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Background: Residual limb volume may change after doffing, affecting the limb shape measured and used as a starting point for socket design.Objectives: The purpose of this study was to compare residual limb fluid volume changes after doffing for different test configurations.Study Design: The study was a repeated measures experimental design with three conditions (Sit, Liner, and Walk).Methods: Residual limb fluid volume on 30 people with trans-tibial amputation was measured using bioimpedance analysis. Three tests were conducted--Sit: sit for 10 minutes, remove the prosthesis, socks and liner, sit for 10 minutes; Liner: sit for 10 minutes, remove the prosthesis and socks but not the liner, sit for 10 minutes; Walk: conduct sit, stand and walk activities for 30 minutes, remove the prosthesis, socks and liner, sit for 10 minutes.Results: The percentage fluid volume increase after doffing was significantly higher for Walk (2.8%) than for Sit (1.8%) (p = 0.03). The time to achieve a maximum or stable fluid volume was shorter for Liner (4.3 min) than for Sit (6.6 min) (p = 0.03).Conclusions: Activity before doffing intensified the post-doffing limb fluid volume increase. Maintaining a liner after doffing caused limb fluid volume to stabilize faster than removing the liner. Clinical relevance To minimize residual limb volume increase before casting or imaging, practitioners should have patients sit with their prosthesis donned for 10 minutes. Leaving a liner on the residuum will not reduce the post-doffing volume increase, but it will help to more quickly achieve a consistent limb fluid volume. [ABSTRACT FROM AUTHOR]

Background: A limitation of tether lanyards is that fastening and unfastening the tether from the liner, which needs to be performed to clean or replace the liner, is difficult for some users., Objective: The purpose of this research was to create a quick connect that allows users to easily attach and detach the tether from the liner., Study Design: Mechanical testing and pilot study., Methods: A slide-and-lock mechanism was used. To operate the quick connect, the prosthesis user turns open the lock, slides it onto a short pin extending from the liner, and releases the mechanism, causing it to spring back to the locked position., Results: Mechanical tests demonstrated that the system well-tolerated tensile loads of 25,000 cycles at 100 N and single cycles at 350 N. Five transtibial users trialed the system and took between 2 and 30 s to fasten and unfasten the quick connect. They found the quick connect intuitive to use, secure, relatively quiet, and stable. However, they preferred their traditional pin lock over the quick connect system, mainly because the quick connect required a multistep procedure (twist-align-slide) that they considered more complex than operating the locking pin to which they were accustomed., Conclusions: In its current form, the quick connect is likely to be used by limited community ambulators who struggle with the pin lock donning procedure. It also has potential use with powered tethers that use a motor to adjust tether length., (Copyright © 2023 International Society for Prosthetics and Orthotics.)

It is essential that people with limb amputation maintain proper prosthetic socket fit to prevent injury. Monitoring and adjusting socket fit, for example by removing the prosthesis to add prosthetic socks, is burdensome and can adversely affect users' function and quality-of-life. This study presents results from take-home testing of a motor-driven adaptive socket that automatically adjusted socket size during walking. A socket fit metric was calculated from inductive sensor measurements of the distance between the elastomeric liner surrounding the residual limb and the socket's inner surface. A proportional-integral controller was implemented to adjust socket size. When tested on 12 participants with transtibial amputation, the controller was active a mean of 68% of the walking time. In general, participants who walked more than 20 min/day demonstrated greater activity, less doff time, and fewer manual socket size adjustments for the adaptive socket compared with a locked non-adjustable socket and a motor-driven socket that participants adjusted with a smartphone application. Nine of 12 participants reported that they would use a motor-driven adjustable socket if it were available as it would limit their socket fit issues. The size and weight of the adaptive socket were considered the most important variables to improve., (© 2024. The Author(s).)

Introduction: Low-level distal weight bearing in transtibial prosthesis users may help maintain perfusion and improve both proprioception and residual limb tissue health., Methods: The primary objectives of this research were to develop a sensor to continuously measure distal weight bearing, evaluate how prosthesis design variables affected weight bearing levels, and assess fluctuations in distal weight bearing during at-home and community use., Results: In-lab testing on a small group of participants wearing adjustable sockets demonstrated that if distal contact was present, when socket size was increased distal weight bearing increased and when socket size was reduced distal weight bearing decreased. During take-home use, participants accepted the distal weight bearing level set by the research team. It ranged between 1.1% and 6.4% BW for all days tested. The coefficient of variation (standard deviation/mean) ranged from 25% to 43% and was expected due in part to differences in walking style, speed, terrain, direction of ambulation, and bout duration. Two participants commented that they preferred presence of distal weight bearing to non-presence., Discussion: Next steps in this research are to develop clinical practices to determine target distal weight bearing levels and ranges, and to simplify the design of the sensor and weight bearing adjustment mechanism for clinical use., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023 Krout, Weissinger, Mertens, Allyn, Larsen, McCarthy, Garbini and Sanders.)

Background: A challenge often faced by people with lower extremity amputation is management of prosthetic socket fit due to changes in fluid volume within their residual limb. Prior research suggests that intermittently doffing the prosthetic socket may help stabilize daily residual limb fluid volume., Methods: To assess the effects of partial doff duration on residual limb fluid volume retention, participants with transtibial amputation were tested by walking on a treadmill in a controlled, laboratory setting under three conditions. An automated system to release the locking pin and enlarge the socket was used to produce the partial doffing. Percent limb fluid volume changes after partial doffing for 4 min (Short Rest) and for 10 min (Long Rest) were compared with no partial doffing (No Release). Limb fluid volume was monitored using bioimpedance analysis., Findings: Mean percent fluid volume changes in the posterior region were  -1.2% for No Release, 2.7% for Short Rest, and 1.0% for Long Rest. Short and Long Rests had larger increases than No Release (P = 0.005 and 0.03, respectively); Short and Long Rests were not statistically different (P = 0.10). Eight of the thirteen participants experienced a higher percent fluid volume gain for both release protocols while four experienced a higher percent fluid volume gain for only one release protocol., Interpretation: A partial doff duration as short as 4 min may be an effective strategy to stabilize limb fluid volume in prosthesis users with transtibial amputation. Trials in at-home settings should be pursued., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Introduction: The purpose of this study was to test a novel activity monitor that tracks the time a prosthesis is worn, and the nature of the ambulatory activity conducted with the prosthesis. These capabilities allow prosthesis users' wear and accommodation practices (e.g., temporary doffing) to be monitored, and the intensity of their activities to be assessed., Methods: A portable limb-socket motion sensing system was used to monitor doffs, walk bouts (≥5 steps), low locomotion (2-4 steps), stationary positions, and weight shifts in a group of transtibial prosthesis users. The relationship between doff time and active motion time was investigated, and durations of low and high intensity active motions were compared., Results: For the 14 participants tested, the median prosthesis day duration ranged from 12.8-18.8 h. Eleven participants typically doffed five or fewer times per day, and three participants typically doffed 10 or more times per day. Nine participants demonstrated a positive correlation between daily doff duration and active motion duration. Six participants spent more time in weight shifts than walk bouts, while eight participants spent more time in walk bouts than weight shifts., Conclusion: Capturing don time and temporary doffs and distinguishing weight shifts from walks may provide insight relevant to patient care. Longer-term monitoring studies should be conducted, and the clinical utility of the data evaluated., Competing Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2023.)

Competing Interests: Authors state no conflicts of interest.

A novel method is described to connect a prosthetic liner to the panels of an adjustable socket to facilitate limb fluid volume stabilization in prosthesis users. Magnets are placed in the socket panels, and iron powder is embedded in the user's prosthetic liner. When the magnet is in close proximity to the liner, a firm connection is formed. The system's capability to execute panel pull on transtibial prosthesis users was tested. The backs of the panels were supported by a bracket mounted to the external surface of the socket that allowed the radial position of the panels to be adjusted. Bench testing demonstrated an optimized strength-to-weight ratio using 1.27-cm thick annular-shaped magnets supported by 0.32-cm thick backplates. Testing on four people with transtibial amputation showed that the maximum socket increase achieved using magnetic panel pull ranged from 5.3% to 13.8% of the initial (panels flush) socket volume. The results indicate that magnetic panel pull induces a meaningful increase in socket volume during sitting. The clinical relevance is a novel strategy that may help stabilize prosthesis users' limb fluid volume over the day., Competing Interests: Declaration of Competing Interest None declared., (Copyright © 2022 IPEM. Published by Elsevier Ltd. All rights reserved.)

Background: Step activity monitors provide insight into the amount of physical activity prosthesis users conduct but not how they use their prosthesis. The purpose of this research was to help fill this void by developing and testing a technology to monitor bodily position and type of activity., Methods: Thin inductive distance sensors were adhered to the insides of sockets of a small group of transtibial prosthesis users, two at proximal locations and two at distal locations. An in-lab structured protocol and a semi-structured out-of-lab protocol were video recorded, and then participants wore the sensing system for up to 7 days. A data processing algorithm was developed to identify sit, seated shift, stand, standing weight-shift, walk, partial doff, and non-use. Sensed distance data from the structured and semi-structured protocols were compared against the video data to characterize accuracy. Bodily positions and activities during take-home testing were tabulated to characterize participants' use of the prosthesis., Findings: Sit and walk detection accuracies were above 95% for all four participants tested. Stand detection accuracy was above 90% for three participants and 62.5% for one participant. The reduced accuracy may have been due to limited stand data from that participant. Step count was not proportional to active use time (sum of stand, walk, and standing weight-shift times)., Interpretation: Step count may provide an incomplete picture of prosthesis use. Larger studies should be pursued to investigate how bodily position and type of activity may facilitate clinical decision-making and improve the lives of people with lower limb amputation., Competing Interests: Declaration of Competing Interest None, (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Introduction: The most suitable elevated vacuum (EV) pressure may differ for each individual prosthesis user depending on suspension needs, socket fit, prosthetic components, and health. Mechanical and physiological effects of EV were evaluated in an effort to determine the optimal vacuum pressure for three individuals., Methods: Instrumented EV sockets were created based on the participants' regular EV sockets. Inductive distance sensors were embedded into the wall of the socket at select locations to measure limb movement relative to the socket. Each participant conducted an activity protocol while limb movement, limb fluid volume, and user-reported comfort were measured at various socket vacuum pressure settings., Results: Increased socket vacuum pressure resulted in reduced limb-socket displacement for each participant; however, 81-93% of limb movement was eliminated by a vacuum pressure setting of 12 (approximately -9 inHg). Relative limb-socket displacement by sensor location varied for each participant, suggesting distinct differences related to socket fit or residual limb tissue content. The rate of limb fluid volume change and the change in socket comfort did not consistently differ with socket vacuum pressure, suggesting a more complex relationship unique to each individual., Conclusions: Practitioners may use individual responses to optimize socket vacuum pressure settings, balancing mechanical and physiological effects of EV for improved clinical outcomes., Competing Interests: Conflict of Interest: Authors state no conflicts of interest.

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., Competing Interests: Declarations of Conflicting interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: MW, EF, ZT, AA, and JC are all employees of WillowWood., (© The Author(s) 2022.)

The purpose of this research was to pursue an innovative cyclic panel-pull strategy during ambulation to minimize limb fluid volume loss in transtibial prosthesis users. Participants' traditional socket shapes were duplicated, and test sockets prepared with three adjustable motor-driven panels that were controlled by a microprocessor. After donning the prosthesis, participants' liners were fastened to the panels. During a 40 min test session, participants conducted three cycles of sitting (5 min) and walking (8 min). During the 5th and 6th min of each cycle of walking, the panels were cyclically pulled outward in late stance phase, decreasing pressure on the residual limb. Panels were returned to their original position in swing phase. Eight of twelve participants gained more fluid volume while walking when panel-pull was added than when it was removed. When the liner was uncoupled from the panels and panel-pull was executed, eight of twelve participants gained less fluid volume compared to when the liner was fastened to the panels. Panel-pull may facilitate limb fluid volume retention in transtibial prosthesis users. Efforts to simplify the design so that it can be implemented in long-term testing during at-home use should be considered., (Copyright © 2022 IPEM. Published by Elsevier Ltd. All rights reserved.)

Introduction: A challenge in the engineering of auto-adjusting prosthetic sockets is to maintain stable operation of the control system while users change their bodily position and activity. The purpose of this study was to test the stability of a socket that automatically adjusted socket size to maintain fit. Socket release during sitting was conducted between bouts of walking., Methods: Adjustable sockets with sensors that monitored distance between the liner and socket were fabricated. Motor-driven panels and a microprocessor-based control system adjusted socket size during walking to maintain a target sensed distance. Limb fluid volume was recorded continuously. During eight sit/walk cycles, the socket panels were released upon sitting and then returned to position for walking, either the size at the end of the prior bout or a size 1.0% larger in volume., Results: In six transtibial prosthesis users, the control system maintained stable operation and did not saturate (move to and remain at the end of the actuator's range) during 98% of the walking bouts. Limb fluid volume changes generally matched the panel position changes executed by the control system., Conclusions: Stable operation of the control system suggests that the auto-adjusting socket is ready for testing in users' at-home settings., Competing Interests: Declaration of Conflicting Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2022.)

Competing Interests: Authors state there are no potential conflicts of interest.

Management of socket fit is challenging for people using lower-limb prostheses because of residual limb volume fluctuation throughout the day. Releasing socket pressures during sitting (partial doffing) may help users increase their limb volume after they have undergone volume loss earlier in the day. The purpose of this research was to develop and evaluate a system to allow for quick and easy locking pin and socket panel release during sitting and relock upon standing. The system was to allow the partial doff tether length to be custom set for each user, accomplish release and relock in less than 2.0 s each, require only one hand, and require a finger push force comparable to a push button on a phone. A motor-driven release/relock system (<240 g build weight) housed within the socket adjusts locking pin tether length, and an instrumented ratcheting dial adjusts socket panel position. Three participants with a trans-tibial amputation operated the system properly using one hand. For a partial doff, users preferred a tether length between 5 and 6 cm. All users executed release within 1.5 s and relock within 1.5 s., Competing Interests: Declaration of Competing Interest None, (Copyright © 2021. Published by Elsevier Ltd.)

Background: Management of fluid in the limbs is a challenge faced by people with disabilities. In prosthetics, a means for transtibial prosthesis users to stabilize their residual limb fluid volume during the day may improve socket fit., Objective: To determine if releasing the panels and locking pin of a cabled-panel adjustable socket during socket release significantly improved limb fluid volume recovery and retention over releasing the panels alone., Design: Repeated-measures experiment to assess the effects on limb fluid volume retention., Setting: Participants were tested in a laboratory setting while walking on a treadmill., Intervention: Release of a locking pin tether during sitting as a limb volume accommodation strategy., Main Outcome Measure: Percent limb fluid volume retention for panel and pin release compared with panel release alone at 2 minutes (short term) and 50 minutes (long term) after subsequent activity. Limb fluid volume was monitored using bioimpedance analysis., Results: Median percent limb fluid volume retention for the panel and pin release was significantly greater than panel release alone for both anterior and posterior regions for the long term (P = .0499 and .0096, respectively) but not the short term (P = .0712 and .1580, respectively)., Conclusion: Augmenting panel release with pin release may be an effective accommodation strategy for prosthesis users with transtibial amputation to better retain limb fluid volume., (© 2020 American Academy of Physical Medicine and Rehabilitation.)

Elevated vacuum (EV) is suggested to improve suspension and limb volume management for lower limb prosthesis users. However, few guidelines have been established to facilitate configuration of EV sockets to ensure their safe and proper function. A benchtop model of an EV socket was created to study how prosthetic liner tensile elasticity, socket fit, and socket vacuum pressure affect liner displacement and subsequent pressure on the residual limb. A domed carbon fiber layup was used to represent an EV socket. Inserts were used to simulate various air gaps between the socket and liner. Various prosthetic liner samples were placed under the carbon fiber layup. Liner displacement and the corresponding pressure change underneath the liner were measured as vacuum was applied between the liner sample and socket wall. Tissue vacuum pressure increased linearly with socket vacuum pressure until the liner contacted the socket wall. Predicted tissue vacuum pressure matched well with experimental results. Findings suggest that the effect of vacuum pressure on the residual limb is primarily determined by air gap distance. The developed model may be used to assess effects of EV on residual limb tissues based on an individual's socket fit, liner characteristics, and applied vacuum. Understanding the physiological effects of EV on the residual limb could help practitioners avoid blister formation and improve EV implementation., Competing Interests: Declaration of Competing Interest The authors declare no conflict of interest., (Copyright © 2020 IPEM. Published by Elsevier Ltd. All rights reserved.)

Background: Residual limb volume loss is a source of prosthetic socket fit problems in people with lower-limb amputation. The aim of this study was to investigate a novel volume recovery strategy for people with trans-tibial amputation., Methods: Test sockets for people with trans-tibial amputation were created that allowed panels of an adjustable socket and the underlying elastomeric liner to be pulled radially outward, using small motors mounted to the socket. One Control and one Intervention session were conducted with each participant. During Intervention sessions, panel-pull was executed during the sits of a multi-cycle sit/walk protocol. No panel-pull was executed during the Control sessions. Residual limb fluid volume was monitored in anterior and posterior regions using bioimpedance analysis., Findings: Results from 12 participants demonstrated that short-term (12 min after the intervention was applied) median posterior residual limb fluid volume change for Intervention (0.44%) was higher than that for Control (-0.02%) (P = .015). Long-term (40 min after the intervention was applied) median posterior residual limb fluid volume change for Intervention (0.95%) was higher than that for Control (-0.26%) (P = .002)., Interpretation: If a panel-pull mechanism that was easy to assemble and operate could be created, then panel-pull may be an effective accommodation strategy to reduce daily limb volume loss in trans-tibial prosthesis users., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Background: Previous studies investigating limb volume change with elevated vacuum have shown inconsistent results and have been limited by out-of-socket volume measurements and short, single-activity protocols., Objectives: To evaluate the effectiveness of elevated vacuum for managing limb fluid volume compared to suction suspension with an in-socket measurement modality during many hours of activity., Study Design: Fixed-order crossover design with a standardized out-of-laboratory activity protocol., Methods: Transtibial electronic elevated vacuum users participated in two sessions. Elevated vacuum was used during the first session, and suction suspension in the second. Participants completed a 5.5-h protocol consisting of multiple intervals of activity. In-socket residual limb fluid volume was continuously measured using a custom portable bioimpedance analyzer., Results: A total of 12 individuals participated. Overall rate of fluid volume change was not significantly different, though the rate of posterior fluid volume change during Cycle 3 was significantly lower with elevated vacuum. Although individual results varied, 11 participants experienced lower overall rates of fluid volume loss in at least one limb region using elevated vacuum., Conclusion: Elevated vacuum may be more effective as a volume management strategy after accumulation of activity. Individual variation suggests the potential to optimize the limb fluid volume benefits of elevated vacuum by reducing socket vacuum pressure for some users., Clinical Relevance: A better understanding of how elevated vacuum (EV) affects residual limb fluid volume will allow prosthetists to make more informed clinical decisions regarding accommodation strategies designed to improve daily socket fit.

Background: Strategies to maintain prosthesis users' daily limb volume are needed., Objectives: Test how intermittent incremental socket volume adjustments affect limb fluid volume and limb-socket distance., Study Design: Repeated measures., Methods: People with transtibial limb loss walked on an outdoor trail wearing a motor-driven adjustable socket that they adjusted a small amount, approximately 0.3% socket volume, every 2 min using a mobile phone app. Limb fluid volume and sensed distance between the socket and a target in their elastomeric liner were monitored. A gradual socket enlargement phase was followed by a gradual socket reduction phase., Results: An incremental socket enlargement significantly increased limb fluid volume ( p  < 0.001) but not sensed distance ( p  = 0.063). An incremental socket reduction significantly decreased both limb fluid volume ( p  < 0.001) and sensed distance ( p  < 0.001)., Conclusion: Participants' residual limb fluid volume increases during ambulation compensated for incremental socket volume increases. For incremental socket volume decreases, residual limb fluid volume decreases did not compensate and the socket fit became tighter., Clinical Relevance: Results support the hypothesis that for people without co-morbidities, intermittent incremental socket volume enlargements are an effective accommodation strategy to increase limb fluid volume while maintaining socket fit. Intermittent incremental socket volume reductions decreased limb fluid volume but also made the socket fit tighter.

Background: Loss of residual limb volume degrades socket fit and may require accommodation., Objectives: To examine if either of two accommodation strategies executed during resting, socket release with full socket size return and socket release with partial socket size return, enhanced limb fluid volume retention during subsequent activity., Study Design: Two repeated-measures experiments were conducted to assess the effects of socket release on limb fluid volume retention., Methods: Limb fluid volume was monitored while participants wore a socket with a single adjustable panel. Participants performed eight activity cycles that each included 10 min of sitting and 2 min of walking. The socket's posterior panel and pin lock were released during the fifth cycle while participants were sitting. In one experiment (Full Return), the socket was returned to its pre-release size; in a second experiment (Partial Return), it was returned to 102% of its pre-release size. Short-term and long-term limb fluid volume retention were calculated and compared to a projected, No Intervention condition., Results: Partial Return and Full Return short-term retentions and Partial Return long-term retention were greater than those projected under the control condition ( p < 0.05)., Conclusion: Socket release during resting after activity, particularly when the socket is returned to a slightly larger size, may be an effective accommodation strategy to reduce fluid volume loss in transtibial prosthesis users., Clinical Relevance: This study suggests that existing prosthetic technologies' adjustable sockets and locking pin tethers can be used in novel ways to help maintain residual limb fluid volume in active prosthesis users.

Background:: The volume of a prosthesis user's residual limb changes during the day and may affect the fit of the prosthesis. These changes must be managed by the user to prevent discomfort, skin breakdown, and falls., Objectives:: The objectives were to test how activity, time of day, and intermittent doffing affected residual limb fluid volume in people with transtibial amputation., Study Design:: Standardized, repeated measure (A-B-A) out-of-laboratory protocol., Methods:: Participants with transtibial amputation completed three 6-h test sessions. Two sessions served as controls (A protocol) during which participants left their prosthesis donned, and one session was an intervention (B protocol) where participants doffed their prosthesis twice for 20 min during the 6 h of testing. Within-socket fluid volume was measured using a custom portable bioimpedance analysis system., Results:: A total of 13 participants completed the study. The rate of limb fluid volume loss was higher early in the session compared with late in the session. Participants experienced less fluid volume loss during high activity than low activity. Socket users with pin suspension experienced less posterior fluid volume loss when they intermittently doffed their prosthesis. Intermittent doffing did not benefit limb fluid volume of mechanical vacuum and suction suspension users., Conclusion:: High activity may reduce fluid volume loss compared with low activity. Intermittent doffing may provide volume accommodation for transtibial prosthesis users with pin suspension., Clinical Relevance: Prosthetists should query their patients about the intensity of activity they conduct when advising them on limb volume management. Patients using sockets with pin suspension may be able to offset limb fluid volume loss by periodically doffing the prosthesis.

Background: Fluctuations in limb volume degrade prosthesis fit and require users to accommodate changes using management strategies, such as donning and doffing prosthetic socks., Objectives: To examine how activities and self-report outcomes relate to daily changes in residual limb fluid volume and volume accommodation., Study Design: Standardized, two-part laboratory protocol with an interim observational period., Methods: Participants were classified as "accommodators" or "non-accommodators," based on self-report prosthetic sock use. Participants' residual limb fluid volume change was measured using a custom bioimpedance analyzer and a standardized in-laboratory activity protocol. Self-report health outcomes were assessed with the Socket Comfort Score and Prosthesis Evaluation Questionnaire. Activity was monitored while participants left the laboratory for at least 3 h. They then returned to repeat the bioimpedance test protocol., Results: Twenty-nine people were enrolled. Morning-to-afternoon percent limb fluid volume change per hour was not strongly correlated to percent time weight-bearing or to self-report outcomes. As a group, non-accommodators ( n = 15) spent more time with their prosthesis doffed and reported better outcomes than accommodators., Conclusion: Factors other than time weight-bearing may contribute to morning-to-afternoon limb fluid volume changes and reported satisfaction with the prosthesis among trans-tibial prosthesis users. Temporary doffing may be a more effective and satisfying accommodation method than sock addition. Clinical relevance Practitioners should be mindful that daily limb fluid volume change and prosthesis satisfaction are not dictated exclusively by activity. Temporarily doffing the prosthesis may slow daily limb fluid volume loss and should be investigated as an alternative strategy to sock addition.

Background: Through play, children develop motor, cognitive, social, and other life skills. Play barriers can impede physical and psychosocial benefits., Objectives: We describe participation in active play, fundamental movement skills, play environment characteristics, and potential play barriers for school-aged children (6-12 years) who use lower extremity prostheses., Study Design: Cross-sectional questionnaire study., Methods: A questionnaire was developed and administered online to parents of children 6-12 years who use lower extremity prostheses. Questions focused on children's valued play activities, participation in active play, fundamental movement skills, body positions for play, and characteristics of play environments., Results: Parents (n = 26) reported their children who use lower extremity prostheses participated in a range of activities including active play (e.g. playgrounds, swimming). Fundamental movement skill limitations were identified (e.g. walking long distances, running fast, hopping on one foot, and skipping). Mobility limitations with floor positions, movement transitions, and uneven or sloped surfaces were reported. Active play with equipment such as roller skating, climbing structures, and bicycling presented challenges., Conclusion: Parents of children who use lower extremity prostheses reported participation restrictions associated with mobility limitations, activity type, and built environment characteristics (e.g. surfaces and equipment). Challenges made it difficult for children who use lower extremity prostheses to keep up with peers in schools and communities. Clinical relevance Understanding potential barriers to participation in active play of children who use lower extremity prostheses may contribute to enhanced prosthetic design, rehabilitation strategies, universal design of play and built environments, and improved outcome measures ultimately enabling these children to participate fully in active play in diverse contexts.

People with transtibial amputation often experience skin breakdown due to the pressures and shear stresses that occur at the limb-socket interface. The purpose of this research was to create a transtibial finite element model (FEM) of a contemporary prosthesis that included complete socket geometry, two frictional interactions (limb-liner and liner-socket), and an elastomeric liner. Magnetic resonance imaging scans from three people with characteristic transtibial limb shapes (i.e., short-conical, long-conical, and cylindrical) were acquired and used to develop the models. Each model was evaluated with two loading profiles to identify locations of focused stresses during stance phase. The models identified five locations on the participants' residual limbs where peak stresses matched locations of mechanically induced skin issues they experienced in the 9 months prior to being scanned. The peak contact pressure across all simulations was 98 kPa and the maximum resultant shear stress was 50 kPa, showing reasonable agreement with interface stress measurements reported in the literature. Future research could take advantage of the developed FEM to assess the influence of changes in limb volume or liner material properties on interface stress distributions. Graphical abstract Residual limb finite element model. Left: model components. Right: interface pressures during stance phase.

The objective of this research was to investigate a strategy for designing and fabricating computer-manufactured socket inserts that were embedded with sensors for field monitoring of limb-socket interactions of prosthetic users. An instrumented insert was fabricated for a single trans-tibial prosthesis user that contained three sensor types (proximity sensor, force sensing resistor, and inductive sensor), and the system was evaluated through a sequence of laboratory clinical tests and two days of field use. During in-lab tests 3 proximity sensors accurately distinguish between don and doff states; 3 of 4 force sensing resistors measured gradual pressure increases as weight-bearing increased; and the inductive sensor indicated that as prosthetic socks were added the limb moved farther out of the socket and pistoning amplitude decreased. Multiple sensor types were necessary in analysis of field collected data to interpret how sock changes affected limb-socket interactions. Instrumented socket inserts, with sensors selected to match clinical questions of interest, have the potential to provide important insights to improve patient care., (Copyright © 2017 IPEM. Published by Elsevier Ltd. All rights reserved.)

The purpose of this research was to conduct a preliminary effort to identify quantitative metrics to distinguish a good socket from an oversized socket in people with trans-tibial amputation. Results could be used to inform clinical practices related to socket replacement. A cross-over study was conducted on community ambulators (K-level 3 or 4) with good residual limb sensation. Participants were each provided with two sockets, a duplicate of their as-prescribed socket and a modified socket that was enlarged or reduced by 1.8mm (∼6% of the socket volume) based on the fit quality of the as-prescribed socket. The two sockets were termed a larger socket and a smaller socket. Activity was monitored while participants wore each socket for 4 weeks. Participants' gait; self-reported satisfaction, quality of fit, and performance; socket comfort; and morning-to-afternoon limb fluid volume changes were assessed. Visual analysis of plots and estimated effect sizes (measured as mean difference divided by standard deviation) showed largest effects for step time asymmetry, step width asymmetry, anterior and anterior-distal morning-to-afternoon fluid volume change, socket comfort score, and self-reported utility. These variables may be viable metrics for early detection of deterioration in socket fit, and should be tested in a larger clinical study., (Copyright © 2017 IPEM. Published by Elsevier Ltd. All rights reserved.)

Background: A diverse range of elastomeric liner products are available to people with transtibial amputation. However, little information is available about how prosthetists select the product best suited to each patient., Objectives: To determine how prosthetists obtain information about liners, which features are most relevant to the selection process, and which products are used most for patients with transtibial amputation., Study Design: Cross-sectional survey., Methods: A custom online survey was developed to solicit information about prosthetists' liner selection practices. Prosthetists with experience managing transtibial patients were recruited via advertisements posted in magazines, at conferences, and on a listserv. Responses were analyzed to characterize prosthetists' liner selection practices., Results: Data from 106 experienced prosthetists (mean age: 44.4 years, mean experience: 15.7 years) were included. Most prosthetists (94%) obtained liner information from manufacturer representatives, websites, or literature. On average, respondents factored nine different liner characteristics into their selection processes. Prosthetists reported experience with 16 unique liner products with their transtibial patients, but routinely used fewer than 3., Conclusion: Although many different prosthetic liners are available, prosthetists regularly use only a few select liner products. Tools or strategies to objectively compare prosthetic liners across manufacturers are likely needed to facilitate more diverse prescription practices. Clinical relevance Knowledge of prosthetists' prosthetic liner selection practices may guide development of evidence-based resources or tools to facilitate matching patients with appropriate liners. Results of this study may also inform researchers and manufacturers about desirable liner characteristics and direct development of novel liner products to address prosthetists' clinical needs.

The objective of this research was to use computer-aided design software and a tabletop 3-D additive manufacturing system to design and fabricate custom plastic inserts for trans-tibial prosthesis users. Shape quality of inserts was tested right after they were inserted into participant's test sockets and again after four weeks of wear. Inserts remained properly positioned and intact throughout testing. Right after insertion the inserts caused the socket to be slightly under-sized, by a mean of 0.11mm, approximately 55% of the thickness of a nylon sheath. After four weeks of wear the under-sizing was less, averaging 0.03mm, approximately 15% of the thickness of a nylon sheath. Thus the inserts settled into the sockets over time. If existing prosthetic design software packages were enhanced to conduct insert design and to automatically generate fabrication files for manufacturing, then computer manufactured inserts may offer advantages over traditional methods in terms of speed of fabrication, ease of design, modification, and record keeping., (Copyright © 2016 IPEM. Published by Elsevier Ltd. All rights reserved.)

Background: Lower-limb prosthesis users typically experience residual limb volume losses over the course of the day that can detrimentally affect socket fit., Objectives: To determine whether temporarily doffing the prosthesis encouraged residual limb fluid volume recovery and whether the recovered fluid was maintained., Study Design: Experimental design., Methods: Residual limb fluid volume was monitored on 16 participants in three test sessions each. Participants conducted six cycles of resting/standing/walking. Between the third and fourth cycles, participants sat for 30 min with the prosthesis and liner: donned (ON), the prosthesis doffed but the liner donned (LINER), or the prosthesis and liner doffed (OFF)., Results: Percentage fluid volume gain and retention were greatest for the OFF condition followed by the LINER condition. Participants experienced fluid volume losses for the ON condition., Conclusion: Doffing the prosthesis or both the prosthesis and liner during rest improved residual limb fluid volume retention compared with leaving the prosthesis and liner donned., Clinical Relevance: Practitioners should advise patients who undergo high daily limb volume losses to consider temporarily doffing their prosthesis. Fluid volume retention during subsequent activity will be highest if both the prosthesis and liner are doffed., (© The International Society for Prosthetics and Orthotics 2015.)

For people who wear a prosthetic limb, residual-limb fluid volume loss during the day may be problematic and detrimentally affect socket fit. The purpose of this research was to test the capability of a novel liner with adjustable bladders positioned within its wall to mitigate volume loss and facilitate limb fluid volume recovery and retention. Bioimpedance analysis was used to monitor fluid volume changes in the anterior and posterior residual limb of participants with transtibial amputation. Participants underwent six cycles of sitting for 90 s, standing for 90 s, and walking for 5 min with liquid within the bladder-liners. Between the third and fourth cycles, participants sat for 10 min with liquid left within the bladders (Liquid-In) or removed (Liquid-Out). Results showed that participants recovered more fluid volume during the 10 min of sitting with Liquid-Out than Liquid-In (p = 0.09 for anterior and p = 0.04 for posterior). However, those fluid volume recoveries were not well retained in the short term (after the fourth cycle) or the long term (after the sixth cycle). Physiologic differences between sessions, reflected in the rates of fluid volume change at the outset of the session, and excessive stiffness of the bladder-liners may have affected fluid volume retentions.

Background: Daily changes in the shape and size of the residual limb affect prosthetic socket fit. Prosthetic socks are often added or removed to manage changes in limb volume. Little has been published about how persons with transtibial amputations use socks to manage diurnal changes in volume and comfort., Objectives: To investigate prosthetic sock use with a customized, self-report questionnaire., Study Design: Cross-sectional survey., Methods: Persons with transtibial amputation reported number, thickness, and timing of socks used over a 14-day period., Results: Data from 23 subjects (16 males and 7 females) were included. On average, socks were changed less than once per day (0.6/day) and ply increased over the day (4.8-5.5 ply). Subjects wore prostheses significantly longer (15.0-14.1 h, p = 0.02) and changed socks significantly more often (0.6/day-0.4/day, p = 0.03) on weekdays compared to weekends. Participants were also divided into two subgroups: those who used socks to manage limb volume and those who used socks for socket comfort. Sock use did not differ (p > 0.05) between subgroups., Conclusions: Sock changes are infrequent among persons with lower limb loss. Initial, verbal reports of sock use were often inconsistent with data measured by logs. Tools (e.g. sock logs or objective instruments) to better understand sock-use habits among persons with limb loss are needed., Clinical Relevance: Knowledge of prosthetic patients' sock use may help practitioners enhance volume management strategies or troubleshoot fitting issues. Results showed that subjects generally added socks to account for volume loss, and end-of-day sock thickness frequently exceeded 5 ply. Use of sock logs in clinical practice may facilitate improved residual limb health., (© The International Society for Prosthetics and Orthotics 2013.)

The purpose of this research was to determine how fluid volume changes in the residual limbs of people with transtibial amputation were affected by activity during test sessions with equal durations of resting, standing, and walking. Residual limb extracellular fluid volume was measured using biompedance analysis in 24 participants. Results showed that all subjects lost fluid volume during standing with equal weight-bearing, averaging a loss rate of -0.4%/min and a mean loss over the 25 min test session of 2.6% (standard deviation [SD] 1.1). Sixteen subjects gained limb fluid volume during walking (mean gain of 1.0% [SD 2.5]), and fifteen gained fluid volume during rest (mean gain of 1.0% [SD 2.2]). Walking explained only 39.3% of the total session fluid volume change. There was a strong correlation between walk and rest fluid volume changes (-0.81). Subjects with peripheral arterial disease experienced relatively high fluid volume gains during sitting but minimal changes or losses during sit-to-stand and stand-to-sit transitioning. Healthy female subjects experienced high fluid volume changes during transitioning from sit-to-stand and stand-to-sit. The differences in fluid volume response among subjects suggest that volume accommodation technologies should be matched to the activity-dependent fluid transport characteristics of the individual prosthesis user.

The purpose of this research was to determine whether prior activity affected the shape of a plaster cast taken of a transtibial residual limb. Plaster casts were taken twice on one day in 24 participants with transtibial limb loss, with 5 s between doffing and casting in one trial (PDI-5s) and 20 min in the other trial (PDI-20m). The ordering of the trials was randomized. The mean +/- standard deviation radial difference between PDI-20m and PDI-5s was 0.34 +/- 0.21 mm when PDI-5s was conducted first and -0.02 +/- 0.20 mm when PDI-20m was conducted first. Ordering of the trials had a statistically significant influence on the mean radial difference between the two shapes (p = 0.008). The result shows that prior activity influenced the residual limb cast shape. Practitioners should be mindful of prior activity and doffing history when casting an individual's limb for socket design and prosthetic fitting.

Adding and removing liquid from socket bladders is a means for people with limb loss to accommodate residual-limb volume change. We fit 19 people with transtibial amputation using their regular prosthetic socket with fluid bladders on the inside socket surface to undergo cycles of bladder liquid addition and removal. In each cycle, subjects sat, stood, and walked for 90 s with bladder liquid added, and then sat, stood, and walked for 90 s again with the bladder liquid removed. The amount of bladder liquid added was increased in each cycle. We used bioimpedance analysis to measure residual-limb fluid volume. Results showed that the preferred bladder liquid volume was 16.8 +/- 8.4 mL (mean +/- standard deviation), corresponding with 1.7% +/- 0.8% of the average socket volume between the bioimpedance voltage-sensing electrodes. Residual-limb fluid volume driven out of the residual limb when bladder liquid was added was typically not recovered upon subsequent bladder liquid removal. Of the 19 subjects, 15 experienced a gradual residual-limb fluid volume loss over the test session. Care should be taken when implementing adjustable socket technologies in people with limb loss. Reducing socket volume may accentuate residual-limb fluid volume loss.

The purpose of this research was to investigate rates of residual-limb fluid volume change within one day for people with transtibial limb loss. Rates of fluid volume change during 30 min test sessions of sitting, standing, and walking activities were measured twice a day, once in the morning and once in the afternoon, on 12 regular prosthesis users with the use of bioimpedance analysis. Between test sessions, all subjects consumed food and drink, and subject activity ranged from low to high. The rate of fluid volume change within sessions ranged from -8.5 to 5.9 %/h (median: -2.2%/h). The rate of fluid volume change between sessions ranged from -2.7 to 0.9 %/h (median: -1.0%/h). The between-session rate of fluid volume change correlated highly with afternoon within-session rates of change (r = 0.9) but was not well correlated with morning within-session rates of change (r = 0.8). Subjects with peripheral arterial complications showed greater fluid volume loss rates during test sessions than between sessions. Rate of fluid volume change may be affected by sitting, standing, and walking activities; presence of peripheral arterial complications; being female; time since amputation; and wearing the socket without doffing for extended periods.

The purpose of this research was to investigate the influence of sock addition and removal on residual-limb fluid volume in people using prosthetic limbs. We used bioimpedance analysis to measure residual-limb extracellular fluid volume on 28 transtibial amputee subjects during 30 min test sessions. Upon addition of a one-ply polyester sock, residual-limb fluid volume changes ranged from -4.0% to 0.8% (mean -0.9 +/- 1.3%) of the initial limb fluid volume. Changes for sock removal ranged from -1.2% to 2.8% (mean 0.5 +/- 0.8%). Subjects who reduced in fluid volume with both addition and removal of a sock and subjects with high positive ratios between the fluid-volume loss upon sock addition and gain upon sock removal (high add/remove [AR] ratios) tended to have arterial disease, were obese, and were smokers. Subjects with low positive AR ratios, subjects who increased in fluid volume both with sock addition and removal, and a single subject who increased in fluid volume with sock addition and decreased with sock removal tended to be nonsmokers and either individuals in good health without complications or individuals without arterial problems. Results are relevant for the anticipation of limb volume changes during prosthetic fitting and toward the design of adjustable-socket technologies.

The purpose of this research was to pursue quality standards for computer-manufacturing of prosthetic sockets for people with transtibial limb loss. Thirty-three duplicates of study participants' normally used sockets were fabricated using central fabrication facilities. Socket-manufacturing errors were compared with clinical assessments of socket fit. Of the 33 sockets tested, 23 were deemed clinically to need modification. All 13 sockets with mean radial error (MRE) greater than 0.25 mm were clinically unacceptable, and 11 of those were deemed in need of sizing reduction. Of the remaining 20 sockets, 5 sockets with interquartile range (IQR) greater than 0.40 mm were deemed globally or regionally oversized and in need of modification. Of the remaining 15 sockets, 5 sockets with closed contours of elevated surface normal angle error (SNAE) were deemed clinically to need shape modification at those closed contour locations. The remaining 10 sockets were deemed clinically acceptable and not in need modification. MRE, IQR, and SNAE may serve as effective metrics to characterize quality of computer-manufactured prosthetic sockets, helping facilitate the development of quality standards for the socket manufacturing industry.

A device using radio frequency identification (RFID) technology was developed to continuously monitor sock use in people who use prosthetic limbs. RFID tags were placed on prosthetic socks worn by subjects with transtibial limb loss, and a high-frequency RFID reader and antenna were placed in a portable unit mounted to the outside of the prosthetic socket. Bench testing showed the device to have a maximum read range between 5.6 cm and 12.7 cm, depending on the RFID tag used. Testing in a laboratory setting on three participants with transtibial amputation showed that the device correctly monitored sock presence during sitting, standing, and walking activity when one or two socks were worn but was less reliable when more socks were used. Accurate detection was sensitive to orientation of the tag relative to the reader, presence of carbon fiber in the prosthetic socket, pistoning of the limb in the socket, and overlap among the tags. Use of ultra-high-frequency RFID may overcome these limitations. With improvements, the technology may prove useful to practitioners prescribing volume accommodation strategies for patients by providing information about sock use between clinical visits, including timing and consistency of daily sock-ply changes.

Bioimpedance analysis was used to measure the residual limb fluid volume of seven transtibial amputee subjects using elevated vacuum sockets and nonelevated vacuum sockets. Fluid volume changes were assessed during sessions with the subjects sitting, standing, and walking. In general, fluid volume losses during 3 or 5 min walks and losses over the course of the 30 min test session were less for elevated vacuum than for suction. Numerous variables, including the time of day that data were collected, soft tissue consistency, socket-to-limb size and shape differences, and subject health, may have affected the results and had an equivalent or greater effect on limb fluid volume compared with elevated vacuum. Researchers should well consider these variables in the study design of future investigations on the effects of elevated vacuum on residual limb volume.

Bioimpedance analysis was used to measure conductive tissue extracellular fluid (ECF) volume changes in the residual limbs of four unilateral transtibial amputee subjects during standing and walking conditions. Results showed that all residual limbs experienced ECF volume decreases during 5 min standing intervals. During 5 min of walking immediately after a standing interval, the residual limbs of healthy subjects increased in ECF volume while those of diseased subjects, one with peripheral vascular disease and another with cardiovascular insufficiency and a high-salt intake, decreased. One subject demonstrated less absolute value ECF volume change during standing and walking at 12 months post-surgical revision compared with at six months. Presentation of bioimpedance data to patients improved compliance to practitioner recommendations and patient understanding. Results were useful towards clinical assessment, patient education, and decision-making about treatment.

Objective: To evaluate differences in function, performance, and preference between mechanical and microprocessor prosthetic knee control technologies., Design: A-B-A-B reversal design., Setting: Home, community, and laboratory environments., Participants: Twenty-one unilateral, transfemoral amputees., Intervention: Mechanical control prosthetic knee versus microprocessor control prosthetic knee (Otto Bock C-Leg)., Main Outcome Measures: Stair rating, hill rating and time, obstacle course time, divided attention task accuracy and time, Amputee Mobility Predictor score, step activity, Prosthesis Evaluation Questionnaire score, Medical Outcomes Study 36-Item Short-Form Health Survey score, self-reported frequency of stumbles and falls, and self-reported concentration required for ambulation., Results: Stair descent score, hill descent time, and hill sound-side step length showed significant (P<.01) improvement with the C-Leg. Users reported a significant (P<.05) decrease in frequency of stumbles and falls, frustration with falling, and difficulty in multitasking while using the microprocessor knee. Subject satisfaction with the C-Leg was significantly (P<.001) greater than the mechanical control prosthesis., Conclusions: The study population showed improved performance when negotiating stairs and hills, reduced frequency of stumbling and falling, and a preference for the microprocessor control C-Leg as compared with the mechanical control prosthetic knee.