Effect of pregnancy on anthropometrics, comfort, and functional performance for women living with transfemoral limb loss: Case report.

Women living with limb loss (amputees) have unique needs that increase during pregnancy. Comfort, pain, and activity are exponentially compromised. Changes in mass and altered center of gravity increase the likelihood of falls and compromise safety for the mother and unborn baby. Subjective and physical functional performance measures data was collected through 2 separate pregnancies on a 36-year-old woman with a right transfemoral amputation. Physiological changes during pregnancy effected comfort, pain, and functional performance. Clinical practice guidelines for prosthetic management should be established to include protocols such as adjustment schedules, specialized socket design, and necessary component changes throughout the course of pregnancy.

Effect of transfemoral prosthetic socket interface design on gait, balance, mobility, and preference: A randomized clinical trial.

BACKGROUND: There are alternative transfemoral (TF) socket interface designs that have not been compared with the standard of care, ischial ramus containment (IRC). The interface directly affects performance. OBJECTIVES: To compare 3 TF interface designs, IRC, dynamic socket (DS), and subischial (Sub-I), regarding gait, balance, mobility, and preference. The authors hypothesized that these more active users may experience gait, mobility, and preference benefits from the less intrusive DS and Sub-I interface designs. STUDY DESIGN: Single-blind, repeated-measures, 3-period randomized controlled crossover clinical trial. METHODS: People with unilateral TF amputation with 1 year or longer prosthesis use experience, independent community ambulatory status, 18 to 60 years of age, of any race or ethnicity, with a body mass of 45 to 125 kg, and with a self-reported ability to walk for 20 minutes continuously were included in the study. Each participant was fit in all 3 interface designs. RESULTS: Thirteen participants completed the clinical trial. Velocity, cadence, mobility, and balance were not statistically different between the 3 socket conditions. The DS demonstrated significantly greater symmetry in swing, stance, single support percentage, and toe angle compared with IRC and Sub-I. Sixty days after study completion, 7 participants changed interfaces, trending away from IRC. CONCLUSIONS: Large differences were not observed. Small differences in spatiotemporal gait measures combined with patient preference may make a meaningful difference to individual patients and should be considered.

Preferences of Physical Therapy Students Regarding Digital and Printed Textbooks.

AIMS: Research has shown mixed results regarding students' preferences of digital over printed textbooks. However, none of the published studies have studied physical therapy students and few have surveyed students across more than one professional program. The purpose of this study was to identify the perceptions and use of digital textbooks and printed textbooks by students in four different physical therapy programs. METHODS: We surveyed first-, second-, and third-year physical therapist students from four physical therapy programs in different regions of the United States. Descriptive statistics were used to report the students' responses. Chi square tests of independence were used for all comparisons between genders and years in the program with a=0.05. RESULTS: More students had purchased or leased printed textbooks than digital textbooks. Students preferred digital textbooks for portability, cost, and search ability. Students preferred printed textbooks for studying and preparing for examinations. Printed textbooks were preferred for readability, comprehension, retention, and studying and were less tiring on the eyes. Males preferred digital textbooks and females preferred printed textbooks. Students in Years 2 and 3 of the programs preferred digital textbooks, and students in Year 1 preferred printed textbooks for some features. CONCLUSION: Students preferred digital textbooks for convenience factors and printed textbooks for learning.

Crossover study of amputee stair ascent and descent biomechanics using Genium and C-Leg prostheses with comparison to non-amputee control.

This study was a randomized crossover of stair ambulation of Transfemoral Amputees (TFAs) using the Genium and C-Leg prosthetic knees. TFAs typically have difficulty ascending and descending stairs, limiting community mobility. The objective of this study was to determine the relative efficacy of the Genium and C-Leg prostheses for stair ascent and descent, and their absolute efficacy relative to non-amputees. Twenty TFAs, and five non-amputees participated in the study. TFAs were randomized to begin the study with the Genium or C-Leg prosthesis. Informed consent was obtained from all participants prior to data collection and the study was listed on clinicaltrials.gov (#NCT01473662). After fitting, accommodation, and training, participants were asked to demonstrate their preferred gait pattern for stair ascent and descent and a step-over-step pattern if able. TFAs then switched prosthetic legs and repeated fitting, accommodation, training, and testing. An eight camera Vicon optical motion analysis system, and two AMTI force plates were used to track and analyze the participants' gait patterns, knee flexion angles, knee moment normalized by body weight, and swing time. For stair descent, no significant differences were found between prostheses. For stair ascent, Genium use resulted in: increased ability to use a step-over-step gait pattern (p=0.03), increased prosthetic side peak knee flexion (p<0.01), and increased swing duration (p<0.01). Changes in contralateral side outcomes and in knee moment were not significant. Overall the Genium knee decreased deficiency in gait patterns for stair ascent relative to the C-Leg, by enabling gait patterns that more closely resembled non-amputees.

EFFECTS OF THE GENIUM KNEE SYSTEM ON FUNCTIONAL LEVEL, STAIR AMBULATION, PERCEPTIVE AND ECONOMIC OUTCOMES IN TRANSFEMORAL AMPUTEES.

Compared to non-microprocessor knees, the C-Leg microprocessor knee (MPK) is bioenergentically and economically more efficient and safer for transfemoral amputation (TFA) patients. The Genium MPK has demonstrated improvements in perceived function, knee kinematics, and physical functional performance compared to C-Leg. Clinical and health economic analyses have not been conducted with the Genium knee system. The purpose of this study was to determine if laboratory determined benefits of Genium are detectable using common clinical assessments and if there are economic benefits associated with its use. This study utilized a randomized AB crossover study with 60 d follow-up including cost-effectiveness analysis. Twenty TFA patients tested with both knees in mobility and preference measures. Incremental cost-effectiveness ratios (ICER) were calculated based on performance measures. Stair Assessment Index scores improved with Genium. Mean stair completion times and descent stepping rate were not different between knees. Stair ascent stepping rate for C-Leg was greater compared with Genium (p = 0.04). Genium use decreased Four square step test completion time and increased functional level and step activity (p ≤ 0.05). Further, Genium use improved (p ≤ 0.05) function and safety in three out of five Activities of Daily Living (ADL) survey domains. Finally, more subjects preferred Genium following testing. Functional measures were used to calculate ICERs. ICER values for Genium fall within established likely-to-accept value ranges. Compared with C-Leg, Genium use improved stair walking performance, multi-directional stepping, functional level, and perceived function. In this group of community ambulators with TFA, Genium was preferred, and, while more costly, it may be worth funding due to significant improvements in functional performance with ADLs.

Functional performance differences between the Genium and C-Leg prosthetic knees and intact knees.

Microprocessor prosthetic knees (MPKs) have advanced technologically, offering new features to decrease impairment and activity limitations for persons with transfemoral amputation (TFA). The Genium knee is functionally untested, and functional differences between it and intact knees are unknown. This study sought to determine whether Genium use improves functional performance compared with the C-Leg. A randomized experimental crossover design was used, with a cross-section of five nonamputee controls for comparison to normal. Twenty community-ambulating persons with TFA were trained and tested for accommodation with study components. All subjects (n = 25) were assessed using the Continuous-Scale Physical Functional Performance-10 (CS-PFP10) assessment. Subjects with TFA used both MPK systems. Genium use improved upper-body flexibility, balance, and endurance domain scores (7.0%-8.4%, p

Differences in Military Obstacle Course Performance Between Three Energy-Storing and Shock-Adapting Prosthetic Feet in High-Functioning Transtibial Amputees: A Double-Blind, Randomized Control Trial.

BACKGROUND: Approximately 683 persons engaged in military service experienced transtibial amputation (TTA) related to recent war in Iraq and Afghanistan. Military TTAs function at a level beyond basic ambulation. No empirical data demonstrate which higher functioning prosthetic feet maximize injured service personnel's ability to continue performing at a level commensurate with return to duty. This study's purpose was to determine which of three high-functioning, energy-storing prosthetic feet maximize performance and preference in a field obstacle course (OC) and to quantify physical performance differences between TTAs and high-functioning nonamputees. PROCEDURES: A randomized, double-blind, repeated measures experimental design compared three prosthetic feet (Ossur Variflex, Endolite Elite Blade, and Ossur Re-Flex Rotate) during performance on a field OC. TTAs accommodated with study feet and the OC before assessment. 14 TTAs and 14 nonamputee controls completed the course. Subjective and objective performance differences were compared across feet conditions and between groups. RESULTS: Total OC completion times were similar between prosthetic feet: Elite-Blade (419 seconds ± 130), Variflex (425 seconds ± 144), and Re-Flex Rotate (444 seconds ± 220). Controls' OC completion time (287.2 seconds ± 58) was less (p ≤ 0.05) than TTA times. In total, controls had faster completion times (p ≤ 0.05) compared to all prosthetic feet conditions in 13/17 obstacles. Re-Flex Rotate had 2 additional obstacles different (p ≤ 0.05) than controls and required more time to complete. Median RPE values were lower (p ≤ 0.05) for controls than TTA regardless of foot. Regarding foot preference for OC completion, 7/14 (50%) preferred Elite Blade, 5/14 (36%) preferred Re-Flex Rotate, and the remaining 2/14 (14%) preferred Variflex. CONCLUSION: Controls completed the OC faster and with less effort than TTAs regardless of prosthetic foot. No clear differences in prosthetic feet emerged during OC completion; however, individual task performance, perceived effort, and preference resulted in trends of slight performance improvement with and preference for Elite Blade, a dual function energy-storing and return foot combined with vertical shock absorption. Understanding how to maximally improve performance in such functional tasks may allow service members to best sustain physical fitness, return to their military occupational specialty and possibly in-theater duty.

Prosthetic interventions for people with transtibial amputation: Systematic review and meta-analysis of high-quality prospective literature and systematic reviews.

Considering transtibial amputation (TTA) rehabilitation costs and complexity, high-quality literature should inform clinical practice. Systematic reviews (SRs) suggest this is not the case. This article's purpose was to review the highest-quality evidence available to guide clinical practice for TTA regarding five prosthetic intervention areas. Six databases were searched for high-quality SRs and prospective clinical trials (randomized clinical trials [RCTs]). Reviewers screened, sorted, rated (i.e., methodologic quality, bias risk), and extracted article data. Meta-analyses were conducted when possible. Thirty-one references were included (25 RCTs and 6 SRs). Five topical areas emerged (alignment, feet and ankles, interface, postoperative care, pylons). Twenty-three evidence statements were supported by level 2 evidence and eight by level 1 evidence. All RCTs reported randomization and reasonable data presentation. Concealed allocation and blinding were not widely used. Mean attrition was 11%. SRs included no meta-analyses. Functional level was poorly reported. Grouping feet and ankle components by functional classification enabled meta-analyses, though variance was considerable given the small sample sizes. Prosthetic interventions are generally safe for TTAs. High-quality literature enabled formulation of evidence statements to support select clinical practice areas, though quantity was lacking. Thus, numerous topics related to TTA care lack rigorous evidence. Although blinding in prosthetic research requires increased funding and effort, it could greatly improve the methodologic quality of prosthetic research.

ECONOMIC EVALUATIONS OF INTERVENTIONS FOR TRANSTIBIAL AMPUTEES: A SCOPING REVIEW OF COMPARATIVE STUDIES.

Transtibial amputation (TTA) is life-altering emotionally, functionally, and economically. The economic impact to all stakeholders is largely unknown, as is the cost-effectiveness of prosthetic intervention. This scoping report's purpose was to determine if there is sufficient evidence to conduct a formal systematic review or meta-analysis in any particular prosthetic intervention area and to determine if any evidence statements could be synthesized relative to economic evaluation of interventions provided to patients with TTA. The scoping review revealed six articles representing three topical areas of transtibial care: Care Models, Prosthetic Treatment, and Prosthetic Sockets. All six articles were cost-identification or cost-consequence design and included a total of 704 subjects. Presently, it can be concluded with moderate confidence that specific weight-bearing and total-contact sockets for transtibial amputees are functionally and economically equivalent in the short term when costs, delivery time, and all stakeholder perspectives are considered. Long-term socket outcomes are relatively unexplored. Further primary research is needed beyond this to determine cost-effectiveness for other areas of transtibial prosthetic care although clinical outcomes are somewhat established through systematic review and meta-analysis in other areas of care. Conversely, evaluation of narrative economic reports relative to transtibial care may be sufficient to warrant further analysis. Guidance from the profession may also be useful in devising a strategy for how to assure economic analyses are a routine element of future prosthetic science.

EFFECTS OF THE GENIUM MICROPROCESSOR KNEE SYSTEM ON KNEE MOMENT SYMMETRY DURING HILL WALKING.

Use of the Genium microprocessor knee (MPK) system reportedly improves knee kinematics during walking and other functional tasks compared to other MPK systems. This improved kinematic pattern was observed when walking on different hill conditions and at different speeds. Given the improved kinematics associated with hill walking while using the Genium, a similar improvement in the symmetry of knee kinetics is also feasible. The purpose of this study was to determine if Genium MPK use would reduce the degree of asymmetry (DoA) of peak stance knee flexion moment compared to the C-Leg MPK in transfemoral amputation (TFA) patients. This study used a randomized experimental crossover of TFA patients using Genium and C-Leg MPKs (n = 20). Biomechanical gait analysis by 3D motion tracking with floor mounted force plates of TFA patients ambulating at different speeds on 5° ramps was completed. Knee moment DoA was significantly different between MPK conditions in the slow and fast uphill as well as the slow and self-selected downhill conditions. In a sample of high-functioning TFA patients, Genium knee system accommodation and use improved knee moment symmetry in slow speed walking up and down a five degree ramp compared with C-Leg. Additionally, the Genium improved knee moment symmetry when walking downhill at comfortable speed. These results likely have application in other patients who could benefit from more consistent knee function, such as older patients and others who have slower walking speeds.

BIOENERGETIC DIFFERENCES DURING WALKING AND RUNNING IN TRANSFEMORAL AMPUTEE RUNNERS USING ARTICULATING AND NON-ARTICULATING KNEE PROSTHESES.

Transfemoral amputation (TFA) patients require considerably more energy to walk and run than non-amputees. The purpose of this study was to examine potential bioenergetic differences (oxygen uptake (VO2), heart rate (HR), and ratings of perceived exertion (RPE)) for TFA patients utilizing a conventional running prosthesis with an articulating knee mechanism versus a running prosthesis with a non-articulating knee joint. Four trained TFA runners (n = 4) were accommodated to and tested with both conditions. VO2 and HR were significantly lower (p ≤ 0.05) in five of eight fixed walking and running speeds for the prosthesis with an articulating knee mechanism. TFA demonstrated a trend for lower RPE at six of eight walking speeds using the prosthesis with the articulated knee condition. A trend was observed for self-selected walking speed, self-selected running speed, and maximal speed to be faster for TFA subjects using the prosthesis with the articulated knee condition. Finally, all four TFA participants subjectively preferred running with the prosthesis with the articulated knee condition. These findings suggest that, for trained TFA runners, a running prosthesis with an articulating knee prosthesis reduces ambulatory energy costs and enhances subjective perceptive measures compared to using a non-articulating knee prosthesis.

CONCURRENT VALIDITY OF THE CONTINUOUS SCALE-PHYSICAL FUNCTIONAL PEFORMANCE-10 (CS-PFP-10) TEST IN TRANSFEMORAL AMPUTEES.

The Continuous Scale-Physical Functional Performance-10 (CS-PFP-10) test consists of 10 standardized daily living tasks that evaluate overall physical functional performance and performance in five individual functional domains: upper body strength (UBS), upper body flexibility (UBF), lower body strength (LBS), balance and coordination (BAL), and endurance (END). This study sought to determine the concurrent validity of the CS-PFP-10 test and its functional domains that involve the lower extremities (LBS, BAL, or END) in comparison to measures that have established validity for use in persons with transfemoral amputation (TFA). Ten TFA patients functioning at K3 or higher (Medicare Functional Classification Level) completed the study. Participants were assessed performing the CS-PFP-10, Amputee Mobility Predictor (AMP), 75 m self-selected walking speed (75 m SSWS) test, timed down stair walking (DN stair time), and the limits of stability (LOS) balance test. Concurrent validity was assessed using correlation analysis. The AMP, 75 m SSWS, LOS, and the DN stair time tests were strongly correlated (r = ± 0.76 to 0.86) with their paired CS-PFP-10 domain score (LBS, BAL, or END) and CS-PFP-10 total score. These findings indicate that the lower limb and balance domains of the CS-PFP-10 are valid measures to assess the physical functional performance of TFA patients.

PSYCHOMETRIC EVALUATION OF THE HILL ASSESSMENT INDEX (HAI) AND STAIR ASSESSMENT INDEX (SAI) IN HIGH-FUNCTIONING TRANSFEMORAL AMPUTEES.

The hill assessment index (HAI) and stair assessment index (SAI) were developed to objectively evaluate ramp and stair gait. This study's purpose was to determine the validity and reliability of these tests in a sample of persons with unilateral transfemoral amputation (TFA) using microprocessor prosthetic knee systems. All subjects were fit with a microprocessor knee system. After accommodation, subjects performed three trials ascending and descending a 5° ramp and a flight of stairs while being recorded on video. Sensitivity and specificity for the HAI was calculated against degree of asymmetry in step length using Dartfish video analysis software. Reliability was assessed using intraclass correlational coefficients calculated using Spearman's Rho (rs). A priori significance level was set at p ≤ 0.05. Twenty (n = 20) individuals with TFA completed the study protocol. Sensitivity and specificity of the HAI were calculated at 88.0% and 75.0% during ascending conditions and 94.0% and 67.0% during descending conditions, respectively. Significant correlations for the HAI included rs = 0.87 and rs = 0.73 within raters uphill and downhill, respectively. Corresponding coefficients of rs = 0.80 and rs = 0.67 were calculated between raters. For the SAI, significant correlations included rs = 1.00 for both comparisons within raters and in the comparison between raters in the ascending condition. A correlation of rs = 0.89 was calculated for the between-rater comparison in the descending condition. The HAI showed moderate to excellent sensitivity and specificity but good to adequate reliability. The SAI showed excellent to good reliability.

Delivery of cosmetic covers to persons with transtibial and transfemoral amputations in an outpatient prosthetic practice.

BACKGROUND: Limb loss negatively impacts body image to the extent that functional activity and societal participation are affected. Scientific literature is lacking on the subject of cosmetic covering for prostheses and the rate of cosmetic cover utilization by cover type, gender, amputation level, and type of healthcare reimbursement. OBJECTIVES: To describe the delivery of cosmetic covers in lower limb prostheses in a sample of people with lower extremity amputation. STUDY DESIGN: Cross-sectional design METHODS: Patient records from an outpatient practice were reviewed for people who received a transtibial or transfemoral prosthesis within a selected 2-year period. RESULTS: A total of 294 records were reviewed. Regardless of the amputation level, females were significantly (p ≤ 0.05) more likely to receive a cover. Type of insurance did not affect whether or not a cover was used, but Medicare reimbursed more pull-up skin covers. CONCLUSION: There were differences regarding cosmetic cover delivery based on gender, and Medicare reimbursed for more pull-up skin covers at the transtibial level than other reimbursors did. This analysis was conducted in a warm, tropical geographic region of the United States. Results may differ in other parts of the world based on many factors including climate and local views of body image and disability. CLINICAL RELEVANCE: Cosmetic covering rates are clinically relevant because they provide insight into which gender is utilizing more cosmetic covers. Furthermore, it can be determined which type of covers are being utilized with greater frequency and which insurance type is providing more coverage for them.

Correlations between residual limb length and joint moments during sitting and standing movements in transfemoral amputees.

BACKGROUND AND AIM: Longer residual limb lengths provide an increased lever arm. Longer residual limbs may produce increased joint moments; the two may be correlated. These correlations have not been evaluated in transfemoral amputees during transitional movements. Correlations between residual limb length and involved side joint moment could contribute to justification supporting maximal residual limb length preservation. This study investigated possible correlations between hip or knee moment and residual limb length. TECHNIQUE: Hip and knee joint moments were determined while 21 transfemoral amputees performed sitting and standing movements and then evaluated for correlation with residual limb length. DISCUSSION: Residual limb length was not correlated with either knee or involved side hip moments during sit to stand or stand to sit. Conversely, weak inverse correlations (p < 0.05) existed between sound hip moment magnitude and residual limb length. These correlations suggest that in community ambulating transfemoral amputees, longer residual limb length could decrease sound hip kinetic burden during transitional movement. Beyond correlations between residual limb length and sound hip transitional movement kinetics, there are other considerations in determining residual limb length during amputation. CLINICAL RELEVANCE: This study examines relationships between lower limb joint moments and residual limb length related to sit-to-stand and stand-to-sit activities. The results have implications for amputation surgery and rehabilitation.

Differences in knee flexion between the Genium and C-Leg microprocessor knees while walking on level ground and ramps.

BACKGROUND: Microprocessor knees have improved the gait and functional abilities of persons with transfemoral amputation. The Genium prosthetic knee offers an advanced sensor and control system designed to decrease impairment by: allowing greater stance phase flexion, easing transitions between gait phases, and compensating for changes in terrain. The aim of this study was to determine differences between the knee flexion angle of persons using the Genium knee, the C-Leg knee, and non-amputee controls; and to evaluate the impact the prostheses on gait and level of impairment of the user. METHODS: This study used a randomized experimental crossover of persons with transfemoral amputation using the Genium and C-Leg microprocessor knees (n=25), with an observational sample of non-amputee controls (n=5). Gait analysis by 3D motion tracking of subjects ambulating at different speeds on level ground and on 5° and 10° ramps was completed. FINDINGS: Use of the Genium resulted in a significant increase in peak knee flexion for swing (5°, p<0.01, d=0.34) and stance (2°, p<0.01, d=0.19) phases relative to C-Leg use. There was a high degree of variability between subjects, and significant differences still remain between the Genium group and the control group's knee flexion angles for most speeds and slopes. INTERPRETATION: The Genium knee generally increases flexion in swing and stance, potentially decreasing the level of impairment for persons with transfemoral amputation. This study demonstrates functional differences between the C-Leg and Genium knees to help prosthetists determine if the Genium will provide functional benefits to individual patients.

Ramp descent performance with the C-Leg and interrater reliability of the Hill Assessment Index.

BACKGROUND: Transfemoral amputees have decreased ability to descend ramps and hills. The Hill Assessment Index quantifies transfemoral amputee ramp performance, but interrater reliability has not been assessed. OBJECTIVES: To determine whether C-Leg use improves hill descent gait and evaluate the Hill Assessment Index's interrater reliability. METHODS: Twenty-one transfemoral amputees descended a ramp while timed and video recorded, using their nonmicroprocessor prosthetic knee. Subjects were fitted and accommodated with a C-Leg and retested. Test times were compared, and ramp performances were independently reviewed using the Hill Assessment Index by two raters. Hill Assessment Index scores were compared between knee conditions within raters for performance and between raters to assess the Hill Assessment Index's interrater reliability. RESULTS: Mean Hill Assessment Index scores were greater for C-Leg compared to nonmicroprocessor prosthetic knee for both raters. C-Leg resulted in faster ramp descent. Strong correlations resulted between raters on Hill Assessment Index scores for nonmicroprocessor prosthetic knee (intraclass correlation coefficient = 0.97) and C-Leg (intraclass correlation coefficient = 0.99). CONCLUSIONS: C-Leg improves Hill Assessment Index ramp descent performance and time. In descent quality, C-Leg offers the possibility of eliminating assistive device use and/or improving step length in the absence of an assistive device. C-Leg resulted in 23% gait speed increase during ramp descent. The Hill Assessment Index had very good interrater reliability but should be assessed for intrarater reliability, minimal detectable change, and validity.