Mechanical testing of transtibial prosthetic sockets: A discussion paper from the American Orthotic and Prosthetic Association Socket Guidance Workgroup.

BACKGROUND: The advent of novel manufacturing technologies, materials, and socket design concepts could introduce risks to prosthetic limb users, as the existing knowledge base for safe fabrication may not apply. Moreover, although structural test standards exist for mass-produced prosthetic components, they are not applicable to prosthetic sockets. METHODS: The "AOPA Socket Guidance Workgroup" was formed in 2020 to provide the prosthetic community with evidence-based clinical best practices and methods in the field of prosthetic socket structural analysis. This multidisciplinary expert workgroup undertook a critical analysis of the knowledge gaps regarding the requirements for mechanical testing of lower limb prosthetic sockets. RESULTS: The Workgroup identified knowledge gaps in 4 domains. Domain 1 describes the shape and composition of a mock residual limb, required to support and generate in vivo representative loading within the socket. Domain 2 concerns prosthetic socket coordinate systems and alignment. Domain 3 regards the components and requirements of test specimens. Finally, Domain 4 considers test conditions, loading parameters, and acceptance criteria. CONCLUSIONS: This paper describes these knowledge gaps in detail and recommends potential solution approaches based on literature review, group consensus around existing knowledge, or the formation of new study groups to fill each knowledge gap. Our intent is for the recommendations arising from this paper to support the community (e.g., researchers in the clinic, academia, industry, and funders) in addressing these knowledge gaps.

Supine arm cycling during the post-flap recovery period for persons with spinal cord injuries: The multi-purpose arm cycle ergometer (M-PACE) safety and pilot testing.

OBJECTIVE: To describe how using a supine arm cycle ergometer can safely reduce deconditioning experienced by patients with spinal cord injury or disorder (SCI/D) during their four to six weeks of complete bed rest after surgery to close a stage 4 pressure injury. DESIGN: This pilot project used a newly designed arm cycle ergometer (known as the M-PACE) that extends over the bed, allowing a patient to lie completely supine while exercising. SETTING: The M-PACE was designed and built at the Minneapolis Veterans Affairs Health Care System (MVAHCS) and pilot tested at the MVAHCS SCI/D Center. PARTICIPANTS: Patients with SCI/D, recovering from flap surgery and deemed appropriate to use the arm cycle ergometer were enrolled in the pilot study (n = 47). OUTCOME MEASURES: A pre-post six-minute arm test (6MAT), a proxy for conditioning, was conducted on a subset (n = 15) of participants before and after the supine cycling exercise training program. Participants' rating of perceived exertion (RPE) scores were collected at cessation of each 6MAT. Participants gave feedback on their perception of using the M-PACE. RESULTS/CONCLUSIONS: The 6MAT RPE was significantly reduced after training with the M-PACE while on bed rest (P = 0.003). Also, significantly more rotations were performed after completing the training program (P = 0.02). Further, study participants who accessed the M-PACE found using it helped offset the tedium of laying supine during flap surgery recovery. The differences in the 6MAT pre- to post measures indicate the M-PACE should be further studied for offsetting the normal deconditioning that occurs with extended bedrest.

Design refinement and evaluation of a mobile manual standing wheelchair.

PURPOSE: There are no manually propelled wheelchairs on the market that are mobile in both seated and standing positions. In response to this product gap, our group formerly designed a mobile manual standing wheelchair (MMSW) and gathered stakeholder feedback. The purpose of this study was to refine the MMSW based on feedback, including weight and width reduction, and evaluate its performance. MATERIALS AND METHODS: The MMSW was subjected to ANSI/RESNA stability testing, and three male participants completed a subset of the wheelchair skills test, including a 100-m roll test in the MMSW (seated and standing) and in their ultralight wheelchair. RESULTS: The MMSW met ANSI/RESNA stability safety standards. During the 100-m roll test, participants reached speeds with the MMSW in both the standing and sitting postures similar or greater than those typical of moving in the home environment (1.11 m/s seated; 0.79 m/s standing). Mobility speeds in the MMSW in the standing position were about three times faster than average walking speeds in exoskeletons (0.26 m/s exoskeletons). With the addition of chain drive bracing to the MMSW, one user was able to reach speeds in the standing position similar to average neurotypical walking speeds indicating the possibility for wheelchair users to be able to move in pace with family and friends. CONCLUSION: All participants expressed interest in the MMSW to facilitate improved quality of life. Further work is needed to test the utility of the MMSW in home and community settings, and its potential effects on standing time and health outcomes.Implications for rehabilitationManual standing wheelchairs with standing mobility may increase functional utility and length of standing time for manual wheelchair usersIncreased standing time may lead to several health benefits for manual wheelchair users.

Toward improving residual limb climate within prostheses for persons with lower limb loss: a technical note.

BACKGROUND: Individuals with lower limb loss often wear a gel liner and enclosed socket for connecting to a terminal prosthetic device. Historically, a significant limitation to traditional liners and sockets is that they are thermal insulators, thereby trapping heat and moisture within, which can lead to numerous deleterious issues, including loss of suspension and residual limb skin problems, and, in turn, reductions in mobility, function, and overall quality of life. To mitigate these issues, new approaches are therefore needed to enhance the residual limb climate (e.g. breathability and air permeability), allowing the dispersal of heat and moisture from within the liner and socket. METHODS: In this study, a multidisciplinary team sought to establish the feasibility of an innovative prosthetic liner-socket system, designed to improve residual limb climate by capitalizing on passive (i.e. nonpowered) ventilation to reduce temperature/moisture and improve socket comfort for persons with transtibial amputations. Focus group meetings, along with an iterative design approach, were implemented to establish innovative design and development concepts that led to a passively ventilated liner-socket system. CONCLUSIONS: Ex vivo design has supported the feasibility of developing a passively ventilated liner-socket. To build on these successes, future development and human subjects testing are needed to finalize a commercially viable system. Implementing a passively ventilated liner-socket system that improves residual limb health and comfort, without compromising function or mobility of the user, into standard clinical care may encourage a more active lifestyle and enhance the quality of life for individuals after lower limb loss.

Biomechanical characterization of the foot-ground interaction among Service members with unilateral transtibial limb loss performing unconstrained drop-landings: Effects of drop height and added mass.

There exist limited data to guide the development of methodologies for evaluating impact resilience of prosthetic ankle-foot systems, particularly regarding human-device interaction in ecologically valid scenarios. The purpose of this study was to biomechanically characterize foot-ground interactions during drop-landings among Service members with and without unilateral transtibial limb loss. Seven males with, and seven males without, unilateral transtibial limb loss completed six drop-landing conditions consisting of all combinations of three heights (20 cm, 40 cm, 60 cm) and two loads (with and without a 22.2 kg weighted vest). Peak ground reaction forces (GRF), vertical GRF loading rate and impulse, as well as ankle-foot, knee, and hip joint negative (absorption) powers and work were compared across groups (i.e., contralateral side and prosthetic side vs. uninjured controls) by height and load conditions. Loading occurred primarily in the vertical direction, and increased with increasing drop height and/or with added load. Vertical GRFs were overall ~ 15% smaller on the prosthetic side (vs. controls) with similar loading rates across limbs/groups. From the most challenging condition (i.e., 60 cm with 22 kg load), ankle-foot absorption energies on the prosthetic side were 64.6 (7.2) J; corresponding values were 187.4 (8.9) J for the contralateral limb and 161.2 (6.7) J among uninjured controls. Better understanding biomechanical responses to drop-landings in ecological scenarios will help inform future iterations of mechanical testing methodologies for evaluating impact resilience of prosthetic ankle-foot systems (enhancing prescription criteria and return-to-activity considerations) as well as identifying and mitigating risk factors for long-term secondary complications within the contralateral limb (e.g., joint degeneration).

Three-dimensional printing in prosthetics: Method for managing rapid limb volume change.

BACKGROUND AND AIM: During post-amputation recovery or rapid body mass change, residual limb volume can change quickly, requiring frequent adjustments or replacement of the socket to maintain fit. The aim of this pilot test was to evaluate the feasibility of using a three-dimensional-printed insert to extend the service life of a prosthetic socket after substantial residual limb volume loss. TECHNIQUE: One research subject with a well-fitting transtibial prosthetic socket had an oversized socket fabricated to simulate substantial limb volume loss. The digital shapes of the oversized and well-fitting sockets were used to create a three-dimensional-printed insert to restore fit. DISCUSSION: Two-minute walk test distance decreased when using the oversized socket without the insert, but not when using the socket with the insert. Socket comfort score was 8+ under all conditions. These results suggest that three-dimensional-printed inserts may be an effective method of extending the service life of prosthetic sockets when rapid limb volume loss occurs. CLINICAL RELEVANCE: Three-dimensional (3D) printing gives prosthetists a new tool to manage large volume changes without refabricating entire sockets. Sockets can be fabricated in anticipation of volume gain/loss, using replaceable 3D-printed inserts to maintain fit and comfort.

Bimodal ankle-foot prosthesis for enhanced standing stability.

Previous work suggests that to restore postural stability for individuals with lower-limb amputation, ankle-foot prostheses should be designed with a flat effective rocker shape for standing. However, most commercially available ankle-foot prostheses are designed with a curved effective rocker shape for walking. To address the demands of both standing and walking, we designed a novel bimodal ankle-foot prosthesis that can accommodate both functional modes using a rigid foot plate and an ankle that can lock and unlock. The primary objective of this study was to determine if the bimodal ankle-foot system could improve various aspects of standing balance (static, dynamic, and functional) and mobility in a group of Veterans with lower-limb amputation (n = 18). Standing balance was assessed while subjects completed a series of tests on a NeuroCom Clinical Research System (NeuroCom, a Division of Natus, Clackamas, OR), including a Sensory Organization Test, a Limits of Stability Test, and a modified Motor Control Test. Few statistically significant differences were observed between the locked and unlocked ankle conditions while subjects completed these tests. However, in the absence of visual feedback, the locked bimodal ankle appeared to improve static balance in a group of experienced lower-limb prosthesis users whose PLUS-M mobility rating was higher than approximately 73% of the sample population used to develop the PLUS-M survey. Given the statistically significant increase in mean equilibrium scores between the unlocked and locked conditions (p = 0.004), future testing of this system should focus on new amputees and lower mobility users (e.g., Medicare Functional Classification Level K1 and K2 prosthesis users). Furthermore, commercial implementation of the bimodal ankle-foot system should include a robust control system that can automatically switch between modes based on the user's activity.

Mechanical and dynamic characterization of prosthetic feet for high activity users during weighted and unweighted walking.

Many Service members and Veterans with lower-limb amputations have the potential for high function and the desire to resume physically demanding occupations that require them to carry heavy loads (e.g., military service, firefighters, farmers, ranchers, construction workers). However, it is currently unclear which prosthetic feet best accommodate heavy load carriage while also providing good overall function and mobility during unweighted activities. The main objective of this study was to investigate the ability of currently available prosthetic ankle-foot systems to accommodate weighted walking by examining the mechanical characteristics (i.e., forefoot stiffness) and dynamic function (i.e., rocker radius, effective foot length ratio, and late-stance energy return) of prosthetic feet designed for high activity users. Load versus deflection curves were obtained for nine prosthetic ankle-foot systems using a servohydraulic test frame and load cell. Effective roll-over shape characteristics and late-stance energy return measures were then obtained using quantitative gait analysis for three users with unilateral, transtibial amputation. Results from mechanical and dynamic testing showed that although forefoot stiffness varied across the nine feet investigated in this study, changes measured in roll-over shape radius and effective foot length ratio were relatively small in response to weighted walking. At the same time, prosthetic feet with more compliant forefoot keel structures appeared to provide more late-stance energy return compared to feet with stiffer forefoot keel structures. These results suggest that prosthetic ankle-foot systems with compliant forefoot keel structures may better accommodate weighted walking by reducing the metabolic cost of physically demanding activities. However, to more fully understand the biomechanical and functional implications of these results, other factors, such as the residual-limb strength of the user and the overall stiffness profile of the prosthetic foot, should also be considered.

The influence of a hydraulic prosthetic ankle on residual limb loading during sloped walking.

In recent years, numerous prosthetic ankle-foot devices have been developed to address the demands of sloped walking for individuals with lower-limb amputation. The goal of this study was to compare the performance of a passive, hydraulic ankle-foot prosthesis to two related, non-hydraulic ankles based on their ability to minimize the socket reaction moments of individuals with transtibial amputation during a range of sloped walking tasks. After a two-week accommodation period, kinematic data were collected on seven subjects with a transtibial amputation walking on an instrumented treadmill set at various slopes. Overall, this study was unable to find significant differences in the torque at the distal end of the prosthetic socket between an ankle-foot prosthesis with a hydraulic range-of-motion and other related ankle-foot prosthesis designs (rigid ankle, multiaxial ankle) during the single-support phase of walking. In addition, socket comfort and perceived exertion were not significantly different for any of the ankle-foot prostheses tested in this study. These results suggest the need for further work to determine if more advanced designs (e.g., those with microprocessor control of hydraulic features, powered ankle-foot designs) can provide more biomimetic function to prosthesis users.

A drive system to add standing mobility to a manual standing wheelchair.

Current manual standing wheelchairs are not mobile in the standing position. The addition of standing mobility may lead to improved health and function for the user and may increase utilization of standing wheelchairs. In this project, a chain drive system was fitted to a manual standing wheelchair, adding mobility in the standing position. The hand rims are accessible from both seated and standing positions. The prototype uses 16-inch drive wheels in front with casters in the rear. Additional anterior casters are elevated when seated for navigating obstacles and then descend when standing to create a six-wheeled base with extended anterior support. Stability testing shows the center of pressure remains within the base of support when leaning to the sides or front in both seated and standing positions. Four veterans with spinal cord injury provided feedback on the design and reported that mobility during standing was very important or extremely important to them. The veterans liked the perceived stability and mobility of the prototype and provided feedback for future refinements. For example, reducing the overall width (width from hand rim to hand rim) and weight could make this system more functional for users.

Passive prosthetic ankle-foot mechanism for automatic adaptation to sloped surfaces.

This article describes the development of a prototype prosthetic ankle-foot system that passively adapts to surface slopes on each step of walking. Engineering analyses were performed to design the cam clutch and clutch engagement and disengagement mechanism. The prototype was tested by a veteran with a unilateral transtibial amputation. Kinematic and kinetic data were recorded while the subject walked on a treadmill at slopes ranging from -10 degrees to +10 degrees. After each slope condition, the subject rated his level of exertion and socket comfort. The subject reported increased comfort and reduced exertion for downhill slopes when using the prototype compared with his usual prosthesis. The subject also expressed that when walking downhill on the prototype, it was the most comfortable he has ever been in a prosthesis. The prosthetic ankle torque-angle relationship shifted toward dorsiflexion for uphill and toward plantar flexion for downhill slopes when using the prototype, indicating slope adaptation, but this effect did not occur when the subject walked with his usual prosthesis. The prototype also demonstrated late-stance plantar flexion, suggesting the potential for storing and returning more energy than standard lower-limb prostheses.

Elastic head support for persons with amyotrophic lateral sclerosis.

This article describes an inexpensive elastic head support for persons with amyotrophic lateral sclerosis (ALS) and neck muscle weakness and also presents a case series to examine its effectiveness. The device offers support to the head while the user is seated, standing, and walking, providing support for persons in various stages of ALS. The head support system was tested in seven male patients with ALS. Before and after the 2 wk trial, the subjects answered questions related to their communication efficacy, difficulty swallowing, level of neck discomfort, number of hours being upright before neck discomfort, comfort in social settings, and rating of perceived dyspnea. Subjects also answered specific questions related to the elastic head support after the 2 wk trial. The results suggested that the elastic head support is useful for some, but not all, patients.

Effects of a flat prosthetic foot rocker section on balance and mobility.

Previous studies have shown that the effective rocker shape of the physiologic ankle-foot system during standing and fore-aft swaying is much flatter than that used during walking, which indicates a more stable base of support for the standing/swaying activity. Previous work suggests that flat regions within the effective rocker shapes of prosthetic ankle-foot systems could provide enhanced stability for standing balance tasks. An experimental prosthetic foot was altered to provide three different flat region lengths within its effective rocker shape. It was hypothesized that longer flat regions of the effective rocker shape would lead to improved standing balance outcomes and reduced walking performance for unilateral transtibial prosthesis users. However, no significant changes were seen in the balance and mobility outcomes of 12 unilateral transtibial prosthesis users when using the three prosthetic foot conditions. Subjects in the study significantly preferred prosthetic feet with relatively low to moderate flat regions over those with long flat regions. All the subjects without loss of light touch or vibratory sensation selected the prosthetic foot with the shortest flat region. More work is needed to investigate the effects of prosthetic foot properties on balance and mobility of prosthesis users.

Strong two-photon absorption in new asymmetrically substituted porphyrins: interference between charge-transfer and intermediate-resonance pathways.

We study two-photon absorption (2PA) in two series of new free-base porphyrins with 4-(diphenylamino)stilbene or 4,4'-bis-(diphenylamino)stilbene (BDPAS) attached via pi-conjugating linkers at the porphyrin meso-position. We show that this new substitution modality increases the 2PA cross section in the Soret band region (excitation wavelength 750-900 nm) of the core porphyrin by nearly 2 orders of magnitude, from sigma(2) approximately 10 GM for the meso-phenyl-substituted analogue to sigma(2) approximately 10(3) GM for the ethynyl-linked BDPAS-porphyrin dyad. The 2PA properties are quantitatively described by considering two different and interfering 2PA quantum transition pathways. The first path involves virtual transition via intermediate one-photon resonance. The second path bypasses the intermediate resonance and occurs due to a large permanent dipole moment difference between the ground and the final electronic states. To our best knowledge, this is the first experimental observation of the combined effect of these two pathways on one particular two-photon transition, resulting in quantum-interference-modulated 2PA strength.