PROTOCOL: STUDY 1 (LABORATORY ASSESSMENT OF THE VACUUM-ASSISTED SOCKET SUSPENSION GROUP)
Study 1 consisted of three tasks presented in the following order: 1) measuring kinematics of gait, 2) measuring functional mobility outcomes, 3) measuring the cost of transport at SSS. Participants wore their current socket during all tasks. Three different suspension conditions were considered: 1) VASS; 2) suction—the prosthetists inactivated the vacuum of the VASS system and a one-way valve prevented air from entering the socket; and 3) sleeve—the prosthetists inactivated the vacuum of the VASS system and blocked the one-way valve. We randomized the order of suspension within a task. Although we did not provide a specific accommodation period after each alteration in suspension, the ordering of tasks allowed acclimation to each suspension (task 1) before collection of the primary outcome data (tasks 2 and 3). Participants completed all suspension conditions within a given task before moving to the next task. All tasks in study 1 were completed during a single testing session lasting 2.5 to 3 hours.
TASK 1: QUANTIFYING GAIT ASYMMETRY
Subjects traversed an 8-m walkway approximately 10 times while an eight-camera motion capture system (Motion Analysis, Satan Rosa, CA, USA) tracked 22 passive reflective markers placed on bony landmarks of the upper and lower limbs.19 Custom software was used to calculate SL, ST, and step time from the motion of these markers. The latter was included based on the established association between step time asymmetry and metabolic costs of walking.20 Step length was calculated as the distance in the sagittal plane between the centroids of the two feet at successive midstances, defined as the point in time at which the ankle marker of the swing limb passed that of the stance. Prosthetic (or sound) side SL was defined for steps taken with the respective limb. We defined ST as the time from heel-strike to ipsilateral toe-off and step time as the time from heel-strike to contralateral heel-strike. We calculated symmetry indices (SIs) for all variables based on the formula from Herzog21: 100 × [(prosthetic − sound)/½(prosthetic + sound)]. A smaller SI implies less asymmetry.
TASK 2: TIMED UP AND GO AND 10-M WALK TESTING
The TUG and timed walking tests such as 10MWT are valid and reliable measures of mobility, recommended as “gold standard measures” for persons with amputation.22,23 For 10MWT, the participant walked a 10-m path as fast as possible and repeated the task three times. A stopwatch recorded the time taken to walk the middle 6 m of the path. We calculated the average completion time for all trials, from which we determined maximum walking speed.
After the 10MWT, subjects completed TUG. For TUG, subjects rose from an armchair of standard height, walked 3 m, turned, and returned to the chair. A certified prosthetist used a stopwatch to measure time from a “go” cue to when the participant's buttocks touched the seat.
TASK 3: QUANTIFYING COST OF TRANSPORT AND COMFORT AT SSS
Participants walked for 6 minutes around a carpeted indoor track (1 lap = 90.58 m) with their prosthetic limb on the inside of the track. Before and throughout the walk, the rate of oxygen (O2) consumption (in mL O2/min) was measured on a breath-by-breath basis using a portable device (K4 b2; Cosmed, Rome, Italy). During the trial, an investigator walked slightly behind the subject while wheeling a distance wheel. After the 6 minutes of walking, subjects self-reported socket fit comfort score (SFCS). The SFCS is a validated assessment of comfort that asks, “If 10 represents the most comfortable socket fit you can imagine and 0 represents the most uncomfortable socket fit you can imagine, rate the comfort of your socket fit at this moment.”24 Before repeating the task with a different suspension, subjects rested until the rate of oxygen consumption was similar to that before the trial. Here, we report data only from those subjects who performed the task at an SSS; some subjects were asked to perform certain conditions at intentionally fast speeds that were greater than SSS (see Figure 1).
We calculated SSS offline based on the distance walked over the entire 6-minute trial. To process the raw oxygen consumption data, we calculated a five-breath running average using custom software (Matlab; Mathworks, Cambridge, MA, USA). To calculate the cost of transport, we normalized the mean rate of O2 consumption over the final 2 minutes of walking by the product of the mass (kg) and the mean speed during that period. The units of cost of transport are (mL O2/kg*m).
PROTOCOL: STUDY 2 (QUESTIONNAIRES)
Both VASS and non-VASS subjects were sent an email with a link to an online version of the ABC scale managed using Research Electronic Data Capture (REDCap) tools hosted at the University of Illinois at Chicago. REDCap is a secure Web-based application designed to support data capture for research studies.25 Participants first completed the ABC scale. The ABC scale is a 16-item survey that asks participants to rate how confident (0% to 100%) they feel in their ability to complete a variety of tasks without losing balance. Total score represents the average of all items. Upon submitting the ABC scale, subjects were sent links to three additional surveys: the LCI5, the Houghton Scale, and selected portions of the PEQ.
The LCI5 measures basic and advanced functional locomotor capabilities using 14 questions with five ordinal responses to reduce ceiling effects; higher scores indicate higher function (maximum score of 56).17,18 The survey includes sections that addresses basic locomotor functions (e.g., walking indoors) and one that addresses advanced functions (e.g., walking outdoors on sloped sidewalks).
The Houghton Scale measures function in terms of prosthetic wear and use and consists of four questions each scored 0 to 3, with a maximum score of 12 indicating high levels of prosthetic use and wear and is recommended for clinical use.16
The PEQ is organized into 10 different domain scales that are valid and reliable measures regarding prosthesis-related quality of life.26 Each scale is scored from 0 to 100. The score is the average of individual questions within a domain. In the original version, participants place a mark on a line with two anchor points and the distance from one end is measured and scaled from 0 to 100. In the current study, responses were provided by sliding a bar along a line with the corresponding value being displayed. We assessed the following PEQ domains: well-being, frustration, social burden, and perceived response.
Before testing the hypotheses, for each outcome variable in study 1, we ran three separate independent-samples t tests, one for each suspension condition, to determine if there was an effect of level of amputation. We observed no significant effects for any comparison and therefore excluded level of amputation as a covariate in the ensuing analysis. Lastly, for each outcome variable in study 2, we collapsed the data across groups and tested for an effect of unilaterality versus bilaterality. We observed an effect for ABC score, overall LCI5, and the advanced function section of the LCI5. To test for an effect of group on these variables, we ran a one-way analysis of variance (ANOVA) with unilaterality versus bilaterality as a covariate. For all other variables, to test for an effect of group, we used independent t tests.
To test H1, that in current users of VASS, a loss of vacuum would increase the energetic costs of gait, we ran a linear mixed model with subjects as a random variable, suspension type as a repeated, fixed factor, and cost of transport at SSS as the dependent variable. We used a mixed model, rather than an ANOVA, as it is able to account for missing data (Figure 1). In the event of a significant effect of suspension, post hoc tests were run using LSD corrections. A similar analysis was performed to test H2, that in current users of VASS a loss of vacuum would worsen performance-based outcomes measures related to function and mobility, with separate models for TUG, 10MWT, and SSS. To test H3, that in current users of VASS, a loss of vacuum would reduce SFCS, we ran a mixed model with SFCS as the dependent variable. Finally, to test H4, that long-term use of VASS would improve self-reported outcomes measures, we ran either independent-sample t tests or ANOVAs, as described above.
In an attempt to validate the work of Ferraro (2011), we used independent-samples t test to test for an effect of group on ABC scores. In an attempt to validate lower ST and SL symmetry with VASS and explore the effect of VASS on step time asymmetry, we used mixed models to test for an effect of suspension condition on each SI. We used IBM SPSS (IBM, Armonk, NY, USA) for all analyses with significance set at p ≤ 0.05.
There was no effect of loss of vacuum on cost of transport (p = 0.47). Table 2 summarizes values for the individual conditions. However, VASS did allow subjects to perform certain locomotor tasks more quickly. In particular, subjects completed the TUG almost 1 second faster with VASS compared with sleeve (p = 0.02 VASS vs. sleeve), although TUG was also performed more quickly with suction compared with sleeve (p = 0.049 suction vs. sleeve). There was no difference in TUG between VASS and suction (p = 0.541).
The maximum walking speed attained with VASS during the 10MWT was 0.07 m/s faster than that with suction and over 0.10 m/s faster than that with sleeve (p = 0.027 VASS vs. suction; p = 0.011 VASS vs. sleeve). Maximum walking speed was not different between suction and sleeve (p = 0.17 suction vs. sleeve). There was no effect of suspension on SSS (p = 0.40). There was no effect of suspension on SI for SL (p = 0.35), step time (p = 0.93), or ST (p = 0.07).
The use of VASS resulted in an average within-subject increase of 1.5 and 3 points on SFCS compared to suction and sleeve, respectively (p = 0.001 VASS vs. suction and VASS vs. sleeve; p = 0.014 suction vs. sleeve; Table 2).
There was no effect of group on any self-reported measures including ABC scores (p = 0.73; Table 3). Table 3 summarizes group average values and corresponding p values for overall F test for all self-reported outcome measures.
The purpose of this study was to quantify the extent to which VASS improved energetic costs of gait, performance-based outcomes measures, and self-reported outcome measures related to functional mobility and well-being. The first hypothesis, that in current users of VASS, a loss of vacuum would increase the cost of transport at a SSS, was not supported. The second hypothesis, that in current users of VASS, a loss of vacuum would worsen performance-based outcomes measures related to function and mobility, was partly supported. When participants used VASS, they obtained faster maximum walking speeds relative to the two other conditions and performed TUG more quickly, although only relative to sleeve condition. However, SSS was unaffected by acute changes in suspension. The third hypothesis, that in current users of VASS, a loss of vacuum would reduce socket comfort, was supported. The fourth hypothesis, that long-term use of VASS would improve self-reported outcomes measures related to prosthetic wear and use, locomotor capabilities, and well-being, was not supported; there were no significant differences in Houghton scale, LCI5, or well-being domain of the PEQ in current users of VASS versus non-VASS users.
The fact that VASS did not affect the cost of transport, although contrary to our expectations, seems to be consistent with the absence of improved symmetry. Previous studies have demonstrated that energetics of gait increase with asymmetry. For example, when healthy young subjects received visual feedback to induce asymmetries in stride time, a 23% increase in SI resulted in a 17% increase in metabolic power.20 Mattes et al.27 demonstrated a similar association between asymmetry and energetic costs in persons with amputation, although in that study, asymmetry was induced by altering inertial properties of the prosthesis, which may differently affect energetics than manipulating SI with visual feedback. Although there is agreement between cost of transport and symmetry measures, given the work of Board et al.,3 it is somewhat surprising that VASS did not reduce asymmetries in SL or ST. An important difference between that study and our study is that Board et al. observed an immediate effect of VASS after providing vacuum to nonvacuum users, which is the reverse process studied here. Moreover, even if their results were replicated, it is unclear if this would have an effect on cost of transport as Board et al. observed only a 1% to 2% change in SI.
The systematic across-condition increase in maximum walking speed observed with VASS seems to be clinically meaningful. For example, a study evaluating the minimum clinically important difference (MCID) in the 10MWT speed, at least for older adults performing the test at a preferred walking speed, concluded that changes of 0.05 and 0.1 m/s represent small and substantially meaningful differences, respectively.28 The speed differences between VASS and suction and between VASS and sleeve are within this range. To our knowledge, similar MCID for the 10MWT for prosthetic users is absent from the literature.
Although we did not quantify stability during 10MWT or SSS, walking at speeds above SSS has been shown to produce less stable locomotor patterns (as measured by variables derived from dynamic system theory).29,30 Nonetheless, VASS allows users to attain faster maximum walking speeds, perhaps because it reduces instability at these speeds. Although we would expect any stabilizing effects of VASS to generalize across speeds and activities, and to contribute to the increased balance confidence reported by Ferraro, for our higher-functioning participants, the impact on outcome measures may be task specific. To observe an effect on outcomes, it may be necessary to present these individuals with a challenge to stability that exceeds that provided either by walking at SSS or by performing basic activities of daily living. The nonsystematic effects of VASS on TUG times are consistent with this notion. Only a small fraction of the TUG involves the dynamically challenging tasks of turning or gait initiation/termination; much of the total TUG time involves sit-to-stand and stand-to-sit transfers and walking at or near SSS. This is, in part, the rationale for using the L Test of Functional Mobility (L Test) to assess functional mobility in high-function individuals. Like TUG, the L Test includes transferring and turning but has participants walking longer distances and performing more turns including at least one on the each side.31
To our knowledge, this is the first study to explicitly report immediate reductions in socket comfort after removal of vacuum. To some extent, this acute effect may also manifest as long-term improvements in comfort after prescription of VASS, which could be one reason why the case subject in the study by Sutton et al.7 reported walking and wearing his prosthesis more after receiving VASS. Accordingly, it is somewhat surprising that in study 2, we observed no differences in any self-reported outcomes between current VASS and non-VASS users. However, the Houghton Scale,16,17 which was used to measure prosthetic use in our study, may have ceiling effects16,17 and may not be sensitive enough to detect small differences in physical activity between high-functioning VASS and non-VASS groups. For example, the scale includes questions such as “When going outside wearing your prosthesis do you use: a wheelchair, two crutches/cane/walker, one cane, nothing?” Physical activity monitoring may provide a more sensitive means to quantify the effects of VASS on prosthetic use in these individuals. A recent crossover study of current users of pin suspension used activity monitors to compare step count between pin and VASS suspension and, surprisingly, reported that participants took nearly twice as many steps with pin suspension.32 However, that study was limited to five participants because of a large number of dropouts after fitting with VASS. In contrast, the study of Ferraro demonstrated a trend toward more activity with VASS as indicated by six of nine subjects reporting an “increase [in] walking time with vacuum (in comparison with pin).” Further work is needed to evaluate the effects of suspension, particularly VASS, on physical activity.
Ceiling effects are also likely to explain, in part, the absence of an effect of VASS on locomotor capabilities as assessed in this study. Referring again to the case study of Sutton, the participant in that study demonstrated immediate improvements in LCI5, achieving a perfect score after only 1 week of VASS. Thus, LCI5 was unable to show further improvements. Despite the fact that LCI5 includes five (rather than four) response choices to avoid earlier observed ceiling effects,17,18 the additional level may be best suited to differentiate persons who do and do not require an aid to independently perform locomotor tasks,18 and the survey is likely to show ceiling effects for higher-functioning subjects. In the current study, 56% of control subjects and 47% of VASS subjects reported perfect scores on the scale. Similarly, the previously reported ceiling effects of the ABC scale33 may explain differences in the current study and that of Ferraro.
In addition to ceiling effects, the study design may have affected our ability to detect between-group differences in self-reported outcome measures. For example, whereas the study of Ferraro used a crossover design to compare individual increases in ABC scores with changes in suspension, the current study compared ABC scores between groups of prosthetic users. Given that the VASS and non-VASS groups were not matched for factors such as level of amputation or time since amputation (see Table 1), the between-group comparison used herein may be inadequate to detect an effect of suspension in absence of a large sample size to account for individual differences. In summary, despite a logical a priori rationale for the choice of surveys used herein, a posteriori knowledge suggests that these surveys are not well suited for identifying difference in high-functioning populations and, in absence of large sample sizes, may be better suited for within-subject comparison.
There are several limitations of the current study. First, only pen-and-paper versions of the surveys from study 2 have been validated (see review by Condie et al.23). Although there is increasing evidence that digital versions of self-reported scales may provide valid assessments of outcome measures,34,35 their use for the measures included herein has yet to be determined. Second, by evaluating current VASS users, it was not possible to blind the participant to alterations in suspension in the laboratory; participants could easily perceive when vacuum was removed.
A third limitation of the study is the lack of accommodation period after altering suspension; the effects of VASS may not have been washed out during the other conditions. Randomization of suspension conditions may have partially countered these effects; for example, within a given task, only one condition was performed directly after removing VASS. In addition, primary outcomes (task 2 and 3) were performed only after participants gained familiarity with all conditions in task 1. Whereas the lack of accommodation may limit our ability to draw conclusions about the effects of suspension on functional mobility, it does provide unique information about an individuals' ability to immediately cope with loss of active vacuum. Many times, patients may have a problem with their vacuum system (leaks or malfunctioning pump), which to some extent was simulated here, but they can manage for several days before visiting a prosthetist. The fact that most subjects completed the protocol with altered suspension corroborates that many patients may be able to perform daily tasks (e.g., walking at SSS or short burst of fast walking) without a properly functioning prosthesis but with potentially compromised comfort. However, there appear to be individuals who rely heavily on the benefits of VASS and may be limited in their ability to perform daily activities in absence of a fully functional vacuum system, for example, subjects who did not complete tasks 2 or 3 because of pain (Figure 1). One possibility, albeit speculative, is that these individuals have residua that are highly sensitive to discomforting (painful) stimuli; one of the two subjects unable to complete the protocol suffered a mangled limb during the trauma that led to her amputation. It would be informative to identify common characteristics in persons incapable of performing activities without VASS to better identify ideal candidates for VASS.
Although accommodation may be important, to our knowledge, no study indicates the amount of time needed to ensure accommodation to VASS. In a previous study of non-VASS users, 30 minutes of continuous walking was sufficient to observe an effect of VASS on limb volume.3,32 Thus, a relatively short accommodation period that allows for changes in limb volume may be sufficient to assess the immediate effects of suspension alteration. In the current study, the fact that VASS did not improve symmetry, SSS, or cost of transport may reflect the fact that sufficient time was not provided during testing to allow for substantial volume loss. However, as participants were current VASS users, it could be contraindicative to provide a long accommodation period or long walking period with other suspension conditions.
A final limitation of this study was that the non-VASS suspension conditions were tested with components and socket design specific for VASS. Although this allows us to consider only the effects of suspension on outcome variables, it creates conditions that are not directly translatable to the clinical setting. For example, the weight of the vacuum was not removed during non-VASS conditions and the added mass could alter kinematics and economy of gait. Indeed, Mattes et al.27 reported an effect of added mass on gait symmetry and even energetic costs of gait. However, vacuum pumps (and batteries) currently available on the market range in total mass from ~130 to 600 g (based on manufacturers' information available online). These values are on the very low end of the mass perturbations in the study of Mattes. Thus, any effects of added mass would likely be small relative to effects reported in their study. An earlier review by Selles et al.36 also points to limited effects of adding up to 0.6 kg of mass on gait economy, stride length or SSS. Regarding the socket, during the sleeve condition, participants wore a total surface-bearing socket, designed for VASS, which may have provided more stability and comfort than afforded by a true sleeve suspension and weakened the observed effects of VASS.
In absence of active vacuum, current users of VASS experience an immediate reduction in comfort, presumably reflecting worse fit, and this may limit their ability to attain faster walking speeds. There is no immediate negative effect of loss of vacuum on the cost of transport or any clear difference in self-reported measures with and without VASS. Therefore, acute loss of vacuum may not negatively impact patients' ability to perform daily tasks before visiting their prosthetist. At the same time, providing VASS could benefit prosthetic users who feel limited by the ability to achieve faster speeds, although a specific study is warranted to test this idea. The self-reported measures used to quantify the effects of suspension on prosthetic use, locomotor capabilities, and domains reflecting prosthesis-related quality of life may not be well suited for identifying difference in the high-functioning, heterogeneous population considered in the current study.
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Keywords:© 2017 by the American Academy of Orthotists and Prosthetists.
prosthetic outcomes; metabolic; gait; biomechanics; elevated vacuum; walking speed