Individualized orthotic alignment and footwear for balance and mobility in children with bilateral spastic cerebral palsy: A randomized trial.

AIM: To examine whether designed-to-be-rigid ankle-foot orthoses and footwear combinations with individualized alignment and footwear designs (AFO-FC/IAFD) would be more effective than designed-to-be-rigid AFO with non-individualized alignment and footwear designs (AFO-FC/NAFD) in children with cerebral palsy (CP). METHOD: Nineteen children with bilateral spastic CP were randomized to AFO-FC/NAFD (n = 10) or AFO-FC/IAFD (n = 9) groups. Fifteen were male, average age 6 years 11 months (range 4 years 2 months-9 years 11 months), classified in Gross Motor Function Classification System levels II (n = 15) and III (n = 4). The Pediatric Balance Scale (PBS), Gait Outcomes Assessment List (GOAL), Patient-Reported Outcomes Measurement Information System (PROMIS), and Orthotic and Prosthetic Users' Survey (OPUS) measures of satisfaction were collected at baseline and after 3 months' wear. RESULTS: Compared with the AFO-FC/NAFD group, those with AFO-FC/IAFD demonstrated greater change in PBS total scores (mean 12.8 [standard deviation 10.5] vs 3.5 [5.8]; p = 0.03) and GOAL total scores (3.5 [5.8] vs -0.44 [5.5]; p = 0.03). There were no significant changes in OPUS or PROMIS scores. INTERPRETATION: After 3 months, individualized orthosis alignment and footwear designs had a greater positive effect on balance and parent-reported mobility than a non-individualized approach. No effect was documented for the PROMIS and OPUS. Results may inform orthotic management for ambulatory children with bilateral spastic CP. WHAT THIS PAPER ADDS: Balance and parent-reported mobility increased more over time for the ankle-foot orthoses and footwear combinations with individualized alignment and footwear designs (AFO-FC/IAFD) group. Changes in balance over time suggest a therapeutic effect of the AFO-FC/IAFD approach.

Accuracy, Repeatability, and Reproducibility of a Hand-Held Structured-Light 3D Scanner across Multi-Site Settings in Lower Limb Prosthetics.

The aim of this work was to assess the accuracy, repeatability, and reproducibility of a hand-held, structured-light 3D scanner (EINScan Pro 2X Plus with High Definition Prime Pack, SHINING 3D Tech. Co., Ltd., Hangzhou, China), to support its potential use in multi-site settings on lower limb prosthetics. Four limb models with different shapes were fabricated and scanned with a metrological 3D scanner (EINScan Laser FreeScan 5X, SHINING 3D Tech. Co., Ltd., Hangzhou, China) by a professional operator (OP0). Limb models were then mailed to three sites where two operators (OP1, OP2) scanned them using their own structured-light 3D scanner (same model). OP1 scanned limb models twice (OP1-A, OP1-B). OP0, OP1-A, and OP2 scans were compared for accuracy, OP1-A and OP1-B for repeatability, and OP1-A and OP2 for reproducibility. Among all comparisons, the mean radial error was <0.25 mm, mean angular error was <4°, and root mean square error of the radial distance was <1 mm. Moreover, limits of agreement were <3.5% for perimeters and volumes. By comparing these results with respect to clinically-relevant thresholds and to the literature available on other 3D scanners, we conclude that the EINScan Pro 2X Plus 3D Scanner with High Definition Prime Pack has good accuracy, repeatability, and reproducibility, supporting its use in multi-site settings.

After scaling to body size hip strength of the residual limb exceeds that of the intact limb among unilateral lower limb prosthesis users.

BACKGROUND: Hip muscles play a prominent role in compensating for the loss of ankle and/or knee muscle function after lower limb amputation. Despite contributions to walking and balance, there is no consensus regarding hip strength deficits in lower limb prosthesis (LLP) users. Identifying patterns of hip muscle weakness in LLP users may increase the specificity of physical therapy interventions (i.e., which muscle group(s) to target), and expedite the search for modifiable factors associated with deficits in hip muscle function among LLP users. The purpose of this study was to test whether hip strength, estimated by maximum voluntary isometric peak torque, differed between the residual and intact limbs of LLP users, and age- and gender-matched controls. METHODS: Twenty-eight LLP users (14 transtibial, 14 transfemoral, 7 dysvascular, 13.5 years since amputation), and 28 age- and gender-matched controls participated in a cross-sectional study. Maximum voluntary isometric hip extension, flexion, abduction, and adduction torque were measured with a motorized dynamometer. Participants completed 15 five-second trials with 10-s rest between trials. Peak isometric hip torque was normalized to body mass × thigh length. A 2-way mixed-ANOVA with a between-subject factor of leg (intact, residual, control) and a within-subject factor of muscle group (extensors, flexors, abductors, adductors) tested for differences in strength among combinations of leg and muscle group (α = 0.05). Multiple comparisons were adjusted using Tukey's Honest-Difference. RESULTS: A significant 2-way interaction between leg and muscle group indicated normalized peak torque differed among combinations of muscle group and leg (p < 0.001). A significant simple main effect of leg (p = 0.001) indicated peak torque differed between two or more legs per muscle group. Post-hoc comparisons revealed hip extensor, flexor, and abductor peak torque was not significantly different between the residual and control legs (p ≥ 0.067) but torques in both legs were significantly greater than in the intact leg (p < 0.001). Peak hip abductor torque was significantly greater in the control and residual legs than the intact leg (p < 0.001), and significantly greater in the residual than control leg (p < 0.001). CONCLUSIONS: Our results suggest that it is the intact, rather than the residual limb, that is weaker. These findings may be due to methodological choices (e.g., normalization), or biomechanical demands placed on residual limb hip muscles. Further research is warranted to both confirm, expand upon, and elucidate possible mechanisms for the present findings; and clarify contributions of intact and residual limb hip muscles to walking and balance in LLP users. CLINICAL TRIAL REGISTRATION: N/A.

Comparison of Ischial Containment and Subischial Sockets Effect on Gait Biomechanics in People With Transfemoral Amputation: A Randomized Crossover Trial.

OBJECTIVE: To compare gait biomechanics of the Northwestern University Flexible Sub-Ischial Vacuum (NU-FlexSIV) Socket to the ischial containment (IC) socket. DESIGN: Randomized crossover trial with 2, 7-week periods. SETTING: Private prosthetic clinics and university research laboratory. PARTICIPANTS: A total of 30 enrolled (n=30); 25 participants completed the study with full (n=18) or partial data (n=7). INTERVENTIONS: Two custom-fabricated sockets (IC and NU-FlexSIV), worn full-time for 7 weeks, with testing at 1, 4, and 7 weeks after socket delivery. MAIN OUTCOME MEASURES: Gait analyses were conducted at 1, 4, and 7 weeks post socket delivery. Differences between sockets in selected gait variables related to hip motion and coronal plane socket stability were assessed. RESULTS: For participants with data for both sockets at week 7 (n=19), there were no significant differences in any gait variables between sockets at self-selected normal walking speed. However, when all participants and all study time points were assessed (n=25), there was a significant main effect of socket (P=.013), with prosthetic side sagittal plane hip range of motion being significantly greater for the NU-FlexSIV Socket at self-selected normal walking speed. There were no other significant effects. CONCLUSIONS: The results suggest that, compared to the IC socket, the NU-FlexSIV Socket did not alter gait biomechanics related to hip motion and coronal plane socket stability in people with unilateral transfemoral amputation.

Comparison of Sagittal Plane Stiffness of Nonarticulated Pediatric Ankle-Foot Orthoses Designed to be Rigid.

INTRODUCTION: When studying the effect of ankle-foot orthoses (AFOs) on gait, it is important to know their sagittal plane stiffness. However, there are no established thresholds for stiffness of non-articulated AFOs designed to be rigid. If wanting to implement published algorithms for ankle-foot orthosis-footwear combinations (AFO-FCs), the AFOs must be equally as stiff as those of the developer of the published AFO-FC algorithms. Hence, the aim of this work was to compare the sagittal plane stiffness of AFOs designed to be rigid, made for a clinical trial in the USA, and following algorithms for AFO-FC designs, to those made and used clinically in the UK by the developer of the AFO-FC algorithms. MATERIALS AND METHODS: Stiffness of 9 pediatric polypropylene AFOs was tested (UK: 6; USA: 3). A computer-controlled motorized device was used in which all AFOs were clamped with the calf shell in a fixed vertical component and the foot section in a rotating plate. Each AFO was tested for 3 trials, loading the foot plate 30 Nm towards dorsiflexion and 20 Nm towards plantarflexion. Torque-angle graphs were plotted and deflection and stiffness compared descriptively across AFOs. RESULTS: Average deflection of AFOs was UK: 3.42±0.83° and USA: 4.81±1.05°. Average stiffness of AFOs was UK: 14.34±3.34 Nm/° and USA: 10.30±1.92 Nm/°. CONCLUSIONS: All tested AFOs deflected only a few degrees in either direction (range: 2.59° to 6.02°), providing the first information reported for the stiffness of rigid pediatric non-articulated AFOs. Overall, the UK AFOs were stiffer and deflected less than the USA study AFOs. AFO design features should be carefully considered as they likely influence sagittal plane stiffness and deflection under load.

Comparison of Ischial Containment and Subischial Sockets on Comfort, Function, Quality of Life, and Satisfaction With Device in Persons With Unilateral Transfemoral Amputation: A Randomized Crossover Trial.

OBJECTIVE: To compare comfort and functional performance of the Northwestern University Flexible Subischial Vacuum (NU-FlexSIV) Socket with the ischial containment (IC) socket in persons with unilateral transfemoral amputation. DESIGN: Randomized crossover trial with two 7-week periods. SETTING: Private prosthetic clinics and university research laboratory. PARTICIPANTS: A total of 30 enrolled (N=30); 25 participants completed the study with full (n=18) or partial data (n=7). INTERVENTIONS: Two custom-fabricated sockets (IC and NU-FlexSIV), worn full-time for 7 weeks, with testing at 1, 4, and 7 weeks after socket delivery. MAIN OUTCOME MEASURES: The primary outcome was change in Socket Comfort Score (SCS) at 7 weeks. Secondary outcomes at 7 weeks included the Orthotic and Prosthetic Users' Survey (OPUS) to assess lower extremity functional status, health-related quality of life, and satisfaction with device, as well as the 5-Times Rapid Sit-to-Stand Test, Four Square Step Test, and T-Test of Agility to assess functional performance. RESULTS: At 7 weeks, the mean SCS for IC (7.0±1.7) and NU-FlexSIV (8.4±1.1) Sockets were significantly different (P<.001; 95% confidence interval, 0.8-2.3). Results from a linear mixed-effects model, accounting for data from all time points, indicated that the SCS was 1.7 (SE=0.45) points higher for the NU-FlexSIV Socket (P<.001). For the secondary outcomes, only OPUS satisfaction with device was significantly better in the NU-FlexSIV Socket after accounting for all data points. CONCLUSIONS: The results suggest that after 7 weeks' accommodation, the NU-FlexSIV Socket was more comfortable and led to greater satisfaction with device than the IC socket in persons with unilateral transfemoral amputation and K3/K4 mobility. Other patient-reported outcomes and function were no different between sockets.

Identifying Instruments to Assess Care Quality for Individuals With Custom Ankle Foot Orthoses: A Scoping Review.

OBJECTIVES: We conducted 2 complementary scoping reviews to identify instruments that assess the experience and outcomes of custom ankle-foot orthosis (AFO) care in individuals with neurologic and traumatic conditions and to determine to what extent they might be psychometrically sound for AFO users. A stakeholder advisory committee considered to what extent the identified and psychometrically sound instruments might be feasible for use in developing quality measures for custom AFO users. DATA SOURCES: Both scoping reviews were conducted using PubMed, the Cumulative Index to Nursing and Allied Health Literature, Embase, and Cochrane Systematic Reviews. The following were used for the first scoping review only: Cochrane Central Register of Controlled Trials and the Physiotherapy Evidence Database. STUDY SELECTION: The initial scoping review yielded 79 articles with 82 instruments, 16 of which were used in 4 or more studies. The second scoping review yielded 57 articles reporting psychometric properties. DATA EXTRACTION: Psychometric properties for populations who use AFOs were summarized for 15 of the 16 instruments. The advisory committee eliminated 2 insrtruments, noted overlap between 4 instruments in terms of the constructs measured, and suggested 6 potential contemporary substitutes. DATA SYNTHESIS: Most instruments assessed activity (specifically mobility) and pertained to the National Quality Forum domain of "Health-Related Quality of Life." The 10-meter walk test, 6-minute walk test, Berg Balance Scale, Timed Up and Go, and Rivermead Mobility Index were reported to have adequate reliability and validity, and were considered feasible for administration in a clinical setting. CONCLUSIONS: Complementary scoping reviews demonstrated that some instruments with reasonable psychometric properties are available that are feasible to use in developing quality measures for custom AFO care. However, experience of care instruments suitable for this population were not identified but are needed for a comprehensive evaluation of care quality for AFO users.

While Mortality Rates Differ After Dysvascular Partial Foot and Transtibial Amputation, Should They Influence the Choice of Amputation Level?

Although there is strong evidence to show that the risk of dying after transtibial amputation is higher than partial foot amputation, we are concerned by the implication that amputation level influences mortality, and that such interpretations of the evidence may be used to inform decisions about the choice of amputation level. We argue that the choice of partial foot or transtibial amputation does not influence the risk of mortality. The highest mortality rates are observed in studies with older people with more advanced systemic disease and multiple comorbidities. Studies that control for the confounding influence of these factors have shown no differences in mortality rates by amputation level. These insights have important implications in terms of how we help inform difficult decisions about amputation at either the partial foot or transtibial level, given a more thoughtful interpretation of the published mortality rates.

How a diverse research ecosystem has generated new rehabilitation technologies: Review of NIDILRR's Rehabilitation Engineering Research Centers.

Over 50 million United States citizens (1 in 6 people in the US) have a developmental, acquired, or degenerative disability. The average US citizen can expect to live 20% of his or her life with a disability. Rehabilitation technologies play a major role in improving the quality of life for people with a disability, yet widespread and highly challenging needs remain. Within the US, a major effort aimed at the creation and evaluation of rehabilitation technology has been the Rehabilitation Engineering Research Centers (RERCs) sponsored by the National Institute on Disability, Independent Living, and Rehabilitation Research. As envisioned at their conception by a panel of the National Academy of Science in 1970, these centers were intended to take a "total approach to rehabilitation", combining medicine, engineering, and related science, to improve the quality of life of individuals with a disability. Here, we review the scope, achievements, and ongoing projects of an unbiased sample of 19 currently active or recently terminated RERCs. Specifically, for each center, we briefly explain the needs it targets, summarize key historical advances, identify emerging innovations, and consider future directions. Our assessment from this review is that the RERC program indeed involves a multidisciplinary approach, with 36 professional fields involved, although 70% of research and development staff are in engineering fields, 23% in clinical fields, and only 7% in basic science fields; significantly, 11% of the professional staff have a disability related to their research. We observe that the RERC program has substantially diversified the scope of its work since the 1970's, addressing more types of disabilities using more technologies, and, in particular, often now focusing on information technologies. RERC work also now often views users as integrated into an interdependent society through technologies that both people with and without disabilities co-use (such as the internet, wireless communication, and architecture). In addition, RERC research has evolved to view users as able at improving outcomes through learning, exercise, and plasticity (rather than being static), which can be optimally timed. We provide examples of rehabilitation technology innovation produced by the RERCs that illustrate this increasingly diversifying scope and evolving perspective. We conclude by discussing growth opportunities and possible future directions of the RERC program.

The Effect of Ankle-Foot Orthoses on Community-Based Walking in Cerebral Palsy: A Clinical Pilot Study.

PURPOSE: To examine the effect of ankle-foot orthoses (AFO) on walking activity in children with cerebral palsy (CP). METHODS: We used a randomized cross-over design with 11 children with bilateral CP, mean age 4.3 years. Subjects were randomized to current AFO-ON or AFO-OFF for 2 weeks and then crossed over. Walking activity (average total steps/day), intensity, and stride rate curves were collected via an ankle accelerometer. Group effects were examined with the Wilcoxon signed-rank test and within-subject effects examined for more than 1 standard deviation change. RESULTS: No significant group difference was found in average total daily step count between treatment conditions (P = .48). For the AFO-ON condition, 2 subjects (18%) increased total steps/day; 4 (36%) increased walking time; 2 (18%) had more strides at a rate of more than 30 strides/min; and 2 (18%) reached higher peak intensity. CONCLUSIONS: Clinically prescribed AFO/footwear did not consistently enhance walking activity levels or intensity. Larger studies are warranted.

Comparison of range-of-motion and variability in upper body movements between transradial prosthesis users and able-bodied controls when executing goal-oriented tasks.

BACKGROUND: Current upper limb prostheses do not replace the active degrees-of-freedom distal to the elbow inherent to intact physiology. Limited evidence suggests that transradial prosthesis users demonstrate shoulder and trunk movements to compensate for these missing volitional degrees-of-freedom. The purpose of this study was to enhance understanding of the effects of prosthesis use on motor performance by comparing the movement quality of upper body kinematics between transradial prosthesis users and able-bodied controls when executing goal-oriented tasks that reflect activities of daily living. METHODS: Upper body kinematics were collected on six able-bodied controls and seven myoelectric transradial prosthesis users during execution of goal-oriented tasks. Range-of-motion, absolute kinematic variability (standard deviation), and kinematic repeatability (adjusted coefficient-of-multiple-determination) were quantified for trunk motion in three planes, shoulder flexion/extension, shoulder ab/adduction, and elbow flexion/extension across five trials per task. Linear mixed models analysis assessed between-group differences and correlation analysis evaluated association between prosthesis experience and kinematic repeatability. RESULTS: Across tasks, prosthesis users demonstrated increased trunk motion in all three planes and shoulder abduction compared to controls (p ≤ 0.004). Absolute kinematic variability was greater for prosthesis users for all degrees-of-freedom irrespective of task, but was significant only for degrees-of-freedom that demonstrated increased range-of-motion (p ≤ 0.003). For degrees-of-freedom that did not display increased absolute variability for prosthesis users, able-bodied kinematics were characterized by significantly greater repeatability (p ≤ 0.015). Prosthesis experience had a strong positive relationship with average kinematic repeatability (r = 0.790, p = 0.034). CONCLUSIONS: The use of shoulder and trunk movements by prosthesis users as compensatory motions to execute goal-oriented tasks demonstrates the flexibility and adaptability of the motor system. Increased variability in movement suggests that prosthesis users do not converge on a defined motor strategy to the same degree as able-bodied individuals. Kinematic repeatability may increase with prosthesis experience, or encourage continued device use, and future work is warranted to explore these relationships. As compensatory dynamics may be necessary to improve functionality of transradial prostheses, users may benefit from dedicated training that encourages optimization of these dynamics to facilitate execution of daily living activity, and fosters adaptable but reliable motor strategies.

The relationship of hip strength to walking and balance performance in unilateral lower limb prosthesis users differs by amputation level.

BACKGROUND: Safe and efficient locomotion is a frequently stated goal of lower limb prosthesis users, for which hip strength may play a central yet poorly understood role. Additional research to identify associations between hip strength, balance, and mobility among transtibial and transfemoral prosthesis users is required. OBJECTIVE: To test whether residual and/or intact limb isometric hip strength was associated with lower limb prosthesis users' walking speed, endurance, and balance. DESIGN: Cross-sectional study. SETTING: Research laboratory. PARTICIPANTS: Convivence sample of 14 transtibial and 14 transfemoral prosthesis users. METHODS: Multiple linear regression was used to evaluate the relationship between isometric measures of residual and intact limb hip strength and walking and balance performance. MAIN OUTCOME MEASUREMENTS: Measures of isometric hip muscle strength, including peak torque, average torque, torque impulse, and torque steadiness (i.e. consistency with which an isometric torque can be sustained) were derived from maximum voluntary hip flexion, extension, abduction and adduction torque signals collected with a motor-driven dynamometer. Walking speed, endurance, and balance were assessed by administering the 10-meter walk test, 2-minute walk test, Four Square Step Test, and Narrowing Beam Walking Test, respectively. RESULTS: Residual limb hip extensor max torque and abductor torque steadiness explained between 51% and 69% of the variance in transtibial prosthesis users' walking speed, endurance, and balance. In contrast, intact limb hip abductor torque impulse explained between 33% and 48% of the variance in transfemoral prosthesis users' walking speed, endurance, and balance. CONCLUSIONS: Our results suggest that unilateral transtibial and transfemoral prosthesis users' walking and balance performance may depend on different hip muscles, and different facets of hip strength. Amputation level-specific hip strength interventions may therefore be required to improve walking and balance performance in unilateral transtibial and transfemoral prosthesis users. The "intact leg strategy" adopted by transfemoral prosthesis users may be due to a variety of prosthesis and biomechanical factors that limit the efficiency with which transfemoral prosthesis users can exploit the strength of their residual limb hip muscles while walking.

Proportionate mortality following dysvascular partial foot amputation and how this compares to transtibial amputation: a systematic review.

PURPOSE: A large proportion of people die in the years following dysvascular partial foot amputation (PFA) or transtibial amputation (TTA) given the long-term consequences of peripheral vascular disease and/or diabetes. A critical appraisal of recent research is needed to understand the underlying cause of variation and synthesise data for use in consultations about amputation surgery and patient-facing resources. This systematic review aimed to describe proportionate mortality following dysvascular PFA and to compare this between PFA and TTA. MATERIALS AND METHODS: The review protocol was registered in PROSPERO (CRD42023399161). Peer-reviewed studies of original research were included if they: were published in English between 1 January 2016, and 12 April 2024, included discrete cohorts with PFA, or PFA and TTA, and measured proportionate mortality following dysvascular amputation. RESULTS: Seventeen studies were included in the review. Following dysvascular PFA, proportionate mortality increased from 30 days (2.1%) to 1-year (13.9%), 3-years (30.1%), and 5-years (42.2%). One study compared proportionate mortality 1-year after dysvascular PFA and TTA, showing a higher relative risk of dying after TTA (RR 1.51). CONCLUSIONS: Proportionate mortality has not changed in recent years. These results are comparable to a previous systematic review that included studies published before 31 December 2015.Implications for rehabilitationIt is important to ensure data describing mortality in the years following dysvascular partial foot or transtibial amputation is up to date and accurate.Evidence about proportionate mortality has not changed in recent years and the results are comparable to previous systematic reviews.Data describing mortality outcomes can be used in decision aids that support conversations about the choice of amputation level.

Development and alpha testing of a patient shared decision aid for prosthesis design for new lower limb prosthesis users.

BACKGROUND: After lower limb amputation, several prosthesis design options exist. However, prosthesis design decisions do not always reflect a prosthesis user's needs, values, and preferences. OBJECTIVE: To develop a patient decision aid (PDA) prototype for prosthetists and new prosthesis users facing prosthesis design decisions after lower limb amputation, and to assess its usability, accuracy, and comprehensibility. STUDY DESIGN: Exploratory mixed methods. METHODS: PDA development was informed by a qualitative needs assessment and guided by the International Patient Decision Aid Standards. The PDA was evaluated by steering groups of experienced prosthesis users and prosthetic professionals (prosthetists and researchers) to test usability, accuracy, and comprehensibility through focus groups, individual interviews, and rating on a Likert scale ranging from 1 to 10. RESULTS: The resulting PDA included 6 sections: (1) Amputation and Early Recovery, (2) Communication, (3) Values, (4) Prosthesis Design, (5) Preferences, and (6) Prosthetic Journey. Usability, accuracy, and comprehensibility were rated as 9.2, 9.6, and 9.6, respectively, by prosthetic professionals, and 9.4, 9.6, and 9.6, respectively, by prosthesis users. DISCUSSION: The PDA incorporated guidance by relevant stakeholders and was rated favorably, emphasizing a need for shared decision-making support in prosthesis design. One challenge was determining the amount of information in the PDA, highlighting the diversity in end users' informational needs. Future iterations of the PDA should undergo beta testing in clinical settings. CONCLUSIONS: A standardized, iterative method was used to develop a PDA for new lower limb prosthesis users and prosthetists when considering prosthesis design decisions. The PDA was considered useable, accurate, and comprehensible.

Deliberations about the functional benefits and complications of partial foot amputation: do we pay heed to the purported benefits at the expense of minimizing complications?

While discussion about the benefits and complications of partial foot amputation (PFA) is not new, much of it has hinged on anecdotal evidence and led to the popular view that the risk of complications and secondary amputation is reasonable when weighed against the perceived benefits associated with maintaining the ankle joint and residual foot length, including more normal walking, reduced energy expenditure, and improved quality of life. The research evidence makes it difficult not to question whether these benefits are valid and worth striving to achieve. When you consider that persons who undergo PFA are typically in the later years of their life and have limited mobility, it raises the question of whether we place too much emphasis on achieving the purported functional benefits of PFA and too little emphasis on achieving primary wound healing and mitigating the high rates of complications and subsequent amputation. If further research supports what we see emerging in the evidence, there will be a case to be made for selecting the level of PFA based primarily on the potential for wound healing, rather than trying to strike a balance with the perceived functional benefits. This may mean that transtibial amputation is preferable in many cases, given the lower rates of complications and secondary amputation, very similar function in terms of walking and energy expenditure, and similar lived experience of limb loss when compared with persons with PFA. Further research is needed to better understand the complications and benefits of PFA to make this a more viable, first-and-final amputation procedure.

Validity and reliability of the Berg Balance Scale for community-dwelling persons with lower-limb amputation.

OBJECTIVE: To evaluate the validity and reliability of the Berg Balance Scale (BBS) for use in people with lower-limb amputation. DESIGN: Cross-sectional study. SETTING: Research laboratory. PARTICIPANTS: Individuals (N=30; age, 54±12y; 20 men) with unilateral transtibial (n=13), unilateral transfemoral (n=14), or bilateral (n=3) lower-limb amputation of dysvascular (n=7), traumatic (n=14), infectious (n=6), or congenital (n=3) origin. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: BBS, 2-minute walk test, L test, Prosthesis Evaluation Questionnaire-Mobility Subscale, Activities-specific Balance Confidence Scale, and Frenchay Activities Index; self-reported descriptors were also collected, including frequency of prosthesis use, number of falls in 12 months before the visit, fear of falling, and daily mobility aid use. RESULTS: The BBS had high interrater reliability (intraclass correlation coefficient =.945) and internal consistency (α=.827). Relations between the BBS scores and those of other outcome measures were all statistically significant (P≤.001). Significant group differences in BBS scores were observed for fear of falling (P=.008) and mobility aid use (P<.001), but not for multiple (≥2) falls in the previous 12 months (P=.381). BBS items involving reaching forward, turning 360°, tandem standing, and standing on 1 leg had relatively greater frequencies of lower scores across participants. CONCLUSIONS: The BBS appears to be a valid and reliable clinical instrument for assessing balance in individuals with lower-limb amputation, but it may not be able to discriminate between individuals with greater or lesser fall risk. Limitations in prosthetic motion and control may be responsible for the challenges experienced on items of lower performance. Future studies would be useful to assess the responsiveness of the BBS to interventions aimed at improving balance in individuals with lower-limb amputation.

Mechanical testing of transtibial prosthetic sockets: A discussion paper from the American Orthotic and Prosthetic Association Socket Guidance Workgroup.

BACKGROUND: The advent of novel manufacturing technologies, materials, and socket design concepts could introduce risks to prosthetic limb users, as the existing knowledge base for safe fabrication may not apply. Moreover, although structural test standards exist for mass-produced prosthetic components, they are not applicable to prosthetic sockets. METHODS: The "AOPA Socket Guidance Workgroup" was formed in 2020 to provide the prosthetic community with evidence-based clinical best practices and methods in the field of prosthetic socket structural analysis. This multidisciplinary expert workgroup undertook a critical analysis of the knowledge gaps regarding the requirements for mechanical testing of lower limb prosthetic sockets. RESULTS: The Workgroup identified knowledge gaps in 4 domains. Domain 1 describes the shape and composition of a mock residual limb, required to support and generate in vivo representative loading within the socket. Domain 2 concerns prosthetic socket coordinate systems and alignment. Domain 3 regards the components and requirements of test specimens. Finally, Domain 4 considers test conditions, loading parameters, and acceptance criteria. CONCLUSIONS: This paper describes these knowledge gaps in detail and recommends potential solution approaches based on literature review, group consensus around existing knowledge, or the formation of new study groups to fill each knowledge gap. Our intent is for the recommendations arising from this paper to support the community (e.g., researchers in the clinic, academia, industry, and funders) in addressing these knowledge gaps.

Improving shared decision-making for prosthetic care: A qualitative needs assessment of prosthetists and new lower-limb prosthesis users.

BACKGROUND: Prosthesis design is complex and multiple appropriate options exist for any individual with lower-limb amputation. However, there is insufficient evidence for guiding decision-making. Shared decision-making (SDM) offers an opportunity to incorporate patient-specific values and preferences where evidence is lacking for prosthesis design decisions. To develop resources to facilitate SDM, and consistent with the International Patient Decision Aid Standards, it is necessary to identify the decisional needs of prosthetists and prosthesis users for prosthesis design decisions. OBJECTIVES: To assess the needs of prosthetists and new prosthesis users for SDM about the first prosthesis design. STUDY DESIGN: Qualitative descriptive design. METHODS: Six focus groups were conducted with 38 prosthetists. Individual semistructured interviews were conducted with 17 new prosthesis users. Transcripts were analyzed using directed content analysis, with codes defined a priori using existing frameworks for SDM: the Three Talk Model for SDM and the Ottawa Decision Support Framework. RESULTS: Four main themes were identified among prosthetists and prosthesis users: acknowledging complexity in communication, clarifying values, recognizing the role of experience to inform preferences , and understanding the prosthetic journey . CONCLUSIONS: Resources that support SDM for the first prosthesis design should consider methods for identifying individual communication needs, support with clarifying values, and resources such as experience for achieving informed preferences, within the context of the overall course of rehabilitation and recovery following lower-limb amputation. The themes identified in this work can inform SDM to promote collaborative discussion between prosthetists and new prosthesis users when making prosthesis design decisions.

Development of an item bank for measuring prosthetic mobility in people with lower limb amputation: The Prosthetic Limb Users Survey of Mobility (PLUS-M).

BACKGROUND: Achieving mobility with a prosthesis is a common post-amputation rehabilitation goal and primary outcome in prosthetic research studies. Patient-reported outcome measures (PROMs) available to measure prosthetic mobility have practical and psychometric limitations that inhibit their use in clinical care and research. OBJECTIVE: To develop a brief, clinically meaningful, and psychometrically robust PROM to measure prosthetic mobility. DESIGN: A cross-sectional study was conducted to administer previously developed candidate items to a national sample of lower limb prosthesis users. Items were calibrated to an item response theory model and two fixed-length short forms were created. Instruments were assessed for readability, effective range of measurement, agreement with the full item bank, ceiling and floor effects, convergent validity, and known groups validity. SETTING: Participants were recruited using flyers posted in hospitals and prosthetics clinics across the United States, magazine advertisements, notices posted to consumer websites, and direct mailings. PARTICIPANTS: Adult prosthesis users (N = 1091) with unilateral lower limb amputation due to traumatic or dysvascular causes. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Candidate items (N = 105) were administered along with the Patient Reported Outcome Measurement Information System Brief Profile, Prosthesis Evaluation Questionnaire - Mobility Subscale, and Activities-Specific Balance Confidence Scale, and questions created to characterize respondents. RESULTS: A bank of 44 calibrated self-report items, termed the Prosthetic Limb Users Survey of Mobility (PLUS-M), was produced. Clinical and statistical criteria were used to select items for 7- and 12-item short forms. PLUS-M instruments had an 8th grade reading level, measured with precision across a wide range of respondents, exhibited little-to-no ceiling or floor effects, correlated expectedly with scores from existing PROMs, and differentiated between groups of respondents expected to have different levels of mobility. CONCLUSION: The PLUS-M appears to be well suited to measuring prosthetic mobility in people with lower limb amputation. PLUS-M instruments are recommended for use in clinical and research settings.