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.

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.

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.

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.

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.