A Clinical Trial Comparing the Transition and Use of a Non-Microprocessor Controlled Prosthesis to the C-Leg Microprocessor Controlled Prosthesis for Transfemoral Amputees
Smith DG, Hafner BJ, Willingham LL, Allyn KJ, Buell NC Prosthetics Research Study, Seattle, Washington, United States of America
This study examined the differences in function, satisfaction, and preference of amputees using non-microprocessor (NMP) controlled and microprocessor (MP) controlled prosthetic limbs. It was hypothesized that satisfaction, preference, and functional ability would improve after users transitioned from a NMP to a MP prosthesis. 20 unilateral, transfemoral amputees of functional level K2 and K3 with well fitting NMP prostheses were recruited for a clinical trial which included a transition (phase I) and a preference period (phase II). Amputation etiologies included trauma (10), cancer (3), diabetes (1), infection (2), and severe dysfunction (1). Data collection sessions included initial testing in the NMP prosthesis (NMP), successful transition to the MP prosthesis (MP), a return to the NMP prosthesis (NMP2) and three user-selected preference sessions spaced at least four months apart (C1, C2, and C3). Outcomes included stair ascent/descent, hill descent, obstacle course, divided attention task, Amputee Mobility Predictor (AMP), step activity, Prosthesis Evaluation Questionnaire (PEQ), short-form 36 (SF-36), stumbles, falls, and mental energy required for ambulation. ANOVA and Tukey follow-up tests were performed to assess differences between sessions (NMP, MP, NMP2, C1, C2, and C3). 17 participants completed the study (mean age 49, eight functional level K2, nine K3). Significant improvements with the C-Leg were shown in the quality of stair descent, the time in hill descent, and the percent of steps taken in the preference phase (p<0.05). A significant decrease in the number of uncontrolled falls and in users’ frustration with falling was also found (p<0.05). An increased functional level was noted in 4 of 8 K2-level subjects (50%) and 3 of 9 K3-level subjects (33.3%). 2 subjects decreased from K3 to K2 and no K2 subjects decreased to K1 over the study period. Results indicate amputees strongly preferred and experienced improvements in functional ability when using the C-Leg prosthesis.
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