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.

Technological Advances in Prosthesis Design and Rehabilitation Following Upper Extremity Limb Loss.

PURPOSE OF REVIEW: The complexity of the human extremity, particularly the upper extremity and the hand, allows us to interact with the world. Prosthetists have struggled to recreate the intuitive motor control, light touch sensation, and proprioception of the innate limb in a manner that reflects the complexity of its native form and function. Nevertheless, recent advances in prosthesis technology, surgical innovations, and enhanced rehabilitation appear promising for patients with limb loss who hope to return to their pre-injury level of function. The purpose of this review is to illustrate recent technological advances that are moving us one step closer to the goal of multi-functional, self-identifiable, durable, and intuitive prostheses. RECENT FINDINGS: Surgical advances such as targeted muscle reinnervation, regenerative peripheral nerve interfaces, agonist-antagonist myoneural interfaces, and targeted sensory reinnervation; development of technology designed to restore sensation, such as implanted sensors and haptic devices; and evolution of osseointegrated (bone-anchored) prostheses show great promise. Augmented and virtual reality platforms have the potential to enhance prosthesis design, pre-prosthetic training, incorporation, and use. Emerging technologies move surgeons, rehabilitation physicians, therapists, and prosthetists closer to the goal of creating highly functional prostheses with elevated sensory and motor control. Collaboration between medical teams, scientists, and industry stakeholders will be required to keep pace with patients who require durable, high-functioning prostheses.

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.

Multisite Evaluation of a Custom Energy-Storing Carbon Fiber Orthosis for Patients with Residual Disability After Lower-Limb Trauma.

BACKGROUND: The Intrepid Dynamic Exoskeletal Orthosis (IDEO) is a custom energy-storing carbon fiber ankle-foot orthosis developed for lower-extremity trauma patients. Studies conducted at the military treatment facility where the IDEO was developed demonstrated benefits of the IDEO when used with the Return to Run Physical Therapy (RTR PT) program. The current study was designed to determine if results could be replicated at other military treatment facilities and to examine whether early performance gains in patient-reported functional outcomes remained at 12 months. METHODS: Study participants included service members who had functional deficits that interfered with daily activities at least 1 year after a traumatic unilateral lower-extremity injury at or below the knee. Participants were evaluated before receiving the IDEO, immediately following completion of RTR PT, and at 6 and 12 months. Agility, strength/power, and speed were assessed using well-established performance tests. Self-reported function was measured using the Short Musculoskeletal Function Assessment (SMFA). The Orthotics and Prosthetics Users' Survey was administered to assess satisfaction with the IDEO. Of 87 participants with complete baseline data, 6 did not complete any physical therapy and were excluded from the analysis. Follow-up rates immediately following completion of the RTR PT and at 6 and 12 months were 88%, 75%, and 79%, respectively. RESULTS: Compared with baseline, improvement at completion of RTR PT was observed in all but 1 performance test. SMFA scores for all domains except hand and arm function were lower (improved function) at 6 and 12 months. Satisfaction with the IDEO was high following completion of RTR PT, with some attenuation at the time of follow-up. CONCLUSIONS: This study adds to the evidence supporting the efficacy of the IDEO coupled with RTR PT. However, despite improvement in both performance and self-reported functioning, deficits persist compared with population norms. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

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.

A Unique Application of Negative Pressure Wound Therapy Used to Facilitate Patient Engagement in the Amputation Recovery Process.

Amputation rates during recent military conflicts were at an all-time high, but medical treatment of those amputations and attitudes of service members to get back to duty are also surging ahead. We present the cases of an active duty rescue C130 pilot with an above-the-knee amputation and a retired army sergeant with a below-the-knee amputation. Successful rehabilitation was augmented in both cases by using negative pressure incorporated in a custom prosthetic socket to accelerate incision closure, improve self-efficacy in wound care, and self-management, ultimately leading to faster recovery times, full engagement of the rehabilitation process, and return to active duty.

Gait biomechanics following lower extremity trauma: Amputation vs. reconstruction.

BACKGROUND: Surgical advances have substantially improved outcomes for individuals sustaining traumatic lower extremity injury. Injuries once requiring lower limb amputation are now routinely managed with limb reconstruction surgery. However, comparisons of functional outcomes between the procedures are inconclusive. PURPOSE: To compare gait biomechanics after lower limb reconstruction and transtibial amputation. METHODS: Twenty-four individuals with unilateral lower limb reconstruction wearing a custom ankle-foot orthosis (Intrepid Dynamic Exoskeletal Orthosis), 24 with unilateral, transtibial amputation, and 24 able-bodied control subjects underwent gait analysis at a standardized Froude speed based on leg length. Lower extremity joint angles, moments, and powers, and ground reaction forces were analyzed on the affected limb of patients and right limb of able-bodied individuals. ANOVA with Tukeys post-hoc tests determined differences among groups and post-hoc paired t-tests with Bonferroni-Holm corrections determined differences between limbs. RESULTS: The ankle, knee, and hip exhibited significant kinematic differences between amputated, reconstructed and able-bodied limbs. The reconstruction group exhibited less ankle power and range of motion while the amputee group exhibited lower knee flexor and extensor moments and power generation. CONCLUSION: Gait deficiencies were more pronounced at the ankle following limb reconstruction with orthosis use and at the knee following transtibial amputation with prosthesis use. Although both groups in the cohorts tested can replicate many key aspects of normative gait mechanics, some deficiencies still persist. These results add to the growing body of literature comparing amputation and limb reconstruction and provide information to inform the patient on functional expectations should either procedure be considered.

Patient Response to an Integrated Orthotic and Rehabilitation Initiative for Traumatic Injuries: The PRIORITI-MTF Study.

Although limb salvage is now possible for many high-energy open fractures and crush injuries to the distal tibia, ankle, hindfoot, and midfoot, orthotic options are limited. The Intrepid Dynamic Exoskeletal Orthosis (IDEO) is a custom, energy-storing carbon fiber orthosis developed for trauma patients undergoing limb salvage. The IDEO differs from other orthoses in that it allows patients with ankle weakness to have more normal ankle biomechanics and increased ankle power. This article describes the design of a study to evaluate the effectiveness of the IDEO when delivered together with a high-intensity, sports medicine-based approach to rehabilitation. It builds on earlier studies by testing the program at military treatment facilities beyond the Brooke Army Medical Center and the Center for the Intrepid where the device was developed. The PRIORITI-MTF study is a multicenter before-after program evaluation where participants at least 1 year out from a traumatic lower extremity injury serve as their own controls. Participants are evaluated before receiving the IDEO, immediately after 4 weeks of physical therapy with the IDEO and at 6 and 12 months after the completion of physical therapy. Primary outcomes include functional performance, measured using well-validated assessments of speed, agility, power, and postural stability and self-reported functioning using the Short Musculoskeletal Function Assessment (SMFA) and the Veterans Health Survey (VR-12). Secondary outcomes include pain, depression, posttraumatic stress, and satisfaction with the IDEO.

Prosthetic management of the burn amputation.

Amputations as a result of thermal or electrical burns present a unique challenge that requires a coordinated effort by the rehabilitation team. Complications of surface and deep tissue injury require adjustment to the more standard approaches to prosthetic provision. Accommodations for the complications of joint contracture, skin adhesions, sensation compromise, skin grafts, and muscle flaps must be made by the treating clinicians. Differences in the treatment timelines, socket designs, material options, and component choices are discussed to familiarize the team for optimization of function in this difficult treatment scenario.

Comparison of satisfaction with current prosthetic care in veterans and servicemembers from Vietnam and OIF/OEF conflicts with major traumatic limb loss.

Prosthetic care is a vital aspect of healthcare and rehabilitation for veterans and servicemembers with major traumatic limb loss. Our survey queried 581 veterans and servicemembers with limb loss from the Vietnam and Operation Iraqi Freedom (OIF)/Operation Enduring Freedom (OEF) conflicts. Among survey participants, 78.2% from the Vietnam conflict and 90.5% from the OIF/OEF conflict currently use prosthetic devices. In Vietnam respondents, 78% received prosthetic care from private sources, 16% from Department of Veterans Affairs (VA) prosthetic laboratories, 0.9% from Department of Defense (DOD), and 5% from multiple sources. In OIF/OEF respondents, 42% received prosthetic care from private sources, 9% percent from VA, 39% from DOD, and 10% from multiple sources. Participants identified their satisfaction with current prosthetic devices and prosthetic services. Reports of pain, sweating, skin irritation, and problems with socket fit continue to be significant issues for participants from both conflicts regardless of level of amputation or site of service. In those with upper-limb loss who used myoelectric prostheses, minimal effect on prosthesis use and satisfaction was noted. Among lower-limb loss participants from both conflicts, notable differences existed in prosthesis satisfaction by source of care.

Recent advances in lower extremity amputations and prosthetics for the combat injured patient.

Blast-related extremity trauma represents a serious challenge because of the extent of bone and soft tissue damage. Fragmentation and blast injuries account for 56% of all injuries produced within the Iraqi and Afghan theaters where, as of July 2009, 723 combatants have sustained lower extremity limb loss. If limb salvage is not practical, or fails, then amputation should be considered. Amputation can be a reliable means toward pain relief and improvement of function. Optimizing functional outcome is paramount when deciding on definitive amputation level. Preservation of joint function improves limb biomechanics in many cases. Increased limb length also allows for the benefits associated with articular and distal limb proprioception. Amputees with improved lower extremity function also usually exhibit less energy consumption. Function and length are generally directly correlated, whereas energy consumption and length are inversely related. This article discusses the surgical principles of lower extremity amputation and postoperative management of amputees, and the various prosthetic options available.

A noncontact sensor for measurement of distal residual-limb position during walking.

A simple noncontact device was implemented for measuring the position of the distal residual limb relative to the prosthetic socket during ambulation. The device was a small and lightweight photoelectric sensor positioned within a frame mounted immediately beneath the socket. Calibration tests showed that the sensor had a displacement range of 60.0 mm. The root-mean-square error for all sources of error considered (different reflective surfaces, peak-to-peak signal noise, drift, nonlinearity, different surface tilt angles, surface curvature, and wetness [simulating sweating]) was <1.95% full-scale output. We used the sensor in a preliminary study on a unilateral, transtibial amputee with diabetes to assess pistoning during ambulation. Results showed an average 41.7 mm proximal displacement during swing phase relative to stance phase. When the subject was walking on a flat surface, pistoning was significantly less (p = 0.000) with a supracondylar strap compared with no supracondylar strap, although the difference was not substantial (0.8 mm). A 5 min rest period caused the limb to displace proximally in the socket approximately 4.8 mm during subsequent walking trials, possibly reflecting limb enlargement and thus a more proximal position in the socket after the rest period. The device can potentially be used in prosthetics research for evaluating clinical features that may affect limb position and pistoning and thus fit.

Testing of elastomeric liners used in limb prosthetics: classification of 15 products by mechanical performance.

The mechanical properties of 15 elastomeric liner products used in limb prosthetics were evaluated under compressive, frictional, shear, and tensile loading conditions. All testing was conducted at load levels comparable to interface stress measurements reported on transtibial amputee subjects. For each test configuration, materials were classified into four groups based on the shapes of their response curves. For the 15 liners tested, there were 10 unique classification sets, indicating a wide range of unique materials. In general, silicone gel liners classified within the same groups thus were quite similar to each other. They were of lower compressive, shear, and tensile stiffness than the silicone elastomer products, consistent with their lightly cross-linked, high-fluid content structures. Silicone elastomer products better spanned the response groups than the gel liners, demonstrating a wide range of compressive, shear, and tensile stiffness values. Against a skin-like material, a urethane liner had the highest coefficient of friction of any liner tested, although coefficients of friction values for most of the materials were higher than interface shear:pressure ratios measured on amputee subjects using Pelite liners. The elastomeric liner material property data and response groupings provided here can potentially be useful to prosthetic fitting by providing quantitative information on similarities and differences among products.

Shape and volume change in the transtibial residuum over the short term: preliminary investigation of six subjects.

A preliminary investigation was conducted to characterize the magnitude and distribution of volume change in transtibial residua at two time intervals: upon prosthesis removal and at 2 week intervals. Six adult male unilateral transtibial amputee subjects, between 0.75 and 40.0 years since amputation, were imaged 10 times over a 35-minute interval with a custom residual limb optical scanner. Volume changes and shape changes over time were assessed. Measurements were repeated 2 weeks later. Volume increase on socket removal for the six subjects ranged from 2.4% to 10.9% (median 6.0% +/- standard deviation 3.6%). Rate of volume increase was highest immediately upon socket removal and decreased with time (five subjects). In four subjects, 95% of the volume increase was reached within 8 minutes. No consistent proximal-to-distal differences were detected in limb cross-sectional area change over time. Limb volume differences 2 weeks apart ranged from -2.0% to 12.6% (0.6% +/- 5.5%) and were less in magnitude than those within a session over the 35-minute interval (five subjects). Multiple mechanisms of fluid movement may be responsible for short-term volume changes, with different relative magnitudes and rates in different amputees.

Energy storage and return prostheses: does patient perception correlate with biomechanical analysis?

The development and prescription of energy storage and return prosthetic feet in favor of conventional feet is largely based upon prosthetist and amputee experience. Regretfully, the comparative biomechanical analysis of energy storage and return and conventional prosthetic feet is rarely a motivation to either the technical development or clinical prescription of such devices. The development and prescription of prosthetic feet without supportive scientific evidence is likely due to the conflicting or non-significant results often presented in the scientific literature. Despite the sizeable history of comparative prosthetic literature and continued analysis of prosthetic components, the link between clinical experience and scientific evidence remains largely unexplored.A review of the comparative analysis literature evaluating energy storage and return and conventional prosthetic feet is presented to illustrate consistencies between the perceptive assessments and the objective biomechanical data. Results suggest that while experimental methodologies may limit the statistical significance of objective gait analysis results, consistent trends in temporal, kinetic, and kinematic parameters correlate well with perceptive impressions of these feet. These correlations provide insight to subtle changes in gait parameters that are deemed neither clinically nor statistically significant, yet are perceived by amputees to affect their preference for and performance of prosthetic feet during locomotion. Acknowledging and targeting areas of perceptive significance will help researchers develop more structured protocols for energy storage and return prosthesis evaluation as well as provide clinicians with information needed to enhance the appropriateness of their clinical recommendations. Expanding test environments to measure activities of perceived improvement such as high-velocity motions, stair ascent/descent, and uneven ground locomotion will provide a more appropriate assessment of the conditions for which energy storage and return prosthetic feet were designed. Concentrating research to specific test populations by age or amputation etiologies can overcome statistical limitations imposed by small study samples. Finally, directing research toward the areas of gait adaptation, heel performance, and the temporal release of energy in energy storage and return feet may reinforce the selection and utilization of advanced prosthetic components. These enhancements to current biomechanical analyses may serve to reduce the boundaries of perceptive significance and provide clinicians, designers, and researchers with the supportive data needed to prescribe, design, and evaluate energy storage and return prosthetic feet.

Transtibial energy-storage-and-return prosthetic devices: a review of energy concepts and a proposed nomenclature.

Prosthetic devices that can store and return energy during gait enhance the mobility and functionality of lower-limb amputees. The process of selecting and fitting such devices is complicated, partly because of confusing literature on the topic. Gait analysis methods for measuring energy characteristics are often incomplete, leading to inconsistencies in the energy classifications of different products. These inconsistencies are part of the reason for the lack of universally accurate terminology in the field. Inaccurate terminology perpetuates misunderstanding. In this paper, important prosthetic energy concepts and methods for measuring energy characteristics are reviewed. Then a technically accurate nomenclature and a method of functional classification are proposed. This review and proposed classification scheme should help to alleviate confusion and should facilitate enhancement of the design, selection, and fitting of prosthetic limbs for amputee patients.