The Promotoer, a brain-computer interface-assisted intervention to promote upper limb functional motor recovery after stroke: a statistical analysis plan for a randomized controlled trial.

BACKGROUND: Electroencephalography (EEG)-based brain-computer interfaces (BCIs) allow to modulate the sensorimotor rhythms and are emerging technologies for promoting post-stroke motor function recovery. The Promotoer study aims to assess the short and long-term efficacy of the Promotoer system, an EEG-based BCI assisting motor imagery (MI) practice, in enhancing post-stroke functional hand motor recovery. This paper details the statistical analysis plan of the Promotoer study. METHODS: The Promotoer study is a randomized, controlled, assessor-blinded, single-centre, superiority trial, with two parallel groups and a 1:1 allocation ratio. Subacute stroke patients are randomized to EEG-based BCI-assisted MI training or to MI training alone (i.e. no BCI). An internal pilot study for sample size re-assessment is planned. The primary outcome is the effectiveness of the Upper Extremity Fugl-Meyer Assessment (UE-FMA) score. Secondary outcomes include clinical, functional, and user experience scores assessed at the end of intervention and at follow-up. Neurophysiological assessments are also planned. Effectiveness formulas have been specified, and intention-to-treat and per-protocol populations have been defined. Statistical methods for comparisons of groups and for development of a predictive score of significant improvement are described. Explorative subgroup analyses and methodology to handle missing data are considered. DISCUSSION: The Promotoer study will provide robust evidence for the short/long-term efficacy of the Promotoer system in subacute stroke patients undergoing a rehabilitation program. Moreover, the development of a predictive score of response will allow transferring of the Promotoer system to optimal clinical practice. By carefully describing the statistical principles and procedures, the statistical analysis plan provides transparency in the analysis of data. TRIAL REGISTRATION: ClinicalTrials.gov NCT04353297 . Registered on April 15, 2020.

Complementary and Integrative Approaches to Cancer: A Pilot Survey of Attitudes and Habits among Cancer Patients in Italy.

Background: Cancer patients are among the main consumers of traditional, complementary, integrative, and alternative medicine (TCIM) such as natural products (herbals, integrators, etc.) and mind and body practices (yoga, acupuncture, etc.). Methods: A questionnaire on TCIM was submitted to 415 Italian cancer patients. The questionnaire consisted of three sections: (i) biographical and clinical information; (ii) use of natural substances; and (iii) use of mind-body practices. Results: 406 patients completed the questionnaire. The prevalence of TCIM use was 72.3%. Of them, 75.6% started to use TCIM after a tumor diagnosis. The main reasons for using TCIM were to mitigate side effects (65.0%), to regain physical and mental balance (35.9%), to relieve pain (18.3%), and to improve the efficacy of cancer therapy (16.0%). 44.7% of patients taking natural products used them during conventional therapies (chemotherapy, radiotherapy, etc.), and in 67.5% of cases without consulting a doctor. As a consequence, only about 50% of patients taking natural substances used these compounds appropriately, and the most common errors were related with the purpose of reducing the side effects of the therapy (52.3%) and for boosting immune system (32.1%). Conclusions: There is an impelling need to provide patients with scientifically validated information to raise awareness about the benefits and risks of using TCIM.

Ten years of telerehabilitation: A literature overview of technologies and clinical applications.

This paper aims at delivering a structured overview of telerehabilitation literature by analysing the entire set of articles under the search terms "telerehabilitation" or "tele-rehabilitation" to portray "state of the art" ten years after the publication of the first scientific article on the topic. A structured study has been conducted by considering all those articles containing the word "telerehabilitation" or "tele-rehabilitation". Medline, Embase, Cochrane, UK Centre for Reviews and Dissemination, Canadian Agency for Drugs and Technologies in Health databases have been interrogated for articles between 1998 and 2008. 146 scientific articles were found. 56 articles focus on patient treatment, 23 are reviews, 3 are to be considered as both patient treatment papers and reviews, 53 are either technical reports, system descriptions or analyses of new approaches; 8 are general discussion on telerehabilitation. The present paper draw the scenario of the first ten years of telerehabilitation, focussing on clinical applications and technologies. Basically, it confirms the lack of comprehensive studies providing evidence for supporting decision and policy-makers in adopting telerehabilitation technologies in the clinical practice. An overall lack of standardisation in the used terminology also results from the analysis of keywords, which is typical of quite recent fields of application.

Tele-rehabilitation and e-learning: the HELLODOC educational experience.

SUMMARY: A web-based learning activity in the field of tele-rehabilitation was conducted by Istituto Superiore di Sanità (ISS), the Italian National Institute of Health, within the EU project HELLODOC. The activity aimed at training professionals to effectively manage the tele-rehabilitation service. ISS adapted the Moodle e-learning platform and implemented the problem-based learning (PBL) methodology. One clinical and one technical module were prepared by using traditional learning sources as well as interactive tools. Each module included 4 units; each unit was based on a 5-days cycle. The courses remained open from January to October 2006. Fifty percent of the registered students attended the courses. Traditional and interactive learning resources were equally used. Overall feedback was positive, unless for the amount of time requested for the study and the lack of an official certificate of attendance. Both modules are now in the process of being revised, improved and generalised, in order to be integrated into the ISS Rehabilitation website.