Categorization and recommendations for outcome measures for lower limb absence by an expert panel.

BACKGROUND: Understanding the psychometric strengths and limitations of outcome measures for use with people with lower limb absence (LLA) is important for selecting measures suited to evaluating patient outcomes, answering clinical and research questions, and informing health care policy. The aim of this project was to review the current psychometric evidence on outcome measures in people with LLA to determine which measures should be included in a stakeholder consensus process. METHODS: An expert panel was assembled, and a 3-stage review process was used to categorize outcome measures identified in a systematic literature review into 3 distinct categories (recommended for measures with better than adequate psychometric properties; recommended with qualification; and unable to recommend). Panelists were asked to individually categorize measures based on results of a systematic review of identified measures' psychometric properties. Each measure's final categorization was based on ≥70% agreement by all panelists. RESULTS: No outcome measure attained the ≥70% consensus threshold needed to achieve a rating of "recommend." Hence, panelists suggested combining "recommend" and "recommend with qualifications" into a single category of "recommend with qualifications." Using this approach, consensus was reached for 59 of 60 measures. Consensus could not be reached on 1 outcome measure (socket comfort score). Thirty-six outcome measures were categorized as "unable to recommend" based on available evidence; however, 23 (12 patient-reported measures and 11 performance-based measures) demonstrated adequate psychometric properties in LLA samples and were thus rated as "recommend with qualification" by the expert panel. The panel of experts were able to recommend 23 measures for inclusion in the subsequent stakeholder review. A key strength of this process was bringing together international researchers with extensive experience in developing and/or using LLA outcome measures who could assist in identifying psychometrically sound measures to include in a subsequent stakeholder consensus process. CONCLUSION: The above categorizations represent the current state of psychometric evidence on outcome measures for people with LLA and hence may change over time as additional research becomes available. The results will be used to achieve wider consensus from clinicians, health policymakers, health clinic managers, researchers, and end users (i.e., individuals with LLA) on outcome measures for the International Society of Prosthetics and Orthotics lower limb Consensus Outcome Measures for Prosthetic and Amputation ServiceS.

Enabling Technology for Remote Prosthetic Alignment Tuning.

INTRODUCTION: This research has resulted in a system of sensors and software for effectively adjusting prosthetic alignment with digital numeric control. We called this suite of technologies the Prosthesis Smart Alignment Tool (ProSAT) system. MATERIALS AND METHODS: The ProSAT system has three components: a prosthesis-embedded sensor, an alignment tool, and an Internet-connected alignment expert system application that utilizes machine learning to analyze prosthetic alignment. All components communicate via Bluetooth. Together, they provide for numerically controlled prosthesis alignment adjustment. The ProSAT components help diagnose and guide the correction of very subtle, difficult-to-see imbalances in dynamic gait. The sensor has been cross-validated against kinetic measurement in a gait laboratory, and bench testing was performed to validate the performance of the tool while adjusting a prosthetic socket based on machine learning analyses from the software application. RESULTS: The three-dimensional alignment of the prosthetic socket was measured pre- and postadjustment from two fiducial points marked on the anterior surface of the prosthetic socket. A coordinate measuring machine was used to derive an alignment angular offset from vertical for both conditions: pre- and postalignment conditions. Of interest is the difference in the angles between conditions. The ProSAT tool is only controlling the relative change made to the alignment, not an absolute position or orientation.Target alignments were calculated by the machine learning algorithm in the ProSAT software, based on input of kinetic data samples representing the precondition and where a real prosthetic misalignment condition was known a priori. Detected misalignments were converted by the software to a corrective adjustment in the prosthesis alignment being tested. We demonstrated that a user could successfully and quickly achieve target postalignment change within an average of 0.1°. CONCLUSIONS: The accuracy of a prototype ProSAT system has been validated for controlled alignment changes by a prosthetist. Refinement of the ergonomic form and technical function of the hardware and clinical usability of the mobile software application are currently being completed with benchtop experiments in advance of further human subject testing of alignment efficiency, accuracy, and user experience.

Gait analysis of low-cost flexible-shank transtibial prostheses.

The latest lower-limb prosthetic designs have been incorporated with dynamic elastic response (DER) components to enhance prosthesis flexibility, which are suggested to be beneficial to gait. Although DER prosthetic. feet are preferred by most transtibial amputees and their benefits to gait are supported by some biomechanical studies, many are still utilizing the simple conventional solid ankle cushioned heel (SACH) designs because of the lower cost. The monolimb, a transtibial prosthesis with the socket and the shank molded from a single piece of thermoplastic material, perhaps is an alternative to DER feet for providing flexibility at the shank. In addition to shank flexibility, low cost and light weight are other characteristics of monolimbs. In spite of the potential benefits, little analysis has been done to examine the simple-structured monolimb prosthesis. The main aim of this study is to evaluate the gait and perception of unilateral transtibial amputees using a flexible elliptical-shank monolimb as compared to a thicker circular-shank monolimb and a conventional rigid-shank prosthesis. Results suggested that a properly designed monolimb may potentially offer similar functional advantages to the relatively expensive DER feet.

Socket reaction moments in transtibial prostheses during walking at clinically perceived optimal alignment.

BACKGROUND AND AIM: The socket reaction moments are directly measured at the base of a socket and may be useful for fitting a prosthesis. Previous studies have focused on the effect of prosthetic alignment changes on them. The aim of this study was to explore their range at clinically perceived optimal alignment by investigating the individual differences. TECHNIQUE: In total, 11 amputees using unilateral transtibial prostheses with solid-ankle-cushion-heel (SACH) feet were recruited. The socket reaction moments were measured using a custom instrumented prosthesis alignment component and plotted. Eight variables that were related to their magnitude (N m/kg) and timing (% stance of event) as well as cadence (steps/minute) were calculated for each amputee. Their mean, standard deviation, maximum value, minimum value, and range were subsequently analyzed. DISCUSSION: This study may serve as a foundation to explore the range of individual differences in socket reaction moments in transtibial prostheses. CLINICAL RELEVANCE: Socket reaction moments can be conveniently measured in the clinical setting. Prosthetists could potentially use them as one of the criteria to align prosthesis in addition to observational gait analysis and amputees perception.

Functional level assessment of individuals with transtibial limb loss: Evaluation in the clinical setting versus objective community ambulatory activity.

The functional level (K level) of prosthetic users is used to choose appropriate prosthetic components, but ratings may highly subjective. A more objective and robust method to determine K level may be appealing. The aim of this study was to determine the relationship between K level determined in the clinic to K level based on real world ambulatory activity data collected by StepWatch. Twelve individuals with transtibial limb loss gave informed consent to participate. K level assessments performed in the clinic by a single treating prosthetist were compared with a calculated estimate based on seven days of real world ambulatory activity patterns using linear regression. There was good agreement between the two methods of determining K level with R 2 = 0.775 (p < 0.001). The calculated estimate of K level based on actual ambulatory activity in real world settings appears to be similar to the treating prosthetist's assessment of K level based on gait observation and patient responses in the clinic. Clinic-based ambulatory capacity in transtibial prosthetic users appears to correlate with real world ambulatory behavior in this small cohort. Determining functional level based on real world ambulatory activity may supplement clinic-based tests of functional capacity.

Comparison of a computerized algorithm and prosthetists' judgment in rating functional levels based on daily step activity in transtibial amputees.

The Medicare Functional Classification Levels: "K-Level" system is a standard scale for functional levels of amputees. But it is problematic to document objectively and reliably. The K-Levels are based on three characteristics: potential to ambulate, cadence variability and energy level of the amputees. Actual mobility patterns of transtibial amputees recorded by a step activity monitor (StepWatch™) were translated using a computerized algorithm to match the three K-Level characteristics: the most active one minute, the ratio of low:medium:high step rates, and the total daily steps, respectively. This study compared prosthetists' ratings of functional levels based on a visual inspection of step activity patterns with the ratings calculated by the computerized algorithm based on the same step activity data in 81 transtibial amputees. The computerized algorithm produced functional level values that closely matched the average of the ratings by 14 experienced prosthetists. The slope of the linear regression line was 1.04 with an R 2 value of 0.829, indicating good linearity and concordance across the range of the two scales. The results of this study demonstrated concurrent validity of the computerized algorithm and suggested that it could potentially serve as a useful tool in rating functional levels of transtibial amputees based on real-world step activities and complement a clinic-based test.

Dynamic alignment of transtibial prostheses through visualization of socket reaction moments.

BACKGROUND AND AIM: Dynamic alignment of transtibial prostheses is generally performed based on visual interpretation of gait without the benefit of any kinetic analysis in the clinic. The aim of this technical note was to present and discuss the possibilities of assisting dynamic alignment of transtibial prostheses through visualization of socket reaction moments. TECHNIQUE: Smart Pyramid™ (currently Europa™) was used to measure the socket reaction moments under various alignment conditions from an amputee with transtibial prosthesis. The socket reaction moments were plotted to visualize the effect of alignment changes on them, and they were clinically interpreted. DISCUSSION: Socket reaction moments could complement information available to prosthetists to optimize prosthetic alignment. They could be used to reduce excessive loading on sensitive areas, to improve gait stability, or to communicate the outcome of dynamic alignment with the amputees. Further research is needed to identify the contribution of kinematics and kinetics for optimal alignment. CLINICAL RELEVANCE: Dynamic alignment of transtibial prostheses is currently tuned subjectively based on prosthetists' experiences and skills. Socket reaction moments may potentially provide objective information for prosthetists to align transtibial prostheses in the clinic.

Microprocessor-based ambulatory activity monitoring in stroke patients.

PURPOSE: Recovery of ambulatory function after stroke is routinely assessed using standardized subject- or observer-rated instruments that do not directly measure ambulatory activities in the home-community setting. Accuracy of conventional pedometers in stroke patients is not established, limiting their application in mobility outcomes monitoring. This study investigates the accuracy and reliability of a mechanical pedometer versus microprocessor-based step activity monitoring (SAM) in gait-impaired hemiparetic stroke patients. METHODS: Accuracy and test-retest reliability of ankle-worn SAM and belt-worn pedometer were tested directly against hand tallied stride counts and cadence during a battery of timed walks in 16 chronic hemiparetic stroke patients. Patients performed replicate 1-min floor walks at self-selected and fastest comfortable paces, and two 6-min walks on separate days. RESULTS: SAM cadence and total stride counts are more accurate than pedometers during 1-min walks at self-selected (99 +/- 1 vs 87 +/- 11.3%, mean +/- SD, P < 0.01); fast pace (98 +/- 2.3% vs 85 +/- 15%, P < 0.01); and repeated 6-min walks performed on separate days (99 +/- 1% vs 89 +/- 12%, P < 0.01). Although SAM is highly reliable (r = 0.97, P < 0.0001) and accurate in all patients under every walking condition tested, the mechanical pedometer demonstrates this high level of accuracy in only half of stroke patients and has poor test-retest reliability (r = 0.64, P < 0.05). CONCLUSION: SAM, but not the conventional pedometer, provides accurate and reliable measures of cadence and total stride counts in hemiparetic stroke patients. Portable microprocessor-based gait monitoring offers potential to quantitatively measure home-community-based ambulatory activity levels in this population.

Individual responses to alignment perturbations in socket reaction moments while walking in transtibial prostheses.

BACKGROUND: The alignment of transtibial prostheses has a systematic effect on the mean socket reaction moments in amputees. However, understanding their individual differences in response to alignment perturbations is also important for prosthetists to fully utilize the socket reaction moments for dynamic alignment in each unique patient. The aim of this study was to investigate individual responses to alignment perturbations in transtibial prostheses with solid-ankle-cushion-heel feet. METHODS: A custom instrumented prosthesis alignment component was used to measure the socket reaction moments while walking in 11 amputees with transtibial prostheses under 17 alignment conditions, including 3° and 6° of flexion, extension, abduction, and adduction of the socket, 5mm and 10mm of anterior, posterior, lateral, and medial translation of the socket, and an initial baseline alignment. Coronal moments at 30% of stance and maximum sagittal moments were extracted for comparisons from each amputee. FINDINGS: In the coronal plane, varus moment at 30% of stance was generally reduced by adduction or medial translation of the socket in all the amputees. In the sagittal plane, extension moment was generally increased by posterior translation or flexion of the socket; however, this was not necessarily the case for all the amputees. INTERPRETATIONS: Individual responses to alignment perturbations are not always consistent, and prosthetists would need to be aware of this variance when addressing individual socket reaction moments during dynamic alignment in clinical setting.

Effect of alignment changes on socket reaction moments while walking in transtibial prostheses with energy storage and return feet.

BACKGROUND: Energy storage and return feet are designed for active amputees. However, little is known about the socket reaction moments in transtibial prostheses with energy storage and return feet. The aim of this study was to investigate the effect of alignment changes on the socket reaction moments during gait while using the energy storage and return feet. METHODS: A Smart Pyramid™ was used to measure the socket reaction moments in 10 subjects with transtibial prostheses while walking under 25 alignment conditions, including a nominal alignment (as defined by conventional clinical methods), as well as angle malalignments of 2°, 4° and 6° (flexion, extension, abduction, and adduction) and translation malalignments of 5mm, 10mm and 15mm (anterior, posterior, lateral, and medial) referenced from the nominal alignment. The socket reaction moments of the nominal alignment were compared with each malalignment. FINDINGS: Both coronal and sagittal alignment changes demonstrated systematic effects on the socket reaction moments. In the sagittal plane, angle and translation alignment changes demonstrated significant differences (P<0.05) in the minimum moment, the moment at 45% of stance and the maximum moment for some comparisons. In the coronal plane, angle and translation alignment changes demonstrated significant differences (P<0.05) in the moment at 30% and 75% of stance for all comparisons. INTERPRETATION: The alignment may have systematic effects on the socket reaction moments in transtibial prostheses with energy storage and return feet. The socket reaction moments could potentially be a useful biomechanical parameter to evaluate the alignment of the transtibial prostheses.

Effect of prosthetic alignment changes on socket reaction moment impulse during walking in transtibial amputees.

The alignment of a lower limb prosthesis affects the way load is transferred to the residual limb through the socket, and this load is critically important for the comfort and function of the prosthesis. Both magnitude and duration of the moment are important factors that may affect the residual limb health. Moment impulse is a well-accepted measurement that incorporates both factors via moment-time integrals. The aim of this study was to investigate the effect of alignment changes on the socket reaction moment impulse in transtibial prostheses. Ten amputees with transtibial prostheses participated in this study. The socket reaction moment impulse was measured at a self-selected walking speed using a Smart Pyramid in 25 alignment conditions, including a nominal alignment (clinically aligned by a prosthetist), as well as angle malalignments of 2°, 4° and 6° (abduction, adduction, extension and flexion) and translation malalignments of 5 mm, 10 mm and 15 mm (lateral, medial, anterior and posterior). The socket reaction moment impulse of the nominal alignment was compared for each condition. The relationship between the alignment and the socket reaction moment impulse was clearly observed in the coronal angle, coronal translation and sagittal translation alignment changes. However, this relationship was not evident in the sagittal angle alignment changes. The results of this study suggested that the socket reaction moment impulse could potentially serve as a valuable parameter to assist the alignment tuning process for transtibial prostheses. Further study is needed to investigate the influence of the socket reaction moment impulse on the residual limb health.

Effect of alignment changes on sagittal and coronal socket reaction moment interactions in transtibial prostheses.

Alignment is important for comfortable and stable gait of lower-limb prosthesis users. The magnitude of socket reaction moments in the multiple planes acting simultaneously upon the residual limb may be related to perception of comfort in individuals using prostheses through socket interface pressures. The aim of this study was to investigate the effect of prosthetic alignment changes on sagittal and coronal socket reaction moment interactions (moment-moment curves) and to characterize the curves in 11 individuals with transtibial amputation using novel moment-moment interaction parameters measured by plotting sagittal socket reaction moments versus coronal ones under various alignment conditions. A custom instrumented prosthesis alignment component was used to measure socket reaction moments during walking. Prosthetic alignment was tuned to a nominally aligned condition by a prosthetist, and from this position, angular (3° and 6° of flexion, extension, abduction or adduction of the socket) and translational (5mm and 10mm of anterior, posterior, medial or lateral translation of the socket) alignment changes were performed in either the sagittal or the coronal plane in a randomized manner. A total of 17 alignment conditions were tested. Coronal angulation and translation alignment changes demonstrated similar consistent changes in the moment-moment curves. Sagittal alignment changes demonstrated more complex changes compared to the coronal alignment changes. Effect of sagittal angulations and translations on the moment-moment curves was different during 2nd rocker (mid-stance) with extension malalignment appearing to cause medio-lateral instability. Presentation of coronal and sagittal socket reaction moment interactions may provide useful visual information for prosthetists to understand the biomechanical effects of malalignment of transtibial prostheses.

Effect of alignment changes on socket reaction moments during gait in transfemoral and knee-disarticulation prostheses: case series.

The alignment of a lower-limb prosthesis is critical to the successful prosthetic fitting and utilization by the wearer. Loads generated by the socket applied to the residual limb while walking are thought to be different in transfemoral and knee-disarticulation prostheses. The aim of this case series was to compare the socket reaction moments between transfemoral and knee-disarticulation prostheses and to investigate the effect of alignment changes on them. Two amputees, one with a transfemoral prosthesis and another with a knee-disarticulation prosthesis, participated in this study. A Smart Pyramid™ was used to measure socket reaction moments while walking under 9 selected alignment conditions; including nominally aligned, angle malalignments of 6° (flexion, extension, abduction and adduction) and translation malalignments of 15 mm (anterior, posterior, medial and lateral) of the socket relative to the foot. This study found that the pattern of the socket reaction moments was similar between transfemoral and knee-disarticulation prostheses. An extension moment in the sagittal plane and a varus moment in the coronal plane were dominant during stance under the nominally aligned condition. This study also demonstrated that alignment changes might have consistent effects on the socket reaction moments in transfemoral and knee-disarticulation prostheses. Extension and posterior translation of the socket resulted in increases in an extension moment, while abduction and lateral translation of the socket resulted in increases in a varus moment. The socket reaction moments may potentially serve as useful biomechanical parameters to evaluate alignment in transfemoral and knee-disarticulation prostheses.

Influence of malalignment on socket reaction moments during gait in amputees with transtibial prostheses.

Alignment - the process and measured orientation of the prosthetic socket relative to the foot - is important for proper function of a transtibial prosthesis. Prosthetic alignment is performed by prosthetists using visual gait observation and amputees' feedback. The aim of this study was to investigate the effect of transtibial prosthesis malalignment on the moments measured at the base of the socket: the socket reaction moments. Eleven subjects with transtibial amputation were recruited from the community. An instrumented prosthesis alignment component was used to measure socket reaction moments during ambulation under 17 alignment conditions, including nominally aligned using conventional clinical methods, and angle perturbations of 3° and 6° (flexion, extension, abduction, and adduction) and translation perturbations of 5mm and 10mm (anterior, posterior, lateral, and medial) referenced from the nominal alignment. Coronal alignment perturbations caused systematic changes in the coronal socket reaction moments. All angle and translation perturbations revealed statistically significant differences on coronal socket reaction moments compared to the nominal alignment at 30% and 75% of stance phase (P<0.05). The effect of sagittal alignment perturbations on sagittal socket reaction moments was not as responsive as that of the coronal perturbations. The sagittal angle and translation perturbations of the socket led to statistically significant changes in minimum moment, maximum moment, and moments at 45% of stance phase in the sagittal plane. Therefore, malalignment affected the socket reaction moments in amputees with transtibial prostheses.

Effect of transtibial prosthesis alignment changes on out-of-plane socket reaction moments during walking in amputees.

Alignment of lower limb prostheses is important for the gait of amputees. Observed deviations in a particular plane are corrected by altering the prosthetic alignment of the same plane. The assumption is that observed deviations are due to alignment errors within the same plane, but no research has confirmed this assumption. Therefore, the aim of this study was to investigate the out-of-plane effect of systematic alignment changes on socket reaction moments measured by an instrumented prosthesis alignment component in the sagittal and coronal planes in eleven amputees with transtibial prostheses. Each subject walked at self-selected walking speed following randomized controlled angular (±3° and ±6°) and translational (±5 mm and ±10 mm) alignment changes from the nominally aligned condition. The following socket reaction moment parameters were subsequently analyzed: 3 parameters (maximum moment, minimum moment, moment at 45% of stance phase) in the sagittal plane and 2 parameters (moment at 30% and 75% of stance phase) in the coronal plane. A statistical comparison was performed between the nominally aligned and mal-aligned conditions using a repeated measures of ANOVA followed by Scheffe's post-hoc tests. Significant differences were found between the nominally aligned (-0.077±0.078 Nm/kg) and 3° extension (-0.033±0.075 Nm/kg; P=0.0258) and 6° extension (-0.029±0.071 Nm/kg; P=0.0098) conditions in the coronal plane socket reaction moments measured at 30% of stance. Our analysis suggests that the alignment of the transtibial prosthesis should be performed in the sagittal plane first followed by the coronal plane.

Perception of socket alignment perturbations in amputees with transtibial prostheses.

A person with amputation's subjective perception is the only tool available to describe fit and comfort to a prosthetist. However, few studies have investigated the effect of alignment on this perception. The aim of this article is to determine whether people with amputation could perceive the alignment perturbations of their prostheses and effectively communicate them. A randomized controlled perturbation of angular (3 and 6 degrees) and translational (5 and 10 mm) alignments in the sagittal (flexion, extension, and anterior and posterior translations) and coronal (abduction, adduction, and medial and lateral translations) planes were induced from an aligned condition in 11 subjects with transtibial prostheses. The perception was evaluated when standing (static) and immediately after walking (dynamic) using software that used a visual analog scale under each alignment condition. In the coronal plane, Friedman test demonstrated general statistical differences in static (p < 0.001) and dynamic (p < 0.001) measures of perceptions with angular perturbations. In the sagittal plane, it also demonstrated general statistical differences in late-stance dynamic measures of perceptions (p < 0.001) with angular perturbations, as well as in early-stance dynamic measures of perceptions (p < 0.05) with translational perturbations. Fisher exact test suggested that people with amputation's perceptions were good indicators for coronal angle malalignments but less reliable when defining other alignment conditions.

Finite-element analysis to determine effect of monolimb flexibility on structural strength and interaction between residual limb and prosthetic socket.

Monolimb refers to a kind of transtibial prostheses having the socket and shank molded into one piece of thermoplastic material. One of its characteristics is that the shank is made of a material that can deform during walking, which can simulate ankle joint motion to some extent. Changes in shank geometry can alter the stress distribution within the monolimb and at the residual limb-socket interface and, respectively, affect the deformability and structural integrity of the prosthesis and comfort perceived by amputees. This paper describes the development of a finite-element model for the study of the structural behavior of monolimbs with different shank designs and the interaction between the limb and socket during walking. The von Mises stress distributions in monolimbs with different shank designs at different walking phases are reported. With the use of distortion energy theory, possible failure was predicted. The effect of the stiffness of the monolimb shanks on the stress distribution at the limb-socket interface was studied. The results show a trend--the peak stress applied to the limb was lowered as the shank stiffness decreased. This information is useful for future monolimb optimization.

Ambulatory activity in men with diabetes: relationship between self-reported and real-world performance-based measures.

The measurement of physical activity, especially walking activity, is important for many outcome studies. In many investigations, the Physical Activity scale of the short-form-36 (SF-36) health assessment questionnaire is used in lieu of an actual physical measurement of walking. This study determined the relationship between the SF-36 questionnaire and the Step Activity Monitor (SAM), a real-world performance-based tool that counts the actual number of steps taken during daily activities. We studied the physical activity of 57 men with diabetes using step count monitoring and the SF-36 questionnaire. The subjects averaged 3,293 steps/day, but had a very wide range (111-11,654) and a large standard deviation (SD = 2,037). The correlations between total daily steps and the SF-36 Physical Component Summary score, and the Physical Function, Bodily Pain, and Vitality scales of the SF-36 were only fair (Pearson's r = 0.376, 0.488, 0.332, 0.380, respectively). The corresponding coefficients of determination range from only 7.7% to 23.8%. Physical activity is a complex concept not completely represented by either the SF-36 or the step counts. The correlation between actual walking activity and the SF-36 is not as strong as many researchers believe. Caution should be exercised with the use of the SF-36 to specifically measure walking activity.

Quantification of prosthetic outcomes: elastomeric gel liner with locking pin suspension versus polyethylene foam liner with neoprene sleeve suspension.

For this randomized crossover trial, we compared two common transtibial socket suspension systems: the Alpha liner with distal locking pin and the Pe-Lite liner with neoprene suspension sleeve. Our original hypotheses asserted that increased ambulatory activity, wear time, comfort, and satisfaction would be found with the elastomeric suspension system. Thirteen subjects completed the study. Following 2.5-month accommodation to each condition, ambulatory activity was recorded (steps/minute for 2 weeks), and subjects completed three questionnaires specific to prosthesis use and pain: the Prosthesis Evaluation Questionnaire (PEQ), a Brief Pain Inventory (BPI) excerpt, and the Socket Comfort Score (SCS). Upon completion, subjects selected their favored system for continued use. Ten subjects preferred the Pe-Lite and three the Alpha. Subjects spent 82% more time wearing the Pe-Lite and took 83% more steps per day. Ambulatory intensity distribution did not differ between systems. No statistically significant differences were found in questionnaire results. Subject feedback for each system was both positive and negative.