Self-aligning prosthetic device for older patients with vascular-related amputations: protocol for a randomised feasibility study (the STEPFORWARD study)

Introduction: The majority of older patients with a transtibial amputation are prescribed a standard (more rigid, not self-aligning) prosthesis. These are mostly suitable for level walking, and cannot adjust to different sloped surfaces. This makes walking more difficult and less energy efficient, possibly leading to longer term disuse. A Cochrane Review concluded that there was insufficient evidence to recommend any individual type of prosthetic ankle-foot mechanism. This trial will establish the feasibility of conducting a large-scale trial to assess the effectiveness and cost-effectiveness of a self-aligning prosthesis for older patients with vascular-related amputations and other health issues compared with a standard prosthesis. Methods and analysis: This feasibility trial is a pragmatic, parallel group, randomised controlled trial (RCT) comparing standard treatment with a more rigid prosthesis versus a self-aligning prosthesis. The target sample size is 90 patients, who are aged 50 years and over, and have a transtibial amputation, where amputation aetiology is mostly vascular-related or non-traumatic. Feasibility will be measured by consent and retention rates, a plausible future sample size over a 24-month recruitment period and completeness of outcome measures. Qualitative interviews will be carried out with trial participants to explore issues around study processes and acceptability of the intervention. Focus groups with staff at prosthetics centres will explore barriers to successful delivery of the trial. Findings from the qualitative work will be integrated with the feasibility trial outcomes in order to inform the design of a full-scale RCT. Ethics and dissemination: Ethical approval was granted by Yorkshire and the Humber—Leeds West Research Ethics Committee on 4 May 2018. The findings will be disseminated via peer-reviewed research publications, articles in relevant newsletters, presentations at relevant conferences and the patient advisory group

STEPFORWARD study: a randomised controlled feasibility trial of a self-aligning prosthetic ankle-foot for older patients with vascular-related amputations

Objectives To determine the feasibility of conducting a full-scale randomised controlled trial (RCT) of the effectiveness and cost-effectiveness of a self-aligning prosthetic ankle-foot compared with a standard prosthetic ankle-foot. Design Multicentre parallel group feasibility RCT. Setting Five prosthetics centres in England recruiting from July 2018 to August 2019. Participants Adults aged ≥50 years with a vascular-related or non-traumatic transtibial amputation for 1 year or longer, categorised as having 'limited community mobility' and using a non-self-aligning ankle-foot. Intervention Participants were randomised into one of two groups for 12 weeks: self-aligning prosthetic ankle-foot or existing non-self-aligning prosthetic ankle-foot. Outcomes Feasibility measures: recruitment, consent and retention rates; and completeness of questionnaire and clinical assessment datasets across multiple time points. Feasibility of collecting daily activity data with wearable technology and health resource use data with a bespoke questionnaire. Results Fifty-five participants were randomised (61% of the target 90 participants): n=27 self-aligning ankle-foot group, n=28 non-self-aligning ankle-foot group. Fifty-one participants were included in the final analysis (71% of the target number of participants). The consent rate and retention at final follow-up were 86% and 93%, respectively. The average recruitment rate was 1.25 participants/site/month (95% CI 0.39 to 2.1). Completeness of questionnaires ranged from 89%–94%, and clinical assessments were 92%–95%, including the activity monitor data. The average completion rates for the EQ-5D-5L and bespoke resource use questionnaire were 93% and 63%, respectively. Conclusions This feasibility trial recruited and retained participants who were categorised as having 'limited community mobility' following a transtibial amputation. The high retention rate of 93% indicated the trial was acceptable to participants and feasible to deliver as a full-scale RCT. The findings support a future, fully powered evaluation of the effectiveness and cost-effectiveness of a self-aligning prosthetic ankle-foot compared with a standard non-self-aligning version with some adjustments to the trial design and delivery

Unexpected features of branched flow through high-mobility two-dimensional electron gases

GaAs-based two-dimensional electron gases (2DEGs) show a wealth of remarkable electronic states, and serve as the basis for fast transistors, research on electrons in nanostructures, and prototypes of quantum-computing schemes. All these uses depend on the extremely low levels of disorder in GaAs 2DEGs, with low-temperature mean free paths ranging from microns to hundreds of microns. Here we study how disorder affects the spatial structure of electron transport by imaging electron flow in three different GaAs/AlGaAs 2DEGs, whose mobilities range over an order of magnitude. As expected, electrons flow along narrow branches that we find remain straight over a distance roughly proportional to the mean free path. We also observe two unanticipated phenomena in high-mobility samples. In our highest-mobility sample we observe an almost complete absence of sharp impurity or defect scattering, indicated by the complete suppression of quantum coherent interference fringes. Also, branched flow through the chaotic potential of a high-mobility sample remains stable to significant changes to the initial conditions of injected electrons.Comment: 22 pages, 4 figures, 1 tabl

The double-mode nature of the HADS star GSC 00144-03031 and the Petersen diagram of the class

The double--mode pulsation of GSC 00144-03031 has been detected when searching for COROT targets. A very large dataset composed of 4722 photometric measurements was collected at six observatories in Europe and America. There is no hint of the excitation of additional modes (down to 0.6 mmag) and therefore GSC 00144-03031 seems to be a pure double--mode pulsator, with a very short fundamental radial mode (P=84 min). From Stromgren photometry and evolutionary tracks it appears to be a Pop. I star with M=1.75 solar masses, located in the middle of the instability strip, close to the Zero--Age Main Sequence. We also discovered other new double--mode pulsators in the databases of large--scale projects: OGLE BW2_V142, OGLE BW1_V207, ASAS3 094303-1707.3, ASAS3 000116-6037.0, NSVS 3234596 and NSVS 3324715. An observational Petersen diagram is presented and explained by means of new models. A common sequence connecting Pop. I stars from the shortest to the longest periods is proposed and the spreads in the period ratios are ascribed to different metallicities (at the shortest periods) and to different masses (at the longest ones). The paper is based on data collected at S. Pedro Martir and Sierra Nevada Observatories and on the contributions from several amateur astronomers.Comment: 9 pages, 5 pages, accepted for publication in Astronomy and Astrophysic

The care unit in nursing home research: Evidence in support of a definition

Abstract Background Defining what constitutes a resident care unit in nursing home research is both a conceptual and practical challenge. The aim of this paper is to provide evidence in support of a definition of care unit in nursing homes by demonstrating: (1) its feasibility for use in data collection, (2) the acceptability of aggregating individual responses to the unit level, and (3) the benefit of including unit level data in explanatory models. Methods An observational study design was used. Research (project) managers, healthcare aides, care managers, nursing home administrators and directors of care from thirty-six nursing homes in the Canadian prairie provinces of Alberta, Saskatchewan and Manitoba provided data for the study. A definition of care unit was developed and applied in data collection and analyses. A debriefing session was held with research managers to investigate their experiences with using the care unit definition. In addition, survey responses from 1258 healthcare aides in 25 of the 36 nursing homes in the study, that had more than one care unit, were analyzed using a multi-level modeling approach. Trained field workers administered the Alberta Context Tool (ACT), a 58-item self-report survey reflecting 10 organizational context concepts, to healthcare aides using computer assisted personal interviews. To assess the appropriateness of obtaining unit level scores, we assessed aggregation statistics (ICC(1), ICC(2), η2, and ω2), and to assess the value of using the definition of unit in explanatory models, we performed multi-level modeling. Results In 10 of the 36 nursing homes, the care unit definition developed was used to align the survey data (for analytic purposes) to specific care units as designated by our definition, from that reported by the facility administrator. The aggregation statistics supported aggregating the healthcare aide responses on the ACT to the realigned unit level. Findings from the multi-level modeling further supported unit level aggregation. A significantly higher percentage of variance was explained in the ACT concepts at the unit level compared to the individual and/or nursing home levels. Conclusions The statistical results support the use of our definition of care unit in nursing home research in the Canadian prairie provinces. Beyond research convenience however, the results also support the resident unit as an important Clinical Microsystem to which future interventions designed to improve resident quality of care and staff (healthcare aide) worklife should be targeted

Internet of Things for Sustainable Human Health

The sustainable health IoT has the strong potential to bring tremendous improvements in human health and well-being through sensing, and monitoring of health impacts across the whole spectrum of climate change. The sustainable health IoT enables development of a systems approach in the area of human health and ecosystem. It allows integration of broader health sub-areas in a bigger archetype for improving sustainability in health in the realm of social, economic, and environmental sectors. This integration provides a powerful health IoT framework for sustainable health and community goals in the wake of changing climate. In this chapter, a detailed description of climate-related health impacts on human health is provided. The sensing, communications, and monitoring technologies are discussed. The impact of key environmental and human health factors on the development of new IoT technologies also analyzed