater reliability, n= 30, 2 raters, 2 occasions Results: Rater 1 Session 1 Session 2 9005.53 8993.10 1504.8 1393.9 (p<0.0001) (p<0.0001) Rater 2 9088.27 1417.1 9102.10 1452.9 (p<0.0001) Phase 3: Use of software • Issue: Software allows limb measurement length to change in two screens • Design: A) reliability study using independent measurement of length B) use of single limb length measures on 2 occasions • Results: Variability A): n=30 B): n=10 Rater 1 = 20% Rater 2 = 16.3% Rater 1= 3.8%, Rater 2 = 5.3% Conclusions Protocol reliable if: 1. 10 min rest period before testing with elevated leg 2. Neutral axial rotation of limb 3. Foot placed in centre of base plate 4. Constant slow speed is maintained 5. Only 1 limb length measurement is taken and used on repeat visits Clinical implications • Use of a standardised protocol will allow reliable data to be collected on repeated basis, • Monitor efficacy of management of patients with changing limb volume. Queen Margaret University Thank You Acknowledgements • MSc pre registration Physiotherapy students: 2007 Francis Burgin Áine O’Connor 2006 Nicola Dinsmore Georgina Enderson MaryAnne Geraghty