Clinical trials

The goal of this clinical trial is to evaluate the efficacy of the Ideomotor Program in healthy older adults living in the community. The main research questions are: 1\) Is the Ideomotor Program effective in improving cognitive function? 2) Is the Ideomotor Program effective in improving motor function? 3) Is the Ideomotor Program effective in improving overall well-being? Researchers will compare the Ideomotor Program to a community group cognitive training program to determine whether the effects are superior. Participants will: undergo assessments at baseline, at the mid-intervention point, and upon program completion; participate in a 16-week group exercise program in a community gym two times per week; keep a diary to monitor the number of falls and any adverse events.

Improving movement control during rehabilitation is still a challenge for people with Parkinson's Disease, mainly because of the motor symptoms caused by the condition. However, new technologies offer promising ways to support therapy. This clinical trial will test whether using TecnoBody® D-Wall technology integrated with two techniques (Action Observation and Motor Imagery) can improve physiotherapy outcomes for people with Parkinson's Disease. The TecnoBody® D-Wall is a type of digital mirror that includes a 3D camera, pressure-sensitive platforms, and a screen. It shows a person's body movements in real time and gives visual feedback on joint mobility, balance, and how weight is distributed during movement. Action Observation and Motor Imagery are two techniques already used in physiotherapy. Action Observation involves watching someone perform a movement, while Motor Imagery involves mentally rehearsing the movement before doing it. Studies have shown that both techniques activate the same brain areas involved in actual movement. In this trial, after watching and imagining the movement, participants will perform the exercise in front of the D-Wall. This setup gives them real-time feedback to help improve how they move, a new approach for these techniques. To see if this approach works, we will measure balance using a test validated for people with Parkinson's Disease and assess mobility using lab-based gait analysis, which tracks how a person walks. Participants in the study will: * Be receiving routine physiotherapy at a hospital that is specialized in Parkinson's Disease rehabilitation. * Be randomly assigned to one of two groups: 1) One group will receive physiotherapy incorporating the D-Wall alongside Action Observation and Motor Imagery; 2) The other group will receive physiotherapy incorporating the D-Wall but, without Action Observation or Motor Imagery. * Take part in therapy for up to four weeks, followed by another four weeks of monitoring, for a total of up to two months. * Complete some initial tests to check if they are eligible for the study. This study includes patients who have been diagnosed with idiopathic Parkinson's Disease and are undergoing rehabilitation as part of their usual hospital care. The intervention lasts as long as their regular hospital stay.

The research project OutProFeed - Italy: Routine outcome monitoring and feedback informed therapy in Italy: 1st Italian RCT large population study, represents the first Italian randomised controlled trial (RCT) to evaluate the effectiveness of feedback-informed psychotherapy (FIT) to improve patients mental health outcomes and psychotherapy processes through the use of the digital platform Mindy. The following project was awarded PRIN 2022 funding by the Ministry of University and Research (MUR). This project has the University of Bergamo as lead partner, with the auxiliary participation of the University of Palermo and the Polytechnic University of Milan. Given the innovative-experimental nature of the following research project, a digital platform -Mindy- will be used, which allows the recruited professionals (once registered) an all-round management of all the professional activities inherent to the psychologist/psychotherapist profession (informed consent, online therapy, administration of psychometric instruments, etc.) and which also facilitates the administration of psychometric instruments. ) and which also facilitates data collection, subsequent analysis and Routine Outcome Monitoring (ROM) and Feedback Informed Therapy (FIT) procedures with ad hoc charts and digital tools, in accordance with the guidelines dictated by the GDPR regulations on health and clinical data. Each therapist involved in the project, after having received guidance on the procedures and after having been instructed to use the platform will involve 5 new patients in the following project. The only inclusion criteria for patients are the following: I) Being of legal age II) Not having a diagnosis of psychosis and/or neurocognitive disorders III) Consent to participate in the following research project IV) Being a new patient (new or less than three sessions carried out) We will randomly assign the previously recruited psychotherapists and their patients to one of three conditions: (1) treatment as usual (TAU) in which therapists and patients proceed with psychotherapy as they normally would without receiving any initial training and using only Mindy as a simplified digital folder (2) process and outcome monitoring (OPM) in which patients will complete process and outcome measures related to each psychotherapy session therapists will receive basic feedback without Clinical Support Tools on these measures, they will use the Mindy platform as a medical record and will not receive specific training on FIT (3) process and outcome monitoring with feedback (OPM-F) where patients will complete process and outcome measures related to each session and therapists will receive feedback on the patient progress and experiences of the therapeutic alliance with specific training on feedback informed therapy (FIT) and will use the Mindy platform with all feedback and Clinical Support Tools information, They will also receive monthly supervision/coaching (for three months) to complete the FIT and ROM training on-going, with practical discussion of the most difficult clinical cases and possible solutions to be implemented in therapy. Recruitment of therapists will take place with the strategic participation of a pool of MIUR-recognised Schools of Specialisation in Psychotherapy (https://www.miur.it/ElencoSSPWeb/). Professionals qualified to practise as psychologists who are in their third year of the Schools of Psychotherapy will be selected, as well as therapists who already have a regular diploma of specialisation in psychotherapy recognised by the MIUR (https://www.miur.it/ElencoSSPWeb/), and who are in active practice. There will be no restrictions on the type of psychotherapy used by the professionals who will be recruited (the only criterion for inclusion is that it must be psychotherapy for a mental health issue). Therapists will not be aware of the randomisation procedure to reduce bias (Zelen design). Specifically, for the following research project we will use data from a maximum of 15 sessions (endpoints) carried out by all therapists of the 3 groups with the Clinical Support System only for the therapists of the group (OPM-F) who, as previously mentioned, will receive ad hoc training; furthermore, various instruments (described in the special section Instruments) will be compiled through the functional use of Mindy and in detail (cadence, purpose and research hypotheses) in the complete protocol in the next section. Finally, through the administration of special questionnaires, factors indicative of therapists aptitude and competences for the use of digital tools in professional practice will be collected in order to obtain statistical clusters that can be used as independent or control variables.