Monitoring in-shoe plantar pressures, temperature, and humidity: reliability and validity of measures from a portable device.

OBJECTIVE: To investigate the reliability and validity of measures obtained from a portable electronic device used to monitor changes in plantar pressure, temperature, and humidity that occur within the shoe during prolonged activity. DESIGN: Descriptive study comparing electronic sensor output with criterion values. SETTINGS: Indoor level walkway for pressure data; uncontrolled, outdoor environment for step count data; enclosed environmental control chamber for humidity and temperature data. PARTICIPANTS: Convenience sample of 4 healthy, sensate subjects. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Correlations between sensor output and criterion measures were determined for pressure and temperature data. The absolute differences between sensor output and criterion values of temperature, humidity, and step count were also determined. RESULTS: Pressure measurements from electronic sensors correlated highly with criterion values (r > or =.82), both before and after prolonged use. Relative humidity sensor output were within 5% of hygrometer values. In-shoe temperature data correlated highly with criterion values (r > or =.99), and differed from known temperatures by.50 degrees +/-.84 degrees C and.96 degrees +/- 1.56 degrees C at the forefoot and heel, respectively. Electronic step counts recorded at the central forefoot were within 1 step of visual step counts. Pressure tracings obtained from the device during different weight-bearing activities revealed qualitatively distinct pressure patterns. CONCLUSION: The device provides valid and reliable measures of in-shoe plantar pressures, temperature, and humidity during prolonged activity.

In-shoe multisensory data acquisition system.

Patients with diabetes and peripheral neuropathy are susceptible to unnoticed trauma on the foot that can cause skin breakdown. We have designed an electronic system in a shoe that monitors temperature, pressure, and humidity, storing the data in a battery-powered device for later uploading to a host computer for data analysis. The pressure sensors are located at the heel, and under three metatarsal heads. Temperature sensors are located under the medial metatarsal head and under the heel. The humidity sensor is located in the toe of the shoe. Correlations of data from pressure sensors with known values were high (r > 0.85), even after extended use. Although data currently are being collected for descriptive purposes, the design potentially can be used to provide feedback to patients.

Accuracy and reliability testing of a portable soft tissue indentor.

We have designed, built, and tested a portable indentor device that allows us to determine force/displacement (F/D) measurements on soft tissue in a clinical or research setting. The indentor system consists of a load cell mounted on a three-dimensional measurement device (Metrecom). The output of the load cell and the Metrecom are recorded and analyzed by software running on a notebook computer. The displacement calibration of the Metrecom gave an average error = 0.005 mm [standard deviation (SD) = 0.062)]. The force calibration of the load cell resulted in an average error = 0.022 N (SD = 0.049) and a linearity of 1.0062 (R2 = 0.9998). The indentor device was tested on six different human soft tissues by two different investigators. The interreliabilities and intrareliabilities were 0.99 [interclass correlation (ICC)] indicating that the results were repeatable by more than one investigator. F/D measurements from indentor testing on two materials were comparable to values measured using an Instron device (5.34 versus. 5.52 N/mm, and 0.98 versus 1.04 N/mm). The device was used to measure the soft tissue characteristics on the plantar surface of the foot of one subject. These data were used to calculate the effective Young's modulus for the tissue using equations derived by Zheng et al. [1] and indicated a wide range of values dependent upon the portion of the F/D curve used. All results indicate data from this portable indentor device are reliable, accurate, and sensitive enough to identify mechanical properties of human tissues.

Optical measurement of isolated canine lung filtration coefficients after alloxan infusion.

In this study, lung filtration coefficient (Kfc) was measured in eight isolated canine lung preparations by using three methods: standard gravimetric (Std), blood-corrected gravimetric (BC), and optical. The lungs were held in zone III conditions and were subjected to an average venous pressure increase of 8.79 +/- 0.93 (mean +/- SD) cmH2O. The permeability of the lungs was increased with an infusion of alloxan (75 mg/kg). The resulting Kfc values (in milliliters . min-1 . cmH2O-1 . 100 g dry lung weight-1) measured by using Std and BC gravimetric techniques before vs. after alloxan infusion were statistically different: Std, 0.527 +/- 0.290 vs. 1. 966 +/- 0.283; BC, 0.313 +/- 0.290 vs. 1.384 +/- 0.290. However, the optical technique did not show any statistical difference between pre- and postinjury with alloxan, 0.280 +/- 0.305 vs. 0.483 +/- 0. 297, respectively. The alloxan injury, quantified by using multiple-indicator techniques, showed an increase in permeability and a corresponding decrease in reflection coefficient for albumin (sigmaf). Because the optical method measures the product of Kfc and sigmaf, this study shows that albumin should not be used as an intravascular optical filtration marker when permeability is elevated. However, the optical technique, along with another means of measuring Kfc (such as BC), can be used to calculate the sigmaf of a tracer (in this study, sigmaf of 0.894 at baseline and 0.348 after injury). Another important finding of this study was that the ratio of baseline-to-injury Kfc values was not statistically different for Std and BC techniques, indicating that the percent contribution of slow blood-volume increases does not change because of injury.

Optical measurement of isolated canine lung filtration coefficients at normal hematocrits.

In this study, lung filtration coefficient (Kfc) values were measured in eight isolated canine lung preparations at normal hematocrit values using three methods: gravimetric, blood-corrected gravimetric, and optical. The lungs were kept in zone 3 conditions and subjected to an average venous pressure increase of 10.24 +/- 0.27 (SE) cmH2O. The resulting Kfc (ml . min-1 . cmH2O-1 . 100 g dry lung wt-1) measured with the gravimetric technique was 0.420 +/- 0.017, which was statistically different from the Kfc measured by the blood-corrected gravimetric method (0.273 +/- 0.018) or the product of the reflection coefficient (sigmaf) and Kfc measured optically (0. 272 +/- 0.018). The optical method involved the use of a Cellco filter cartridge to separate red blood cells from plasma, which allowed measurement of the concentration of the tracer in plasma at normal hematocrits (34 +/- 1.5). The permeability-surface area product was measured using radioactive multiple indicator-dilution methods before, during, and after venous pressure elevations. Results showed that the surface area of the lung did not change significantly during the measurement of Kfc. These studies suggest that sigmafKfc can be measured optically at normal hematocrits, that this measurement is not influenced by blood volume changes that occur during the measurement, and that the optical sigmafKfc agrees with the Kfc obtained via the blood-corrected gravimetric method.

Laser system for measuring small changes in plasma tracer concentrations.

The authors developed a laser-diode system that can be used for on-line optical concentration measurements in physiologic systems. Previous optical systems applied to whole blood have been hampered by artifacts introduced by red blood cells (RBCs). The system introduced here uses a commercially available filter cartridge to separate RBCs from plasma before plasma concentration measurements are made at a single wavelength. The filtering characteristics of the Cellco filter cartridge (#4007-10, German-town, MD) were adequate for use in the on-line measurement system. The response time of the filter cartridge was less than 40 seconds, and the sieving characteristics of the filter for macromolecules were excellent, with filtrate-to-plasma albumin ratios of 0.98 +/- 0.11 for studies in sheep and 0.94 +/- 0.15 for studies in dogs. The 635-nm laser diode system developed was shown to be more sensitive than the spectrophotometer used in previous studies (Klaesner et al., Annals of Biomedical Engineering, 1994; 22, 660-73). The new system was used to measure the product of filtration coefficient (Kfc) and reflection coefficient for albumin (delta f) in an isolated canine lung preparation. The delta fKfc values [mL/(cmH2O.min.100 g dry lung weight)] measured with the laser diode system (0.33 +/- 0.22) compared favorably with the delta fKfc obtained using a spectrophotometer (0.27 +/- 0.20) and with the Kfc obtained using the blood-corrected gravimetric method (0.32 +/- 0.23). Thus, this new optical system was shown to accurately measure plasma concentration changes in whole blood for physiologic levels of Kfc. The same system can be used with different optical tracers and different source wavelengths to make optical plasma concentration measurements for other physiologic applications.

Optical measurements of lung microvascular filtration coefficient using polysulfone fibers.

Lung fluid balance, which is governed by the product of net transvascular pressure difference and lung filtration coefficient, can be altered in pulmonary diseases. A simple measurement of the lung filtration coefficient (Kfc) would be clinically useful and has been examined by several researchers. Current methods of determining Kfc include gravimetric measurement in isolated lungs and lymph node cannulation, neither of which can be extended to human use. Optical measurements of protein concentration changes in venous blood can be combined with pressure measurements to calculate Kfc. Blood, though, contains red corpuscles, which tend to absorb and scatter light, obscuring these optical measurements. In this study, an optical system was developed in which a polysulfone filter cartridge was used to remove red blood cells before the filtrate was passed through a spectrophotometer. Absorbance changes caused by changes in concentration of albumin labeled with Evans Blue were monitored at 620 nm after venous pressure was elevated by about 13 cm H2O. Optical measurements of Kfc averaged 0.401 +/- 0.074 (ml/min cm H2O 100 g DLW) for an isolated canine lung. Optical measurements of Kfc (0.363 +/- 0.120 ml/min cm H2O 100 g DLW) were made for the first time in an intact, closed chest sheep in which pulmonary pressure was altered by inflating a Foley balloon in the left atrium. We conclude that absorbance and scattering artifacts introduced by red blood cells can be eliminated by first filtering the blood through polysulfone fibers. Kfc measurements using the optical method are similar to values obtained by others using gravimetric methods. Finally, we have demonstrated that the technique can be used to estimate Kfc in an intact animal.