Creación de un ensayo clínico: algunas sugerencias metodológicas.

Well-designed clinical trials are the gold standard for evidence-based research and for the assessment of the effectiveness of a clinical intervention. Methodological guidelines are available from various sources, such as textbook, funding applications and institutional guidelines. Nevertheless, a high number of published trials still lack methodological rigor, decreasing their utility, quality and scientific validity. In this article, we aim at providing some methodological recommendations for the development and report of a clinical trial, including the definition and recruitment of the sample, the basic study designs, randomization, blindness, data analysis and data report. Finally, we will discuss some of the most important ethical issues. Los ensayos clínicos bien diseñados son el estándar por excelencia para la investigación basada en la evidencia y para la evaluación de la eficacia de una intervención clínica. Las directrices metodológicas se encuentran disponibles en varias fuentes, tales como libros de texto, solicitudes de financiamiento y directrices institucionales. Sin embargo, un gran número de ensayos publicados todavía carecen de rigor metodológico, disminuyendo su utilidad, calidad y validez científica. En este artículo, nuestro objetivo es proporcionar algunas recomendaciones metodológicas para el desarrollo e informe de un ensayo clínico, incluyendo la definición y selección de la muestra, los diseños básicos de estudio, la aleatorización, el cegamiento, el análisis y el reporte de datos. Finalmente, discutiremos algunas de las consideraciones éticas más importantes

Egocentric and allocentric spatial reference frames in aging: A systematic review

Abstract Aging affects many aspects of everyday living, such as autonomy, security and quality of life. Among all, spatial memory and spatial navigation show a gradual but noticeable decline, as a result of both neurobiological changes and the general slowing down of cognitive functioning. We conducted a systematic review using the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines to identify studies that specifically investigated the role of allocentric and egocentric frames in healthy aging. Concerning spatial navigation, our results showed a preservation of egocentric strategies, along with specific impairments in the use of allocentric and switching abilities. Regarding spatial memory, instead, outcomes were more divergent and not frame-specific. With this perspective, spatial impairments were discussed considering the cognitive profile of mild cognitive impairment (MCI) and Alzheimer's Disease (AD)

Gulliver’s virtual travels: active embodiment in extreme body sizes for modulating our body representations

It is noted that the perceptual experience of body and space can be modulated by changing the action capabilities or by manipulating the perceived body dimensions through a multisensory stimulation. This study adds to pre-existing literature by investigating the alterations in bodily experience following embodiment to both enlarged and shrunked bodies, while participants actively navigated in a virtual environment. A normal-sized body served as a reference condition. After each embodied navigation, participants estimated the height and width of three different body parts. Results revealed that the embodiment over shrunked body induced a significant reduction in participants’ body image, while no changes were reported after the embodiment over the enlarged body. Findings were discussed in terms of previous literature exploring the constraints implicated in the ownership over different bodies

Building Embodied Spaces for Spatial Memory Neurorehabilitation with Virtual Reality in Normal and Pathological Aging

Along with deficits in spatial cognition, a decline in body-related information is observed in aging and is thought to contribute to impairments in navigation, memory, and space perception. According to the embodied cognition theories, bodily and environmental information play a crucial role in defining cognitive representations. Thanks to the possibility to involve body-related information, manipulate environmental stimuli, and add multisensory cues, virtual reality is one of the best candidates for spatial memory rehabilitation in aging for its embodied potential. However, current virtual neurorehabilitation solutions for aging and neurodegenerative diseases are in their infancy. Here, we discuss three concepts that could be used to improve embodied representations of the space with virtual reality. The virtual bodily representation is the combination of idiothetic information involved during virtual navigation thanks to input/output devices; the spatial affordances are environmental or symbolic elements used by the individual to act in the virtual environment; finally, the virtual enactment effect is the enhancement on spatial memory provided by actively (cognitively and/or bodily) interacting with the virtual space and its elements. Theoretical and empirical findings will be presented to propose innovative rehabilitative solutions in aging for spatial memory and navigation

“Positive Bike” – An immersive biking experience for combined physical and cognitive training of elderly patients

Previous evidence shows that combined cognitive and physical exercises (dual-task intervention, (I-DT)) potentiates cognitive performance more than either type of single training alone (Lauenroth et al., 2015). Here, we describe the rationale, the design and the implementation of the “Positive Bike”, a fully-immersive virtual reality biking experience for implementing I-DT training protocols in older patients. The system consists of a cycle-ergometer positioned within a Cave Automatic Virtual Environment (CAVE). The system also features a cloud-based platform which allows the therapist to configure the exercise parameters (i.e, duration and load). Using the Positive Bike, the patient can take a virtual ride by physically pedalling at variable paces within a simulated scenario (i.e., a park). During the virtual ride, the patient can be presented with different interactive cognitive exercises (attentional, memory etc). In one of such exercises, for example, the patient has to recognize different animals appearing on the route sides and press a button if such animal has a name beginning with a specific letter. Potential applications of Positive Bike in geriatric wellness and rehabilitation are discussed

Assessment of Unilateral Spatial Neglect Using a Free Mobile Application for Italian Clinicians

Background: Unilateral Spatial Neglect (USN) is traditionally assessed with paper-and-pencil tests or computer-based tests. Thanks to the wide-spreading of mobile devices, and the extensive capabilities that they have in dealing complex elements, it is possible to provide clinicians with tools for cognitive assessment. Contemporary 3D engine is, in general generally, able to deploy complex 3D environments for iOS, Android and Windows mobile, i.e., most of the mobile phone and tablet operative systems.Results: This brand-new scenario and pressing requests from professionals, pushed us to build an application for the assessment of USN. Our first attempt was to replicate the classic cognitive tests, traditionally used at this purpose. Ecological assessment is difficult in real scenarios so we implemented virtual environments to assess patients’ abilities in realistic situations. At the moment, the application is available only for iPad and iPhone for free, from the Apple Store, under the name of “Neglect App.” The App contains traditional tests (e.g., barrage with and without distractors) and ecological tests (e.g., to distribute the tea in a table to close people). Scoring of each test is available to the clinicians through a database with the executed ecological tasks, that are stored locally.Conclusion: In conclusion, Neglect App is an advanced mobile platform for the assessment of Neglect

Cerebellar Transcranial Direct Current Stimulation (tDCS), Leaves Virtual Navigation Performance Unchanged

Spatial cognition is an umbrella term used to refer to the complex set of abilities necessary to encode, categorize, and use spatial information from the surrounding environment to move effectively and orient within it. Experimental studies indicate that the cerebellum belongs to the neural network involved in spatial cognition, although its exact role in this function remains unclear. Our aim was to investigate in a pilot study using a virtual reality navigation task in healthy subjects whether cerebellar transcranial direct current stimulation (tDCS), a non-invasive technique, influences spatial navigation. Forty healthy volunteers (24 women; age range = 20–42 years; years of education range 13–18) were recruited. The virtual reality spatial navigation task comprised two phases: encoding, in which participants actively navigated the environment and learned the spatial locations for one object, and retrieval, in which they retrieved the position of the object they had discovered and memorized in the previous encoding phase, starting from another starting point. Participants received tDCS stimulation (anodal or sham according to the experimental condition they were assigned to) for 20 min before beginning the retrieval phase. Our results showed that cerebellar tDCS left the accuracy of the three indexes used to measure effective navigational abilities unchanged. Hence, cerebellar tDCS had no influence on the retrieval phase for the spatial maps stored. Further studies, enrolling a larger sample and testing a different stimulation protocol, may give a greater insight into the role of the cerebellum in spatial navigation

COVID Feel Good-An Easy Self-Help Virtual Reality Protocol to Overcome the Psychological Burden of Coronavirus

Background: Living in the time of the COVID-19 means experiencing not only a global health emergency but also extreme psychological stress with potential emotional side effects such as sadness, grief, irritability, and mood swings. Crucially, lockdown and confinement measures isolate people who become the first and the only ones in charge of their own mental health: people are left alone facing a novel and potentially lethal situation, and, at the same time, they need to develop adaptive strategies to face it, at home. In this view, easy-to-use, inexpensive, and scientifically validated self-help solutions aiming to reduce the psychological burden of coronavirus are extremely necessary. Aims: This pragmatic trial aims to provide the evidence that a weekly self-help virtual reality (VR) protocol can help overcome the psychological burden of the Coronavirus by relieving anxiety, improving well-being, and reinforcing social connectedness. The protocol will be based on the 'Secret Garden' 360 VR video online (www.covidfeelgood.com) which simulates a natural environment aiming to promote relaxation and self-reflection. Three hundred sixty-degree or spherical videos allow the user to control the viewing direction. In this way, the user can explore the content from any angle like a panorama and experience presence and immersion. The 'Secret Garden' video is combined with daily exercises that are designed to be experienced with another person (not necessarily physically together), to facilitate a process of critical examination and eventual revision of core assumptions and beliefs related to personal identity, relationships, and goals. Methods: This is a multicentric, pragmatic pilot randomized controlled trial involving individuals who experienced the COVID-19 pandemic and underwent a lockdown and quarantine procedures. The trial is approved by the Ethics Committee of the Istituto Auxologico Italiano. Each research group in all the countries joining the pragmatic trial, aims at enrolling at least 30 individuals in the experimental group experiencing the self-help protocol, and 30 in the control group, over a period of 3 months to verify the feasibility of the intervention. Conclusion: The goal of this protocol is for VR to become the 'surgical mask' of mental health treatment. Although surgical masks do not provide the wearer with a reliable level of protection against the coronavirus compared with FFP2 or FFP3 masks, surgical masks are very effective in protecting others from the wearer's respiratory emissions. The goal of the VR protocol is the same: not necessarily to solve complex mental health problems but rather to improve well-being and preserve social connectedness through the beneficial social effects generated by positive emotions

A Computational Approach for the Assessment of Executive Functions in Patients with Obsessive–Compulsive Disorder

Previous studies on obsessive–compulsive disorder (OCD) showed impairments in executive domains, particularly in cognitive inhibition. In this perspective, the use of virtual reality showed huge potential in the assessment of executive functions; however, unfortunately, to date, no study on the assessment of these patients took advantage of the use of virtual environments. One of the main problems faced within assessment protocols is the use of a limited number of variables and tools when tailoring a personalized program. The main aim of this study was to provide a heuristic decision tree for the future development of tailored assessment protocols. To this purpose, we conducted a study that involved 58 participants (29 OCD patients and 29 controls) to collect both classic neuropsychological data and precise data based on a validated protocol in virtual reality for the assessment of executive functions, namely, the VMET (virtual multiple errands test). In order to provide clear indications for working on executive functions with these patients, we carried out a cross-validation based on three learning algorithms and computationally defined two decision trees. We found that, by using three neuropsychological tests and two VMET scores, it was possible to discriminate OCD patients from controls, opening a novel scenario for future assessment protocols based on virtual reality and computational techniques

Technology and Cognitive Empowerment for Healthy Elderly

The progressive growth of the ageing population represents opportunities as well as challenges. Consistently, the identification of effective cognitive empowerment programs in elderly population is now a worldwide health policy priority, specially for their preventive effect. In this chapter, within the paradigm of Positive Technology, the main focus will be on the use advanced technologies as effective tools for a new class of applications aimed at improving the traditional cognitive empowerment in elderly. Specifically, the attention will be devoted on how advanced technologies may be used to support elderly in reaching engaging and self-actualizing experiences. On the basis of the most recent evidence in literature, it will be discussed the possible advantages in using such advanced technologies for improving well-being in frail elderly: coupled with an increase in cognitive skills acquisition, the advantages may range increased self-efficacy and decreased subjective weakness, with a consequent improvement in both physical and cognitive performance