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Purpose: This study aimed to evaluate the pressure distribution and comfort of transtibial prosthesis wearers using an affordable ethyl-vinyl acetate (EVA) roll-on (AERO) liner. Method: Fifteen unilateral transtibial prosthesis users wore patella tendon bearing (PTB) sockets with a polyethylene foam (PE-lite) liner were enrolled this study. AERO liners were provided to all participants. Six force sensors were applied to the residual limb to evaluate pressure distribution during treadmill walking, and the socket comfort score (SCS) was used to evaluate comfortability. Fourier transform infrared (FT-IR) spectroscopy was performed on the EVA and PE-lite liners. Results: Eleven participants used prefabricated AERO liners and four participants used custom-made AERO liners. The pressure distribution was analysed by the coefficient of variation (CV): PE-lite was 75.7±6.0 and AERO liner 83.3±4.1. Residual limb pressure was significantly decreased when using the AERO liner (p=.0007), with a large effect size (r=0.87). Mean SCS was 7.5±1.3 and 8.9±1.1 for PE-lite and AERO liner respectively. Conclusion: Better pressure distribution and comfort were observed when the participants used the AERO liner. AERO had a greater proportion of calcium carbonate (CaCO3). These findings suggest that the AERO liner is a better off-the-shelf option for persons using traditional prosthetic sockets and liners. [ABSTRACT FROM AUTHOR]

BACKGROUND: Functional mobility, comfort and the absence of pain are key goals of prosthetic treatment. Outcome measures (OMs) evaluate the impact of treatment and normative and minimal detectable change (MDC) values are key to interpreting these scores and measuring treatment outcomes. OBJECTIVES: This study seeks to 1) present practice-based normative values of four commonly used OMs at four prosthetic milestones and 2) explore the MDC of the measures over the treatment period. METHODOLOGY: A chart review was conducted of OMs collected with individuals with lower limb loss between January 1, 2015, and December 31, 2023. This included data for individuals with unilateral transtibial (TT), transfemoral (TF) and rotationplasty (RP) amputations and bilateral transtibial amputation (BTT). OMs included the Socket Comfort Score (SCS), Pain Scale (PS), 2 Minute Walk Test (2MWT), and Prosthetic Limb Users Survey of Mobility (PLUS-M). Data were collected at four milestone time points: (1) Baseline and (2) Discharge from Rehabilitation for those in initial prosthetic rehabilitation, and (3) Initial Evaluation and (4) Definitive Delivery for those receiving a replacement socket. Normative values and MDC values were calculated. FINDINGS: Data from 30 individuals undergoing in-patient rehabilitation and 74 individuals receiving a replacement socket were included. Practice-based normative data were different for each level of amputation and milestone and had the following ranges: SCS: 5.7 – 9.1, PS: 0.8 – 3.7, 2MWT: 68.4 – 146.3 m and PLUS-M: 38.9 – 57.3. MDC values also varied based on time in treatment (Rehabilitation: SCS = 2.5, PS = 1.6, 2MWT = 32.6, PLUS-M = 8.8; Replacement Socket: SCS = 3.1, PS = 2.6, 2MWT = 38.9, PLUS-M = 4.0). All measures had a statistically significant change over the intervention, however, no average scores changed by greater than the MDC. CONCLUSIONS: The normative data and MDC scores demonstrate the PS & PLUS-M are useful measures of pain and mobility at all points within treatment. The 2MWT is indicated for individuals in rehabilitation, while the SCS is indicated for those receiving a replacement socket, as both effectively measure treatment goals that are particularly important for each phase of rehabilitation. This provides clinicians with practice-based evidence that enables them to interpret OM scores, a critical part of the decision-making process along the treatment journey. Layman's Abstract When someone receives a prosthesis, the key goals are to promote mobility and comfort and to reduce pain. Outcome measures are questionnaires or performance-based tests that measure the impact of prosthetic treatment. The scores are interpreted by comparing them to normal values and assessing changes over time against a predetermined threshold for what constitutes a significant amount of change. This study analyzed outcome measure scores collected in clinical practice over a 9-year period, from 2015 - 2023. We included individuals with lower limb loss and presented normal values along with threshold change values taken from a clinical setting for four commonly used measures that assess comfort, pain, and mobility. The data included 30 individuals currently attending initial rehabilitation and 74 individuals who had prior experience using a prosthesis. All the normal values were different for each level of amputation and each milestone within rehabilitation. Suggestions are provided regarding which outcome measures are most useful for assessing changes at different points in time. By providing clinicians with evidence based on clinical practice, we can help them use outcome measures to inform decision-making throughout the rehabilitation journey. Article PDF Link: https://jps.library.utoronto.ca/index.php/cpoj/article/view/43890/33243 How To Cite: Pousett B.M, Harasym C.C, Rapaport M.S, Richardson T, Spellen J, Moe D.W, et al. Detecting changes in comfort, pain, and mobility over clinical milestones for individuals with lower limb loss. Canadian Prosthetics & Orthotics Journal. 2024; Volume 7, Issue 1, No.7. https://doi.org/10.33137/cpoj.v7i1.43890 Corresponding Author: Brittany Mae Pousett, CP(C), MSc. 540 SE Marine Dr, Vancouver, BC, Canada, V5X 2T4 Tel: 604.321.1115 E-Mail: brittany@pousett.ca ORCID ID: https://orcid.org/0000-0002-2272-7847

Purpose: This study aimed to evaluate the pressure distribution and comfort of transtibial prosthesis wearers using an affordable ethyl-vinyl acetate (EVA) roll-on (AERO) liner., Method: Fifteen unilateral transtibial prosthesis users wore patella tendon bearing (PTB) sockets with a polyethylene foam (PE-lite) liner were enrolled this study. AERO liners were provided to all participants. Six force sensors were applied to the residual limb to evaluate pressure distribution during treadmill walking, and the socket comfort score (SCS) was used to evaluate comfortability. Fourier transform infrared (FT-IR) spectroscopy was performed on the EVA and PE-lite liners., Results: Eleven participants used prefabricated AERO liners and four participants used custom-made AERO liners. The pressure distribution was analysed by the coefficient of variation (CV): PE-lite was 75.7 ± 6.0 and AERO liner 83.3 ± 4.1. Residual limb pressure was significantly decreased when using the AERO liner ( p  = .0007), with a large effect size ( r  = 0.87). Mean SCS was 7.5 ± 1.3 and 8.9 ± 1.1 for PE-lite and AERO liner respectively., Conclusion: Better pressure distribution and comfort were observed when the participants used the AERO liner. AERO had a greater proportion of calcium carbonate (CaCO 3 ). These findings suggest that the AERO liner is a better off-the-shelf option for persons using traditional prosthetic sockets and liners.

Background: Functional mobility, comfort and the absence of pain are key goals of prosthetic treatment. Outcome measures (OMs) evaluate the impact of treatment and normative and minimal detectable change (MDC) values are key to interpreting these scores and measuring treatment outcomes., Objectives: This study seeks to 1) present practice-based normative values of four commonly used OMs at four prosthetic milestones and 2) explore the MDC of the measures over the treatment period., Methodology: A chart review was conducted of OMs collected with individuals with lower limb loss between January 1, 2015, and December 31, 2023. This included data for individuals with unilateral transtibial (TT), transfemoral (TF) and rotationplasty (RP) amputations and bilateral transtibial amputation (BTT). OMs included the Socket Comfort Score (SCS), Pain Scale (PS), 2 Minute Walk Test (2MWT), and Prosthetic Limb Users Survey of Mobility (PLUS-M). Data were collected at four milestone time points: (1) Baseline and (2) Discharge from Rehabilitation for those in initial prosthetic rehabilitation, and (3) Initial Evaluation and (4) Definitive Delivery for those receiving a replacement socket. Normative values and MDC values were calculated., Findings: Data from 30 individuals undergoing in-patient rehabilitation and 74 individuals receiving a replacement socket were included. Practice-based normative data were different for each level of amputation and milestone and had the following ranges: SCS: 5.7 - 9.1, PS: 0.8 - 3.7, 2MWT: 68.4 - 146.3 m and PLUS-M: 38.9 - 57.3. MDC values also varied based on time in treatment (Rehabilitation: SCS = 2.5, PS = 1.6, 2MWT = 32.6, PLUS-M = 8.8; Replacement Socket: SCS = 3.1, PS = 2.6, 2MWT = 38.9, PLUS-M = 4.0). All measures had a statistically significant change over the intervention, however, no average scores changed by greater than the MDC., Conclusions: The normative data and MDC scores demonstrate the PS & PLUS-M are useful measures of pain and mobility at all points within treatment. The 2MWT is indicated for individuals in rehabilitation, while the SCS is indicated for those receiving a replacement socket, as both effectively measure treatment goals that are particularly important for each phase of rehabilitation. This provides clinicians with practice-based evidence that enables them to interpret OM scores, a critical part of the decision-making process along the treatment journey., Competing Interests: The authors have no conflicts of interest to disclose., (Copyright (c) 2024 Pousett B.M, Harasym C.C, Rapaport M.S, Richardson T, Spellen J, Moe D.W, Miller W.C.)

Introduction: In the United States, access to microprocessor-controlled prosthetic ankles is limited to patients with lower-limb loss classified as unlimited community ambulators or greater. However, the potential benefits of these devices have not been evaluated among patients classified as household or limited community ambulators. This study examined the benefit of hydraulic- and microprocessor-controlled prosthetic ankles for patients classified as limited community ambulators. Materials and Methods: Four different treatment configurations were evaluated using a randomized crossover study design. These four configurations included the participant's current flexible keel (FK) prosthetic foot, an energy-storage-and-return foot (ESAR), a hydraulic ankle (HA), and amicroprocessor ankle (MPA). After a 2-week accommodation period, both patient-reported and performance-based outcome measures were recorded for each ankle foot system. A StepWatch activity monitor and two-dimensional video motion analysis were also used to evaluate each system. Results: A single participant meeting the inclusion criteria was recruited. The patient-reportedmobility and socket fit instruments were greatest with the HA system. When assessed on slopes and stairs, the MPA demonstrated benefits on hill ascent and stair descent. In considering the walking speed and perceived exertion jointly, the HA system allowed similar walking speed but lower exertion compared with fixed-ankle systems. The patient-reported low back pain and balance confidence instruments did not provide useful data for interpretation. Two-dimensional videomotion analysis showed that the HA and MPA contributed to improved ankle and knee postures when ascending and descending a slope. The step activity data showed the greatest activity with the HA. Discussion: The results from the outcome measures showed a varying level of benefit across all four of the treatment configurations. Both the HA and MPA had favorable scores in varying performance-based outcome measures, but the HA scored the most favorable in a majority of the patient-reported outcome measures. Conclusion: The results show varying benefits of the microprocessor- and hydraulic-controlled prosthetic components over fixed-ankle ESAR and FK feet, based on both performance-based and patient-reported outcome measures. Further studies are needed to fully evaluate these benefits in larger sample sizes. [ABSTRACT FROM AUTHOR]

Introduction: Microprocessor ankles (MPAs) have recently been developed for persons with lower-limb amputation to overcome known limitations of fixed-ankle energy-storing-and-returning (ESAR) feet. This study aimed to examine differences in patient-reported balance, mobility, socket comfort, and preference between an ESAR foot and an MPA in persons with unilateral transtibial amputation (UTA). Materials and Methods: Twenty-three participants with UTA enrolled in an institutional review board–approved, randomized crossover protocol with ESAR (Pacifica LP) and microprocessor-ankle configurations (Kinnex, Freedom Innovations) and a 4-week accommodation period. The outcome measures collected included Activities Specific Balance Confidence Scale (ABC), Prosthesis Evaluation Questionnaire–Mobility Subscale (PEQ-MS), and Prosthetic Limb User Survey of Mobility (PLUS-M). Participants were asked to rate Socket Comfort Score (SCS) while ascending and descending a 15° sloped ramp. Finally, ankle-foot preference and aspects liked and disliked about each configuration were recorded. Results: Significant improvements were seen with the MPA in patient-reported mobility in the community (PEQ-MS, ρ = 0.0465) and socket comfort walking and standing on slopes (SCS, ρ < 0.001). Differences in balance confidence (ABC) did not reach a level of significance, whereas improvement in perceived mobility with a prosthesis approached a level of significance (PLUS-M, ρ = 0.102). When asked, 81% of participants preferred the MPA over the ESAR foot. Participants reported positively about the reduced weight of the ESAR foot, whereas they frequently reported that the MPA was better on slopes and uneven terrain. Conclusions: The 30° range of motion in the MPA can allow greater mobility when ambulating on typical environmental barriers (e.g., uneven terrain, ramps, and stairs) and allow patients to stand and walk on slopes with less socket discomfort. Most participants preferred the MPA. Frequently reported positive and negative aspects of both systems may be useful for patient consultation regarding ankle-foot technology. This study represents the largest known investigation of MPAs, and the results provide evidence of benefits from MPAs over ESAR feet in persons with UTA. [ABSTRACT FROM AUTHOR]

Background:: Prosthetic socket fit is an important element associated with successful ambulation and use of a prosthesis. Prosthetists and rehabilitation clinicians would benefit from an assessment tool that discriminates between and quantifies the multiple determinants that influence the lower limb amputee's performance and satisfaction of a prosthetic socket.Objectives:: To determine the internal consistency of the comprehensive lower limb amputee socket survey, a new self-report measure of prosthetic socket satisfaction that quantifies suspension, stability, comfort, and appearance.Study Design:: Cross-sectional sample of active amputees.Methods:: Interviews were conducted with prosthetists, physical therapists, and lower limb amputees to identify clinical concerns and common activities influencing socket fit. An expert panel of five clinicians reviewed the items and constructed the original version of the comprehensive lower limb amputee socket survey which was then administered to a convenience sample of 47 active lower limb amputees. Item analysis and Cronbach's alpha were used to determine the final version of the comprehensive lower limb amputee socket survey.Results:: Following item raw score-to-total score correlation with Cronbach's alpha for comprehensive lower limb amputee socket survey determinants, internal consistency improved when nine questions were eliminated.Conclusion:: The comprehensive lower limb amputee socket survey is a self-report measure of prosthetic socket satisfaction with very good internal consistency.Clinical Relevance: When socket problems occur, the ability to determine the specific cause can reduce modification time, enhance socket fit, and promote patient satisfaction. A standardized multi-dimensional assessment measure of socket satisfaction enables prosthetists to quantify the multiple determinants of socket satisfaction, improve patient communication, and demonstrate the value of socket interventions. [ABSTRACT FROM AUTHOR]

Aims: Persons with lower-limb amputations need to achieve more natural gait through more effort, leading to an increase in the energy consumption in them compared to the healthy persons. The aim of this study was to investigate the effects of the socket fit on gait energy consumption level in persons with lower limb amputations. Materials & Methods: In the semi-experimental study, 9 persons with below knee amputation, referred to Tehran Veterans Foundation Center, were studied in 2015. The subjects were selected via available sampling method. The study was consisted of two steps, including improper fit and proper fit conditions. The socket fitting was assessed by the trinity amputation scale and the socket comfort scale. The level of energy consumption of the subjects was measured by the physiological cost index. Data was analyzed by SPSS 19 software using paired T test. Findings: Mean values of persons’ gait speed (p=0.001) and the physiological cost index (p=0.019) with improper fit and proper fit were significantly different. Nevertheless, the difference between gait heart beat and resting heart beat at two steps was not significant (p=0.093). Conclusion: Lower energy consumption can be achieved in persons with lower-limb amputations through the utilization of a proper fit, leading to a better gait.

The interface pressure between the residual limb and prosthetic socket has a significant effect on the amputee’s mobility and level of comfort with their prosthesis. This paper presents a socket interface pressure (SIFP) system to compare the interface pressure differences during gait between two different types of prosthetic sockets for a transtibial amputee. The system evaluates the interface pressure in six critical regions of interest (CROI) of the lower limb amputee and identifies the peak pressures during certain moments of the gait cycle. The six sensors were attached to the residual limb in the CROIs before the participant with transtibial amputation donned a prosthetic socket. The interface pressure was monitored and recorded while the participant walked on a treadmill for 10 min at 1.4 m/s. The results show peak pressure differences of almost 0.22 kgf/cm2 between the sockets. It was observed that the peak pressure occurred at 50% of the stance phase of the gait cycle. This SIFP system may be used by prosthetists, physical therapists, amputation care centers, and researchers, as well as government and private regulators requiring comparison and evaluation of prosthetic components, components under development, and testing.

Background: The choice of prosthetic socket interface material significantly affects user comfort and satisfaction. The Affordable Ethylene-Vinyl Acetate Roll-On (AERO) liner was created with the aim of improving functionality and streamlining the wearing process for users., Objective: The purpose of this study was to comprehensively assess user satisfaction, comfort, and durability of the AERO liner and compare it with the common soft Pe-Lite liner., Methodology: Fourteen individuals with transtibial amputation participated in this three-month randomized crossover trial study. The Prosthesis Evaluation Questionnaire (PEQ), Expanded Socket Comfort Score (ESCS), and liner thickness measurements were used to comprehensively compare the AERO and Pe-Lite liner., Findings: The AERO liner demonstrated notable improvements in prosthetic comfort and functionality over Pe-Lite liner. After three months use, there was a significant reduction in reported frustration with the AERO liner (p=0.023, r=0.604) in the PEQ subscale. Specific aspects, such as walking with the prosthesis (p=0.030, r=0.601) and odor perception (p=0.024, d=0.579), favored the use of the AERO liner. The expanded socket comfort score (ESCS) revealed significant superiority for the AERO liner "at best" (p=0.04) and "on average" (p=0.02) after one and three months, respectively. Liner thickness analysis showed significant reductions at the mid-patellar tendon location for the AERO liner at one (0.57±0.48) and three months (0.90±0.69, p=0.01) and in the posterior region after three months (0.63±0.64, p=0.05)., Conclusion: Our study highlights the potential advantages of the AERO liner in enhancing comfort and satisfaction. Yet, durability and thinning of the liner when compared to Pe-Lite may be a concern which may eventually affect socket fit. These findings contribute to ongoing efforts to optimize prosthetic interventions and improve the quality of life of individuals with lower limb prosthesis in resource-limited environments., Competing Interests: The authors declare no conflicts of commercial or financial interest in this research., (Copyright (c) 2023 Miyata Y, Sasaki K, Guerra G, Dacharux W, Chaiwan P.)

Background: Changes in the volume and shape of the stump causes difficulties in maintaining A comfortable and exact fit. Improper fit causes pain, discomfort and movement between stump and socket. There is not enough document to identify how much volume fluctuation causes fitting problem . To identify and understand the relationship between the changes of interface pressure between stump and socket with mentally feeling of amputees in "good" and "bad" fitting conditions. Method and Material: The study was conducted on two below knee amputees. The method has 2similar stages, SCS was evaluated at both stages with the difference that one was done in bad and other in good fitting condition. To examine stump-socket interface pressure at each stage,static tests with applying half and full body weight to the artifical limb and walking tests were done. Results: With volume reduction, it seems adding several sock layers to improve fitting condition (force couple correction)imposes high interface pressure to patellar tendon and fibular head which lowers amputees feeling of comfort. Without adding sock layers,stump movement to distal causes unbearable pressure to the distal of tibia. Conclusion: In static tests, interface pressure increased in good fitting condition at patellar tendon and popliteal region. Walking tests in good fitting condition showed less movement between stump and socket and less improper pressure. Using too many layers of socks to improve fitting causes intolareable interface pressure at regions such as petellar tendon and fibular head.

The objectives of the current study were to compare intra-socket pressure differences between comfortable and uncomfortable socket conditions, and the usefulness of subject perception of satisfaction, activity limitations, and socket comfort in distinguishing between these two socket conditions. Five unilateral trans-tibial amputees took part in the study. They answered the Socket Comfort Score (SCS) and Trinity Amputation and Prosthetic Experience Scale (TAPES) questionnaires before the interface pressure (in standing and walking) was measured for the uncomfortable socket condition at five regions of the residual limb. Participants were then provided with a comfortable socket and wore it for two weeks. Participants who were satisfied with the socket fit after two weeks repeated the SCS and TAPES questionnaires and interface pressure measurements. The differences between the test results of the two conditions were not statistically significant, except for the interface pressure at the popliteal region during the early stance phase, TAPES socket fit subscale, and the SCS. Due to large variability of the data and the lack of statistical significance, no firm conclusion can be made on the possible relationship between the interface pressure values and the patient-reported outcomes of the two socket conditions. A larger sample size and longer acclimation period are required to locate significant differences. [ABSTRACT FROM PUBLISHER]

Little research describes which transfemoral socket design features are important for coronal plane stability, socket comfort, and gait. Our study objectives were to (1) relate socket comfort during gait to a rank order of changes in ischial containment (IC) and tissue loading and (2) compare socket comfort during gait when tissue loading and IC were systematically manipulated. Six randomly assigned socket conditions (IC and tissue compression) were assessed: (1) IC and high, (2) IC and medium, (3) IC and low, (4) no IC and high, (5) no IC and medium, and (6) no IC and low. For the six subjects in this study, there was a strong negative relationship between comfort and changes in IC and tissue loading (rho = 0.89). With the ischium contained, tissue loading did not influence socket comfort (p = 0.47). With no IC, the socket was equally comfortable with high tissue loading (p = 0.36) but the medium (p = 0.04) and low (p = 0.02) tissue loading conditions decreased comfort significantly. Coronal plane hip moments, lateral trunk lean, step width, and walking speed were invariant to changes in IC and/or tissue loading. Our results suggest that in an IC socket, medial tissue loading mattered little in terms of comfort. Sockets without IC required high tissue loading to be as comfortable as those with IC, while suboptimal tissue loading compromised comfort. [ABSTRACT FROM AUTHOR]

The article presents information on a study conducted to compare the results of two types of transtibial prosthetic sockets. In the study, two independent samples of adult amputees, who wore transtibial prostheses with either patellar tendon bearing (PTB) or total surface bearing (TSB) sockets, were refitted with new prostheses with sockets of either PTB or hydrocast TSB (HCTSB) design. Socket comfort levels were found to be higher for amputees whose socket types had not changed.

The interface pressure between the residual limb and prosthetic socket has a significant effect on the amputee's mobility and level of comfort with their prosthesis. This paper presents a socket interface pressure (SIFP) system to compare the interface pressure differences during gait between two different types of prosthetic sockets for a transtibial amputee. The system evaluates the interface pressure in six critical regions of interest (CROI) of the lower limb amputee and identifies the peak pressures during certain moments of the gait cycle. The six sensors were attached to the residual limb in the CROIs before the participant with transtibial amputation donned a prosthetic socket. The interface pressure was monitored and recorded while the participant walked on a treadmill for 10 min at 1.4 m/s. The results show peak pressure differences of almost 0.22 kgf/cm 2 between the sockets. It was observed that the peak pressure occurred at 50% of the stance phase of the gait cycle. This SIFP system may be used by prosthetists, physical therapists, amputation care centers, and researchers, as well as government and private regulators requiring comparison and evaluation of prosthetic components, components under development, and testing. [ABSTRACT FROM AUTHOR]