Laboratory- and community-based health outcomes in people with transtibial amputation using crossover and energy-storing prosthetic feet: A randomized crossover trial

Sara J Morgan, Cody L McDonald, Elizabeth G Halsne, Sarah M Cheever, Rana Salem, Patricia A Kramer, Brian J Hafner, Sara J Morgan, Cody L McDonald, Elizabeth G Halsne, Sarah M Cheever, Rana Salem, Patricia A Kramer, Brian J Hafner

Abstract

Contemporary prosthetic feet are generally optimized for either daily or high-level activities. Prosthesis users, therefore, often require multiple prostheses to participate in activities that span a range of mobility. Crossover feet (XF) are designed to increase the range of activities that can be performed with a single prosthesis. However, little evidence exists to guide clinical prescription of XF relative to traditional energy storing feet (ESF). The objective of this study was to assess the effects of XF and ESF on health outcomes in people with transtibial amputation. A randomized crossover study was conducted to assess changes in laboratory-based (endurance, perceived exertion, walking performance) and community-based (step activity and self-reported mobility, fatigue, balance confidence, activity restrictions, and satisfaction) outcomes. Twenty-seven participants were fit with XF and ESF prostheses with standardized sockets, interfaces, and suspensions. Participants were not blinded to the intervention, and wore each prosthesis for one month while their steps were counted with an activity monitor. After each accommodation period, participants returned for data collection. Endurance and perceived exertion were measured with the Six-Minute Walk Test and Borg-CR100, respectively. Walking performance was measured using an electronic walkway. Self-reported mobility, fatigue, balance confidence, activity restrictions, and satisfaction were measured with survey instruments. Participants also reported foot preferences upon conclusion of the study. Differences between feet were assessed with a crossover analysis. While using XF, users experienced improvements in most community-based outcomes, including mobility (p = .001), fatigue (p = .001), balance confidence (p = .005), activity restrictions (p = .002), and functional satisfaction (p < .001). Participants also exhibited longer sound side steps in XF compared to ESF (p < .001). Most participants (89%) reported an overall preference for XF; others (11%) reported no preference. Results indicate that XF may be a promising alternative to ESF for people with transtibial amputation who engage in a range of mobility activities.

Trial registration: ClinicalTrials.gov NCT02440711.

Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Fig 1. Prostheses with an ESF (left)…
Fig 1. Prostheses with an ESF (left) and an XF (right).
Fig 2. Activities along the mobility spectrum…
Fig 2. Activities along the mobility spectrum that ESF, RSF, and XF are estimated to span for most prosthetic limb users.
The black sections of the arrows indicate that the foot is well-designed for these activites, the faded sections indicate that the foot design can be used for these activities, however, performance may be suboptimal.
Fig 3. Overview of the randomized crossover…
Fig 3. Overview of the randomized crossover study design.
Fig 4. CONSORT participant flow diagram.
Fig 4. CONSORT participant flow diagram.

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