Review of the socket design and interface pressure measurement for transtibial prosthesis.
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ABSTRACT:
SUBMITTER: Pirouzi G
PROVIDER: S-EPMC4147352 | biostudies-other | 2014
REPOSITORIES: biostudies-other
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Project description:Lower-limb prosthesis design and manufacturing still rely mostly on the workshop process of trial-and-error using expensive unrecyclable composite materials, resulting in time-consuming, material-wasting, and, ultimately, expensive prostheses. Therefore, we investigated the possibility of utilizing Fused Deposition Modeling 3D-printing technology with inexpensive bio-based and bio-degradable Polylactic Acid (PLA) material for prosthesis socket development and manufacturing. The safety and stability of the proposed 3D-printed PLA socket were analyzed using a recently developed generic transtibial numeric model, with boundary conditions of donning and newly developed realistic gait cycle phases of a heel strike and forefoot loading according to ISO 10328. The material properties of the 3D-printed PLA were determined using uniaxial tensile and compression tests on transverse and longitudinal samples. Numerical simulations with all boundary conditions were performed for the 3D-printed PLA and traditional polystyrene check and definitive composite socket. The results showed that the 3D-printed PLA socket withstands the occurring von-Mises stresses of 5.4 MPa and 10.8 MPa under heel strike and push-off gait conditions, respectively. Furthermore, the maximum deformations observed in the 3D-printed PLA socket of 0.74 mm and 2.66 mm were similar to the check socket deformations of 0.67 mm and 2.52 mm during heel strike and push-off, respectively, hence providing the same stability for the amputees. We have shown that an inexpensive, bio-based, and bio-degradable PLA material can be considered for manufacturing the lower-limb prosthesis, resulting in an environmentally friendly and inexpensive solution.
| S-EPMC10004398 | biostudies-literature
Project description:Prosthetic elevated vacuum is a suspension method used to reduce daily volume changes of the residual limb. Evaluation of the effectiveness of these systems is limited due to a lack of correlation to actual socket air pressure, particularly during unconstrained movements. This may explain some of the variability in functional outcomes reported in the literature. Our objective was to develop a light-weight portable socket measurement system to quantify internal socket air pressure, temperature, and acceleration; and to present preliminary results from implementation with three transtibial prosthesis users with mechanical elevated vacuum pumps. Participants completed five functional tasks with and without the vacuum pumps actively connected, including the 2-Minute Walk test, 5-Times Sit-to-Stand test, 4-Square Step test, L-Test, and Figure-8 test. Results demonstrated different gait profiles and pressure ranges for each user. Two of the participants demonstrated substantially lower air pressure (higher vacuum) over time while the pump was active compared to inactive. The minimum air pressure measured for all participants was -34.6 ± 7.7 kPa. One participant did not show substantial changes in pressure over time for either pump condition. Functional task performance was not significantly different between pump conditions. Correlation with accelerometer readings indicated peak positive pressures occurred just following initial contact of the foot in early stance, and the most negative pressures (highest vacuum) were observed throughout swing. This study has demonstrated the use of a portable data logging tool that may serve the clinical and research communities to quantify the operation of elevated vacuum systems, and better understand the variability of mechanical pump operation and overall system performance.
| S-EPMC6197629 | biostudies-literature
Project description: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.
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Project description: Not available
| S-EPMC10773776 | biostudies-literature
Project description:ObjectiveTo evaluate test-retest reliability and related measurement properties of items developed to assess best, worst, and average prosthetic socket comfort.DesignMethodological research to assess test-retest reliability of 4 individual socket comfort survey items. Socket comfort items were included in a self-report paper survey, which was administered to participants 2 to 3 days apart.SettingGeneral community.ParticipantsA minimum convenience sample of participants (N=63) was targeted for this study; 72 lower limb prosthesis users (>1y postamputation) completed the survey and were included in the final dataset.InterventionsNot applicable.Main outcome measureThe expanded socket comfort score (ESCS) was adapted from the original socket comfort score (SCS). The original SCS is a single-item self-report instrument developed to assess a lower limb prosthesis user's current socket comfort. Three additional items were designed to assess the user's best, worst, and average socket comfort over the previous 7 days.ResultsBest, worst, and average socket comfort items demonstrated better reliability, as indicated by higher intraclass correlation coefficients. As such, these items also exhibited lower measurement error and smaller minimal detectable change values than the item that measured current socket comfort. However, test-retest coefficients for all 4 ESCS items were below the level desired for evaluation of within-individual changes of socket comfort.ConclusionsItems that assess best, worst, and average comfort provide a more stable measurement of socket fit than the existing SCS instrument. Although administration of all 4 ESCS items may provide more comprehensive assessment of a lower limb prosthesis user's socket fit, administrators should expect variations in scores over time owing to the variable nature of the underlying construct over time. Future research should examine whether the ESCS provides an improved overall assessment of socket fit.
| S-EPMC9072595 | biostudies-literature
Project description:BackgroundAmputation at the transfemoral (TF) level reduces the rate of successful prosthetic fitting, functional outcome, and quality of life (QoL) compared with transtibial amputation. The TF socket interface is considered the most critical part of the prosthesis, but socket discomfort is still the most common user complaint. Direct Socket for transfemoral prosthesis users is a novel interface fabrication process where the socket is shaped and laminated directly on the residual limb and delivered in a single visit.ObjectivesThe aim of this study was to investigate if prosthetic users' quality of life (QoL), comfort, and mobility with a Direct Socket TF interface were comparable to their experience with their previous prostheses.MethodologyThe pre/post design prospective cohort study included 47 subjects. From this cohort, 36 subjects completed the 6-months follow-up (mean age 58 years, 27 males). Outcomes at baseline included EQ-5D-5L®, PLUS-M™, CLASS, ABC, AMPPRO, and TUG. At 6-weeks and 6-months, subjects repeated all measures. Seven Certified Prosthetist (CP) investigators performed observations and data collection at six different sites (from July 2018 to April 2020).FindingsResults showed significant improvement in all outcome measures for the 36 subjects that completed both 6-weeks and 6-months follow-ups. CLASS sub-scales showed significantly improved stability, suspension, comfort, and socket appearance. Improvement in K-Level and less use of assistive devices were observed with the AMPPRO instrument, indicating improved user mobility and performance. QoL was also increased, as measured in Quality-Adjusted-Life-Years (QALY) from the EQ-5D-5L.ConclusionsEvidence from the findings demonstrate that the Direct Socket TF system and procedure can be a good alternative to the traditional method of prosthetic interface delivery.
| S-EPMC10443471 | biostudies-literature
Project description:BackgroundLoss of residual limb volume degrades socket fit and may require accommodation.ObjectivesTo 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 designTwo repeated-measures experiments were conducted to assess the effects of socket release on limb fluid volume retention.MethodsLimb 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.ResultsPartial 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).ConclusionSocket 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 relevanceThis 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.
| S-EPMC7447526 | biostudies-literature
Project description:BackgroundImproper suspension between the residual limb and prosthesis can result in pistoning, which may compromise skin integrity and reduce overall user comfort. In addition to objective measures of limb pistoning, user perspective may provide insight into suspension system effectiveness.ObjectivesThe primary objective of this analysis was to explore differences in self-reported measures among adults with transtibial amputation (TTA) using pinlock vs suction suspension systems.Study designThis is a secondary analysis of cross-sectional data.MethodsParticipants (n = 48) were included if they (1) were ≥18 years of age, (2) were community-dwelling, (3) had a unilateral TTA of ≥6 months, and (4) were prescribed a prosthesis with either pinlock or suction suspension. Participants completed self-reported measures evaluating socket comfort (Socket Comfort Score [SCS]), prosthesis-enabled mobility (Prosthesis Evaluation Questionnaire-Mobility Section [PEQ-MS]; Locomotor Capabilities Index [LCI]), and balance-confidence (Activities-Specific Balance Confidence Scale [ABC]).ResultsParticipants using suction suspension reported significantly higher SCS as compared with participants using pinlock suspension (P ≤ .001). No differences were observed between groups for PEQ-MS, LCI, and/or ABC.ConclusionsIndividuals with TTA using suction suspension may report greater socket comfort than peers using pinlock suspension, but prosthesis-enabled mobility and balance-confidence may be similar. Future research is warranted to confirm these preliminary findings using a prospective, crossover study design that controls for all suspected factors that might influence socket comfort.
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Project description:The purpose of this investigation was to assess participants' self-reported satisfaction with an adjustable, immediate fit transtibial prosthetic system as compared to their conventionally fabricated prosthetic device. A prospective study involving a two-week single-group pre-post intervention design. Physical medicine and rehabilitation clinic of a university hospital. Adults (N=27) with transtibial limb loss. Participants were fit with the iFIT prosthetic system and instructed to wear it for a two-week evaluation period. A modified PEQ scale was completed on the participant's conventional prosthetic during the initial visit and the iFIT system after the two weeks. Twenty-seven persons with lower limb loss were enrolled. Three were lost to follow up leaving twenty-four subjects with completed data. Three subjects had recent amputations with no conventional device for comparison. The Modified PEQ scores were significantly higher for the iFIT prosthetic in comparison to their conventional device (29.18 [SD= 4.63] vs 23.82 [SD=6.38], p <0.01). Subjects were also found to perceive significantly better temperature control with the iFIT prosthetic system (4.19 [SD= 0.68] vs 2.97 [SD=1.02], p <0.001). Subjects did not report any skin breakdown, prosthetic issues, or falls. This immediate fit, adjustable transtibial prosthesis demonstrated significantly better patient satisfaction and temperature perception compared to conventional devices. These results are consistent with previous findings and further support the efficacy of an immediate fit adjustable transtibial prosthetic system. Longer term studies in the United States and internationally are underway to assess the durability and efficacy of this new prosthesis in different populations and settings.
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Project description:The transcatheter mitral valve prosthesis is ideally suited for patients with inoperable mitral etiology. The transcatheter mitral valve implantation (TMVI) procedure has closely followed the evolution of transcatheter aortic procedures. There are considerable design variations amongst the limited TMVI prostheses currently available, and the implantation profiles of the devices are notably different. This comprehensive review will provide an overview of the current clinically tried TMVI devices with a focused outcome analysis. In addition, we have discussed the various design characteristics of TMVI and its associated failure mode, implantation technology, delivery methods, first-in-man trials, and pivotal trial summary for the synthesis of recent evidence.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021255241, identifier: CRD42021255241.
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