Laboratory and clinical tests of a prototype pressure sensor for clincial assessment of prosthetic socket fit.

Lower limb prosthetic socket fabrication is a highly refined process relying on the prosthetist's skill and experience. Despite their best efforts, patients often return with complications. Additionally, clinical application of technological advances for the quantification of biomechanical factors at the socket interface has not changed in practice. Measuring pressure levels at the stump/socket interface could provide valuable information in the process of prosthetic socket fabrication, fit and modification. This paper presents findings on the performance of a prototype capacitance pressure sensor designed for prosthetic socket use. Bench tests using compressed air were performed to measure accuracy, hysteresis and drift responses in both a flatbed chamber and a custom-modified pressure vessel. For the contoured testing, the sensors were placed on nine sites on a positive trans-tibial stump mould and enveloped with a silicone liner. Additionally, a preliminary clinical evaluation was performed with two trans-tibial amputee subjects at the nine sites during normal ambulation. Bench test results showed that the prototype capacitance sensor performed well in all categories, exhibiting a 2.42% (flatbed) and 9.96% (contoured) accuracy error, a 12.93% (flatbed) and 12.95% (contoured) hysteresis error, and a 4.40% (flatbed) and 6.20% (contoured) drift error. The clinical study showed that after three hours of continual use, no noticeable sensor drift occurred between pre and post-test calibration values. The results from this study were encouraging and the authors hope to conduct further laboratory and clinical trials to assess the influence of shear force and dynamic loading on sensor response.

Establishing predictive indicators for the status of loaded soft tissues.

Two complementary techniques were employed to assess the soft tissue response to applied pressure. The noninvasive methods involve the simultaneous measurement of the local tensions of oxygen and carbon dioxide (tcPO2 and tcPCO2) and the collection and subsequent analysis of sweat collected from the sacrum, a common site for the development of pressure sores. All tests were performed on able-bodied subjects. Results have indicated that oxygen levels (tcPO2) were lowered in soft tissues subjected to applied pressures of between 40 (5.3 kPa) and 120 mmHg (16.0 kPa). At the higher pressures, this decrease was generally associated with an increase in carbon dioxide levels (tcPCO2) well above the normal basal levels of 45 mmHg (6 kPa). There were also considerable increases, in some cases up to twofold, in the concentrations of both sweat lactate and urea at the loaded site compared with the unloaded control. By comparing selected parameters, a threshold value for loaded tcPO2 was identified, representing a reduction of ~60% from unloaded values. Above this threshold, there was a significant relationship between this parameter and the loaded/unloaded concentration ratios for both sweat metabolites. These parameters may prove useful in identifying those subjects whose soft tissue may be compromised during periods of pressure ischemia.

Scientific validation of two commercial pressure sensor systems for prosthetic socket fit.

The concept of measuring pressure at the interface between the stump and the prosthetic socket could provide valuable information in the process of prosthetic socket fabrication, modification, and fit. Two systems, the Rincoe Socket Fitting System (SFS) and Tekscan's F-Socket Pressure Measurement System, have been commercially designed for in situ interface pressure measurement over the past decade. Their use is not common in prosthetic practice, perhaps due to questions of cost effectiveness and the difficulties of interpreting the data. Another concern is the use of sensors for pressure measurements in areas of high contour and complex geometries such as the stump. Before these systems can be used in a clinical setting, it is necessary to determine the reliability and accuracy of each system. In order to assess the clinical validity of the Rincoe SFS and F-Socket systems, a series of trials was conducted to evaluate different aspects of sensor performance, namely; accuracy, hysteresis, drift and the effect of curvature. The sensors were subjected to tests in flatbed and custom-designed pressure vessels. Overall results indicated an accuracy error for the Rincoe SFS system of 25% (flatbed) and 33% (mould), with a corresponding 15% (flatbed) and 23% (mould) error in hysteresis, and 7% (flatbed) and 11% (mould) drift errors. The F-Socket system demonstrated an 8% (flatbed) and 11% (mould) accuracy errors, 42% (flatbed) and 24% (mould) hysteresis errors, and 12% (flatbed) and 33% (mould) drift errors. These findings indicate favourable results for the F-Socket Pressure Measurement System compared to the Rincoe Socket Fitting System with respect to its accuracy errors only. Nevertheless, it is the authors' belief that these systems are adequate in indicating areas of high pressure at the stump socket interface for clinical purposes, but both systems should be used with caution.

The analysis of metabolites in human sweat: analytical methods and potential application to investigation of pressure ischaemia of soft tissues.

A straightforward technique was developed for sweat collection applicable to tissues subjected to external load without introducing distortion of underlying tissues, and for analysis of six metabolites in the collected sweat. Chloride was measured colorimetrically and lactate, urea and urate by enzymatic methods on a centrifugal analyser. Sodium and potassium were measured by flame photometry. The methods showed good precision, recovery and linearity. To assess the technique sweat was collected: (i) from the sacrum, ischium, forearm and calf in healthy individuals at 32 degrees C for 1 h; (ii) from the sacrum of healthy subjects at ambient temperature for 9 h; (iii) at ambient temperature from the sacrum of a patient with a history of pressure sores. Sweat rates were greater at the sacrum and ischium than the calf or forearm. There were differences in the concentrations of lactate and urea between sites but these were smaller when expressed as amount secreted. Sweat rates were significantly lower in groups (ii) and (iii), but sweat could be collected reliably. This technique has potential clinical application to the investigation of susceptibility to pressure sores.