Does Terminology Matter? Perspectives From People With Limb Difference, Clinicians, and Researchers.

OBJECTIVE: To elicit the preferred terminology among people with limb difference as well as health care and/or research professionals. DESIGN: Cross-sectional survey. SETTING: Online. PARTICIPANTS: A convenience sample of N=122 individuals (people with limb difference, n=65; health care and/or research professionals, n=57) completed an online survey. People were included if they (1) were aged ≥18 years; (2) self-identified as having limb difference (regardless of etiology) or as a health care or research professional (with experience working with people with limb difference); and (3) lived in the United States for most of the time in their selected role. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Importance of terminology, preference toward person-first or identity-first terms, preferred terms, and individual perspectives on terminology preferences. RESULTS: Most participants identified as White (92.6%). Age significantly differed between groups (people with limb difference, 49.9±15.4y; professionals, 41.0±14.3y; P=.001). Approximately 50% of people with limb difference stated terminology was very or extremely important, compared to 70% of professionals (χ2=16.6, P=.002). While 73.7% of professionals reported a preference for person-first terminology, the sample of people with limb difference were more evenly split, as 42.9% reported a preference for identity-first terminology and 50.8% reported a preference for person-first terminology. The most frequently selected limb and population terms, respectively, were residual limb and individual/person with limb difference; however, many people with limb difference indicated they preferred "amputee" when speaking about a population. CONCLUSIONS: Most of the participants indicated terminology was very or extremely important, and both groups tended to prefer the terms residual limb (limb term) and individual/person with limb difference (population term). However, this study was not intended to recommend terminology, but rather help inform terminology choices that are centered around people with limb difference. Individuality and context should be considered when deciding terminology. Future studies should include more participants from racially/ethnically minoritized groups and people with limb difference who have dysvascular and/or congenital etiologies.

3D-printed orthoses and prostheses for people with physical disability in rehabilitation centers: a scoping review.

AIMS: The World Health Organization points out that, by 2030, two billion people will need at least one assistive product. 3D printing can be used to meet the demands when dispensing these products. PURPOSE: This review aims to map the use of 3D printing in the manufacture of orthoses and prostheses for people with physical disability at rehabilitation centers. METHODS: Publications that deal with the use of 3D printing for the manufacture of orthoses and prostheses were used, preferably studies from 2012 to 2022. RESULTS: The majority of studies, 56.25%, were quantitative and 46.25% were evaluative research. None of the studies were characterized as developed at rehabilitation centers. 75% of them had the participation of people with physical disability. The use of 3D printing was, for the most part, for the development of assistive technologies for the upper limbs at 56.25%, while 31.25% were for the lower limbs. CONCLUSION: The assistive products developed were orthoses and prostheses for the wrist, hands, fingers, upper limbs, writing devices, sockets, knees, and feet. Although there were positive results in their performance, some limitations related to strength, stiffness, and resistance were observed.

Robotic-Enhanced Prosthetic Liners for Vibration Therapy: Reducing Phantom Limb Pain in Transfemoral Amputees.

Phantom limb pain, a common challenge for amputees, lacks effective treatment options. Vibration therapy is a promising non-pharmacologic intervention for reducing pain intensity, but its efficacy in alleviating phantom limb pain requires further investigation. This study focused on developing prosthesis liners with integrated vibration motors to administer vibration therapy for phantom limb pain. The prototypes developed for this study addressed previous issues with wiring the electronic components. Two transfemoral amputees participated in a four-week at-home trial, during which they used the vibration liner and rated their initial and final pain intensity on a numeric rating scale each time they had phantom pain. Semi-structured interviews were conducted to gather feedback following the at-home trial. Both participants described relaxing and soothing sensations in their residual limb and phantom limb while using vibration therapy. One participant reported a relaxation of his phantom limb sensations, while both participants noted a decrease in the intensity of their phantom limb pain. Participants said the vibration liners were comfortable but suggested that the vibration could be stronger and that aligning the contacts could be easier. The results of this study highlight the potential effectiveness of using vibration therapy to reduce the intensity of phantom limb pain and suggest a vibration liner may be a feasible mode of administering the therapy. Future research should address optimizing the performance of the vibration liners to maximize their therapeutic benefits.

Walking ability of individuals fitted with transfemoral bone-anchored prostheses: A comparative study of gait parameters.

OBJECTIVE: This study presents the walking abilities of participants fitted with transfemoral bone-anchored prostheses using a total of 14 gait parameters. DESIGN: Two-centre retrospective cross-sectional comparative study. SETTING: Research facilities equipped with tridimensional motion capture systems. PARTICIPANTS: Two control arms included eight able-bodied participants arm (54 ± 9 years, 1.75 ± 0.07 m, 76 ± 7 kg) and nine participants fitted with transfemoral socket-suspended prostheses arm (59 ± 9 years, 1.73 ± 0.07 m, 80 ± 16 kg). The intervention arm included nine participants fitted with transfemoral bone-anchored prostheses arm (51 ± 13 years, 1.78 ± 0.09 m, 87.3 ± 16.1 kg). INTERVENTION: Fitting of transfemoral bone-anchored prostheses. MAIN MEASURES: Comparisons were performed for two spatio-temporal, three spatial and nine temporal gait parameters. RESULTS: The cadence and speed of walking were 107 ± 6 steps/min and 1.23 ± 0.19 m/s for the able-bodied participants arm, 88 ± 7 steps/min and 0.87 ± 0.17 m/s for the socket-suspended prosthesis arm, and 96 ± 6 steps/min and 1.03 ± 0.17 m/s for bone-anchored prosthesis arm, respectively. Able-bodied participants and bone-anchored prosthesis arms were comparable in age, height, and body mass index as well as cadence and speed of walking, but the able-bodied participant arm showed a swing phase 31% shorter. Bone-anchored and socket-suspended prostheses arms were comparable for age, height, mass, and body mass index as well as cadence and speed of walking, but the bone-anchored prosthesis arm showed a step width and duration of double support in seconds 65% and 41% shorter, respectively. CONCLUSIONS: Bone-anchored and socket-suspended prostheses restored equally well the gait parameters at a self-selected speed. This benchmark data provides new insights into the walking ability of individuals using transfemoral bionics bone-anchored prostheses.

The multi-grip and standard myoelectric hand prosthesis compared: does the multi-grip hand live up to its promise?

BACKGROUND: Multi-grip myoelectric hand prostheses (MHPs), with five movable and jointed fingers, have been developed to increase functionality. However, literature comparing MHPs with standard myoelectric hand prostheses (SHPs) is limited and inconclusive. To establish whether MHPs increase functionality, we compared MHPs with SHPs on all categories of the International Classification of Functioning, Disability, and Health-model (ICF-model). METHODS: MHP users (N = 14, 64.3% male, mean age = 48.6 years) performed physical measurements (i.e., Refined Clothespin Relocation Test (RCRT), Tray-test, Box and Blocks Test, Southampton Hand Assessment Procedure) with their MHP and an SHP to compare the joint angle coordination and functionality related to the ICF-categories 'Body Function' and 'Activities' (within-group comparisons). SHP users (N = 19, 68.4% male, mean age = 58.1 years) and MHP users completed questionnaires/scales (i.e., Orthotics and Prosthetics Users' Survey-The Upper Extremity Functional Status Survey /OPUS-UEFS, Trinity Amputation and Prosthesis Experience Scales for upper extremity/TAPES-Upper, Research and Development-36/RAND-36, EQ-5D-5L, visual analogue scale/VAS, the Dutch version of the Quebec User Evaluation of Satisfaction with assistive technology/D-Quest, patient-reported outcome measure to assess the preferred usage features of upper limb prostheses/PUF-ULP) to compare user experiences and quality of life in the ICF-categories 'Activities', 'Participation', and 'Environmental Factors' (between-group comparisons). RESULTS: 'Body Function' and 'Activities': nearly all users of MHPs had similar joint angle coordination patterns with an MHP as when they used an SHP. The RCRT in the upward direction was performed slower in the MHP condition compared to the SHP condition. No other differences in functionality were found. 'Participation': MHP users had a lower EQ-5D-5L utility score; experienced more pain or limitations due to pain (i.e., measured with the RAND-36). 'Environmental Factors': MHPs scored better than SHPs on the VAS-item holding/shaking hands. The SHP scored better than the MHP on five VAS-items (i.e., noise, grip force, vulnerability, putting clothes on, physical effort to control) and the PUF-ULP. CONCLUSION: MHPs did not show relevant differences in outcomes compared to SHPs on any of the ICF-categories. This underlines the importance of carefully considering whether the MHP is the most suitable option for an individual taking into account the additional costs of MHPs.

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.

Use of Standardized Outcome Measures for People With Lower Limb Amputation: A Survey of Prosthetic Practitioners in the United States.

OBJECTIVE: To assess the clinical resources available for the assessment of health outcomes in people with lower limb amputation and to understand barriers and facilitators associated with use of standardized outcome measures in clinical practice. DESIGN: Cross-sectional survey. SETTING: General community (online). PARTICIPANTS: A volunteer sample of prosthetic practitioners was recruited through national professional organizations. Eligible participants were practitioners certified by a professional prosthetics organization and currently practicing as a prosthetist, prosthetist-orthotist, or prosthetic assistant. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: A custom-designed online survey on clinical use of patient-reported and performance-based standardized outcome measures to assess patients with lower limb amputation. RESULTS: A total of 375 participants completed the survey. Most participants (79%) reported that they are encouraged or required to administer standardized outcome measures in their clinic or facility. Most participants reported that use of patient-reported and performance-based outcome measures are within their scope of practice (88%) and that they have the knowledge required for outcomes measurement (84%). Few participants agreed that outcomes measurement is standardized across the profession (30%). Most participants had access to small spaces and equipment for outcomes measurement, such as short hallways (65%-94%), stairs (69%), and tablets with wireless internet connection (83%). Most participants reported that they would be willing to spend between 5 (36% of participants) and 10 (43% of participants) minutes on self-reported surveys, and between 10 (41% of participants) and 20 (28% of participants) minutes on performance-based tests. CONCLUSIONS: Outcomes measurement is encouraged or expected in contemporary prosthetic practice. Strategies to improve standardization and efficiency of administration are needed to facilitate routine use of outcome measures in clinical care.

Measurements of Best, Worst, and Average Socket Comfort Are More Reliable Than Current Socket Comfort in Established Lower Limb Prosthesis Users.

OBJECTIVE: To evaluate test-retest reliability and related measurement properties of items developed to assess best, worst, and average prosthetic socket comfort. DESIGN: Methodological 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. SETTING: General community. PARTICIPANTS: A 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. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: The 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. RESULTS: Best, 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. CONCLUSIONS: Items 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.

Clinical Resources for Assessing Mobility of People with Lower-Limb Amputation: Interviews with Rehabilitation Clinicians.

Introduction: Mobility tests are increasingly used in prosthetic rehabilitation to evaluate patient outcomes. Knowledge of the space, equipment, and time resources available to clinicians who work in different settings can guide recommendations for which tests are most clinically-feasible and promote coordination of mobility testing among members of the rehabilitation team. The primary aim of this study was to characterize the different resources available to clinicians for measuring mobility of people with lower limb amputation. A secondary aim was to identify performance tasks that clinicians use to evaluate prosthetic mobility. Materials and methods: Semi-structured interviews were conducted with prosthetists, physical therapists, and physiatrists who treat people with lower limb amputation. Researchers used convenience and snowball sampling to identify participants. Interviews included questions about the resources available for conducting mobility tests, as well as questions about which tasks clinicians deemed valuable to assessing mobility of patients with lower limb amputation. Interviews were audio-recorded and transcribed. Summary and frequency statistics were calculated for quantitative data; explanatory comments were summarized. Results: Interviews were conducted with 25 clinicians (8 prosthetists, 9 physical therapists, and 8 physiatrists). Participants had access to multiple spaces and basic measurement equipment. The maximum time participants were willing to spend on performance tests varied. Physiatrists reported less time available (median=10 minutes, range 5-30 minutes) than prosthetists and physical therapists (median=30 minutes, range 5-60 minutes for both professions). Mobility tasks commonly used to evaluate patients with lower limb amputation included sit-to-stand, standing balance, walking, and varying speed. Participant comments suggested that mobility tests need to be quick, simple, and add value; existing mobility tests are beneficial but challenging to incorporate into practice; mobility tests should reflect real-world activities; and technological advancements could improve mobility testing. Conclusions: Clinicians generally had small-to-medium spaces, basic measurement equipment, and sufficient training to administer mobility tests in their clinics. A limiting factor was time, which can be addressed through selection of efficient measures and collaboration within the rehabilitation team.

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.

Effects of Handrail and Cane Support on Energy Cost of Walking in People With Different Levels and Causes of Lower Limb Amputation.

OBJECTIVE: The energy cost of walking with a lower limb prosthesis is higher than able-bodied walking and depends on both cause and level of amputation. This increase might partly be related to problems with balance control. In this study we investigated to what extent energy cost can be reduced by providing support through a handrail or cane and how this depends on level and cause of amputation. DESIGN: Quasi-experimental study. SETTING: Rehabilitation gait laboratory. PARTICIPANTS: Twenty-six people with a lower limb amputation were included: 9 with vascular and 17 with nonvascular causes, 16 at transtibial, and 10 at transfemoral or knee disarticulation level (N=26). INTERVENTIONS: Participants walked on a treadmill with and without handrail support and overground with and without a cane. MAIN OUTCOME MEASURES: Energy cost was assessed using respirometry. RESULTS: On the treadmill, handrail support resulted in a 6% reduction in energy cost on average. This effect was attributed to an 11% reduction in those with an amputation attributable to vascular causes, whereas the nonvascular group did not show a significant difference. No interaction with level of amputation was found. Overground, no main effect of cane support was found, although an interaction effect with cause of amputation demonstrated a small nonsignificant decrease in energy cost (3%) in the vascular group and a significant increase (6%) in the nonvascular group when walking with a cane. The effect of support was positively correlated with self-selected walking speed. CONCLUSIONS: This study demonstrates that providing external support can contribute to a reduction in energy cost in people with an amputation due to vascular causes with reduced walking ability while walking in the more challenging condition of the treadmill. Although it is speculated that this effect might be related to problems with balance control, this will need further investigation.

Trunk Muscle Characteristics: Differences Between Sedentary Adults With and Without Unilateral Lower Limb Amputation.

OBJECTIVE: The primary purpose of this study was to compare trunk muscle characteristics between adults with and without unilateral lower limb amputation (LLA) to determine the presence of modifiable trunk muscle deficits (ie, impaired activity, reduced volume, increased intramuscular fat) evaluated by ultrasonography (US) and magnetic resonance imaging (MRI). We hypothesized that compared with adults without LLA (controls), individuals with transfemoral or transtibial LLA would demonstrate reduced multifidi activity, worse multifidi and erector spinae morphology, and greater side-to-side trunk muscle asymmetries. DESIGN: Cross-sectional imaging study. SETTING: Research laboratory and imaging center. PARTICIPANTS: Sedentary adults (n=38 total) with LLA (n=9 transfemoral level; n=14 transtibial level) and controls without LLA (n=15). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: We examined bilateral multifidi activity using US at levels L3/L4-L5/S1. MRI was performed using 3-dimensional quantitative fat-water imaging; bilateral L1-L5 multifidi and erector spinae were manually traced, and muscle volume (normalized to body weight) and percentage intramuscular fat were determined. Between-group and side-to-side differences were evaluated. RESULTS: Compared with adults without LLA, participants with LLA demonstrated reduced sound-side multifidi activity; those with transfemoral LLA had larger amputated-side multifidi volume, whereas those with transtibial LLA had greater sound- and amputated-side erector spinae intramuscular fat (P<.050). With transfemoral LLA, side-to-side differences in erector spinae volume, as well as multifidi and erector spinae intramuscular fat, were found (P<.050). CONCLUSIONS: Impaired trunk muscle activity and increased intramuscular fat may be modifiable targets for intervention after LLA.

[Surgical management of peripheral nerves after extremity loss]. / Der chirurgische Umgang mit peripheren Nerven nach Extremitätenverlust.

BACKGROUND: After limb loss, it is the surgeon's task to provide the patient with a pain-free and resilient residual limb. Particularly in the upper extremity, there is an additional functional aspect, as appropriate muscle signals are needed to control myoelectric prostheses. Surgical management of peripheral nerves within the residual limb plays a central role both in terms of pain treatment as well as functional human-machine interfacing. OBJECTIVES: The presentation of current surgical procedures for dealing with peripheral nerves after limb amputation. MATERIAL AND METHODS: A literature search is carried out regarding the surgical prophylaxis and therapy of neuroma and phantom limb pain, as well as techniques to improve the functional interface between residual limb and prosthesis. Practical recommendations are formulated based on relevant literature, as well as the experiences of the authors. RESULTS AND CONCLUSIONS: There is a large number of different surgical techniques, particularly for the management of painful neuromas. Of the conventional methods, intramuscular implantation of the terminal nerves is commonly used with good results. Newer techniques such as targeted muscle reinnervation (TMR) and the regenerative peripheral nerve interface (RPNI) aim for the first time to provide functional end organs to the nerve even after amputation. In addition to the improved control of myoelectric prostheses, these methods further show excellent results for treatment and prevention of neuroma and phantom limb pain.

Psychometric Properties of Functional, Ambulatory, and Quality of Life Instruments in Lower Limb Amputees: A Systematic Review.

OBJECTIVE: Summarize the psychometric properties of functional, ambulatory, and quality of life instruments among adult lower limb amputees, highlighting evidence deemed generalizable to the United States Medicare population. DATA SOURCES: Six databases and existing systematic reviews through October 30, 2017. Searches included terms for lower limb amputation or prostheses and outcome measures in humans, without language restriction. STUDY SELECTION: We included peer-reviewed studies of at least 20 adults (≥18 years) with lower limb amputation. Eligible studies reported on psychometric properties of functional, ambulatory, or quality of life instruments. Fifty-three of 425 retrieved articles (12%) met criteria. DATA EXTRACTION: Study characteristics and psychometric property data (validity, reliability, responsiveness, minimum detectable change, minimal important difference, or floor or ceiling effect) were extracted into a customized form based on standardized criteria. All extracted data were confirmed by 2 experts in systematic review and rehabilitation outcome measurement. Instruments were categorized regarding having been validated and found reliable. Other reported psychometric properties were recorded. Studies were also assessed for applicability to the Medicare population based on age and amputation etiology (dysvascular). DATA SYNTHESIS: Fifty-six studies (in 53 articles) reported psychometric properties of 50 instruments. There is evidence for both validity and reliability for 30 instruments, 17 of which have evidence that was deemed generalizable to the Medicare population. Most of the remaining instruments have evidence of either validity or reliability, but not both. Twelve instruments have been assessed specifically among lower limb amputees prior to prosthesis prescription. Thirteen instruments have been assessed regarding their predictive properties for future outcomes. CONCLUSIONS: Numerous instruments assessing ambulation, function, quality of life, and other patient-centered outcomes have evidence of validity and reliability for adults with lower limb amputations. Researchers and clinicians should use validated, reliable instruments when feasible. Many existing and new instruments require validation for use with lower limb amputees.

Functional performance and safety of bone-anchored prostheses in persons with a transfemoral or transtibial amputation: a prospective one-year follow-up cohort study.

OBJECTIVES:: (1) To compare level of function, activity, health-related quality of life (HRQoL) and satisfaction in persons with a lower extremity amputation before surgery and 6- and 12-months after implantation of an osseointegration implant and (2) to report adverse events. DESIGN:: Prospective cohort study. SETTING:: University medical centre. SUBJECTS:: A total of 40 consecutive persons (median age: 56 years) who received a transfemoral (31) or transtibial (9) osseointegration implant, between April 2014 and March 2016. INTERVENTION:: Osseointegration implant surgery followed by a predefined rehabilitation programme. MAIN MEASURES:: Hip abductor strength, prosthetic use, back pain frequency, postoperative pain, mobility level (Timed-Up and Go (TUG) and wheelchair-boundedness), walking ability (6 minute walking test (6MWT) and walking distance in daily life), HRQoL, satisfaction regarding the prosthesis, and adverse events. RESULTS:: Strength, prosthetic use, walking distance, HRQoL, and satisfaction level increased significantly at 6- and 12-month follow-up compared to baseline ( P ⩽ 0.002). The TUG showed no change at 6-month follow-up ( P = 0.420) but improved significantly at 12-month follow-up compared to baseline ( P = 0.005). Wheelchair-boundedness decreased from 12/40 participants at baseline to 0 at follow-ups. The 6MWT ( P ⩾ 0.038) and back pain ( P ⩾ 0.437) did not change over time. Stump pain was present in 28/39 and 22/40 of the participants at 6-and 12-month follow-up, respectively. The major adverse events were managed successfully and included three dual-cone breakages and four bone fractures. An uneventful course was completed by 19/31 transfemoral and 4/9 transtibial bone-anchored prostheses users. CONCLUSION:: Bone-anchored prostheses lead to improved performance and appear to be safe, so they might be considered for persons with socket-related problems.

[Study on gait symmetry based on simulation and evaluation system of prosthesis gait].

A software and hardware platform for gait simulation and system evaluation for lower limb intelligent prosthesis is proposed and designed, in order that the wearable symmetry effect of the intelligent knee prosthesis can be quantitatively analyzed by machine test instead of human wear test. The whole-body three-dimensional gait and motion analysis system instrument, a device to collect gait data such as joint angle and stride of adults, was used for extracting simulated gait characteristic curve. Then, the gait curve was fitted based on the corresponding joint to verify the feasibility of the test platform in the experiment. Finally, the developed artificial knee prosthesis was worn on the prosthetic evaluation system to quantitatively analyze the gait symmetry effect. The results showed that there was no significant difference in gait symmetry between the developed knee joints at different speeds, which could reach more than 88%. The simulation and evaluation of the prosthetic gait have good effects on the functional simulation and evaluation of the lower limb intelligent prosthesis.

Case-study of a user-driven prosthetic arm design: bionic hand versus customized body-powered technology in a highly demanding work environment.

BACKGROUND: Prosthetic arm research predominantly focuses on "bionic" but not body-powered arms. However, any research orientation along user needs requires sufficiently precise workplace specifications and sufficiently hard testing. Forensic medicine is a demanding environment, also physically, also for non-disabled people, on several dimensions (e.g., distances, weights, size, temperature, time). METHODS: As unilateral below elbow amputee user, the first author is in a unique position to provide direct comparison of a "bionic" myoelectric iLimb Revolution (Touch Bionics) and a customized body-powered arm which contains a number of new developments initiated or developed by the user: (1) quick lock steel wrist unit; (2) cable mount modification; (3) cast shape modeled shoulder anchor; (4) suspension with a soft double layer liner (Ohio Willowwood) and tube gauze (Molnlycke) combination. The iLimb is mounted on an epoxy socket; a lanyard fixed liner (Ohio Willowwood) contains magnetic electrodes (Liberating Technologies). An on the job usage of five years was supplemented with dedicated and focused intensive two-week use tests at work for both systems. RESULTS: The side-by-side comparison showed that the customized body-powered arm provides reliable, comfortable, effective, powerful as well as subtle service with minimal maintenance; most notably, grip reliability, grip force regulation, grip performance, center of balance, component wear down, sweat/temperature independence and skin state are good whereas the iLimb system exhibited a number of relevant serious constraints. CONCLUSIONS: Research and development of functional prostheses may want to focus on body-powered technology as it already performs on manually demanding and heavy jobs whereas eliminating myoelectric technology's constraints seems out of reach. Relevant testing could be developed to help expediting this. This is relevant as Swiss disability insurance specifically supports prostheses that enable actual work integration. Myoelectric and cosmetic arm improvement may benefit from a less forgiving focus on perfecting anthropomorphic appearance.

Cross-Sectional Assessment of Factors Related to Pain Intensity and Pain Interference in Lower Limb Prosthesis Users.

OBJECTIVE: To determine relationships between pain sites and pain intensity/interference in people with lower limb amputations (LLAs). DESIGN: Cross-sectional survey. SETTING: Community. PARTICIPANTS: Lower limb prosthesis users with unilateral or bilateral amputations (N=1296; mean time since amputation, 14.1y). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Patient-Reported Outcomes Measurement Information System (PROMIS) pain intensity (1 item to assess average pain), PROMIS pain interference (4-item short form to assess the consequences of pain in desired activities), and questions that asked participants to rate the extent to which each of the following were a problem: residual limb pain (RLP), phantom limb pain (PLP), knee pain on the nonamputated side, back pain, and shoulder pain. RESULTS: Nearly three quarters (72.1%) of participants reported problematic pain in 1 or more of the listed sites. Problematic PLP, back pain, and RLP were reported by 48.1%, 39.2%, and 35.1% of participants, respectively. Knee pain and shoulder pain were less commonly identified as problems (27.9% and 21.7%, respectively). Participants also reported significantly (P<.0001) higher pain interference (T-score ± SD, 54.7±9.0) than the normative sample based on the U.S. population (T-score ± SD, 50.0±10.0). Participants with LLAs rated their pain intensity on average ± SD at 3.3±2.4 on a 0-to-10 scale. Pain interference (ρ=.564, P<.0001) and intensity (ρ=.603, P<.0001) were positively and significantly correlated with number of pain sites reported. CONCLUSIONS: Problematic pain symptoms, especially RLP, PLP, and back pain, affect most prosthetic limb users and have the potential to greatly restrict participation in life activities.

Construct Validity of the Prosthetic Limb Users Survey of Mobility (PLUS-M) in Adults With Lower Limb Amputation.

OBJECTIVE: To assess construct validity of the Prosthetic Limb Users Survey of Mobility (PLUS-M), a self-report mobility measure for people with lower limb amputation (LLA). DESIGN: Cross-sectional study. SETTING: Private prosthetic clinics (n=37). PARTICIPANTS: Current lower limb prosthesis users (N=199; mean age ± SD, 55.4±14.3y; 71.4% men) were assessed before receiving a replacement prosthesis, prosthetic socket, and/or prosthetic knee. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Convergent construct validity was examined using correlations between participants' PLUS-M T-scores and measures of physical function, mobility, and balance, including the Amputee Mobility Predictor (AMP), timed Up and Go (TUG), Patient-Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF), Prosthesis Evaluation Questionnaire-Mobility Subscale (PEQ-MS), and Activities-specific Balance Confidence (ABC) Scale. Known-groups construct validity was evaluated by comparing differences in PLUS-M T-scores among participants grouped by Medicare Functional Classification Level (MFCL). RESULTS: PLUS-M T-scores demonstrated a moderate positive relationship with AMP scores (ρ=.54, P<.001) and a moderate negative relationship with TUG times (ρ=-.56, P<.001). The PLUS-M also showed a strong positive relationship with PEQ-MS scores (ρ=.78, P<.001), ABC Scale scores (ρ=.81, P<.001), and PROMIS-PF T-scores (ρ=.81, P<.001). Significant differences (P<.05) in PLUS-M T-scores were found among groups of people classified by different MFCLs. CONCLUSIONS: Study results support the validity of the PLUS-M as a self-report measure of prosthetic mobility. Correlations between PLUS-M and measures of physical function, mobility, and balance indicate convergent construct validity. Similarly, significant differences in PLUS-M T-scores across MFCL groups provide evidence of known-groups construct validity. In summary, evidence indicates that PLUS-M has good construct validity among people with LLA.

The Compress® transcutaneous implant for rehabilitation following limb amputation.

Amputation is an unfortunate outcome of a variety of orthopedic conditions. Many amputees can be functionally fitted with conventional suspension sockets. A substantial subset, however, fails this conventional treatment and is unable to function. In Europe, an alternative to socket-based prostheses has been available for 25 years. Patients there who are unable to functionally use socket-based prostheses have been offered the possibility for transcutaneous osseointegration. With this technology, the prosthetic limb can be rigidly attached to the residual bone, and the socket is eliminated, in many cases enabling improved function and patient satisfaction. In the United States, regulatory barriers have greatly limited the adoption and acceptance of transdermal osseointegration. The Compress® device was developed as an alternate means of fixation for massive endoprostheses, such as distal femoral replacements. A uniquely designed prosthesis is rigidly anchored to the end of the cortical bone and is then subjected to a large axial stress. The bone then grows avidly into the device, providing permanent osseointegration. We have recently adopted this device for transcutaneous use. These procedures have been performed in the United States on a custom regulatory basis. Results of this have been encouraging, and we are planning to begin a regulatory trial in the near future.