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.

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.

Automatic Control of Prosthetic Socket Size for People WithTranstibial Amputation: Implementation and Evaluation.

OBJECTIVE: The purpose was to design, implement, and test a control system for a motor-actuated, cable-panel prosthetic socket that automatically maintains socket fit by continuous adjustment of the socket size. METHODS: Sockets with motor-driven adjustable panels were fabricated for participants with transtibial amputation. A proportional-integral control system was implemented to adjust socket size based on Socket Fit Metric (SFM) data collected by an inductive sensor embedded within the socket wall. The sensed distance was representative of limb-to-socket distance. Testing was conducted with participants walking on a treadmill to characterize the system's capability to maintain a set point and to respond to a change in the set point. RESULTS: Test results from 10 participants with transtibial amputation showed that the Integral of Absolute Error (IAE) to maintain a set point ranged from 0.001 to 0.046 mm with a median of 0.003 mm. When the set point was changed, IAE errors ranged from 0.001 to 0.005 mm, with a median of 0.003 mm. An IAE of 0.003 mm corresponded to approximately a 0.08% socket volume error, which was considered clinically acceptable. CONCLUSION: The capability of the control system to maintain and respond to a change in set point indicates that it is ready for evaluation outside of the laboratory. SIGNIFICANCE: Integration of the developed control system into everyday prostheses may improve quality of life of prosthesis users by relieving them of the burden of continually adjusting socket size to maintain fit.

Incorporating a Ferrous Polymer Target into Elastomeric Liners for Socket Fit Sensing in Prosthesis Users.

Liner-to-socket distance measurement using inductive sensing may be an effective means to continuously monitor socket fit in people using trans-tibial prostheses. A practical limitation, however, is a means to incorporate a thin uniform-thickness layer of conductive or magnetically permeable target material into the wide range of prosthetic liner products that people with limb amputation commonly use. In this paper, a method is presented whereby a 0.50-mm thickness ferrous polymer made from a SEEPS polymer and iron powder that is formed adjacent to a 0.25-mm thick non-ferrous layer of SEEPS polymer is assembled between two sheets of elastic fabric material. Bench testing showed that the fabrication procedure achieved a root-mean-square error in the thickness of this construct of 58 µm, helping to create a consistent calibration result over the entire surface. The original fabric backing of an off-the-shelf prosthetic liner was removed and replaced with the developed construct. When worn in the shoe of an able-bodied participant for 7.5 h per day for 28 days, the sensor well maintained the shape of its calibration curve at the start of wear, but a distance offset (shifting of the y-intercept) was introduced that increased during the initial approximately 12 days of wear. When the distance offset was corrected, for the primary distance range of clinical interest for this application (0.00-5.00 mm), the sensor maintained its calibration within 4.4%. Before being used in clinical application for liner-to-socket distance monitoring, new ferrous liners may need to be pre-worn so as to achieve a consistent distance reference.

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.

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.

Thin Magnetically Permeable Targets for Inductive Sensing: Application to Limb Prosthetics.

The purpose of this research was to create a thin ferrous polymer composite to be used as a target for inductive sensing in limb prosthetics. Inductive sensors are used to monitor limb-to-socket distance in prosthetic sockets, which reflects socket fit. A styrene-ethylene-ethylene/propylene-styrene (SEEPS) polymer was mixed with iron powder at three concentrations (75, 77, 85 wt%), and thin disk-shaped samples were fabricated (0.50, 0,75, 1.00 mm thickness). For 85 wt% samples of 0.50 mm thickness, which proved the best combination of high signal strength and low target volume, inductive sensor sensitivity ranged from 3.2E5 counts/mm at 0.00-1.00 mm distances to 7.2E4 counts/mm at 4.00-5.00 mm distances. The application of compressive stress (up to 425 kPa) introduced an absolute measurement error of less than 3.3 µm. Tensile elasticity was 282 kPa, which is comparable to that of commercial elastomeric liners. Durability testing in the shoe of an able-bodied participant demonstrated a change in calibration coefficient of less than 3.8% over two weeks of wear. The ferrous polymer composite may facilitate the development of automatically adjusting sockets that use limb-to-socket distance measurement for feedback control.

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.

A motor-driven adjustable prosthetic socket operated using a mobile phone app: A technical note.

Sockets that allow incremental size adjustment during ambulation may help prosthesis users improve management of their changes in limb volume and the quality of their prosthetic fit. A platform system was developed that allowed people with trans-tibial limb loss to adjust the radial positions of socket panels during ambulation in small increments via a motor mounted beneath the socket. The motor altered the length of a cable running through the socket panels according to commands communicated from a mobile phone. A proportional-integral-derivative controller adjusted the voltage applied to the motor via pulse-width modulation to achieve target settings. Bench test results showed that when the system was subjected to loads comparable to those expected during clinical use, maximum absolute steady state error was 0.036 mm. Treadmill testing on 16 people with trans-tibial limb amputation demonstrated that the range of cable lengths over which participants deemed fit clinically acceptable varied between 24 mm and 114 mm depending on the user. In field testing 11 of 13 participants were comfortable making socket size adjustments while walking. The developed system achieves incremental socket size adjustments appropriate for research and development of ambulatory adjustable sockets.

Socket size adjustments in people with transtibial amputation: Effects on residual limb fluid volume and limb-socket distance.

BACKGROUND: Small intermittent adjustments of socket size using adjustable sockets may be a means for people with transtibial amputation to better maintain residual limb fluid volume and limb position while using a prosthesis. METHODS: Socket size, limb fluid volume, and distance from the limb to the socket, termed "sensed distance," were recorded while participants with transtibial amputation walked on a treadmill wearing a motor-driven, cabled-panel, adjustable socket. Researchers made frequent socket size adjustments using a mobile phone app to identify participants' acceptable socket size range. Limb fluid volume and sensed distance were then monitored as incremental adjustments were made to the socket. FINDINGS: Prosthesis users in this study (n = 10) accepted socket sizes between -5% and +5% of their neutral socket volume. There was a rapid increase in limb fluid volume and sensed distance upon socket enlargement, and a rapid decrease upon reduction. Subsequently, there were gradual changes in fluid volume and sensed distance. While visually monitoring limb fluid volume data in real time, researchers were able to adjust socket size to maintain consistent limb fluid volume within a -0.7% to +0.9% volume change for 24 min. INTERPRETATION: Participant residual limbs compensated to socket size adjustment. Using socket-mounted sensors to monitor limb-socket mechanics, an automatic adjustable socket that maintains limb fluid volume may be possible and may improve socket fit in instances where fit deteriorates during use.

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.

An Inductive Sensing System to Measure In-Socket Residual Limb Displacements for People Using Lower-Limb Prostheses.

The objective of this research was to assess the performance of an embedded sensing system designed to measure the distance between a prosthetic socket wall and residual limb. Low-profile inductive sensors were laminated into prosthetic sockets and flexible ferromagnetic targets were created from elastomeric liners with embedded iron particles for four participants with transtibial amputation. Using insights from sensor performance testing, a novel calibration procedure was developed to quickly and accurately calibrate the multiple embedded sensors. The sensing system was evaluated through laboratory tests in which participants wore sock combinations with three distinct thicknesses and conducted a series of activities including standing, walking, and sitting. When a thicker sock was worn, the limb typically moved further away from the socket and peak-to-peak displacements decreased. However, sensors did not measure equivalent distances or displacements for a given sock combination, which provided information regarding the fit of the socket and how a sock change intervention influenced socket fit. Monitoring of limb⁻socket displacements may serve as a valuable tool for researchers and clinicians to quantitatively assess socket fit.

Instrumented socket inserts for sensing interaction at the limb-socket interface.

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.

Effects of socket size on metrics of socket fit in trans-tibial prosthesis users.

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.

Technical note: Computer-manufactured inserts for prosthetic sockets.

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.