Elizabeth G. Halsne

Intuitive Control of a Powered Prosthetic Leg During Ambulation: A Randomized Clinical Trial

IMPORTANCE Some patients with lower leg amputations may be candidates for motorized prosthetic limbs. Optimal control of such devices requires accurate classification of the patients ambulation mode (eg, on level ground or ascending stairs) and natural transitions between different ambulation modes. OBJECTIVE To determine the effect of including electromyographic (EMG) data and historical information from prior gait strides in a real-time control system for a powered prosthetic leg capable of level-ground walking, stair ascent and descent, ramp ascent and descent, and natural transitions between these ambulation modes. DESIGN, SETTING, AND PARTICIPANTS Blinded, randomized crossover clinical trial conducted between August 2012 and November 2013 in a research laboratory at the Rehabilitation Institute of Chicago. Participants were 7 patients with unilateral above-knee (n = 6) or knee-disarticulation (n = 1) amputations. All patients were capable of ambulation within their home and community using a passive prosthesis (ie, one that does not provide external power). INTERVENTIONS Electrodes were placed over 9 residual limb muscles and EMG signals were recorded as patients ambulated and completed 20 circuit trials involving level-ground walking, ramp ascent and descent, and stair ascent and descent. Data were acquired simultaneously from 13 mechanical sensors embedded on the prosthesis. Two real-time pattern recognition algorithms, using either (1) mechanical sensor data alone or (2) mechanical sensor data in combination with EMG data and historical information from earlier in the gait cycle, were evaluated. The order in which patients used each configuration was randomized (1:1 blocked randomization) and double-blinded so patients and experimenters did not know which control configuration was being used. MAIN OUTCOMES AND MEASURES The main outcome of the study was classification error for each real-time control system. Classification error is defined as the percentage of steps incorrectly predicted by the control system. RESULTS Including EMG signals and historical information in the real-time control system resulted in significantly lower classification error (mean, 7.9% [95% CI, 6.1%-9.7%]) across a mean of 683 steps (range, 640-756 steps) compared with using mechanical sensor data only (mean, 14.1% [95% CI, 9.3%-18.9%]) across a mean of 692 steps (range, 631-775 steps), with a mean difference between groups of 6.2% (95% CI, 2.7%-9.7%] (P = .01). CONCLUSIONS AND RELEVANCE In this study of 7 patients with lower limb amputations, inclusion of EMG signals and temporal gait information reduced classification error across ambulation modes and during transitions between ambulation modes. These preliminary findings, if confirmed, have the potential to improve the control of powered leg prostheses.

Unrestricted migration favours virulent pathogens in experimental metapopulations: evolutionary genetics of a rapacious life history

Understanding pathogen infectivity and virulence requires combining insights from epidemiology, ecology, evolution and genetics. Although theoretical work in these fields has identified population structure as important for pathogen life-history evolution, experimental tests are scarce. Here, we explore the impact of population structure on life-history evolution in phage T4, a viral pathogen of Escherichia coli. The host–pathogen system is propagated as a metapopulation in which migration between subpopulations is either spatially restricted or unrestricted. Restricted migration favours pathogens with low infectivity and low virulence. Unrestricted migration favours pathogens that enter and exit their hosts quickly, although they are less productive owing to rapid extirpation of the host population. The rise of such ‘rapacious’ phage produces a ‘tragedy of the commons’, in which better competitors lower productivity. We have now identified a genetic basis for a rapacious life history. Mutations at a single locus (rI) cause increased virulence and are sufficient to account for a negative relationship between phage competitive ability and productivity. A higher frequency of rI mutants under unrestricted migration signifies the evolution of rapaciousness in this treatment. Conversely, spatially restricted migration favours a more ‘prudent’ pathogen strategy, in which the tragedy of the commons is averted. As our results illustrate, profound epidemiological and ecological consequences of life-history evolution in a pathogen can have a simple genetic cause.

Delaying Ambulation Mode Transition Decisions Improves Accuracy of a Flexible Control System for Powered Knee-Ankle Prosthesis

Powered lower limb prostheses can assist users in a variety of ambulation modes by providing knee and/or ankle joint power. This study’s goal was to develop a flexible control system to allow users to perform a variety of tasks in a natural, accurate, and reliable way. Six transfemoral amputees used a powered knee-ankle prosthesis to ascend/descend a ramp, climb a 3- and 4-step staircase, perform walking and standing transitions to and from the staircase, and ambulate at various speeds. A mode-specific classification architecture was developed to allow seamless transitions at four discrete gait events. Prosthesis mode transitions (i.e., the prosthesis’ mechanical response) were delayed by 90 ms. Overall, users were not affected by this small delay. Offline classification results demonstrate significantly reduced error rates with the delayed system compared to the non-delayed system (p < 0.001). The average error rate for all heel contact decisions was 1.65% [0.99%] for the non-delayed system and 0.43% [0.23%] for the delayed system. The average error rate for all toe off decisions was 0.47% [0.16%] for the non-delayed system and 0.13% [0.05%] for the delayed system. The results are encouraging and provide another step towards a clinically viable intent recognition system for a powered knee-ankle prosthesis.

Laboratory- and community-based health outcomes in people with transtibial amputation using crossover and energy-storing prosthetic feet: A randomized crossover trial

Contemporary prosthetic feet are generally optimized for either daily or high-level activities. Prosthesis users, therefore, often require multiple prostheses to participate in activities that span a range of mobility. Crossover feet (XF) are designed to increase the range of activities that can be performed with a single prosthesis. However, little evidence exists to guide clinical prescription of XF relative to traditional energy storing feet (ESF). The objective of this study was to assess the effects of XF and ESF on health outcomes in people with transtibial amputation. A randomized crossover study was conducted to assess changes in laboratory-based (endurance, perceived exertion, walking performance) and community-based (step activity and self-reported mobility, fatigue, balance confidence, activity restrictions, and satisfaction) outcomes. Twenty-seven participants were fit with XF and ESF prostheses with standardized sockets, interfaces, and suspensions. Participants were not blinded to the intervention, and wore each prosthesis for one month while their steps were counted with an activity monitor. After each accommodation period, participants returned for data collection. Endurance and perceived exertion were measured with the Six-Minute Walk Test and Borg-CR100, respectively. Walking performance was measured using an electronic walkway. Self-reported mobility, fatigue, balance confidence, activity restrictions, and satisfaction were measured with survey instruments. Participants also reported foot preferences upon conclusion of the study. Differences between feet were assessed with a crossover analysis. While using XF, users experienced improvements in most community-based outcomes, including mobility (p = .001), fatigue (p = .001), balance confidence (p = .005), activity restrictions (p = .002), and functional satisfaction (p < .001). Participants also exhibited longer sound side steps in XF compared to ESF (p < .001). Most participants (89%) reported an overall preference for XF; others (11%) reported no preference. Results indicate that XF may be a promising alternative to ESF for people with transtibial amputation who engage in a range of mobility activities. Trial registration: ClinicalTrials.gov NCT02440711

Improved Weight-Bearing Symmetry for Transfemoral Amputees During Standing Up and Sitting Down With a Powered Knee-Ankle Prosthesis

OBJECTIVE To test a new user-modulated control strategy that enables improved control of a powered knee-ankle prosthesis during sit-to-stand and stand-to-sit movements. DESIGN Within-subject comparison study. SETTING Gait laboratory. PARTICIPANTS Unilateral transfemoral amputees (N=7; 4 men, 3 women) capable of community ambulation. INTERVENTIONS Subjects performed 10 repetitions of sit-to-stand and stand-to-sit with a powered knee-ankle prosthesis and with their prescribed passive prosthesis in a randomized order. With the powered prosthesis, knee and ankle power generation were controlled as a function of weight transferred onto the prosthesis. MAIN OUTCOME MEASURES Vertical ground reaction force limb asymmetry and durations of movement were compared statistically (Wilcoxon signed-rank test, α=.05). RESULTS For sit-to-stand, peak vertical ground reaction forces were significantly less asymmetric using the powered prosthesis (mean, 19.3%±11.8%) than the prescribed prosthesis (57.9%±13.5%; P=.018), where positive asymmetry values represented greater force through the intact limb. For stand-to-sit, peak vertical ground reaction forces were also significantly less asymmetric using the powered prosthesis (28.06%±11.6%) than the prescribed prosthesis (48.2%±16%; P=.028). Duration of movement was not significantly different between devices (sit-to-stand: P=.18; stand-to-sit: P=.063). CONCLUSIONS Allowing transfemoral amputees more control over the timing and rate of knee and ankle power generation enabled users to stand up and sit down with their weight distributed more equally between their lower limbs. Increased weight bearing on the prosthetic limb may make such activities of daily living easier for transfemoral amputees.

Assessment of low- and high-level task performance in people with transtibial amputation using crossover and energy-storing prosthetic feet: A pilot study

Background: Crossover feet incorporate features of energy-storing feet and running-specific feet. As such, crossover feet may be suitable for both daily ambulation and participation in physically demanding activities. Objectives: To compare crossover feet and energy-storing feet on performance-based tests including a range of low-level (e.g. sit-to-stand) and high-level (e.g. jogging) activities. Study design: Cross-sectional, repeated measures. Methods: Participants with transtibial amputation completed a battery of performance-based outcome measures, including the Five Times Sit-to-Stand, Timed-Up-and-Go, Four Square Step Test, and the Comprehensive High-level Activity Mobility Predictor. Participants wore duplicate prostheses fit with crossover feet and energy-storing feet to perform the tests; the order of foot conditions was randomized. Paired t tests were used to evaluate differences between feet and order of testing. Results: Data from seven participants showed improvements in all measures while using crossover feet. Improvements in the second foot condition were also observed, indicating a practice effect for all measures. However, differences between feet and order of conditions were not statistically significant (p > 0.05). Conclusion: Results of this study suggest that crossover feet may improve low- and high-level mobility outcomes. However, intervention effects are small and practice effects were observed in all outcomes. Future research is needed to evaluate the influence of practice effects on performance-based mobility measures. Clinical relevance Crossover feet may improve transtibial prosthesis users’ performance compared to energy-storing feet across a range of activities, but additional research is needed. Practice effects may be an influential factor in the measurement of performance-based mobility outcomes and should be considered when performing a clinical assessment.

A novel gel liner system with embedded electrodes for use with upper limb myoelectric prostheses

We present the development and evaluation of a gel liner system for upper limb prosthesis users that enables acquisition of electromyographic (myoelectric) control signals through embedded electrodes and flexible, conductive fabric leads. This liner system is constructed using a manufacturing approach rather than by modifying a commercially available liner. To evaluate the efficacy, eight male individuals with transhumeral amputations used this system, with standard myoelectric prostheses, for home trials lasting an average of 7.3 weeks. Before and after the home trials, electrical resistance of the cumulative 218 embedded electrodes and leads within 10 gel liner systems was measured and found to increase slightly (from an average of 13.4 to 27.5 Ω) after usage. While this increase was statistically significant (p = 0.001), all but one of the final resistance values remained low enough to enable consistent myoelectric control. User impressions were evaluated through a questionnaire comparing the liner prototypes to their own myoelectric prosthesis socket interface. Subjects preferred the liner prototype (p = 0.008) over their own system in the clinical areas of comfort, suspension, function, and, especially, ease of use. These results suggest that this gel liner system is a clinically viable option and that it may offer advantages over current clinical technology for users of upper limb myoelectric prostheses.

Energy expenditure in people with transtibial amputation walking with crossover and energy storing prosthetic feet: A randomized within-subject study

BACKGROUND Energy storing feet are unable to reduce the energy required for normal locomotion among people with transtibial amputation. Crossover feet, which incorporate aspects of energy storing and running specific feet, are designed to maximize energy return while providing stability for everyday activities. RESEARCH QUESTION Do crossover prosthetic feet reduce the energy expenditure of walking across a range of speeds, when compared with energy storing feet among people with transtibial amputation due to non-dysvascular causes? METHODS A randomized within-subject study was conducted with a volunteer sample of twenty-seven adults with unilateral transtibial amputation due to non-dysvascular causes. Participants were fit with two prostheses. One had an energy storing foot (Össur Variflex) and the other a crossover foot (Össur Cheetah Xplore). Other components, including sockets, suspension, and interface were standardized. Energy expenditure was measured with a portable respirometer (Cosmed K4b2) while participants walked on a treadmill at self-selected slow, comfortable, and fast speeds with each prosthesis. Gross oxygen consumption rates (VO2 ml/min) were compared between foot conditions. Energy storing feet were used as the baseline condition because they are used by most people with a lower limb prosthesis. Analyses were performed to identify people who may benefit from transition to crossover feet. RESULTS On average, participants had lower oxygen consumption in the crossover foot condition compared to the energy storing foot condition at each self-selected walking speed, but this difference was not statistically significant. Participants with farther six-minute walk test distances, higher daily step counts, and higher Medicare Functional Classification Levels at baseline were more likely to use less energy in the crossover foot. SIGNIFICANCE Crossover feet may be most beneficial for people with higher activity levels and physical fitness. Further research is needed to examine the effect of crossover feet on energy expenditure during high-level activities.