Changes in Dynamic Mean Ankle Moment Arm in Unimpaired Walking Across Speeds, Ramps, and Stairs.

Understanding the natural biomechanics of walking at different speeds and activities is crucial to develop effective assistive devices for persons with lower-limb impairments. While continuous measures such as joint angle and moment are well-suited for biomimetic control of robotic systems, whole-stride summary metrics are useful for describing changes across behaviors and for designing and controlling passive and semi-active devices. Dynamic mean ankle moment arm (DMAMA) is a whole-stride measure representing the moment arm of the ground reaction impulse about the ankle joint-effectively, how "forefoot-dominated" or "hindfoot-dominated" a movement is. DMAMA was developed as a target and performance metric for semi-active devices that adjust once per stride. However, for implementation in this application, DMAMA must be characterized across various activities in unimpaired individuals. In our study, unimpaired participants walked at "slow," "normal," and "fast" self-selected speeds on level ground and at a normal self-selected speed while ascending and descending stairs and a 5-degree incline ramp. DMAMA measured from these activities displayed a borderline-significant negative sensitivity to walking speed, a significant positive sensitivity to ground incline, and a significant decrease when ascending stairs compared to descending. The data suggested a nonlinear relationship between DMAMA and walking speed; half of the participants had the highest average DMAMA at their "normal" speed. Our findings suggest that DMAMA varies substantially across activities, and thus, matching DMAMA could be a valuable metric to consider when designing biomimetic assistive lower-limb devices.

The effects of slope-adaptive prosthetic feet on sloped gait performance and quality in unilateral transtibial prosthesis users: A scoping review.

Introduction: In non-impaired human locomotion, sagittal-plane slope adaptation of the foot-ankle complex is a volitional function driven by neuromotor control to support upright posture and forward ambulation. Loss of this adaptation due to transtibial amputation can lead to instability and compensatory motions as most commercially-available prosthetic feet do not permit automatic slope adjustments. A selection of slope-adaptive feet (SAF) have been developed to promote biomimetic ankle motion while ambulating over slopes. This review evaluated the current literature to assess the effects of SAF prostheses on sloped gait performance in unilateral transtibial prosthesis users. Methods: Four databases (PubMed, Embase, CINAHL, IEEE Xplore) were searched on April 28, 2022, for relevant articles. Search keywords covered the general terms "transtibial," "amputation," "slope," "adaptive," and "gait", and included articles comparing a SAF prosthesis to a non-SAF prosthesis condition. Data were extracted for analysis and results were grouped according to outcomes to identify trends and aid interpretation of slope adaptation effects on gait. Results: Of the 672 articles screened, 24 met the selection criteria and were included in this review, published between 2009 and 2022. The non-SAF condition included dynamic response feet and SAF prostheses with the adaptability function inactive. Outcomes included biomechanical variables (joint dynamics, gait symmetry, toe clearance), clinical outcome measures, and energy expenditure. All SAF demonstrated some form of foot-ankle slope gradient adaptability, but effects on other joint dynamics were inconsistent. Minimum toe clearance during incline and decline walking was greater when using SAF compared to non-SAF in all reporting studies. Conclusions: Results generally suggest improvements in gait quality, comfort, and safety with use of SAF compared to non-SAF during slope walking. However, variations in tested SAF and walking gradients across studies highlight the need for research to elucidate walking condition effects and advantages of specific designs. Clinical Relevance: Slope-adaptive prosthetic feet may improve user gait quality and comfort and enhance gait safety by increasing minimum toe clearance. Patients who encounter slopes regularly should be considered as potential users of SAF if indicated appropriately.

Systematic Assessment of Prosthesis Stiffness on User Biomechanics Using the Lower Leg Trajectory Error Framework and Its Implication for the Design and Evaluation of Ankle-Foot Prostheses.

Advances in understanding the effects the mechanical characteristics of prosthetic feet on user biomechanics have enabled passive prostheses to improve the walking pattern of people with lower limb amputation. However, there is no consensus on the design methodology and criteria required to maximize specific user outcomes and fully restore their mobility. The Lower Leg Trajectory Error (LLTE) framework is a novel design methodology based on the replication of lower leg dynamics. The LLTE value evaluates how closely a prosthetic foot replicates a target walking pattern. Designing a prosthesis that minimizes the LLTE value, optimizes its mechanical function to enable users to best replicate the target lower leg trajectory. Here, we conducted a systematic sensitivity investigation of LLTE-optimized prostheses. Five people with unilateral transtibial amputation walked overground at self-selected speeds using five prototype energy storage and return feet with varying LLTE values. The prototypes' LLTE values were varied by changing the stiffness of the participant's LLTE-optimized design by 60%, 80%, 120%, and 167%. Users most closely replicated the target able-bodied walking pattern with the LLTE-optimized stiffness, experimentally demonstrating that the predicted optimum was a true optimum. Additionally, the predicted LLTE values were correlated to the user's ability to replicate the target walking pattern, user preferences, and clinical outcomes including roll-over geometries, trunk sway, prosthetic energy return, and peak push-off power. This study further validates the use of the LLTE framework as a predictive and quantitative tool for designing and evaluating prosthetic feet.

Long-term outcomes and interventions of postoperative type 1a endoleak following elective endovascular aortic aneurysm repair.

OBJECTIVE: This study evaluated the incidence and long-term outcomes of postoperative type 1a endoleak (PT1a) following endovascular aortic aneurysm repair (EVAR). METHODS: A retrospective review of consecutive aortoiliac EVARs performed at a single institution from June 2006 to June 2012 was conducted. Patients with PT1a were identified by postoperative imaging and compared with those who did not develop a PT1a. Late outcomes were also studied of a subset of patients with PT1a who had persistent intraoperative type 1a endoleak (iT1a) on completion angiogram during EVAR that had resolved on initial follow-up imaging. RESULTS: Three hundred eighty-nine patients underwent EVAR with median follow-up of 87 months (interquartile range, 64-111 months). The incidence of PT1a was 8.2% (n = 32) with a median follow-up of 74 months (interquartile range, 52-138 months). Compared with the total cohort, those who developed PT1a were statistically more likely to be female (32% vs 17%; P = .03) and have a higher all-cause mortality (71% vs 40%; P < .01) and aneurysm-related mortality (15.6% vs 1.7%; P < .01). Median time to presentation was 52 months. Of the 32 patients with PT1a, five (15.6%) presented with aortic rupture, of which three underwent extension cuff placement, one had open graft explant, and one declined intervention. Six patients in total (18.7%) declined intervention; five of these died of nonaneurysmal causes and one remains alive. Of the 26 patients with PT1a who had intervention, 21 (80.7%) showed resolution of PT1a, and five (19.2%) had recurrence. For patients with recurrent PT1a, two had resulting aneurysm-related mortality, two endoleaks resolved after relining with an endograft, and one patient declined intervention but remains alive. Patients with PT1a who had intervention with resolution showed no significant difference in median survival estimates (140.0 months) compared with the remaining EVAR cohort (120.0 months; P = .80). Within the PT1a cohort, 6 (18.7%) had also experienced iT1a with a mean time to presentation of the late PT1a of 45 months. iT1a was associated with a significantly increased likelihood of developing a PT1a (P < .01) and decreased median survival (P < .01), but there was no known aneurysm-related mortality. CONCLUSIONS: Development of PT1a following elective EVAR is associated with increased all-cause and aneurysm-related mortality and presents an average of 52 months postoperatively. This underscores the importance of long-term surveillance. Patients with PT1a who had a successful intervention showed no significant difference in median survival. Those with iT1a had a higher risk for PT1a compared with the EVAR cohort overall and had decreased median survival, without increased aneurysm-related mortality.

Predictors of mortality in nonagenarians undergoing abdominal aortic aneurysm repair: Analysis of the National Surgical Quality Improvement Program dataset.

BACKGROUND: The present study used the American College of Surgeons National Surgical Quality Improvement Program dataset to identify the predictors of 30-day mortality for nonagenarians undergoing endovascular aortic aneurysm repair (EVAR) or open surgical repair (OSR). METHODS: Patients aged >90 years who had undergone abdominal aortic aneurysm repair from 2005 to 2017 were identified using procedure codes. Those with operative times <15 minutes were excluded. The demographics, preoperative comorbidities, and postoperative complications of those who had died by 30 days were compared with those of the patients alive at 30 days. RESULTS: A total of 1356 nonagenarians met the criteria: 1229 (90.6%) had undergone EVAR and 127 (9.4%) had undergone OSR. The overall 30-day mortality was 10.4%. The patients who had died within 30 days were significantly more likely to have undergone OSR than EVAR (40.9% vs 7.2%; P < .001). They also had a greater incidence of dependent functional status (22.0% for those who had died vs 8.1% for those alive at 30 days; P < .001), American Society of Anesthesiology (ASA) classification of ≥4 (81.2% vs 18.8%; P < .001), perioperative blood transfusion (59.6% vs 20.3%; P < .001), postoperative pneumonia (12.1% vs 2.9%; P = .001), mechanical ventilation >48 hours (22.7% vs 2.6%; P < .001), and acute renal failure (12.1% vs 0.5%; P < .001). The EVAR group had a 30-day mortality rate of 2.6% in 1008 elective cases and 28.6% in 221 emergent cases. The OSR group had a 30-day mortality rate of 19.1% in 47 elective cases and 53.7% in 80 emergent cases. In the EVAR cohort, the 30-day mortality group had had a significantly greater incidence of dependent functional status (17% for those who had died vs 8% for those alive at 30 days; P = .004), ASA classification of ≥4 (76.4% vs 40.3%; P < .001), perioperative blood transfusion (57% vs 19%; P < .001), emergency surgery (71% vs 14%; P < .001), and longer operative times (150 vs 128 minutes; P = .001). CONCLUSIONS: Nonagenarians had an incrementally increased, but acceptable, risk of 30-day mortality with EVAR in elective and emergent cases compared with that reported for octogenarians and cohorts of patients not selected for age. We found greater mortality for patients with dependent status, a higher ASA classification, emergent repair, and OSR. These preoperative risk factors could help identify the best surgical candidates. Given these results, consideration for EVAR or OSR might be reasonable for highly selected patients, especially for elective patients with a larger abdominal aortic aneurysm diameter for whom the risk of rupture is higher.

Comparison of Ischial Containment and Subischial Sockets Effect on Gait Biomechanics in People With Transfemoral Amputation: A Randomized Crossover Trial.

OBJECTIVE: To compare gait biomechanics of the Northwestern University Flexible Sub-Ischial Vacuum (NU-FlexSIV) Socket to the ischial containment (IC) socket. DESIGN: Randomized crossover trial with 2, 7-week periods. SETTING: Private prosthetic clinics and university research laboratory. PARTICIPANTS: A total of 30 enrolled (n=30); 25 participants completed the study with full (n=18) or partial data (n=7). INTERVENTIONS: Two custom-fabricated sockets (IC and NU-FlexSIV), worn full-time for 7 weeks, with testing at 1, 4, and 7 weeks after socket delivery. MAIN OUTCOME MEASURES: Gait analyses were conducted at 1, 4, and 7 weeks post socket delivery. Differences between sockets in selected gait variables related to hip motion and coronal plane socket stability were assessed. RESULTS: For participants with data for both sockets at week 7 (n=19), there were no significant differences in any gait variables between sockets at self-selected normal walking speed. However, when all participants and all study time points were assessed (n=25), there was a significant main effect of socket (P=.013), with prosthetic side sagittal plane hip range of motion being significantly greater for the NU-FlexSIV Socket at self-selected normal walking speed. There were no other significant effects. CONCLUSIONS: The results suggest that, compared to the IC socket, the NU-FlexSIV Socket did not alter gait biomechanics related to hip motion and coronal plane socket stability in people with unilateral transfemoral amputation.

The Use of Paclitaxel-Coated Devices in the Treatment of Peripheral Arterial Disease is Not Associated With Increased Mortality or Amputations.

BACKGROUND: Strategies for the most effective treatment for peripheral arterial disease (PAD) remain controversial among clinicians. Several trials have shown improved primary patency of femoropopliteal interventions with the utilization of paclitaxel-coated balloons or stents compared to conventional balloons or stents. However, a 2018 meta-analysis suggested an increased mortality risk for patients receiving drug-coated balloons or stents (DCBS), resulting in an international pause in the use of DCBS. A 2021 meta-analysis by the same group suggested an increased risk of major amputation following DCBS use in peripheral arterial revascularization procedures. Here we report our long-term institutional outcomes comparing uncoated devices to DCBS. METHODS: A retrospective review of all patients who underwent peripheral arterial angioplasty, stenting, atherectomy, or a combination between 2011 and 2020 within a regional healthcare system was performed. Univariate, multivariate, and survival analyses were performed using standard statistical methods to assess the primary end points of overall survival, 5-year survival, and amputation-free survival. RESULTS: A total of 2,717 patients were identified, of whom 1,965 were treated with conventional uncoated devices and 752 were treated with DCBS. A univariate analysis showed that patients treated with non-DCBS had higher rates of overall mortality, major amputations, and mortality at 1, 3, and 5 years. A multivariable analysis demonstrated that the use of conventional devices, age, diabetes, chronic kidney disease, myocardial infarction, transient ischemic attack, warfarin use, and atrial fibrillation all significantly increased the risk of 5-year mortality, overall mortality, and combined mortality and/or amputation. CONCLUSIONS: DCBS are not associated with increased mortality or worse amputation-free survival in this real-world cohort of patients treated for PAD. Our data suggest that mortality is more closely linked with pre-existing patient comorbidities rather than device selection at the time of revascularization.

Experimental Demonstration of the Lower Leg Trajectory Error Framework Using Physiological Data as Inputs.

While many studies have attempted to characterize the mechanical behavior of passive prosthetic feet to understand their influence on amputee gait, the relationship between mechanical design and biomechanical performance has not yet been fully articulated from a fundamental physics perspective. A novel framework, called lower leg trajectory error (LLTE) framework, presents a means of quantitatively optimizing the constitutive model of prosthetic feet to match a reference kinematic and kinetic dataset. This framework can be used to predict the required stiffness and geometry of a prosthesis to yield a desired biomechanical response. A passive prototype foot with adjustable ankle stiffness was tested by a unilateral transtibial amputee to evaluate this framework. The foot condition with LLTE-optimal ankle stiffness enabled the user to replicate the physiological target dataset within 16% root-mean-square (RMS) error. Specifically, the measured kinematic variables matched the target kinematics within 4% RMS error. Testing a range of ankle stiffness conditions from 1.5 to 24.4 N·m/deg with the same user indicated that conditions with lower LLTE values deviated the least from the target kinematic data. Across all conditions, the framework predicted the horizontal/vertical position, and angular orientation of the lower leg during midstance within 1.0 cm, 0.3 cm, and 1.5 deg, respectively. This initial testing suggests that prosthetic feet designed with low LLTE values could offer benefits to users. The LLTE framework is agnostic to specific foot designs and kinematic/kinetic user targets, and could be used to design and customize prosthetic feet.

Reducing stiffness of shock-absorbing pylon amplifies prosthesis energy loss and redistributes joint mechanical work during walking.

BACKGROUND: A shock-absorbing pylon (SAP) is a modular prosthetic component designed to attenuate impact forces, which unlike traditional pylons that are rigid, can compress to absorb, return, or dissipate energy. Previous studies found that walking with a SAP improved lower-limb prosthesis users' comfort and residual limb pain. While longitudinal stiffness of a SAP has been shown to affect gait kinematics, kinetics, and work done by the entire lower limb, the energetic contributions from the prosthesis and the intact joints have not been examined. The purpose of this study was to determine the effects of SAP stiffness and walking speed on the mechanical work contributions of the prosthesis (i.e., all components distal to socket), knee, and hip in individuals with a transtibial amputation. METHODS: Twelve participants with unilateral transtibial amputation walked overground at their customary (1.22 ± 0.18 ms-1) and fast speeds (1.53 ± 0.29 ms-1) under four different levels of SAP stiffness. Power and mechanical work profiles of the leg joints and components distal to the socket were quantified. The effects of SAP stiffness and walking speed on positive and negative work were analyzed using two-factor (stiffness and speed) repeated-measure ANOVAs (α = 0.05). RESULTS: Faster walking significantly increased mechanical work from the SAP-integrated prosthesis (p < 0.001). Reducing SAP stiffness increased the magnitude of prosthesis negative work (energy absorption) during early stance (p = 0.045) by as much as 0.027 Jkg-1, without affecting the positive work (energy return) during late stance (p = 0.159), suggesting a damping effect. This energy loss was partially offset by an increase in residual hip positive work (as much as 0.012 Jkg-1) during late stance (p = 0.045). Reducing SAP stiffness also reduced the magnitude of negative work on the contralateral sound limb during early stance by 11-17% (p = 0.001). CONCLUSIONS: Reducing SAP stiffness and faster walking amplified the prostheses damping effect, which redistributed the mechanical work, both in magnitude and timing, within the residual joints and sound limb. With its capacity to absorb and dissipate energy, future studies are warranted to determine whether SAPs can provide additional user benefit for locomotor tasks that require greater attenuation of impact forces (e.g., load carriage) or energy dissipation (e.g., downhill walking).

Focusing research efforts on the unique needs of women prosthesis users.

INTRODUCTION: Women with lower limb loss represent a relevant and growing patient cohort with unique rehabilitation needs. These needs are emphasized in a growing body of literature and the most recent Veteran Affairs/Department of Defense clinical practice guidelines. PROSTHETICS CHALLENGES: Women with limb loss experience greater dissatisfaction with prosthetic fit, appearance, and types of footwear they can use. There is a lack of prosthetics solutions to accommodate the desire of women to wear different footwear varieties, including high heels. The choice to wear a variety of footwear is important to attire and hence community participation. Despite these recognized challenges, women are still underserved in prosthetics research, which limits available information to guide the rehabilitation process. RESEARCH INITIATIVES: This narrative review describes considerations of lower limb prosthesis prescription and use by women, and examples of current research to address these topics. Research efforts are beginning to explore factors that contribute to prosthetics prescription for women, and design creative prosthetics solutions to expand the range of available footwear options. Research is still needed to characterize the types of footwear women with limb loss prefer to use, and the effects of prosthesis designs, footwear, and lower limb loss on women mobility outcomes and community participation. CONCLUSIONS: Through targeted research initiatives, scientists and clinicians can be responsive to the specific needs of women to provide evidence-based guidelines for prosthetics prescription and improve the patient-centered care after limb loss.

Type II endoleak with an enlarging aortic sac after endovascular aneurysm repair predisposes to the development of a type IA endoleak.

OBJECTIVE: The most common endoleak after endovascular aneurysm repair is type II. Although type II endoleaks (TIIEL) are generally considered benign, there are reports that they can lead to aortic rupture. In this study, we reviewed the effect of TIIEL on sac size change to determine if sac expansion owing to a TIIEL could result in the development of a type IA endoleak (TIAEL). METHODS: After internal review board approval, all aortoiliac endovascular aneurysm repairs performed at a single institution between June 2006 and June 2012 were retrospectively reviewed. Patient demographics, comorbidities, aneurysm diameter, graft type, need for reintervention, and complications were collected. Patients with TIIEL diagnosed on follow-up imaging were categorized as those who underwent intervention for their TIIEL and those who did not. Outcomes were tabulated with attention to sac size change, development of TIAEL, rupture, and survival. RESULTS: Six hundred twenty-seven patients underwent aortoiliac stent graft placement at our institution during this time period. Patients with an operative indication other than nonruptured infrarenal abdominal aortic aneurysm and those without preoperative computed tomography angiography or follow-up data available for review were excluded. The total number of patients included was 389 with an average follow-up of 58.8 months (range, 0-194 months). Follow-up imaging diagnosed 124 patients with TIIEL (32%). Patients with TIIEL were significantly older (P < .0001) and more likely to be hypertensive (P < .05) but less likely to be smokers (P = .01). They had a significantly larger sac size increase than patients without TIIEL (9.50 vs -0.78 mm; P < .0001). Those with TIIEL were significantly more likely to develop a TIAEL than patients who did not have TIIEL (14% vs 5%; P = .004), but the rate of rupture was not significantly different (4% vs 2%; P = .33). In those with a TIIEL, the average sac size increase at which TIAEL developed was 13 mm. Patients in the TIIEL group who underwent intervention for their TIIEL survived significantly longer than patients who did not undergo intervention (140 months vs 100 months; P = .004). CONCLUSIONS: Our data suggest that there is an increased incidence of late TIAEL in patients with TIIEL compared with those without a TIIEL. Our study also demonstrates an increased overall survival in TIIEL patients who underwent intervention. Future studies are necessary to better define the association between TIIEL with enlarging sac and the development of TIAEL. However, it is reasonable to conclude that intervention for TIIEL should be undertaken at or before a cumulative sac size increase of 13 mm.

The feasibility and validity of a wearable sensor system to assess the stability of high-functioning lower-limb prosthesis users.

INTRODUCTION: Lower-limb prosthesis users (LLPUs) experience increased fall risk due to gait and balance impairments. Clinical outcome measures are useful for measuring balance impairment and fall risk screening but suffer from limited resolution and ceiling effects. Recent advances in wearable sensors that can measure different components of gait stability may address these limitations. This study assessed feasibility and construct validity of a wearable sensor system (APDM Mobility Lab) to measure postural control and gait stability. MATERIALS AND METHODS: Lower-limb prosthesis users (n=22) and able-bodied controls (n=24) completed an Instrumented Stand-and-Walk Test (ISAW) while wearing the wearable sensors. Known-groups analysis (prosthesis versus controls) and convergence analysis (Prosthetic Limb Users Survey of Mobility [PLUS-M] and Activity-specific Balance Confidence [ABC] Scale) were performed on 20 stability-related measures. RESULTS: The system was applied without complications; however missing anticipatory postural adjustment data points for nine subjects affected the analysis. Of the 20 analyzed measures output by the sensors, only three significantly differed (p≤.05) between cohorts, and two demonstrated statistically significant correlations with the self-report measures. CONCLUSIONS: The results of this study suggest the clinical feasibility but only partial construct validity of the wearable sensor system in conjunction with the ISAW test to measure LLPU stability and balance. The sample consisted of high-functioning LLPUs, so further research should evaluate a more representative sample with additional outcome measures and tasks.

Does Decreasing Below-Knee Prosthesis Pylon Longitudinal Stiffness Increase Prosthetic Limb Collision and Push-Off Work During Gait?

Investigations have begun to connect leg prosthesis mechanical properties and user outcomes to optimize prosthesis designs for maximizing mobility. To date, parametric studies have focused on prosthetic foot properties, but not explicitly longitudinal stiffness that is uniquely modified through shock-absorbing pylons. The linear spring function of these devices might affect work performed on the body center-of-mass during walking. This study observed the effects of different levels of pylon stiffness on individual limb work of unilateral below-knee prosthesis users walking at customary and fast speeds. Longitudinal stiffness reductions were associated with minimal increase in prosthetic limb collision and push-off work, but inconsistent changes in sound limb work. These small and variable changes in limb work did not suggest an improvement in mechanical economy due to reductions in stiffness. Fast walking generated greater overall center-of-mass work demands across stiffness conditions. Results indicate limb work asymmetry as the prosthetic limb experienced on average 61% and 36% of collision and push-off work, respectively, relative to the sound limb. A series spring model to estimate residuum and pylon stiffness effects on prosthesis energy storage suggested that minimal changes to limb work may be due to influences of the residual limb which dominate the system response.

Do Upper Limb Loss and Prosthesis Use Affect Lower Limb Gait Dynamics?

INTRODUCTION: Intentional interruption of upper and lower limb coordination of able-bodied subjects alters their gait biomechanics. However, the effect of upper-limb loss (ULL) on lower-limb gait biomechanics is not fully understood. The aim of this secondary study was to perform a follow-up analysis of a previous dataset to characterize the spatiotemporal parameters and lower-limb kinematics and kinetics of gait for persons with ULL when wearing and not wearing an upper limb prosthesis (ULP). We were particularly interested in quantifying the effects of matching the mass and inertia of the prosthetic limb to the sound limb. MATERIALS AND METHODS: Ten persons with unilateral ULL walked at a self-selected speed under three randomly presented conditions: 1) not wearing a prosthesis, 2) wearing their customary prosthesis, and 3) wearing a mock prosthesis that can be adjusted to match the length, mass, and inertial properties of each subject's sound limb. Walkway-embedded force plates and a 12-camera digital motion capture system recorded ground reaction forces (GRFs) and retroreflective marker position data, respectively. Average spatiotemporal (walking speed, cadence, stance time, swing time, step length, double support time), lower-limb kinematic (joint angles), and lower-limb kinetic (ground forces, joint moments and powers) data were processed and their statistical significance were analyzed. RESULT: Walking speed for each condition was nearly equivalent (1.20±0.01 m/s) and differences between condition were non-significant (p=0.769). The interaction effect (side× prosthesis) was significant for peak hip extension (p=0.01) and second peak (propulsive) vertical GRF (p=0.028), but separate follow-up analyses of both main effects were not significant (p≥0.099). All other main effect comparisons were not significant (p≥0.102). CONCLUSIONS: Although the sample cohort was small and heterogeneous, the results of this study suggest that persons with unilateral ULL did not display significant limb side asymmetry in lower-limb gait spatiotemporal, kinetic, and kinematic parameters, regardless of ULP use.

Amputee perception of prosthetic ankle stiffness during locomotion.

BACKGROUND: Prosthetic feet are spring-like, and their stiffness critically affects the wearer's stability, comfort, and energetic cost of walking. Despite the importance of stiffness in ambulation, the prescription process often entails testing a limited number of prostheses, which may result in patients receiving a foot with suboptimal mechanics. To understand the resolution with which prostheses should be individually optimized, we sought to characterize below-knee prosthesis users' psychophysical sensitivity to prosthesis stiffness. METHODS: We used a novel variable-stiffness ankle prosthesis to measure the repeatability of user-selected preferred stiffness, and implemented a psychophysical experiment to characterize the just noticeable difference of stiffness during locomotion. RESULTS: All eight subjects with below-knee amputation exhibited high repeatability in selecting their Preferred Stiffness (mean coefficient of variation: 14.2 ± 1.7%) and were able to correctly identify a 7.7 ± 1.3% change in ankle stiffness (with 75% accuracy). CONCLUSIONS: This high sensitivity suggests prosthetic foot stiffness should be tuned with a high degree of precision on an individual basis. These results also highlight the need for a pairing of new robotic prescription tools and mechanical characterizations of prosthetic feet.

Survey of U.S. Practitioners on the Validity of the Medicare Functional Classification Level System and Utility of Clinical Outcome Measures for Aiding K-Level Assignment.

OBJECTIVE: To characterize the opinion of the prosthetic clinical care community on the Medicare Functional Classification Level (K-level) assignment process to classify the mobility and rehabilitation potential of persons with lower-limb loss, including limitations and practicalities involved with the integration of outcome measures (OMs) into the clinical practice framework for K-level assignment. DESIGN: Survey. SETTING: English online questionnaire with built-in logic. PARTICIPANTS: Volunteer sample of prosthetics practitioners (N=236). Data were analyzed only for U.S. practitioners (n=213). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Subjective responses to 19 multiple choice, Likert scale, and open-ended questions. RESULTS: Forty-seven percent of respondents indicated that they were the sole determinant in the K-level assignment process, while 43% indicated that it was a collaborative process with other health care professionals. Sixty-nine percent of respondents reported using standardized OMs to assist in K-level assignment, and most did not agree that commonly reported barriers to implementation (eg, lack of time and training) were relevant. Sixty-seven percent of respondents did not believe the K-level system can accurately assign a level of rehabilitation potential, with 75% agreeing that incorporating OMs into clinical practice would enhance objectivity of the K-level assignment process. CONCLUSIONS: The results suggest that most prosthetics practitioners are involved in the K-level assignment at some level, and most agreed that there are considerable limitations with this system. To address these issues, many practitioners are using OMs to assess various aspects of patient mobility and rehabilitation potential, and minimize the subjectivity of the assignment process.

Validity of the iPhone M7 motion co-processor as a pedometer for able-bodied ambulation.

Physical activity benefits for disease prevention are well-established. Smartphones offer a convenient platform for community-based step count estimation to monitor and encourage physical activity. Accuracy is dependent on hardware-software platforms, creating a recurring challenge for validation, but the Apple iPhone® M7 motion co-processor provides a standardised method that helps address this issue. Validity of the M7 to record step count for level-ground, able-bodied walking at three self-selected speeds, and agreement with the StepWatchTM was assessed. Steps were measured concurrently with the iPhone® (custom application to extract step count), StepWatchTM and manual count. Agreement between iPhone® and manual/StepWatchTM count was estimated through Pearson correlation and Bland-Altman analyses. Data from 20 participants suggested that iPhone® step count correlations with manual and StepWatchTM were strong for customary (1.3 ± 0.1 m/s) and fast (1.8 ± 0.2 m/s) speeds, but weak for the slow (1.0 ± 0.1 m/s) speed. Mean absolute error (manual-iPhone®) was 21%, 8% and 4% for the slow, customary and fast speeds, respectively. The M7 accurately records step count during customary and fast walking speeds, but is prone to considerable inaccuracies at slow speeds which has important implications for certain patient groups. The iPhone® may be a suitable alternative to the StepWatchTM for only faster walking speeds.

Comparison of range-of-motion and variability in upper body movements between transradial prosthesis users and able-bodied controls when executing goal-oriented tasks.

BACKGROUND: Current upper limb prostheses do not replace the active degrees-of-freedom distal to the elbow inherent to intact physiology. Limited evidence suggests that transradial prosthesis users demonstrate shoulder and trunk movements to compensate for these missing volitional degrees-of-freedom. The purpose of this study was to enhance understanding of the effects of prosthesis use on motor performance by comparing the movement quality of upper body kinematics between transradial prosthesis users and able-bodied controls when executing goal-oriented tasks that reflect activities of daily living. METHODS: Upper body kinematics were collected on six able-bodied controls and seven myoelectric transradial prosthesis users during execution of goal-oriented tasks. Range-of-motion, absolute kinematic variability (standard deviation), and kinematic repeatability (adjusted coefficient-of-multiple-determination) were quantified for trunk motion in three planes, shoulder flexion/extension, shoulder ab/adduction, and elbow flexion/extension across five trials per task. Linear mixed models analysis assessed between-group differences and correlation analysis evaluated association between prosthesis experience and kinematic repeatability. RESULTS: Across tasks, prosthesis users demonstrated increased trunk motion in all three planes and shoulder abduction compared to controls (p ≤ 0.004). Absolute kinematic variability was greater for prosthesis users for all degrees-of-freedom irrespective of task, but was significant only for degrees-of-freedom that demonstrated increased range-of-motion (p ≤ 0.003). For degrees-of-freedom that did not display increased absolute variability for prosthesis users, able-bodied kinematics were characterized by significantly greater repeatability (p ≤ 0.015). Prosthesis experience had a strong positive relationship with average kinematic repeatability (r = 0.790, p = 0.034). CONCLUSIONS: The use of shoulder and trunk movements by prosthesis users as compensatory motions to execute goal-oriented tasks demonstrates the flexibility and adaptability of the motor system. Increased variability in movement suggests that prosthesis users do not converge on a defined motor strategy to the same degree as able-bodied individuals. Kinematic repeatability may increase with prosthesis experience, or encourage continued device use, and future work is warranted to explore these relationships. As compensatory dynamics may be necessary to improve functionality of transradial prostheses, users may benefit from dedicated training that encourages optimization of these dynamics to facilitate execution of daily living activity, and fosters adaptable but reliable motor strategies.