Dataset Information

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

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.

SUBMITTER: Morgan SJ

PROVIDER: S-EPMC5802443 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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

Morgan Sara J SJ McDonald Cody L CL Halsne Elizabeth G EG Cheever Sarah M SM Salem Rana R Kramer Patricia A PA Hafner Brian J BJ

PloS one 20180207 2

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 th ...[more]

PMID: 29414988

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Project description:People with lower limb amputation present greater displacements of their centre of gravity in a static situation than able-bodied individuals, as they depend on visual information to a greater extent, which implies an altered stability pattern. The efficacy of different hardness of plantar support to help maintain stability has not yet been determined. The aim of the present study is to assess stability in people with unilateral transtibial amputation with prosthesis in a static situation with insoles of different degrees of hardness and visual conditions with respect to the able-bodied population. For this purpose, 25 patients with amputation and 25 able-bodied individuals were included in both groups, postural stability was assessed by stabilometry. This assessment was carried out under normal conditions (on the floor of the dynamometric platform with eyes open), and under altered conditions (with the interposition of different materials such as plantar support: rigid and soft insoles and, eyes shut). Three variables were considered to assess stability: length of movement of the barycenter (mm), lateral velocity (mm/sg) and anterior velocity (mm/sg). All of them were analysed with the patient in static on the dynamometric platform. The results showed statistically significant differences between the two groups, (amputees and controls) with less stability in the amputee group (p < 0.05) when analysing the variables of length of movement of the barycenter, lateral velocity and anterior velocity. Amputee patients with open eyes exhibited greater stability than those with closed eyes. The hard insoles improved the stability data in amputees (length of movement of the barycenter and anterior velocity) with respect to the barefoot condition, and the soft insoles showed less stability than the patients with hard insoles, or than the barefoot patients. From the results obtained in this study, we can conclude that the PP-DWST 4 mm rigid insoles improve static stability in people with amputation. However, soft insoles impair stability and are therefore discouraged.

Project description:BackgroundAchieving mobility with a prosthesis is a common post-amputation rehabilitation goal and primary outcome in prosthetic research studies. Patient-reported outcome measures (PROMs) available to measure prosthetic mobility have practical and psychometric limitations that inhibit their use in clinical care and research.ObjectiveTo develop a brief, clinically meaningful, and psychometrically robust PROM to measure prosthetic mobility.DesignA cross-sectional study was conducted to administer previously developed candidate items to a national sample of lower limb prosthesis users. Items were calibrated to an item response theory model and two fixed-length short forms were created. Instruments were assessed for readability, effective range of measurement, agreement with the full item bank, ceiling and floor effects, convergent validity, and known groups validity.SettingParticipants were recruited using flyers posted in hospitals and prosthetics clinics across the United States, magazine advertisements, notices posted to consumer websites, and direct mailings.ParticipantsAdult prosthesis users (N = 1091) with unilateral lower limb amputation due to traumatic or dysvascular causes.InterventionsNot applicable.Main outcome measuresCandidate items (N = 105) were administered along with the Patient Reported Outcome Measurement Information System Brief Profile, Prosthesis Evaluation Questionnaire - Mobility Subscale, and Activities-Specific Balance Confidence Scale, and questions created to characterize respondents.ResultsA bank of 44 calibrated self-report items, termed the Prosthetic Limb Users Survey of Mobility (PLUS-M), was produced. Clinical and statistical criteria were used to select items for 7- and 12-item short forms. PLUS-M instruments had an 8th grade reading level, measured with precision across a wide range of respondents, exhibited little-to-no ceiling or floor effects, correlated expectedly with scores from existing PROMs, and differentiated between groups of respondents expected to have different levels of mobility.ConclusionThe PLUS-M appears to be well suited to measuring prosthetic mobility in people with lower limb amputation. PLUS-M instruments are recommended for use in clinical and research settings.

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Dataset Information

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

Publications

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

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