Powered knee and ankle prosthesis use with a K2 level ambulator: a case report.

Powered prosthetic knees and ankles have the capability of restoring power to the missing joints and potential to provide increased functional mobility to users. Nearly all development with these advanced prostheses is with individuals who are high functioning community level ambulators even though limited community ambulators may also receive great benefit from these devices. We trained a 70 year old male participant with a unilateral transfemoral amputation to use a powered knee and powered ankle prosthesis. He participated in eight hours of therapist led in-lab training (two hours per week for four weeks). Sessions included static and dynamic balance activities for improved stability and comfort with the powered prosthesis and ambulation training on level ground, inclines, and stairs. Assessments were taken with both the powered prosthesis and his prescribed, passive prosthesis post-training. Outcome measures showed similarities in velocity between devices for level-ground walking and ascending a ramp. During ramp descent, the participant had a slightly faster velocity and more symmetrical stance and step times with the powered prosthesis compared to his prescribed prosthesis. For stairs, he was able to climb with reciprocal stepping for both ascent and descent, a stepping strategy he is unable to do with his prescribed prosthesis. More research with limited community ambulators is necessary to understand if further functional improvements are possible with either additional training, longer accommodation periods, and/or changes in powered prosthesis control strategies.

Footwear limitations in women prosthesis users relate to more than preference.

BACKGROUND: The option to wear desired footwear may be an important part of community reintegration after lower-limb amputation. OBJECTIVES: This study explored outcomes related to footwear, health, and participation in women Veterans with lower-limb amputation. METHODS: A cross-sectional questionnaire was mailed to all women Veterans age 18-82 years with major lower-limb amputation(s) who had received prosthetics services in the US Department of Veterans Affairs (N = 538). The questionnaire assessed Perceived Challenges (including clothing limitations, prosthetic foot limitations [width, height, and shape], and shoe avoidance for safety concerns), type of footwear used and preference, and included subscales from the Patient-Reported Outcome Measurement Information System, Amputee Body Image Scale Prosthetic Limb Users' Survey of Mobility, Community Participation Index, Activities-Specific Balance Confidence Scale, and Prosthesis Evaluation Questionnaire. Bivariate correlations examined relationships between a composite measure of Perceived Challenges and patient-reported outcomes. RESULTS: One hundred questionnaires were returned (18.6% response rate; 3 excluded for limited prosthesis use). The Perceived Challenges score was significantly correlated with scores for the Amputee Body Image Scale-Revised (r = 0.24, p = 0.019), Patient-Reported Outcome Measurement Information System (ability to participate: r = -0.25, p = 0.014), Prosthesis Evaluation Questionnaire (utility: r = -0.32, p = 0.001, appearance: r = -0.48, p < 0.001), Activities-Specific Balance Confidence Scale (r = -0.20, p = 0.046), and Prosthetic Limb Users' Survey of Mobility (r = -0.21, p = 0.036), but not depression or anxiety. CONCLUSIONS: Women who have greater issues with how their prosthesis affects the shoes and clothing they can wear also have poorer body image, reduced functional capabilities, and lower reported participation in activities. Improved prosthetic foot design may help to improve social participation and other important outcomes for women prosthesis users.

Corrigendum: Powered knee and ankle prosthesis use with a K2 level ambulator: a case report.

[This corrects the article DOI: 10.3389/fresc.2023.1203545.].

The impact of added mass placement on metabolic and temporal-spatial characteristics of transfemoral prosthetic gait.

BACKGROUND: Despite prosthetic technology advancements, individuals with transfemoral amputation have compromised temporal-spatial gait parameters and high metabolic requirements for ambulation. It is unclear how adding mass at different locations on a transfemoral prosthesis might affect these outcomes. Research question Does walking with mass added at different locations on a transfemoral prosthesis affect temporal-spatial gait parameters and metabolic requirements compared to walking with no additional mass? METHODS: Fourteen participants with unilateral transfemoral amputations took part. A 1.8 kg mass was added to their prostheses in three locations: Knee, just proximal to the prosthetic knee; Shank, mid-shank on the prosthesis; or Ankle, just proximal to the prosthetic foot. Temporal-spatial gait parameters were collected as participants walked over a GAITRite® walkway and metabolic data were collected during treadmill walking for each of these conditions and with no mass added, the None condition. Separate linear mixed effects models were created and post-hoc tests to compare with the control condition of None were performed with a significance level of 0.05. RESULTS: Overground self-selected walking speed for Ankle was significantly slower than for None (p < 0.05) (None: 1.16 ± 0.24; Knee: 1.15 ± 0.19; Shank: 1.14 ± 0.24; Ankle 0.99 ± 0.20 m/s). Compared to None, Ankle showed significantly increased oxygen consumption during treadmill walking (p < 0.05) (None: 13.82 ± 2.98; Knee: 13.83 ± 2.82; Shank: 14.30 ± 2.89; Ankle 14.56 ± 2.99 ml O2/kg/min). Other metabolic outcomes (power, cost of transport, oxygen cost) showed similar trends. Knee and Shank did not have significant negative effects on any metabolic or temporal-spatial parameters, as compared to None (p > 0.05). Significance Results suggest that additional mass located mid-shank or further proximal on a transfemoral prosthesis may not have negative temporal-spatial or metabolic consequences. Clinicians, researchers, and designers may be able to utilize heavier components, as long as the center of mass is not further distal than mid-shank, without adversely affecting gait parameters or metabolic requirements.

Ambulation Control System Design for a Hybrid Knee Prosthesis.

Prosthetic knees available to individuals with transfemoral amputation seek to restore functional ability to the user. Passive prosthetic knees are lightweight but can restore only limited, dissipative ambulation activities whereas active knees can provide energy to restore additional ambulation activities such as stair climbing and standing up from a chair. Semi-active prosthetic devices aim to only power a subset of activities and use passive components and control when that power is not necessary. Here, we outline an ambulation control system for a lightweight Hybrid Knee prosthesis that is powered for climbing stairs and passive for other ambulation activities (level-ground walking, walking on an incline, and stair descent). We include preliminary offline and online intent recognition system results for one able-bodied user and one individual with a transfemoral amputation demonstrating low error rates in predicting between active and passive control.

The effect of custom carbon ankle-foot orthosis alignment on roll-over shape and center of pressure velocity.

BACKGROUND: Maintaining an optimal rolling of the foot over the ground is thought to increase the stability and efficiency of pathologic gait. Ankle-foot orthoses are often prescribed to improve gait mechanics in individuals with lower extremity injuries; however, their design may compromise how the foot rolls over the ground. OBJECTIVES: The aim of this study was to investigate the effects of the sagittal plane ankle-foot orthosis alignment on roll-over shape and center of pressure velocity in individuals with lower limb reconstructions. STUDY DESIGN: Randomized cross-over study with a control group comparison. METHODS: In total, 12 individuals with lower limb reconstruction who used a custom carbon ankle-foot orthosis and 12 uninjured controls underwent gait analysis. Ankle-foot orthosis users were tested in their clinically-provided ankle-foot orthosis alignment, with an alignment that was 3° more plantarflexed, and with an alignment that was 3° more dorsiflexed. Components of roll-over shape and center of pressure velocity were calculated from heel strike on the ankle-foot orthosis limb to contralateral heel strike. RESULTS: Roll-over shape radius was not affected by 3° changes to alignment and was not significantly different from controls. Aligning the ankle-foot orthosis in more dorsiflexion than clinically provided resulted in a smaller peak center of pressure velocity that occurred later in stance. CONCLUSION: Individuals using custom carbon ankle-foot orthoses can accommodate 3° alterations in the dorsiflexion or plantarflexion alignment.

Clinical Outcomes with the Intrepid Dynamic Exoskeletal Orthosis: A Retrospective Analysis.

INTRODUCTION: Severe lower limb injuries have a negative impact on many aspects of an individual's life. One rehabilitative option for patients who have undergone limb salvage is the Intrepid Dynamic Exoskeletal Orthosis (IDEO). The IDEO is a custom-made dynamic response device which is used to restore function for patients with a wide variety of injuries. Clinical outcomes were routinely collected on patients fit with IDEOs at the Center for the Intrepid, Brooke Army Medical Center. The purpose of this retrospective study was to analyze the clinical outcomes collection process and the patient outcomes collected as part of routine clinical care. METHODS: The Brooke Army Medical Center IRB approved this study and granted waivers of informed consent and HIPAA authorization. Electronic medical records were reviewed over an 18-month period from July 2014 to January 2016. Records were examined to obtain the date of IDEO delivery, date of outcomes form completion, responses on the forms, and to verify diagnosis or injury. Data gathered included wear time, IDEO comfort, pain with and without the IDEO, Lower Extremity Functional Scale scores with and without the IDEO, and global rating of change questions for everyday activities and high impact activities. Wilcoxon signed-ranked tests were used to compare pain and function with vs. without the IDEO. RESULTS: During the 18-month period, new IDEOs were delivered to 156 unique patients. Outcomes forms were collected as part of routine clinical care from 90 of these 156 patients (58%). An additional nine forms were collected from patients who received their IDEOs prior to July 2014. In all, 99 outcomes forms were collected. Mean follow-up time from IDEO delivery to outcomes form completion was 35 ± 31 days for the original 90 patients. The most common patient diagnoses were fracture, nerve injury, arthritis, and fusion. Responses on the forms indicated that patients were generally comfortable wearing their IDEOs (8.3 ± 1.3 on a 0-10 scale) and wore them most of the day (10.7 ± 3.4 hours per day). Improvement in pain (from 5.2 ± 2.9 to 1.7 ± 1.6 points on a 0-10 scale) and Lower Extremity Functional Scale scores (from 29.7 ± 16.6 to 59.5 ± 13.6 points) with the IDEO were both more than the minimal clinically important difference and were statistically significant (p < 0.001). CONCLUSION: This descriptive retrospective study demonstrated that it was feasible to collect clinical outcomes data which were relevant for characterizing the effects of IDEO use and enabled quantification of improvements in self-reported function and walking pain with the IDEO. Due to the retrospective nature of this study, limitations include missing data and the lack of any performance measures to complement the self-reported data. Clinical outcomes collection continues as a routine part of clinical care and there remains an ongoing aim to collect information on all patients to obtain an accurate assessment of devices and services and ultimately better serve our patients.

Upper Extremity Amputation and Prosthetics Care Across the Active Duty Military and Veteran Populations.

The hand and arm are exceptionally dexterous, exquisitely sensitive, and proficient in performing tasks and functions. Given the invaluable functions of the upper extremity in daily life, replacement of a missing limb through prosthetic substitution is challenging. Prosthetic and rehabilitation needs of injured Service members from recent military conflicts have brought upper extremity amputation to the forefront, which has led to an increase in attention and resource allocation. This article provides an overview of the care of the upper extremity amputee including surgical considerations, prosthetic design and fitting, and preprosthetic and post-prosthetic rehabilitation considerations.

Effects of altering heel wedge properties on gait with the Intrepid Dynamic Exoskeletal Orthosis.

BACKGROUND: The Intrepid Dynamic Exoskeletal Orthosis is a custom-made dynamic response carbon fiber device. A heel wedge, which sits in the shoe, is an integral part of the orthosis-heel wedge-shoe system. Because the device restricts ankle movement, the system must compensate to simulate plantarflexion and allow smooth forward progression during gait. OBJECTIVES: To determine the influence of wedge height and durometer on the walking gait of individuals using the Intrepid Dynamic Exoskeletal Orthosis. STUDY DESIGN: Repeated measures. METHODS: Twelve individuals walked over level ground with their Intrepid Dynamic Exoskeletal Orthosis and six different heel wedges of soft or firm durometer and 1, 2, or 3 cm height. Center of pressure velocity, joint moments, and roll-over shape were calculated for each wedge. RESULTS: Height and durometer significantly affected time to peak center of pressure velocity, time to peak internal dorsiflexion and knee extension moments, time to ankle moment zero crossing, and roll-over shape center of curvature anterior-posterior position. Wedge height had a significant influence on peak center of pressure velocity, peak dorsiflexion moment, time to peak knee extension moment, and roll-over shape radius and vertical center of curvature. CONCLUSION: Changes in wedge height and durometer systematically affected foot loading. Participants preferred wedges which produced ankle moment zero crossing timing, peak internal knee extension moment timing, and roll-over shape center of curvature anterior-posterior position close to that of able-bodied individuals. Clinical relevance Adjusting the heel wedge is a simple, straightforward way to adjust the orthosis-heel wedge-shoe system. Changing wedge height and durometer significantly alters loading of the foot and has great potential to improve an individual's gait.

Evaluation of NU-FlexSIV Socket Performance for Military Service Members with Transfemoral Amputation.

Ischial containment sockets are the current standard of care for military service members with transfemoral amputation. However, they fit intimately with the ischium, which may limit hip motion and contribute to proximal socket discomfort, a common complaint among prosthesis users. Subischial sockets, such as the newly described Northwestern University Flexible Subischial Vacuum (NU-FlexSIV) Socket technique, do not interact with the ischium, potentially increasing hip motion and improving comfort. PURPOSE: To transfer the NU-FlexSIV Socket technique to military prosthetists and evaluate performance among military service members with transfemoral amputation. STUDY DESIGN: case series. METHODS: Four of the 11 enrolled subjects completed the study protocol comparing the NU-FlexSIV Socket to the ischial containment socket. Gait kinematics (over ground and on stairs), physical performance measures (Four-Square Step Test, T-test of Agility, and an obstacle course), limb-socket motion, and socket comfort were assessed after accommodation time in each socket. RESULTS: While wearing the NU-FlexSIV Socket, sagittal plane hip motion generally increased while coronal plane trunk motion and walking speed remained largely unaffected during over ground walking. During stair ascent, sagittal plane hip motion increased while wearing the NU-FlexSIV Socket, with minimal changes in walking speed for all subjects. Pre- and post-walking fluoroscopy measures suggest fit of the NU-FlexSIV Socket was less affected by activity. Most subjects reported that the NU-FlexSIV Socket was more comfortable for sitting but some found it less comfortable for walking and running. Performance measure results were mixed. Although attempts were made to consistently implement the NU-FlexSIV Socket technique, some challenges were experienced. CONCLUSIONS: The NU-FlexSIV Socket provided greater hip motion across a variety of tasks without adversely affecting other movement mechanics but did not consistently improve socket comfort. Variability in the liners and socket materials used may have contributed to variability in results. Overall, the design was a viable alternative to traditional ischial containment sockets for some individuals with transfemoral amputation.

A scoping literature review of the provision of orthoses and prostheses in resource-limited environments 2000-2010. Part two: research and outcomes.

BACKGROUND: Despite the activities of many orthotic and prosthetic provision organizations in resource-limited environments, there is still a great need and there are several areas for improvement, as identified in Part One of this series. OBJECTIVES: Our goal was to examine outcomes and conclusions of research studies to produce an evidence base for determining factors that may lead to successful provision of orthoses and prostheses in resource-limited environments. STUDY DESIGN: Literature review. METHODS: We conducted a scoping literature review of all information related to orthotic and prosthetic provision in resource-limited environments published from 2000 to 2010. We extracted measured outcomes reported in all types of articles and analyzed conclusions from research studies. RESULTS: Reported outcomes included durability, cost, satisfaction, use/nonuse of device, amount of utilization, walking speed, discomfort, pain, fit, misalignment, capacity for service provision, number of devices produced or delivered, and number of graduates from training programs. CONCLUSIONS: There are many gaps in the evidence base, notably in measuring inclusion, participation, and quality of life for orthosis and prosthesis users in resource-limited environments. There is a paucity of reported outcomes for orthotics. Valid, reliable, and standard methods of data collection and reporting are needed to advance the field and enhance the evidence base.

A scoping literature review of the provision of orthoses and prostheses in resource-limited environments 2000-2010. Part one: considerations for success.

STUDY DESIGN: Literature Review BACKGROUND: We estimate that over 29 million people worldwide in resource-limited environments (RLEs) are in need of orthotic and prosthetic (O&P) devices and services. OBJECTIVES: Our goal was to ascertain the current state of O&P provision in RLEs and identify factors that may lead to more successful O&P provision. METHODS: We conducted a comprehensive scoping literature review of all information related to O&P provision in RLEs published from 2000 to 2010. We targeted Vietnam, Cambodia, Tanzania, Malawi, Colombia, and the Navajo Nation, but also included information about developing countries in general. We searched academic databases and grey literature. We extracted information from each article in the areas of design, manufacturing, distribution, service provision, and technology transfer. RESULTS: We identified commonly reported considerations and strategies for O&P provision from 431 articles. Analysis of expert consensus documents revealed recurring themes for improving O&P provision. We found that some suggestions from the consensus documents are being followed, but many are overlooked or have not yet been implemented. CONCLUSIONS: Areas for improvement include conducting field testing during the design process, providing services to rural environments, offering follow-up services, considering government collaboration, and encouraging an active role of the orthosis/prosthesis user. Outcomes and research studies will be further discussed in Part Two.

Á priori alignment of transtibial prostheses: a comparison and evaluation of three methods.

PURPOSE: The objectives of this study were to compare three á priori alignment methods and evaluate them based on initial gait quality and further alignment changes required to optimize gait. Á priori alignment is requisite for monolimbs, transtibial prostheses in which the socket and pylon are made from one piece of plastic, because monolimbs have no alignment adjustability. METHOD: The three methods investigated were traditional bench alignment (TRAD), vertical alignment axis (VAA) and anatomical based alignment (ABA). Endoskeletal components were utilized for the study, rather than monolimbs, so that alignment could be experimentally manipulated. Three endoskeletal prostheses were aligned, one according to each á priori method, for each of seven subjects. Gait and alignment data were captured, dynamic alignment was performed to optimize gait, and data were captured again. RESULTS: VAA and TRAD methods required less change compared to ABA in socket flexion angle. Looking at subjects individually, VAA produced a better alignment and better gait for the greatest number of subjects. CONCLUSIONS: A new refined method of á priori alignment is proposed based on the results of this study, and is applicable for á priori alignment of monolimbs or any type of transtibial prosthesis.

Plastic soda bottles: a reusable material for making transradial sockets.

This paper describes a new fabrication process for making low-cost transradial sockets using recyclable plastic soda bottles. Easy, fast, and inexpensive to fabricate, the resulting socket can be used as a temporary device for stump care. Multiple sockets can be made and individually incorporated with various terminal devices for light-duty self-care or functional activities, such as feeding, showering, typing, swimming, or gardening. The formed socket is lightweight and also suitable for use with a cosmetic passive hand prosthesis. This process has been developed as a potential cost-effective assistive technology appropriate for individuals with transradial amputation in resource-limited countries.