Early motion and directed exercise (EMADE) versus usual care post ankle fracture fixation: study protocol for a pragmatic randomised controlled trial

Background: Following surgical fixation of ankle fractures, the traditional management has included immobilisation for 6 weeks in a below-knee cast. However, this can lead to disuse atrophy of the affected leg and joint stiffness. While early rehabilitation from 2 weeks post surgery is viewed as safe, controversy remains regarding its benefits. We will compare the effectiveness of early motion and directed exercise (EMADE) ankle rehabilitation, against usual care, i.e. 6 weeks’ immobilisation in a below-knee cast. Method/design: We have designed a pragmatic randomised controlled trial (p-RCT) to compare the EMADE intervention against usual care. We will recruit 144 independently living adult participants, absent of tissue-healing comorbidities, who have undergone surgical stabilisation of isolated Weber B ankle fractures. The EMADE intervention consists of a non-weight-bearing progressive home exercise programme, complemented with manual therapy and education. Usual care consists of immobilisation in a non-weight-bearing below-knee cast. The intervention period is between week 2 and week 6 post surgery. The primary outcome is the Olerud and Molander Ankle Score (OMAS) patient-reported outcome measure (PROM) at 12 weeks post surgery. Secondary PROMs include the EQ-5D-5 L questionnaire, return to work and return to driving, with objective outcomes including ankle range of motion. Analysis will be on an intention-to-treat basis. An economic evaluation will be included. Discussion: The EMADE intervention is a package of care designed to address the detrimental effects of disuse atrophy and joint stiffness. An advantage of the OMAS is the potential of meta-analysis with other designs. Within the economic evaluation, the cost-utility analysis, may be used by commissioners, while the use of patient-relevant outcomes, such as return to work and driving, will ensure that the study remains pertinent to patients and their families. As it is being conducted in the clinical environment, this p-RCT has high external validity. Accordingly, if significant clinical benefits and cost-effectiveness are demonstrated, EMADE should become a worthwhile treatment option. A larger-scale, multicentre trial may be required to influence national guidelines. Trial registration: ISRCTN, ID: ISRCTN11212729. Registered retrospectively on 20 March 2017

EXACT: EXercise or Advice after ankle fraCTure. Design of a randomised controlled trial

<p>Abstract</p> <p>Background</p> <p>Ankle fractures are common. Management of ankle fractures generally involves a period of immobilisation followed by rehabilitation to reduce pain, stiffness, weakness and swelling. The effects of a rehabilitation program are still unclear. However, it has been shown that important components of rehabilitation programs may not confer additional benefits over exercise alone. The primary aim of this trial is to determine the effectiveness and cost-effectiveness of an exercise-based rehabilitation program after ankle fracture, compared to advice alone.</p> <p>Methods/Design</p> <p>A pragmatic randomised trial will be conducted. Participants will be 342 adults with stiff, painful ankles after ankle fracture treated with immobilisation. They will be randomly allocated using a concealed randomisation procedure to either an <it>Advice </it>or <it>Rehabilitation </it>group. Participants in the <it>Advice </it>group will receive verbal and written advice about exercise at the time of removal of immobilisation. Participants in the <it>Rehabilitation </it>group will be provided with a 4-week rehabilitation program that is designed, monitored and progressed by a physiotherapist, in addition to verbal and written advice. Outcomes will be measured by a blinded assessor at 1, 3 and 6 months. The primary outcomes will be activity limitation and quality-adjusted life years.</p> <p>Discussion</p> <p>This pragmatic trial will determine if a rehabilitation program reduces activity limitation and improves quality of life, compared to advice alone, after immobilisation for ankle fracture.</p

Environmental dilemmas revisited: structural consequences from the angle of institutional ergonomics

The structure of a social dilemma lies behind many environmental problems. Mingling temporal aspects of resources with the structure of the social dilemma often leads to wrong conclusions. Therefore, it is worth analytically separating temporal aspects from structural aspects of the dilemma. This article concentrates solely on the structural aspects of the dilemma and the grades of complexity with respect to the number and stakes of the people involved, as well as the asymmetry of endowments and the salience of the optimal use of the resource in order to come close to the welfare optimum. Dilemmas with sufficient complexity are extremely vulnerable to individual defectors, and therefore institutions are necessary for the solution of the dilemma. Consequently, research in environmental psychology should not only target the individuals, but focus on institutional design with respect to (1) the structural diagnosis of environmental dilemmas; (2) methods that provide an insight into the structural problem of environmental dilemmas; (3) the impact of institutions on internalizing norms; and (4) the impact of structural knowledge about the dilemma of accepting institutions that help to solve the environmental dilemma. In analogy to software-ergonomics, psychology should initiate research in institutional ergonomics that helps to create addressee-friendly institutions

Playing strategically against nature? – Decisions viewed from a game-theoretic frame

Common research on decision-making investigates non-interdependent situations, i.e., “games against nature”. However, humans are social beings and many decisions are made in social settings, where they mutually influence each other, i.e., “strategic games”. Mathematical game theory gives a benchmark for rational decisions in such situations. The strategic character makes psychological decision-making more complex by introducing the outcomes for others as an additional attribute of that situation; it also broadens the field for potential coordination and cooperation problems. From an evolutionary point of view, behavior in strategic situations was at a competitive edge. This paper demonstrates that even in games against nature, people sometimes decide as if they were in a strategic game; it outlines theoretical and empirical consequences of such a shift of the frame. It examines whether some irrationalities of human decision-making might be explained by such a shift in grasping the situation. It concludes that the mixed strategies in games against nature demand a high expertise and can only be found in situations where these strategies improve the effects of minimax-strategies that are used in cases of risk-aversion