Design and testing of a simple quick connect for a prosthetic liner tether.

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.

Short partial doffs of release/relock sockets may effectively stabilize limb fluid volume in prosthesis users with transtibial amputation.

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.

Beyond step counts: Including wear time in prosthesis use assessment for lower-limb amputation.

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.

Distal weight bearing in transtibial prosthesis users wearing pin suspension.

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.

Mechanically and physiologically optimizing prosthetic elevated vacuum systems in people with transtibial amputation: a pilot study.

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.

Using magnetic panels to enlarge a transtibial prosthetic socket.

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.

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.

A novel portable sensor to monitor bodily positions and activities in transtibial prosthesis users.

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.

Performance of an auto-adjusting prosthetic socket during walking with intermittent socket release.

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.

Cyclic socket enlargement and reduction during walking to minimize limb fluid volume loss in transtibial prosthesis users.

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.

Socket release/relock: An innovative mechanism to maintain residual limb volume.

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.

Modeling the mechanics of elevated vacuum systems in prosthetic sockets.

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.

Does actively enlarging socket volume during resting facilitate residual limb fluid volume recovery in trans-tibial prosthesis users?

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.

Effectiveness of elevated vacuum and suction prosthetic suspension systems in managing daily residual limb fluid volume change in people with transtibial amputation.

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.

Fluid Volume Management in Prosthesis Users: Augmenting Panel Release with Pin Release.

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.

How do transtibial residual limbs adjust to intermittent incremental socket volume changes?

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.

Adjustable sockets may improve residual limb fluid volume retention in transtibial prosthesis users.

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.

Effects of activity intensity, time, and intermittent doffing on daily limb fluid volume change in people with transtibial amputation.

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.