Mechanical testing of frontal plane adaptability of commercially available prosthetic feet.

Introduction: Prosthetic feet have limited adaptability in the frontal plane. Research shows walking on uneven terrain is difficult for many prosthesis users. A new prosthetic foot, the META Arc, was designed with a polycentric ankle joint that allows relatively free movement in the frontal plane to address this limitation. Previous simulations of the polycentric ankle mechanism found potential benefits such as reduced lateral movement of a proximal mass during forward progress and reduced forces being transferred upward from the ground through the foot. Methods: Standard mechanical testing protocols were used to evaluate the Meta Arc prosthetic foot's performance and six comparable feet commercially available. Results: The results found the META Arc prosthetic foot had increased frontal plane adaptability as well as reduced lateral forces, and reduced inversion eversion moment compared to the six comparison feet on 10-degree cross-slope test conditions. All included prosthetic feet had similar results for the percent of energy return and dynamic force in the sagittal plane. Conclusions: These results suggest the inclusion of the polycentric ankle within the META Arc foot will provide more stability without sacrificing forward walking performance.

Progress Toward Optimizing Prosthetic Socket Fit and Suspension Using Elevated Vacuum to Promote Residual Limb Health.

Objective: Prosthetic sockets are custom made for each amputee, yet there are no quantitative tools to determine the appropriateness of socket fit. Ensuring a proper socket fit can have significant effects on the health of residual limb soft tissues and overall function and acceptance of the prosthetic limb. Previous work found that elevated vacuum pressure data can detect movement between the residual limb and the prosthetic socket; however, the correlation between the two was specific to each user. The overall objective of this work is to determine the relationship between elevated vacuum pressure deviations and prosthetic socket fit. Approach: A tension compression machine was used to apply repeated controlled forces onto a residual limb model with sockets of different internal volume. Results: The vacuum pressure-displacement relationship was dependent on socket fit. The vacuum pressure data were sensitive enough to detect differences of 1.5% global volume and can likely detect differences even smaller. Limb motion was reduced as surface area of contact between the limb model and socket was maximized. Innovation: The results suggest that elevated vacuum pressure data provide information to quantify socket fit. Conclusions: This study provides evidence that the use of elevated vacuum pressure data may provide a method for prosthetists to quantify and monitor socket fit. Future studies should investigate the relationship between socket fit, limb motion, and limb health to define optimal socket fit parameters.

Standardized Approach to Quantitatively Measure Residual Limb Skin Health in Individuals with Lower Limb Amputation.

Objective: (1) Develop a standardized approach to quantitatively measure residual limb skin health. (2) Report reference residual limb skin health values in people with transtibial and transfemoral amputation. Approach: Residual limb health outcomes in individuals with transtibial (n = 5) and transfemoral (n = 5) amputation were compared to able-limb controls (n = 4) using noninvasive imaging (hyperspectral imaging and laser speckle flowmetry) and probe-based approaches (laser doppler flowmetry, transcutaneous oxygen, transepidermal water loss, surface electrical capacitance). Results: A standardized methodology that employs noninvasive imaging and probe-based approaches to measure residual limb skin health are described. Compared to able-limb controls, individuals with transtibial and transfemoral amputation have significantly lower transcutaneous oxygen tension, higher transepidermal water loss, and higher surface electrical capacitance in the residual limb. Innovation: Residual limb health as a critical component of prosthesis rehabilitation for individuals with lower limb amputation is understudied in part due to a lack of clinical measures. Here, we present a standardized approach to measure residual limb health in people with transtibial and transfemoral amputation. Conclusion: Technology advances in noninvasive imaging and probe-based measures are leveraged to develop a standardized approach to quantitatively measure residual limb health in individuals with lower limb loss. Compared to able-limb controls, resting residual limb physiology in people that have had transfemoral or transtibial amputation is characterized by lower transcutaneous oxygen tension and poorer skin barrier function.

Differences in Military Obstacle Course Performance Between Three Energy-Storing and Shock-Adapting Prosthetic Feet in High-Functioning Transtibial Amputees: A Double-Blind, Randomized Control Trial.

BACKGROUND: Approximately 683 persons engaged in military service experienced transtibial amputation (TTA) related to recent war in Iraq and Afghanistan. Military TTAs function at a level beyond basic ambulation. No empirical data demonstrate which higher functioning prosthetic feet maximize injured service personnel's ability to continue performing at a level commensurate with return to duty. This study's purpose was to determine which of three high-functioning, energy-storing prosthetic feet maximize performance and preference in a field obstacle course (OC) and to quantify physical performance differences between TTAs and high-functioning nonamputees. PROCEDURES: A randomized, double-blind, repeated measures experimental design compared three prosthetic feet (Ossur Variflex, Endolite Elite Blade, and Ossur Re-Flex Rotate) during performance on a field OC. TTAs accommodated with study feet and the OC before assessment. 14 TTAs and 14 nonamputee controls completed the course. Subjective and objective performance differences were compared across feet conditions and between groups. RESULTS: Total OC completion times were similar between prosthetic feet: Elite-Blade (419 seconds ± 130), Variflex (425 seconds ± 144), and Re-Flex Rotate (444 seconds ± 220). Controls' OC completion time (287.2 seconds ± 58) was less (p ≤ 0.05) than TTA times. In total, controls had faster completion times (p ≤ 0.05) compared to all prosthetic feet conditions in 13/17 obstacles. Re-Flex Rotate had 2 additional obstacles different (p ≤ 0.05) than controls and required more time to complete. Median RPE values were lower (p ≤ 0.05) for controls than TTA regardless of foot. Regarding foot preference for OC completion, 7/14 (50%) preferred Elite Blade, 5/14 (36%) preferred Re-Flex Rotate, and the remaining 2/14 (14%) preferred Variflex. CONCLUSION: Controls completed the OC faster and with less effort than TTAs regardless of prosthetic foot. No clear differences in prosthetic feet emerged during OC completion; however, individual task performance, perceived effort, and preference resulted in trends of slight performance improvement with and preference for Elite Blade, a dual function energy-storing and return foot combined with vertical shock absorption. Understanding how to maximally improve performance in such functional tasks may allow service members to best sustain physical fitness, return to their military occupational specialty and possibly in-theater duty.

EFFECTS OF THE GENIUM MICROPROCESSOR KNEE SYSTEM ON KNEE MOMENT SYMMETRY DURING HILL WALKING.

Use of the Genium microprocessor knee (MPK) system reportedly improves knee kinematics during walking and other functional tasks compared to other MPK systems. This improved kinematic pattern was observed when walking on different hill conditions and at different speeds. Given the improved kinematics associated with hill walking while using the Genium, a similar improvement in the symmetry of knee kinetics is also feasible. The purpose of this study was to determine if Genium MPK use would reduce the degree of asymmetry (DoA) of peak stance knee flexion moment compared to the C-Leg MPK in transfemoral amputation (TFA) patients. This study used a randomized experimental crossover of TFA patients using Genium and C-Leg MPKs (n = 20). Biomechanical gait analysis by 3D motion tracking with floor mounted force plates of TFA patients ambulating at different speeds on 5° ramps was completed. Knee moment DoA was significantly different between MPK conditions in the slow and fast uphill as well as the slow and self-selected downhill conditions. In a sample of high-functioning TFA patients, Genium knee system accommodation and use improved knee moment symmetry in slow speed walking up and down a five degree ramp compared with C-Leg. Additionally, the Genium improved knee moment symmetry when walking downhill at comfortable speed. These results likely have application in other patients who could benefit from more consistent knee function, such as older patients and others who have slower walking speeds.

EFFECTS OF THE GENIUM KNEE SYSTEM ON FUNCTIONAL LEVEL, STAIR AMBULATION, PERCEPTIVE AND ECONOMIC OUTCOMES IN TRANSFEMORAL AMPUTEES.

Compared to non-microprocessor knees, the C-Leg microprocessor knee (MPK) is bioenergentically and economically more efficient and safer for transfemoral amputation (TFA) patients. The Genium MPK has demonstrated improvements in perceived function, knee kinematics, and physical functional performance compared to C-Leg. Clinical and health economic analyses have not been conducted with the Genium knee system. The purpose of this study was to determine if laboratory determined benefits of Genium are detectable using common clinical assessments and if there are economic benefits associated with its use. This study utilized a randomized AB crossover study with 60 d follow-up including cost-effectiveness analysis. Twenty TFA patients tested with both knees in mobility and preference measures. Incremental cost-effectiveness ratios (ICER) were calculated based on performance measures. Stair Assessment Index scores improved with Genium. Mean stair completion times and descent stepping rate were not different between knees. Stair ascent stepping rate for C-Leg was greater compared with Genium (p = 0.04). Genium use decreased Four square step test completion time and increased functional level and step activity (p ≤ 0.05). Further, Genium use improved (p ≤ 0.05) function and safety in three out of five Activities of Daily Living (ADL) survey domains. Finally, more subjects preferred Genium following testing. Functional measures were used to calculate ICERs. ICER values for Genium fall within established likely-to-accept value ranges. Compared with C-Leg, Genium use improved stair walking performance, multi-directional stepping, functional level, and perceived function. In this group of community ambulators with TFA, Genium was preferred, and, while more costly, it may be worth funding due to significant improvements in functional performance with ADLs.

Elevated vacuum suspension preserves residual-limb skin health in people with lower-limb amputation: Randomized clinical trial.

A growing number of clinical trials and case reports support qualitative claims that use of an elevated vacuum suspension (EVS) prosthesis improves residual-limb health on the basis of self-reported questionnaires, clinical outcomes scales, and wound closure studies. Here, we report first efforts to quantitatively assess residual-limb circulation in response to EVS. Residual-limb skin health and perfusion of people with lower-limb amputation (N = 10) were assessed during a randomized crossover study comparing EVS with nonelevated vacuum suspension (control) over a 32 wk period using noninvasive probes (transepidermal water loss, laser speckle imaging, transcutaneous oxygen measurement) and functional hyperspectral imaging approaches. Regardless of the suspension system, prosthesis donning decreased perfusion in the residual limb under resting conditions. After 16 wk of use, EVS improved residual-limb oxygenation during treadmill walking. Likewise, prosthesis-induced reactive hyperemia was attenuated with EVS following 16 wk of use. Skin barrier function was preserved with EVS but disrupted after control socket use. Taken together, outcomes suggest chronic EVS use improves perfusion and preserves skin barrier function in people with lower-limb amputation. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov; "Evaluation of limb health associated with a prosthetic vacuum socket system": NCT01839123; https://clinicaltrials.gov/ct2/show/NCT01839123?term=NCT01839123&rank=1.

Differences in knee flexion between the Genium and C-Leg microprocessor knees while walking on level ground and ramps.

BACKGROUND: Microprocessor knees have improved the gait and functional abilities of persons with transfemoral amputation. The Genium prosthetic knee offers an advanced sensor and control system designed to decrease impairment by: allowing greater stance phase flexion, easing transitions between gait phases, and compensating for changes in terrain. The aim of this study was to determine differences between the knee flexion angle of persons using the Genium knee, the C-Leg knee, and non-amputee controls; and to evaluate the impact the prostheses on gait and level of impairment of the user. METHODS: This study used a randomized experimental crossover of persons with transfemoral amputation using the Genium and C-Leg microprocessor knees (n=25), with an observational sample of non-amputee controls (n=5). Gait analysis by 3D motion tracking of subjects ambulating at different speeds on level ground and on 5° and 10° ramps was completed. FINDINGS: Use of the Genium resulted in a significant increase in peak knee flexion for swing (5°, p<0.01, d=0.34) and stance (2°, p<0.01, d=0.19) phases relative to C-Leg use. There was a high degree of variability between subjects, and significant differences still remain between the Genium group and the control group's knee flexion angles for most speeds and slopes. INTERPRETATION: The Genium knee generally increases flexion in swing and stance, potentially decreasing the level of impairment for persons with transfemoral amputation. This study demonstrates functional differences between the C-Leg and Genium knees to help prosthetists determine if the Genium will provide functional benefits to individual patients.

Golf hand prosthesis performance of transradial amputees.

BACKGROUND: Typical upper limb prostheses may limit sports participation; therefore, specialized terminal devices are often needed. The purpose of this study was to evaluate the ability of transradial amputees to play golf using a specialized terminal device. CASE DESCRIPTION AND METHODS: Club head speed, X-factor, and elbow motion of two individuals with transradial amputations using an Eagle Golf terminal device were compared to a non-amputee during a golf swing. Measurements were collected pre/post training with various stances and grips. FINDINGS AND OUTCOMES: Both prosthesis users preferred a right-handed stance initially; however, after training, one preferred a left-handed stance. The amputees had slower club head speeds and a lower X-factor compared to the non-amputee golfer, but increased their individual elbow motion on the prosthetic side after training. CONCLUSION: Amputees enjoyed using the device, and it may provide kinematic benefits indicated by the increase in elbow flexion on the prosthetic side. CLINICAL RELEVANCE: The transradial amputees were able to swing a golf club with sufficient repetition, form, and velocity to play golf recreationally. Increased elbow flexion on the prosthetic side suggests a potential benefit from using the Eagle Golf terminal device. Participating in recreational sports can increase amputees' health and quality of life.