Prosthetics and Orthotics International - Fondazione Santa Lucia

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Brunelli et al. 3 Figure 2. The three conditions of the pistoning test on the hypobaric Iceross Seal-In ® X5: The baseline evaluation is on the left, 0 N applied to the prosthesis is in the middle, and 30 N applied is on the right. Note the markers on the tight and on the socket. the TTA held the prosthetic leg straight in the air. We calculated the displacements (in mm) of the markers located on the greater trochanter (GT), proximal lateral end of the liner (PL), proximal lateral end of the socket (PS), and distal end of the socket (DS), as in the procedure described by Gholizadeh et al. 12 To minimize measurement errors, we calculated the means of the following displacements in each measure: GT-PS, GT-DS, and PL-DS. The amount of displacement from the baseline identifies the pistoning movement: lesser the displacement, lesser is the pistoning. Data were collected by photos acquired by high-resolution camera (Figure 2). Due to the presence of the sleeve in the SSS, the PS and the PL markers were positioned at the same level as the HIS but above the sleeve. (Figure 3). Compared with Gholizadeh et al.’s procedure, we did not test pistoning by adding 60 and 90 N because we noticed excessive knee flexion on the prosthetic side due to a load reflex of the knee muscles, which affected the pistoning measurements. ECW tests ECW tests were performed on the floor (floor walking test (FWT) and on a treadmill (treadmill walking test (TWT)). During the walking tests, metabolic data were collected using a portable metabolimeter K4b2 (Cosmed, Italy). This device guarantees breath-by-breath collection of oxygen consumption data. TWT were performed with ascendant slope (12%), descendent slope (5%), and without slope (0%). Slopes used in a treadmill test in amputees were reported by Göktepe et al. 19 and Huang et al. 20 In previous studies, TWTs were widely used to compare the effect of different prosthetic components on energy expenditure during ambulation. 21,22 FWT is also widely used in amputee ECW evaluation. 23–25 In both TWT and FWT, amputees were Figure 3. Position of markers on suction suspension system. requested to walk at their own self-selected speed wearing the portable metabolimeter. ECW at steady state was calculated using the formula: “oxygen consumption/speed” (mL/kg/m). Trials were performed in a random sequence. The interval time between each trial was 30 min for recovery to baseline, as used by Schmalz et al. 22 PEQ The PEQ is a self-report questionnaire that measures prosthesis-related quality of life and functional outcomes. It consists of nine independent functional domain scales: appearance, ambulation, frustration, perceived response, residual limb health, social burden, sounds, utility, and well-being. 26 Downloaded from poi.sagepub.com at Fondazione Santa Lucia on May 22, 2013
4 Prosthetics and Orthotics International 0(0) Houghton Scale Questionnaire The HSQ was used to measures time spent wearing the prosthesis and its functional use. 27 It consists of four items: amount of time the prosthesis is used, manner in which it is used, individual’s perception of stability, and whether walking aids are used while walking outside on a variety of terrains. Each item is scored on a 4-point ordinal scale, and the perception of stability questions are binary yes/no answers. The maximum score is 12. TUGT We used the TUGT to assess participants’ motor ability when they were wearing the prosthesis. 28 The test measures the time (in seconds) needed to stand up from a standard arm chair, walk 3 m, turn, walk back to the chair, and sit down again. LCI-5 10 K-level 3 or 4 transbial amputees, Standard Sucon Socket (SSS) and carbon fiber foot users, never used a hypobaric Iceross Seal-In® X5 (HIS) Evaluaon session with SSS (PEQ, HSQ, Pistoning test, ECW tests (on floor and treadmill), LCI-5 and TUGT) Construcon of the new socket for the HIS by an experienced prosthest who kept all other prosthesis components unchanged Intermediate evaluaon (Pistoning and ECW) aer 2 and 5 weeks of HIS use Final evaluaon aer 7 weeks of HIS use (PEQ, HSQ, Pistoning test, floor and treadmill ECW tests, LCI-5 and TUGT) Figure 4. Study flow chart diagram. The LCI-5 was used to evaluate lower-limb amputees’ ambulatory skills with the prosthesis. 29 The LCI tests the ability to perform a number of motor tasks. It provides an aggregated score for 14 items. The maximum total score of the index was 56. Timing In a pretest morning session, the same prosthetist on our team who had previously designed the SSS, checked the alignment and adequacy of each participant’s prosthesis. Then each participant was administered the PEQ and the HSQ. Anthropometric (body mass, height) and anamnestic data were also collected. In the afternoon, the participants performed the PT with SSS. Preliminary walking tests on the treadmill (at three different slopes) were also conducted to allow TTAs to become familiar with the equipment and to avoid a learning effect. Two days later, TTAs were administered the ECW tests, LCI-5, and TUGT. Meanwhile, the same experienced prosthetist began to construct the HIS starting from the plaster cast of the new socket, which is necessary for the Seal-In system. During the 2 weeks or so required to manufacture the HIS, the amputees met with the prosthetist three times. All other prosthesis components remained unchanged. After 2, 5, and 7 weeks of HIS use, the participants performed the ECW tests and the PT at the same time as the SSS tests and wearing the same shoes. Before each session, body mass was measured to avoid erroneous comparisons between tests. The length of the acclimation periods was established on the basis of Datta et al.’s 21 results. These authors reported that TTAs needed a minimum of 6 weeks to become accustomed to a new socket. LCI-5, TUGT, PEQ, and HSQ were administered after 7 weeks of HIS use. Figure 4 presents a flow chart of the study. Statistical analysis Statistical analyses were performed using Statistical Package for Social Sciences (SPSS) version 17.0 for Windows. All data were reported as means and standard deviations (SDs). A repeated-measures analysis of variance (ANOVA) was performed on continuous measures (TUGT, PT, and ECW tests) as within-subject factor along the observation period. Where ANOVAs were significant at a p = 0.05 level, a post hoc analysis was performed, setting the critical adjusted α value by using Bonferroni’s inequality. For nonparametric variables (PEQ, HSQ, and LCI), the Wilcoxon signed-rank test analysis was performed. Results Ten male TTAs were recruited to participate in the trial. Their mean age was 44.9 years (SD = 9.5 years). All had been using a SSS prosthesis daily for at least 18 months and continuously for at least 6 h a day. All participants were able to walk without aids, and were active and employed. Demographic data are summarized in Table 1. Downloaded from poi.sagepub.com at Fondazione Santa Lucia on May 22, 2013
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Prosthetics and Orthotics International - Fondazione Santa Lucia

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