Introduction The objective of this study was to investigate the accuracy and reliability of Modus Trex–derived K-level to differentiate between Medicare Functional Classification levels (K-levels) in individuals with lower-limb amputation. Methods This study was a prospective study monitoring walking behavior. Subjects were recruited from an outpatient clinic for persons with amputation at a Veterans Affairs medical center. Subjects were blinded to results of the Global Positioning System and activity data. Physicians were blinded to Modus Trex–derived K-level, 6-minute walk test (6MWT), and Amputee Mobility Predictor with Prosthesis (AMPPRO) results. The study enrolled 29 subjects with transtibial amputation. Twenty-seven subjects were included in the data analysis. Two subjects were excluded due to incomplete or unreliable data. Patients were eligible if they were at least 1 year postamputation surgery and could walk with a well-fitting and functioning prosthesis. Patients were excluded if they had other musculoskeletal injuries that impacted their ambulation ability. A clinical K-level, 6MWT, and AMPPRO were obtained. An activity monitor and Global Positioning System device were attached to the prosthesis to record activity for 2 weeks. Study physicians used number of steps in community, steps per day, peak cadence, and environmental barriers traversed in the subjects' first 6 to 10 days, as well as clinical judgement, to determine a Modified Clinical K-level (MCK-level) for each subject. The MCK-level was the criterion to which all other measures were compared. Results The Modus Trex–derived K-level correlated most strongly with the MCK-levels (r = 0.96, P < 0.001) with 85% accuracy/sensitivity. Repeat (week 1 to week 2) was excellent (interclass correlation coefficient = 0.92). Other outcome measures also correlated to MCK-levels: AMPPRO (r = 0.93), 6MWT (r = 0.89), peak cadence (r = 0.89), and daily steps (r = 0.76). Conclusions The Modus Trex–derived K-level was reliable and accurate at estimating MCK-levels and can be useful as a component in K-level evaluation.
An insole system was constructed with 32 sensors inside a size 10 men's shoe. This system allows evaluation of the contributions of individual sensors spread throughout the surface area of the insole. The kinetic variables of interest in this initial study are ground reaction force and anterior-posterior ankle moment. Use of all 32 sensors are able to replicate the shape of the ground reaction force and ankle moment in a stroke patient who has regained a more normal gait, but less so in a stroke patient with impaired gait. Subsets of sensors can now be evaluated in order to ultimately identify an optimum set of sensors for determining kinetic variables necessary to classify presence or absence of a particular gait abnormality or other pathology.
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