Regular use of prostheses is critical for individuals with lower limb amputations to achieve everyday mobility, maintain physical and physiological health, and achieve a better quality of life. Use of prostheses is influenced by numerous factors, with prosthetic design playing a critical role in facilitating mobility for an amputee. Thus, prostheses design can either promote biomechanically efficient or inefficient gait behavior. In addition to increased energy expenditure, inefficient gait behavior can expose prosthetic user to an increased risk of secondary musculoskeletal injuries and may eventually lead to rejection of the prosthesis. Consequently, researchers have utilized the technological advancements in various fields to improve prosthetic devices and customize them for user specific needs. One evolving technology is powered prosthetic components. Presently, an active area in lower limb prosthetic research is the design of novel controllers and components in order to enable the users of such powered devices to be able to reproduce gait biomechanics that are similar in behavior to a healthy limb. In this case series, we studied the impact of using a powered knee-ankle prostheses (PKA) on two transfemoral amputees who currently use advanced microprocessor controlled knee prostheses (MPK). We utilized outcomes pertaining to kinematics, kinetics, metabolics, and functional activities of daily living to compare the efficacy between the MPK and PKA devices. Our results suggests that the PKA allows the participants to walk with gait kinematics similar to normal gait patterns observed in a healthy limb. Additionally, it was observed that use of the PKA reduced the level of asymmetry in terms of mechanical loading and muscle activation, specifically in the low back spinae regions and lower extremity muscles. Further, the PKA allowed the participants to achieve a greater range of cadence than their predicate MPK, thus allowing them to safely ambulate in variable environments and dynamically control speed changes. Based on the results of this case series, it appears that there is considerable potential for powered prosthetic components to provide safe and efficient gait for individuals with above the knee amputation.
Background Individuals with transfemoral amputations who are considered to be limited community ambulators are classified as Medicare functional classification (MFCL) level K2. These individuals are usually prescribed a non-microprocessor controlled knee (NMPK) with an appropriate foot for simple walking functions. However, existing research suggests that these individuals can benefit from using a microprocessor controlled knee (MPK) and appropriate foot for their ambulation, but cannot obtain one due to insurance policy restrictions. With a steady increase in older adults with amputations due to vascular conditions, it is critical to evaluate whether advanced prostheses can provide better safety and performance capabilities to maintain and improve quality of life in individuals who are predominantly designated MFCL level K2. To decipher this we conducted a 13 month longitudinal clinical trial to determine the benefits of using a C-Leg and 1M10 foot in individuals at K2 level with transfemoral amputation due to vascular disease. This longitudinal clinical trial incorporated recommendations prescribed by the lower limb prosthesis workgroup to design a study that can add evidence to improve reimbursement policy through clinical outcomes using an MPK in K2 level individuals with transfemoral amputation who were using an NMPK for everyday use. Methods Ten individuals (mean age: 63 ± 9 years) with unilateral transfemoral amputation due to vascular conditions designated as MFCL K2 participated in this longitudinal crossover randomized clinical trial. Baseline outcomes were collected with their current prosthesis. Participants were then randomized to one of two groups, either an intervention with the MPK with a standardized 1M10 foot or their predicate NMPK with a standardized 1M10 foot. On completion of the first intervention, participants crossed over to the next group to complete the study. Each intervention lasted for 6 months (3 months of acclimation and 3 months of take-home trial to monitor home use). At the end of each intervention, clinical outcomes and self-reported outcomes were collected to compare with their baseline performance. A generalized linear model ANOVA was used to compare the performance of each intervention with respect to their own baseline. Results Statistically significant and clinically meaningful improvements were observed in gait performance, safety, and participant-reported measures when using the MPK C-Leg + 1M10 foot. Most participants were able to achieve higher clinical scores in gait speed, balance, self-reported mobility, and fall safety, while using the MPK + 1M10 combination. The improvement in scores were within range of scores achieved by individuals with K3 functional level as reported in previous studies. Conclusions Individuals with transfemoral amputation from dysvascular conditions designated MFCL level K2 benefited from using an MPK + appropriate foot. The inference and evidence from this longitudinal clinical trial will add to the knowledgebase related to reimbursement policy-making. Trial registration This study is registered on clinical trials.gov with the study title “Functional outcomes in dysvascular transfemoral amputees” and the associated ClinicalTrials.gov Identifier: NCT01537211. The trial was retroactively registered on February 7, 2012 after the first participant was enrolled.
BackgroundWearable sensors gather data that machine-learning models can convert into an identification of physical activities, a clinically relevant outcome measure. However, when individuals with disabilities upgrade to a new walking assistive device, their gait patterns can change, which could affect the accuracy of activity recognition.ObjectiveThe objective of this study was to assess whether we need to train an activity recognition model with labeled data from activities performed with the new assistive device, rather than data from the original device or from healthy individuals.MethodsData were collected from 11 healthy controls as well as from 11 age-matched individuals with disabilities who used a standard stance control knee-ankle-foot orthosis (KAFO), and then a computer-controlled adaptive KAFO (Ottobock C-Brace). All subjects performed a structured set of functional activities while wearing an accelerometer on their waist, and random forest classifiers were used as activity classification models. We examined both global models, which are trained on other subjects (healthy or disabled individuals), and personal models, which are trained and tested on the same subject.ResultsMedian accuracies of global and personal models trained with data from the new KAFO were significantly higher (61% and 76%, respectively) than those of models that use data from the original KAFO (55% and 66%, respectively) (Wilcoxon signed-rank test, P=.006 and P=.01). These models also massively outperformed a global model trained on healthy subjects, which only achieved a median accuracy of 53%. Device-specific models conferred a major advantage for activity recognition.ConclusionsOur results suggest that when patients use a new assistive device, labeled data from activities performed with the specific device are needed for maximal precision activity recognition. Personal device-specific models yield the highest accuracy in such scenarios, whereas models trained on healthy individuals perform poorly and should not be used in patient populations.
Introduction After stroke, upper limb impairment affects independent performance of activities of daily living. We evaluated the usability, functionality, and efficacy of a myoelectric elbow-wrist-hand orthosis to provide support, limit unsafe motion, and enhance the functional motion of paralyzed or weak upper limbs. Methods Individuals with stroke participated in a single-session study to evaluate the device. Ability to activate the device was tested in supported and unsupported shoulder position, as well as the elbow range of motion, ability to maintain elbow position, and ability to lift and hold a range of weights while using the device. Results No adverse events were reported. 71% of users were able to operate the device in all three active myoelectric activation modes (Biceps, Triceps, Dual) during testing. Users were able to hold a range of wrist weights (0.5–2 lbs) for 10–120 seconds, with the largest percentage of participants able to hold weights with the device in Biceps Mode. Conclusions The myoelectric elbow-wrist-hand orthosis improved range of motion during use and was efficacious at remediating upper extremity impairment after stroke. All users could operate the device in at least one mode, and most could lift and hold weights representative of some everyday objects using the device.
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