Prosthetics and Orthotics International - Fondazione Santa Lucia

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Brunelli et al. 5 Table 1. Participants’ demographic information and components of their standard suction socket. Subjects M/F Age (years) Body mass (kg) Height (cm) Time since amputation (months) Functional level Etiology Foot Liner 1 M 40 68.6 182 96 K4 Traumatic Sprilgite Styrene gel 2 M 43 90.2 179 96 K4 Traumatic Trustep Styrene gel 3 M 37 76.6 175 228 K4 Traumatic Vari-Flex Low Profile Styrene gel 4 M 24 50.0 160 84 K4 Traumatic Trustep Styrene gel 5 M 44 98.2 173 288 K4 Traumatic Modular III Polyurethane 6 M 51 74.6 172 36 K3 Infection Trustep Styrene gel 7 M 53 82.8 182 28 K3 Traumatic Vari-Flex Low Profile Styrene gel 8 M 50 101.0 167 25 K3 Vascular Vari-Flex Low Profile Styrene gel disease 9 M 54 95.8 180 144 K4 Traumatic Modular III Polyurethane 10 M 53 73.2 168 22 K3 Traumatic Vari-Flex Low Profile Styrene gel Mean 44.9 81.1 173.8 104.7 SD 9.5 15.8 7.3 91.1 SD: standard deviation. Table 2. Results of the PEQ (means ± SDs) administered with the SSS and after 7 weeks of HIS use. Appearance Ambulation Frustration Perceived response Residual limb health Social burden Sounds Utility Well-being SSS 79 ± 21 71 ± 13 93 ± 0 95 ± 4 73 ± 26 87 ± 10 87 ± 10 68 ± 19 76 ± 8 HIS 88 ± 11* 84 ± 9 ** 90 ± 1 92 ± 9 76 ± 22 90 ± 8 90 ± 8 78 ± 14 87 ± 8 *** PEQ: Prosthesis Evaluation Questionnaire; SD: standard deviation; SSS: suction suspension system; HIS: hypobaric Iceross Seal-In ® X5 *p = 0.003, **p = 0.036, ***p = 0.029. All participants completed the trial. The results of the PEQ are summarized in Table 2. Significant improvement can be observed in the “Appearance,” “Ambulation,” and “Well-being” domains, as reported by participants when utilizing the HIS compared to their answers when they were using SSS. Pistoning With no additional weight, the vertical mean displacement with SSS was 7.5 ± 4.7 mm; with HIS, it was 4.7 ± 3.1, 4.6 ± 2.9, and 3.6 ± 3.1 mm after 2, 5, and 7 weeks of HIS use, respectively. As can be seen in Figure 5, use of the HIS led to reduced pistoning, with a statistically significant difference between the first and the last assessment (p = 0.016), in which the mean difference between SSS and HIS displacement was 3.9 mm. When an additional 30 N weight was applied to the prosthesis prior to the PT, HIS use produced a significant improvement after only 2 weeks (p = 0.025); and after 5 and 7 weeks of HIS use, the statistical difference could still be observed, with p values of 0.010 and 0.006, respectively (Figure 4). The mean vertical displacement with SSS was 12.4 ± 5.6 mm; with HIS, it was 6.7 ± 4.1, 6.1 ± 3.1, and 5.6 ± 3.1 mm after 2, 5, and 7 weeks of HIS [mm] 14 12 10 8 6 4 2 SSS Pistoning Test p=.020 HIS 2wk p=.010 HIS 5wk p=.016 p=.006 HIS 7wk Figure 5. Prosthesis displacement with no weight on the prosthesis (continuous line) and with 30 N applied (dotted line). HIS: hypobaric Iceross Seal-In; SSS refers to evaluation with standard suction suspension system. HIS 2wk, HIS 5wk, and HIS 7wk refer to evaluations after 2, 5, and 7 weeks of hypobaric Iceross Seal-In ® X5 use, respectively. use, respectively. In this test, the difference between the displacements with SSS and after 7 weeks of HIS was 6.8 mm. In both pistoning conditions (i.e. no weight and 30 N applied), no statistical differences were found in the data at 2 versus 5 weeks, 2 versus 7 weeks, and 5 versus 7 weeks of HIS use. Downloaded from poi.sagepub.com at Fondazione Santa Lucia on May 22, 2013
6 Prosthetics and Orthotics International 0(0) ECW [ml/kg/m] 0,60 0,55 0,50 0,45 0,40 0,35 0,30 0,25 0,20 0,15 0,10 SSS HIS 2 wk HIS 5 wk HIS 7wk FWT TWT +12% TWT -5% TWT 0% Figure 6. ECW in the four evaluation sessions on floor and on treadmill at different slopes. ECW: energy cost of walking; FWT: floor walking test; TWT: treadmill walking test. SSS here refers to evaluation with standard suction suspension system. HIS 2 wk, HIS 5 wk, and HIS 7 wk: evaluations after 2, 5, and 7 weeks of hypobaric Iceross Seal-In ® X5 use, respectively. Table 3. TUGT, HSQ, and LCI results (mean ± SD). Evaluation methods SSS (N = 10) HIS (N = 10) TUGT Time (s) 7.94 ± 1.59 7.37 ± 1.33 HS Score 10.6 ± 1.8 11.1± 1.3* LCI Score 52 ± 11 54 ± 4 SD: standard deviation; TUGT: Timed Up&Go Test; HSQ: Houghton Scale Questionnaire; LCI: Locomotor Capability Index; SSS: suction suspension system; HIS: hypobaric Iceross Seal-In ® X5. SSS subjects used their own habitual SSS prosthesis, and HIS, subjects used the HIS for 7 weeks. *p = 0.005. ECW tests As shown in Figure 6, use of the HIS produced a reduction in ECW, which was more marked on the treadmill with the +12% slope. Improvement (mL/kg/m) in the evaluation with SSS and after 7 weeks of HIS use ranged from 0.20 ± 0.21 to 0.18 ± 0.03 (+10%) in FWT, from 0.35 ± 0.1 to 0.31 ± 0.04 (+11.5%) in TWT 0%, from 0.55 ± 0.1 to 0.44 ± 0.13 (+20%) in TWT +12%, and from 0.33 ± 0.11 to 0.28 ± 0.01 (+14.8%) in TWT −5%. Nevertheless, no statistical significance was observed between the two systems in the four conditions. Although walking speed showed a trend toward improvement, it did not reach statistical significance. When evaluated with the SSS, the mean FWT speed was 70.34 ± 11.11 m/min, and after 7 weeks of HIS use the mean speed was 74.21 ± 5.9 m/min, thus showing an increase of 5.5%. TUGT, HSQ, and LCI LCI and TUGT data show a trend toward improvement using the HIS (Table 3). Statistically significant improvement was observed in HSQ (Table 3). Discussion This study investigated two of the most used passive vacuum suspension systems: the HIS system and the SSS. To ensure suspension of the prosthesis, both systems have a one-way valve that creates a vacuum between the liner and the socket, but the HIS needs a seal that adheres to the liner, not a sleeve. Gholizadeh et al. 1 investigated the HIS and reported a 71% pistoning decrease with its use compared with a Dermo ® liner (shuttle lock system), but their study was limited to the PT. In this study, we used a wide range of evaluations (PEQ, PT, HSQ, ECW, TUGT, and LCI) to explore a wider range of prosthetic function. The PEQ data showed a statistically significant improvement in the “Appearance” domain, that is, the amputees thought the HIS prosthesis had a more pleasing appearance than the SSS prosthesis. Moreover, participants rated their abilities to ambulate higher when wearing the HIS (“Ambulation” domain). After 7 weeks of HIS use, participants also reported significant improvement in the “Well Being” domain. The PEQ improvements may also explain the significant improvement in the HSQ. In fact, the HSQ asks amputees whether they feel unstable when walking outside on slopes with the prosthesis and for how long and when they wear the prosthesis. In light of these results, we also expected a significant improvement in “Utility,” but, despite an improvement of 12.8% the p level of significance in this domain was 0.057. Perhaps subjects were influenced by difficulty in donning the Seal-In X5 because it takes some effort to reverse the liner and roll it over the residual limb. The importance of a proper suspension system to guarantee amputees’ comfort and prosthetic function has been widely indicated in the literature, and vertical displacement or pistoning within the socket has been suggested to be one of the main indicators of suspension system efficacy in lower-limb prostheses. 1,4,12,14,30 We found a 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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