This scoping review provides an overview of studies comparing the (cost-)effectiveness of shape capture and socket design techniques for transtibial and transfemoral prostheses. The review compares manual, hybrid, and digital methods, identifies the measurement tools used, and assesses their methodological quality. Effectiveness refers to clinical and functional outcomes such as socket fit, comfort, and user function, whereas cost-effectiveness reflects the balance between resource use and these outcomes. Following Preferred Reporting Items for Systematic Reviews and Meta-analysis guidelines, 5 databases (PubMed, Embase, Web of Science, CINAHL, and Cochrane) were systematically searched. Studies involving humans with transtibial or transfemoral prostheses that compared at least 2 of the 3 methods and reported (cost-)effectiveness outcomes were included. Of 556 articles screened, 20 met the inclusion criteria (497 participants). Sixteen studies evaluated transtibial prostheses and 4 transfemoral prostheses. Manual and hybrid methods were compared in 14 studies, and digital and manual methods in 6, whereas none compared hybrid and digital methods. Eighteen studies were rated as low quality, 2 as moderate, and none as high. Effectiveness constructs mainly covered the International Classification of Functioning, Disability and Health domains "Body functions & Body structures" and "Activities and participation," but many were not clearly defined within this framework. Reported outcomes most often addressed production time, number of socket attempts, and socket fit or comfort. Overall, evidence remains limited and inconsistent, with a clear lack of direct comparisons between digital and hybrid techniques. Tentatively, hybrid and digital approaches may improve efficiency and comfort compared with manual methods, but robust, standardized research is needed to confirm these effects.
Prosthesis-specific outcome measures are essential for assessing the quality of life among lower-limb amputees. While the prosthesis evaluation questionnaire (PEQ) is internationally recognized and endorsed by the International Society for Prosthetics and Orthotics through the Consensus Outcome Measures for Prosthetic and Amputation Services framework, no culturally adapted Thai version currently exists. To translate, culturally adapt, and evaluate the psychometric properties of the Thai version of the PEQ (PEQ-TH) for use among lower-limb prosthesis users in Thailand. Cross-sectional validation study. Following standard cross-cultural adaptation guidelines, the PEQ was translated into Thai, back-translated, and reviewed by a multidisciplinary expert panel. Eighty-three lower-limb amputees from 5 rehabilitation centers completed the PEQ-TH and short form 36 health survey Thai version at baseline; 71 completed the PEQ-TH again after 14 days. Psychometric evaluation included content and construct validity, internal consistency (Cronbach alpha), test-retest reliability (intraclass correlation coefficients), and floor/ceiling effects. The PEQ-TH demonstrated strong content validity (item-objective congruence = 0.99). Construct validity was supported by moderate correlations between PEQ-TH subscales (e.g., Ambulation, Social Burden) and corresponding short form 36 health survey Thai version domains. Internal consistency was acceptable for most subscales (α > 0.70), though Appearance, Well-Being, and Social Burden were marginally lower. Test-retest reliability ranged from moderate to good (intraclass correlation coefficient = 0.55-0.76). No floor or ceiling effects were observed. The PEQ-TH is a valid and reliable patient-reported outcome measure aligned with International Society for Prosthetics and Orthotics's Lower Extremity Amputation Data set and Consensus Outcome Measures for Prosthetic and Amputation Services recommendations. It enables culturally relevant assessment of prosthesis-related quality of life in Thai lower-limb amputees and supports patient-centered care and outcome monitoring.
To evaluate prosthetic devices delivered during an intensive fitting camp in Cambodia, considering device quality and client satisfaction. We conducted an observational cohort study in which we assessed prosthetic devices produced and delivered by an international nongovernmental organization at an intensive fitting camp. We conducted our assessment in two stages: at prosthetic device provision using a checklist to assess device quality and client satisfaction at discharge, and at 3-month follow-up using a telephone interview to assess the client's device usage and preference for a future device. We found that many of the devices fitted at the camp failed to meet International Society for Prosthetics and Orthotics' standards. Assessments revealed dissatisfaction with quality of work (33%; 175/525), fit (57%; 297/525) and function (26%; 139/525). At follow-up, 36% of clients (115/321) reported discomfort or pain. Most clients (78%; 238/305) stated preference for a domestically-produced device in future. Most clients (81%; 253/313) reported using their new device not very often, rarely or never, whereas 88% (243/277) of clients with a previous device reported using that device often or always. At least 29% (93/321) continued to use a previous device that they had described during the camp as unused, broken, painful or poorly fitting. Our findings indicate that shortcomings in quality and satisfaction of the studied prosthesis system persist as many clients rely on an inadequate or potentially dangerous prosthesis. The findings also raise new questions about client selection and the effective use of funding for the intensive camp provision format. Évaluer les prothèses fournies lors d’un camp d’appareillage intensif au Cambodge, en tenant compte de la qualité des prothèses et de la satisfaction des clients. Nous avons mené une étude de cohorte observationnelle pour évaluer les prothèses produites et fournies par une organisation non gouvernementale internationale lors d’un camp d’appareillage intensif. Nous avons mené notre évaluation en deux étapes: lors de la fourniture des prothèses, à l’aide d’une liste de contrôle pour évaluer la qualité des prothèses et la satisfaction des clients à leur sortie, et lors d’un suivi à trois mois, à partir d’un entretien téléphonique pour évaluer l’utilisation des prothèses par les clients et leurs préférences pour une éventuelle future prothèse. Nous avons constaté que de nombreuses prothèses posées lors du camp ne répondaient pas aux normes de la Société internationale de prothèse et orthèse . Les évaluations ont révélé une insatisfaction concernant la facture des prothèses (33%; 175/525), leur ajustement (57%; 297/525) et leur fonctionnement (26%; 139/525). Lors du suivi, 36% des clients (115/321) ont signalé une gêne ou une douleur. La plupart d’entre eux (78%; 238/305) ont déclaré préférer une prothèse fabriquée localement à l’avenir. La plupart (81%; 253/313) ont déclaré utiliser leur nouvelle prothèse peu souvent, rarement ou jamais, tandis que 88% (243/277) des clients possédant une ancienne prothèse ont déclaré l’utiliser souvent ou toujours. Au moins 29% (93/321) ont continué à utiliser une ancienne prothèse qu’ils avaient décrite auparavant (pendant le camp) comme inutilisée, cassée, provoquant des douleurs ou mal ajustée. Nos résultats indiquent que les lacunes en matière de qualité et de satisfaction du système d’appareillage étudié persistent, car de nombreux clients dépendent d’une prothèse inadéquate ou potentiellement dangereuse. Les résultats soulèvent également de nouvelles questions concernant la sélection des clients et l’utilisation efficace des fonds pour le format de prestation intensive lors du camp. Evaluar las prótesis suministradas durante un campamento intensivo de adaptación en Camboya, considerando la calidad de los dispositivos y la satisfacción de los usuarios. Se realizó un estudio de cohorte observacional en el que se evaluaron las prótesis producidas y entregadas por una organización no gubernamental internacional en un campamento intensivo de adaptación. La evaluación se realizó en dos fases: en el momento de la entrega de la prótesis, mediante una lista de verificación para valorar la calidad del dispositivo y la satisfacción del usuario al alta, y a los tres meses de seguimiento, mediante una entrevista telefónica para conocer el uso del dispositivo y la preferencia de los usuarios respecto a futuras prótesis. Se observó que muchas de las prótesis adaptadas durante el campamento no cumplían las normas de la Sociedad Internacional de Prótesis y Órtesis. Las evaluaciones revelaron insatisfacción con la calidad de la fabricación (33%; 175/525), el ajuste (57%; 297/525) y la función (26%; 139/525). En el seguimiento, el 36% de los usuarios (115/321) refirió malestar o dolor. La mayoría (78%; 238/305) manifestó preferir en el futuro una prótesis de fabricación nacional. Además, el 81% (253/313) informó usar su nueva prótesis con poca frecuencia, raramente o nunca, mientras que el 88% (243/277) de quienes disponían de una prótesis anterior declaró usarla a menudo o siempre. Al menos el 29% (93/321) continuó utilizando una prótesis previa que, durante el campamento, había descrito como inutilizada, rota, dolorosa o mal ajustada. Los resultados indican que persisten deficiencias en la calidad y la satisfacción de los usuarios del sistema protésico evaluado, ya que muchos siguen dependiendo de prótesis inadecuadas o potencialmente peligrosas. Los resultados también plantean nuevos interrogantes sobre la selección de los usuarios y la eficacia del uso de los recursos destinados al formato de campamentos intensivos de adaptación protésica. الغرض تقييم الأجهزة الاصطناعية المُقدمة خلال معسكر تركيب مكثف في كمبوديا، مع مراعاة جودة الجهاز ورضا العملاء. الطريقة قمنا بإجراء دراسة رصدية جماعية، حيث قمنا بتقييم الأجهزة الاصطناعية التي أنتجتها وسلمتها منظمة دولية غير حكومية في معسكر تركيب مكثف. قمنا بإجراء التقييم على مرحلتين: عند توفير الأجهزة الاصطناعية باستخدام قائمة مرجعية لتقييم جودة الجهاز ورضا العملاء عند الخروج من المستشفى، وعند متابعة بعد 3 أشهر عبر مقابلة هاتفية لتقييم استخدام العميل للجهاز وتفضيله لجهاز آخر في المستقبل. النتائج وجدنا أن العديد من الأجهزة التي تم تركيبها في المعسكر لم تستوفِ معايير الجمعية الدولية للأطراف الاصطناعية وتقويم العظام. كشفت التقييمات عن عدم الرضا بخصوص جودة الصنع (%33؛ 175/525)، والملاءمة (%57؛ 297/525)، والوظيفة (%26؛ 139/525). عند المتابعة، أبلغ %36 من العملاء (115/321) عن شعورهم بعدم الراحة أو الألم. أوضح معظم العملاء (%78؛ 238/305) تفضيلهم لجهاز محلي الصنع في المستقبل. أبلغ معظم العملاء (%81؛ 253/313) عن استخدامهم لأجهزتهم الجديدة بشكل غير متكرر، أو نادر، أو عدم الاستخدام مطلقًا، بينما أعلن %88 (243/277) من العملاء الذين لديهم جهاز سابق، عن استخدامهم هذا الجهاز كثيرًا أو دائمًا. استمر ما لا يقل عن %29 (93/321) في استخدام جهاز سابق وصفوه سابقًا (أثناء المعسكر) بأنه غير مستخدم، أو مكسور، أو مؤلم، أو غير مناسب. الاستنتاج تشير نتائجنا إلى أن أوجه القصور في الجودة والرضا المتعلقة بنظام الأطراف الاصطناعية المدروس، لا تزال قائمة حيث يعتمد العديد من العملاء على أطراف اصطناعية غير مناسبة أو يحتمل أن تكون خطرة. كما تثير النتائج أسئلة جديدة حول اختيار العملاء، والاستخدام الفعال للتمويل لتنسيق الإمداد في المعسكر المكثف. 旨在评估柬埔寨某个密集型假肢适配营地内交付的假肢装置的质量和用户满意度。. 我们开展了一项观察性队列研究,在研究期间,我们评估了某一国际非政府组织在某个密集型假肢适配营地处生产和交付的假肢装置。我们分别在以下两个阶段开展了评估工作:在假肢装置交付阶段,利用检查单来评估假肢装置的质量和用户出院时的满意度;在为期 3 个月的后续随访阶段,通过开展电话调查来评估用户的假肢装置使用情况以及对未来假肢装置的偏好。. 我们发现,在该适配营地装配的很多假肢装置均不符合国际假肢矫形学会的相关标准。评估结果显示,对假肢装置的工艺、适配度和功能感到不满意的用户所占比例分别为 33% (175/525)、57% (297/525) 和 26% (139/525)。在后续随访阶段,36% 的用户 (115/321) 报告其出现了不适或疼痛现象。大多数用户(78%,238/305)表示其未来更倾向于选择国产假肢装置。大多数用户(81%,253/313)报告其不常、很少或从未使用过其新假肢装置,然而 88% (243/277) 拥有旧假肢装置的用户称其经常或总是使用其旧装置。至少有 29% (93/321) 的用户继续使用其之前(在适配营地内)声称从未使用过、已损坏、会引发疼痛或适配度极低的旧假肢装置。. 鉴于很多用户声称其所用假肢质量不够好或存在潜在危险,研究结果表明,我们研究的假肢系统始终存在质量缺陷和用户满意度较低的问题。根据研究结果和针对密集型假肢适配营地交付方式,我们还发现了一系列涉及用户选择和资金有效利用的新问题。. Оценить протезные устройства, предоставленные в ходе интенсивной программы подгонки на базе временного пункта протезирования в Камбодже, с точки зрения качества устройств и удовлетворенности клиентов. Авторы провели обсервационное когортное исследование, в рамках которого оценили протезные устройства, изготовленные и предоставленные международной неправительственной организацией в ходе интенсивной программы на базе временного пункта протезирования. Оценка проводилась в два этапа: при предоставлении изделия его качество и удовлетворенность пациента в момент выписки оценивали с помощью контрольного опросного листа, а три месяца спустя контроль осуществлялся путем опроса по телефону с оценкой использования клиентом полученного устройства и его предпочтений в отношении подобных устройств в будущем. Было обнаружено, что многие устройства, подогнанные во временном пункте, не отвечали стандартам Международного общества протезирования и ортопедии. В ходе оценки было выявлено недовольство качеством изготовления (33%, 175/525), подгонки (57%, 297/525) и функциональностью протеза (26%, 139/525). В контрольном опросе 36% клиентов (115/321) сообщали о неудобстве или боли. Большинство клиентов (78%, 238/305) высказались в пользу протезов местного изготовления на будущее. Подавляющая часть клиентов (81%, 253/313) сообщали, что используют новое устройство не очень часто, редко или не пользуются им вовсе, при этом 88% клиентов (243/277) с имевшимся ранее устройством сообщали, что используют его часто или на постоянной основе. По меньшей мере 29% участников опроса (93/321) продолжили использовать предыдущее устройство, о котором ранее (во время пребывания во временном пункте) говорили, что тот протез сломан, не используется, плохо подогнан или причиняет боль. Результаты опроса демонстрируют, что проблемы недостаточного качества и удовлетворенности в отношении исследованной системы протезирования остаются нерешенными и что многие клиенты полагаются на неподходящие или потенциально опасные для них протезы. Результаты также ставят на повестку дня новые вопросы подбора клиентов и эффективного использования финансирования в формате интенсивных программ на базе временных протезных пунктов.
Biological female participants with lower extremity amputation (LEA) report decreased satisfaction with their prosthesis and increased pain and social isolation after amputation, compared with male participants. Despite representing 33% of amputees in the United States, female participants are often underrepresented in research, which can perpetuate health disparities. Female participants with LEA report feeling invisible and that their needs are unmet currently. A deeper understanding of female participants with LEA lived experiences and activities can help improve health outcomes and decrease health disparities. To highlight female participants with LEA experiences during a clinical trial and compare the lived experiences of female and male participants with LEA during the trial. Secondary qualitative analysis. Twenty-four semi-structured interview transcripts were reviewed that explored participants' experiences while testing a novel prosthetic foot (2 interviews per participant). Two reviewers independently reviewed all self-identified female participants (n = 6) and randomly selected self-identified male participants (n = 6) using an inductive, phenomenological approach, practicing reflexivity and peer debriefing. Four distinct themes were identified, highlighting female participants' experiences and comparing the female and male participants' interviews: (1) experiences of embodiment, (2) the progression of apprehension toward confidence while participating in a clinical trial, (3) footwear as a form of self-expression and functional ability, and (4) using side-to-side movement to navigate tight and community spaces. Female participants discussed some aspects of daily experiences and prosthesis needs different from male participants. Therefore, it is vital to include a diversity of sexes in clinical trials involving people with LEAs to improve health outcomes and reduce health disparities.
Despite advancements in prosthetic design, many lower limb amputees continue to experience discomfort and report abandonment rates between 25% and 57%. Issues at the residual limb-socket interface, such as pressure, friction, and poor fit, remain critical challenges affecting long-term prosthesis use. Objective: This study introduces a comprehensive protocol to collect and analyze quantitative data from transtibial amputees, incorporating thermal imaging and biomechanical measures to enhance prosthesis fitting in clinical settings.Study Design: Cross-sectional quantitative clinical study evaluating thermal and biomechanical parameters of prosthetic socket fitting in unilateral transtibial amputees. This is a cross-sectional study that employs quantitative analysis of thermal and biomechanical parameters in transtibial amputees. The study, conducted in a clinical setting, included independent unilateral transtibial amputees. Participants underwent a series of evaluations that included thermograms of the residual limb captured with a thermal camera, weight distribution using a plantar pressure platform, gait symmetry via an inertial sensor, and the 2-minute walk test (2MWT). The protocol aimed to compare the effectiveness of different suspension systems on prosthetic fit. The analysis targets temperature variations at the stump-socket interface and between-system differences in thermal and biomechanical metrics. We hypothesize that suction-based systems demonstrate better thermal consistency and symmetry, pin-lock systems exhibit higher proximal temperature, and valve systems achieve the longest 2-minute walk test distances. Variability in weight distribution and symmetry will inform individualized socket adjustments. The integration of thermal imaging and biomechanical analysis provides a more comprehensive evaluation of prosthesis fitting. Infrared thermography (IRT), although underused, is a promising tool for identifying critical adjustments in prosthetic design. Further research and standardization of such protocols can enhance clinical outcomes and user satisfaction.
Efficacy of custom-made foot orthoses largely depends on geometric characterization and outcomes can be suboptimal due to insufficient quantitative insights thereof. Addressing this is crucial for understanding geometric characteristics in dosage-response modeling. This study evaluates the reliability of digitizing traditional and advanced geometric foot features, using a handheld 3-dimensional (3D) scanning system. Two examiners used a handheld 3D scanner to capture the foot shape of 30 healthy participants in a non-weight-bearing condition. Intra-tester, test-retest, and inter-tester reliabilities of several linear anthropometric and geometric variables were evaluated. Subsequently, the consistency of capturing the geometry of the plantar foot surface was assessed by quantifying 2 anteroposterior and 2 mediolateral curvilinear plantar surface metrics. Intraclass correlation coefficients for the linear geometric and anthropometric variables' intra- and inter-tester reliability ranged from 0.84 to 1.00. The standard error of measurement for the Z-coordinate of the proximal medial arch point and the forefoot-rearfoot angle was substantially higher compared with the standard error of measurements observed in the other metrics. A pairwise comparison of the 4 curvilinear metrics showed no statistically significant difference on intra-tester and test-retest levels for both examiners. Inter-tester analysis identified significant (p < 0.05) differences in specific segments of the anteroposterior and mediolateral curvilinear metrics, particularly near the distal and medial ends. These results demonstrated that the digitization of linear anthropometric and geometric measurements of the human foot, obtained using a handheld 3D scanning system in a non-weight-bearing condition, exhibit good to excellent reliability. Additionally, the curvilinear metrics, related to the plantar surface curvature, showed high consistency, supporting its usage to quantify plantar geometry and provide insights into the role of geometric characteristics in dosage-response modeling in custom-made foot orthoses practice.
Amputation leads to disability and loss of mobility. This study focuses on the short-term recovery, especially early functionality gains and quality of life (QOL) improvements and how rehabilitation practices, particularly, timely fitting of prostheses and how educational status in specific, influence rehabilitation success. To assess the health-related quality of life (HRQOL) and functionality at 1, 3, and 6 months after unilateral trans-tibial amputation in a tertiary care hospital, South India. A longitudinal cohort study was conducted among 76 participants over 1.5 years using the tools, Research and Development (RAND-36) survey to measure HRQOL and Amputee Mobility Predictor (AMP), to assess functionality.Inclusion criteria: 1) Age-18-75 years; 2) unilateral trans-tibial amputees; and 3) operated at the given setting. Diabetic foot was the leading cause for amputation. At the end of 6th month, there was significant improvement (p < 0.05) in all parameters with confidence interval of 95%, QOL (95.8-103.9), and functionality (10.1-20.8). In comparison to nonusers, prosthetic users had significant improvements by the 6th month, w.r.t HRQOL (106.3) and AMP scores (26.1); nonusers (102.2 and 17.2, respectively). Amputees with higher education had significantly higher, HRQOL (106.1), AMP (26.9) scores, Medicare Functional Classification Levels (K2 and K3), and prosthesis usage rates (73.7%). Approximately 55.6% prosthetic users returned to work, vs. 32.1% nonusers. The HRQOL and functionality improved remarkably by the 6th month. Prosthesis has a positive impact on functionality, QOL, and return to work. Education is a significant determinant of prosthesis adoption and rehabilitation success.
Upper limb prosthetics aim to restore function and aesthetics of a lost arm and/or hand, which affects a growing population. A "Golden Period," the first month after the amputation, has been identified as the optimal time when a prosthesis should be fitted to amputees to maximize their chances for a fast and successful return to their daily life. This time window is often surpassed because of delays in approvals by health insurance companies and time requirements for producing personally customized and costly sockets. This study aims to develop an adaptable and versatile temporary transradial socket design capable of multidimensional adjustments and easy user fitting to better capitalize on the "Golden Period" and allow for early prosthetic training. In addition, the socket should be useable within research in need for flexible prosthesis as well as a hybrid prosthesis within the context of bionic reconstruction. The socket was designed, 3D printed, and assembled as a wearable prototype, hosting all relevant myoelectric hand components. The estimated satisfaction with the socket was evaluated in a monocentric, explorative study with both, prosthetic users and experts in the field. The proposed design is able to change its diameter and length. Moreover, according to the conducted survey, it is perceived as satisfactory with respect to both user needs and expectations of the experts. "Weight," "ease in donning and doffing," and "breathability" were rated particularly well, whereas an improved, more versatile, and smaller design is needed for broad clinical use.
Individuals with unilateral lower-limb amputation (LLA) are exposed to conditions such as low-back pain, which limit everyday activities and trunk musculature for stability. To determine the trunk kinematics and muscle activation of lumbar-erector-spinae (LES) and rectus-abdominis during the instrumented timed-up-and-go (iTUG) test and its correlation with co-activation, muscle activation pattern, gait asymmetry, and center-of-pressure (CoP) sway measures between individuals with and without LLA. The kinematic (trunk forward and lateral flexion, and rotation) and the ratio of muscle activation of LES over rectus-abdominis (LRR) were compared between LLA (n = 26) and the control (n = 16) performing the iTUG test, gait (symmetry-index [SI], co-activation index, and muscle activation pattern), and static test (measures of CoP sway). The LLA group showed greater alterations in balance indicators than the control (iTUG duration, gait SI, weight-bearing SI, CoP-excursion, and CoP-velocity). The trunk's kinematic variables were higher during turn-to-sit than in sit-to-walk, but the LRR was higher during sit-to-walk. The turn-to-sit peak-angular-velocity significantly correlated with the LRR, co-activation index, gait SI, weight-bearing SI, and the measurements of CoP sway. The peak-angular-velocity of the turn-to-sit component indicates balance impairment and trunk muscle disorders better than the iTUG duration or turning times. Slow turning movements may be linked to increased CoP sway, gait and weight-bearing asymmetries, and muscle activation issues in the LES during daily activities, which could raise the risk of low-back pain over time.
A better understanding of the abilities and difficulties of children with unilateral congenital below-elbow deficiency, and the functional abilities they would like to improve by using a bionic prosthesis would inform the development and prescription of bionic prostheses. This study aimed to describe the functional abilities and desires for bionic prosthetic assistance of children with unilateral congenital below-elbow deficiency. Preliminary, retrospective, cross-sectional, observational single-centre study. Eight children with unilateral congenital below-elbow deficiency were included (7 girls and 1 boy), with a median (Q1-Q3) age of 10.6 (10.1-11.4) years. We used the Disabilities of the Arm Shoulder and Hand Questionnaire to assess difficulties with activities of daily living and the Canadian Occupational Performance Measure to determine the child's needs and desires in terms of a bionic prosthesis. Descriptive statistics were conducted. The children were able to perform most activities of daily living but had difficulty with bimanual tasks. Most limitations related to schoolwork. The children described 35 significant activities that they desired a bionic prosthesis to facilitate: 15 related to leisure/sports, 5 to productivity and 15 to self-care activities. Children with unilateral congenital below-elbow deficiency can perform many activities of daily living and sports and leisure activities without a prosthesis; however, they desire to improve their performance of these activities. Activities that are of particular importance to them include personal care and sports and leisure activities.
Restoring independent daily activity is crucial for patients with a lower extremity amputation. Amputations at or distal to the midtarsal level pose unique challenges, necessitating specialized prosthetic and orthotic interventions to improve functionality, wellness, and quality of life. The objective of this scoping review was to examine the impact of prosthetic and orthotic use on clinical and health care outcomes in adults with a minor lower extremity amputation. Following Arksey and O'Malley's framework and the updated Joanna Briggs Institute's methodology, a systematic search of MEDLINE, CINAHL, SPORTDiscus, APA PsycInfo, Scopus, and the Cochrane Database of Systematic Reviews, was conducted. Fifty-nine relevant studies, primarily originating from the United States of America and Australia, were included. Trauma (47.5%) and diabetes (35.6%) were the leading causes of amputation. The most reported biomechanical outcomes were gait alterations (49.2%), revealing deficits and improvements in spatiotemporal parameters (33.9%), and plantar pressure distribution (22.0%). Custom-made devices insertable into the shoe, such as toe fillers and foot orthoses, enhanced walking speed and plantar pressure distribution, whereas above-ankle devices were more effective than foot orthoses in more proximal amputations. Well-fitted devices increased satisfaction and quality of life, but economic impacts were less frequently addressed. Despite most of the included studies being case reports (23.7%), which have a higher risk of bias, the review underscores the essential role of prosthetic and orthotic prescriptions based on tailored patient-centered care. The findings highlight the need for higher-quality research considering cost, and a broader range of patient-related outcomes and experiences measures, including psycho-social aspects.
Spinal orthoses can be used to limit active range of motion in different directions and to support trunk extension; however, their effect on movement and muscle activity remains uncertain. This study explored the effects of two semi-rigid spinal orthoses on trunk kinematics and muscle activity compared to no brace (NB). A pre-clinical, feasibility study. Markerless motion capture and surface electromyography was collected from 20 healthy participants each performing 5 repetitions of a sit-to-stand-to-sit task under three conditions: NB, Brace A (Medi Spinomed®, Bayreuth, Germany), and Brace B (DonJoy® Osteostrap, Enovis, UK). Repeated measures analysis of variance was used to evaluate trunk kinematics and muscle activity between conditions. During sit-to-stand, average muscle activity of the dominant latissimus dorsi was significantly reduced in Brace A compared to NB (MD = 0.13, p = 0.019), but there were no differences between Brace A and Brace B (MD = -0.08, p = 0.097). During both standing and sitting, participants were significantly more flexed forward in Brace A compared to NB (MD = 1.65-2.23, p < 0.015) and Brace B (MD = 1.46-1.55, p = 0.040). During stand-to-sit, peak extension angular velocity significantly increased in Brace A and Brace B compared to NB (MD = 5.74, p = 0.011, MD = 6.68, p = 0.046, respectively). Central tendencies for perceived comfort were "comfortable" for both braces, and perceived ease of task performance was "very easy" for Brace A and "easy" for Brace B, with brace preference split equally. Active range of motion was not limited using either brace; however, these did assist movement into extension, which may offer a clinical benefit, with small changes also seen in latissimus dorsi muscle activity. Further work including clinical populations is warranted using intervention periods that reflects clinical practice.
Prosthetic alignment is a critical factor in the functionality and comfort of transtibial prostheses, which are still based on amputee's feedback prosthetist experience and clinical judgment. Proper alignment involves a series of procedures, including bench, static, and dynamic alignment, each contributing to the overall success of the prosthesis. This cross-sectional study aims to explore transtibial prosthetic alignment practices among prosthetists in Malaysia, Jordan, and Saudi Arabia, focusing on the associations of demographic data, occupational status, and knowledge on common prosthetic alignment guidelines.Study Design:A cross-sectional study. A survey-based approach among experienced prosthetists was conducted via Google Forms and distributed online through email and professional networks that had prosthetists' demographics, 3 main sections relevant to common guidelines regarding transtibial prosthetic alignment, and an open feedback question allowed respondents to give feedback on their current prosthetic alignment practices. Quantitative data analysis involved duplicate removal, categorizing responses into themes, and calculation of alignment scores, whereas associations of demographic data with engagement in prosthetic alignment were tested using χ 2 tests. The findings revealed significant associations between higher education levels ( P < 0.01) and monthly income ( P < 0.01) in relation to average score of dynamic alignment practices. Despite the availability of advanced technology, 86.79% of prosthetists rely on traditional tools and qualitative methods. The study highlights the need for standardized guidelines that incorporate personalized considerations to improve the quality and consistency of prosthetic alignment. These guidelines should address the diverse practices and preferences of prosthetists to enhance patient outcomes.
Intensive care unit (ICU) admissions among older patients are increasing, posing significant challenges to already strained healthcare systems. Decision-making around ICU admission in times of limited resources may provide important knowledge about difficult prioritisations, particularly for older patients. Thus, the aim was to investigate ICU-admission decisions for older patients with COVID-19. A mixed-methods approach. We audio-recorded ten COVID Rounds and nine Moral Case Deliberations for 34 patients across three Swedish hospitals during the pandemic, and collected data from medical records of 329 patients aged ≥ 65 diagnosed with COVID-19. Data were analysed using qualitative content analysis and multiple regression. Among 239 patients with documented decisions in medical records, 56% included explicit justifications. The justifications included considerations of medical benefit (not-too- ill/too-ill), general condition (good/frail), age (not-too-old/high age), professional duty (benefit of the doubt/do no harm) and "worth giving it a go" (grit and will to live/lack of will and coping). A minority (31%) of decisions favoured ICU admission. Justifications supporting admission were predominantly drawn from discussions in COVID Rounds and MCDs, where patient grit was a recurring argument. In regression analyses, age ≥ 80 years was the only factor significantly associated with not being admitted to ICU and having a documented justification. Few decisions explicitly referred to COVID-19-specific factors. Our findings reflect patterns similar to pre-pandemic ICU decision-making, suggesting continuity in clinical reasoning. However, the limited documentation of justifications-especially in favour of admission-warrants attention, emphasising the need for clearer reasoning in medical records. Our findings identify chronological age as a key triage factor, normatively supported by the ethical principles of non-maleficence, justice, and Sweden's legal priority-setting principle of Needs and Solidarity-which emphasises care only when benefit is likely. We therefore advocate for national (and potentially international) guidance on triage systems that support a palliative approach for very old patients. While grit may be relevant to ICU admission due to its link to potential benefit, its use raises ethical concerns, particularly in relation to Needs and Solidarity and Human Dignity. We recommend its cautious application pending further research.
Routine health care data remain underused for enhancing care quality, safety, and cost-effectiveness, and for research. Little is known about data collection and outcome measurement (OM) in English prosthetic services. This insight could inform health care quality improvement and future nationwide data initiatives. To examine data collection and OM practice undertaken during implementation of the Microprocessor Controlled Prosthetic Knee Clinical Commissioning policy in English prosthetic services. Nationwide survey of practice. An online survey was developed and piloted with clinicians working in English prosthetic rehabilitation centers. The survey was deployed to all 35 of England's prosthetic services. Centers were asked to complete one survey per center. Twenty-two centers completed the survey. Twenty of 21 patient data items were collected at rates >80%, whereas 5 of the 6 core outcomes were captured at rates exceeding 90%. Variation was observed in the scoring and administration methods of OMs across centers, limiting comparison of scores. Clinically, patient outcome data were most often used to inform individual decision making regarding microprocessor knee prescription (95%). However, 50% of centers suggested OMs needed to be more useful and relevant. Forty-one percent of centers do not collate data across patients. The consistency of types of data captured demonstrate the importance of this data for implementation of the National Health Service England microprocessor knee policy. This work has identified several areas of variability, such as OM administration and collation of data, that present operational and educational challenges for the clinical use of routine health care data and OMs. These challenges need to be considered for those implementing future service provision policies or aiming to develop a national prosthetic data collection initiative.
Spinal bracing remains the gold standard for conservative management of adolescent idiopathic scoliosis (AIS). However, poor adherence often limits treatment efficacy. The development of a brace that enhances compliance while maintaining sufficient corrective force is crucial. This study aimed to develop and evaluate the effectiveness of a novel semi-rigid brace for AIS based on wearing time and correction rate. Multicenter prospective observational study. We enrolled patients who met the following Scoliosis Research Society criteria for brace treatment: (1) confirmed AIS diagnosis, (2) Risser sign ≤2, (3) Cobb angle between 25° and 40°, (4) age ≥10 years, and (5) single-curve pattern. Wearing time was objectively measured over 180 d using embedded temperature sensors. Correction rates were assessed at initiation and after 12 months or more. A total of 60 patients with AIS were included. Among them, 24 had thoracic curves, and 36 had thoracolumbar/lumbar curves. The mean daily wearing time was 16.3 h for thoracic curves and 18.2 h for thoracolumbar/lumbar curves. The median initial correction rate was 32% for thoracic curves and 45% for thoracolumbar/lumbar curves. After 12 months or more, the median correction rate was 20% and 48%, respectively. The dropout rate was 5%, and no severe skin complications were observed. The novel semi-rigid brace demonstrated high compliance and effective curve correction over 12 months. These findings support its potential as a comfortable and effective conservative treatment option for patients with AIS.
Limb rotation within prosthetic sockets significantly affects the comfort, gait, and stability of lower-limb amputees. Despite advancements in suspension systems, empirical evidence validating their rotational control remains limited. This study aims to systematically compare the rotational resistance of 3 prosthetic suspension systems-Pin-Lock, Suction, and Hook-and-Loop (HOLO)-under controlled conditions, addressing a critical gap in prosthetic design research. We evaluate the rotational resistance of 3 different prosthetic suspension systems-Pin-Lock, Suction, and HOLO-under varying axial loads (0/40/80 kg) and both (medial and lateral) rotational directions. Using a custom-designed mock limb and identical 3D-printed sockets, each suspension system was evaluated using a materials testing machine. The angular displacement of the limb inside each socket was measured under a constant torque ramp of 1 Nm/s, up to a maximum torque of 8.5 Nm. The HOLO system (9.67° at 80 kg) showed significantly less rotation than the Pin-Lock (13.34° at 80 kg, p < 0.01) and Suction (14.42° at 80 kg, p < 0.01) systems. The medial rotation was 10.5% and 26.9% less than lateral rotation for Pin-Lock and HOLO systems, respectively, and 25.5% greater for Suction (all p < 0.01). Increasing axial loads reduced rotation for the Pin-Lock system only. This is the first study to measure the effectiveness of different prosthetic suspension systems using a representative mock limb. The results show that there are significant differences between the systems, highlighting the need to consider a user's activity level and rotational demands in prosthetic provision.
Transfemoral and transhumeral amputees rely on socket prosthetics, which are susceptible to difficulties with fit, skin integrity, pain, and biomechanical disadvantage, ultimately decreasing prosthetic limb utilization. Osseointegrated percutaneous prosthetic systems may help eliminate these challenges. However, no study has identified the estimated number of patients who may be candidates for osseointegrated prosthetics. To indentify the estimated number of patients who may be candidates for osseointegrated prosthetics using the National Inpatient Sample (NIS) Database. Observational. We queried the National Inpatient Sample (NIS) database for all above knee amputations (AKA) and above elbow amputations (AEA) occurring between 2001 and 2014, in patients aged 22‒65, using International Classification of Diseases-9 procedure codes 84.17 and 84.07, respectively. International Classification of Diseases-9 diagnosis codes for the amputation were categorized as dysvascular, malignancy, prosthetic joint infection, trauma, and other. Weighted National Estimates (WNE) were calculated using NIS sampling weights. Amputations secondary to dysvascular conditions, prosthetic joint infections, or nonconnective tissue neoplasms were excluded as contraindications for osseointegration surgery. The NIS query revealed a WNE of 362,867 AKAs and 5544 AEAs performed between 2001 and 2014. Applying exclusion criteria, there were 1776 AKAs (WNE: 8444) and 415 AEAs (WNE: 1984). Seven patients had both AKA and AEA. A mean estimate of 603 transfemoral and 142 transhumeral amputees may be candidates for osseointegration each year. Our analysis of the NIS reveals that 745 US civilians per year, including 603 AKA and 142 AEA patients, may be candidates for an osseointegrated percutaneous prosthetic system. This amounts to an estimated incidence of 2/million/year in the US population.
Ankle foot orthoses (AFOs) and foot orthoses (FOs) are 2 commonly prescribed lower limb orthoses. Traditionally produced using artisanal methods, the design and manufacture of these devices have increasingly used computer-aided design (CAD) and computer-aided manufacturing technologies in recent decades. The CAD workflows can vary considerably, making generalization of research findings difficult. In this scoping review, research studies of any design that reported using CAD to produce designs for AFOs or FOs were eligible for inclusion. The review was developed following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR). Six electronic databases were searched till December 2024. Seventy-three articles were included in this review. A wide range of CAD programs was used to produce orthotic devices; however, the procedures and reproducibility of the design processes were poorly or not at all described in 46.6% of the included articles. A mix of general-purpose and orthotic-specific CAD software was recorded, with SolidWorks and Rhinoceros being the most popular options. OrthoModel and Rodin4D were the most reported currently available orthotic-specific CAD software for FOs and AFOs, respectively. The CAD operation time for general-purpose software was generally longer than that for orthotic-specific ones. In addition, we have developed a checklist to assist in standardizing and ensuring reproducibility of FOs and AFOs studies. Researchers, clinicians, and those in industry need to exchange their knowledge to help address real-world need, enhance CAD functionalities, and support CAD programs in clinical studies.
Females with lower limb amputations have different risk factors and lower success with their prostheses overall. Studying priorities of this population, specifically in how they differ between sexes, through survey methods may improve understanding of female-specific needs and inform sex-specific prosthetic design. To adapt the Prosthesis Evaluation Questionnaire and use this to assess sex differences in needs and priorities of people with lower limb amputations (pLLAs). Cross-sectional questionnaire study. A committee was formed to modify the Prosthesis Evaluation Questionnaire. The modified questionnaire was completed online by 26 pLLAs (13 females, 13 males). Sex differences in subscale and individual closed-question responses were analyzed using Mann-Whitney U tests. Sex differences in open-ended question responses were analyzed using affinity diagramming. Significant sex differences were found in subscale scores and separate closed questions, with resulting qualitative themes further suggesting sex-specific priorities and perspectives. Females reported lower satisfaction with prosthetic appearance, poorer overall ambulation abilities, and greater perception of social burden than males. Sex differences were also found in themes related to prosthesis satisfaction and other psychosocial factors including social adjustment. Findings demonstrated all-encompassing sex differences in the priorities and needs of pLLAs. This work can be used to better understand and target female's unique priorities through sex-specific considerations in research and prosthetic design.