ABSTRACT
Introduction: Bilateral microprocessor-controlled prosthetic knee (MPK) users have unique needs in traversing environmental barriers compared to unilateral users. An enhancement to the Genium™/Genium X3™ MPK which included an updated ruleset, hydraulics, and new bilateral parameter presets was made to improve safety while stumbling and the smoothness of gait for all users while also improving the experience of bilateral users. The purpose of the study was to evaluate the effectiveness of the enhancements in a sample with unilateral and bilateral amputation. Methods: A convenience sample of MPK users was recruited from two sites in the USA in two phases. Assessments included the L-Test of Functional Mobility, Activity-specific Balance Confidence Scale, Prosthetic Limb User Survey of Mobility, a study-specific questionnaire, and the Comparative Activities of Daily Living (ADL) Questionnaire. Statistical significance of extracted data was tested with the Wilcoxon Rank-Sum Test for independent data and Wilcoxon Signed-Rank for paired data with an a priori significance level of p < 0.05. Unilateral subjects were age-matched to the group of bilateral subjects for between-groups and within-groups analyses. Results: Twenty-six subjects (n = 26) were enrolled. Stumble frequency reduced 85% from 16.0 ± 39.7 to 2.4 ± 2.3 (p = 0.008) between baseline and final assessment overall. The bilateral group reported 50% (p = 0.009) and 57% (p = 0.009) greater relative improvement in patient-reported ease and safety, respectively, of completing ADLs compared to the unilateral group. The unilateral group reported residual limb pain and low back pain reduced from 2.3 to 1.4 (p = 0.020) and 3.8 to 1.8 (p = 0.027), respectively, whereas the bilateral group did not. Discussion: Substantial reductions in stumbles, residual limb pain, and back pain were shown overall. These reductions were driven by the unilateral group who also showed improvements in comfort, exertion, and concentration while walking. The enhancements to the knee likely reduced some gait asymmetry for unilateral users. Improvements in patient-reported ease and safety of completing ADLs were shown overall and were driven by the bilateral group. This study shows further improvement in patient experience is achievable through innovation in MPK technology even for patients who appear to be functioning well.
ABSTRACT
Introduction: Studies with a powered prosthetic ankle-foot (PwrAF) found a reduction in sound knee loading compared to passive feet. Therefore, the aim of the present study was to determine whether anecdotal reports on reduced musculoskeletal pain and improved patient-reported mobility were isolated occurrences or reflect a common experience in PwrAF users. Methods: Two hundred and fifty individuals with transtibial amputation (TTA) who had been fitted a PwrAF in the past were invited to an online survey on average sound knee, amputated side knee, and low-back pain assessed with numerical pain rating scales (NPRS), the PROMIS Pain Interference scale, and the PLUS-M for patient-reported mobility in the free-living environment. Subjects rated their current foot and recalled the ratings for their previous foot. Recalled scores were adjusted for recall bias by clinically meaningful amounts following published recommendations. Statistical comparisons were performed using Wilcoxon's signed rank test. Results: Forty-six subjects, all male, with unilateral TTA provided data suitable for analysis. Eighteen individuals (39%) were current PwrAF users, whereas 28 subjects (61%) had reverted to a passive foot. After adjustment for recall bias, current PwrAF users reported significantly less sound knee pain than they recalled for use of a passive foot (-0.5 NPRS, p = 0.036). Current PwrAF users who recalled sound knee pain ≥4 NPRS with a passive foot reported significant and clinically meaningful improvements in sound knee pain (-2.5 NPRS, p = 0.038) and amputated side knee pain (-3 NPRS, p = 0.042). Current PwrAF users also reported significant and clinically meaningful improvements in patient-reported mobility (+4.6 points PLUS-M, p = 0.016). Individuals who had abandoned the PwrAF did not recall any differences between the feet. Discussion: Current PwrAF users reported significant and clinically meaningful improvements in patient-reported prosthetic mobility as well as sound knee and amputated side knee pain compared to recalled mobility and pain with passive feet used previously. However, a substantial proportion of individuals who had been fitted such a foot in the past did not recall improvements and had reverted to passive feet. The identification of individuals with unilateral TTA who are likely to benefit from a PwrAF remains a clinical challenge and requires further research.
