Description

• The sample size was determined considering the primary outcome (the change in COPM): the superiority of robotic treatment compared to conventional treatment; a power of 80%; a number of groups equal to 2; a number of measurements equal to 3; and an effect size of 0.1. Based on these parameters, a sample size of 162 patients (81 per group) is obtained. Additionally, considering a dropout rate of 20%, a total sample size of 194 patients is required.
  • For each recruited subject, a specific checklist (CRF) will be completed to collect the demographic, clinical, and technological data required by the study. All collected data will be pseudonymized (using a technique that modifies and masks personal and sensitive data to prevent it from being directly and easily attributed to an individual), in accordance with current privacy regulations. This will allow for regular monitoring of the study's progress, particularly regarding the number of subjects enrolled and recruited in the different phases, the evaluation tests conducted, adherence to the study, and the treatment protocols implemented.
  • A high adherence to the study is anticipated, especially if the children involved receive treatment during the care period in rehabilitation facilities, in compliance with current regulations. To ensure the quality and consistency of the intervention, a careful assessment of adherence will be conducted. This assessment will be carried out by an independent team of clinical reviewers, who will regularly monitor treatment sessions. The reviewers will then implement targeted strategies to maintain and improve adherence, including periodic training sessions for the staff involved and timely feedback directed to the therapists in both study groups. A diary will also be maintained regarding the treatments performed by each patient to monitor adherence to the proposed treatment.
  • Regarding the collection of data obtained from standardized clinical evaluations, each subject will be assigned a numeric ID code in accordance with current privacy regulations, allowing for the preservation and sharing of data in a completely anonymous form with other participating centers. The list linking the assigned code to each child's name will be kept by the principal investigator and stored in a locked cabinet. Only the principal investigator and other researchers involved in the project will have access to this information.

Similarly, information obtained during the rehabilitation phase from technological tools will be stored and shared with other participating centers in a completely anonymous manner, using the same numeric code previously defined. The data collected throughout the study, excluding the subject's name, will be recorded, processed, and stored for at least seven (7) years after the conclusion of the study, along with the assigned code, on password-protected hard drives stored in a physically secured location or within protected electronic archives (Research Electronic Data Capture (RedCap)), accessible only to the principal investigator and authorized researchers. After seven years, the data will be destroyed.

All collected information will not be processed or used for purposes other than those indicated in the study's objectives, nor for direct profit, and will not be communicated or transferred to unauthorized third parties.

Personal data will be collected and processed in accordance with the principle of data minimization and in compliance with all general principles outlined in Article 5 of the GDPR. Data, particularly personal and health-related data, will be processed only to the extent necessary in relation to the objectives of the trial, in accordance with EU Regulation 2016/679 (GDPR) and Legislative Decree No. 101 of August 10, 2018.

At the time of data collection, whether obtained from standardized clinical evaluations or from device reports, the Data Controllers will ensure that the collected data is pseudonymized by identifying the recruited subjects with codes or adopting other solutions compliant with point 5.4 of the Privacy Authority Provision No. 146/2019. The use of encryption techniques allows for the storage and processing of the data subject's information in a way that prevents identification by any external person. Only the Project Manager at each center and authorized personnel can link each code to the name of the participating subject.

•Regarding any events to be reported, the mode and timing of reporting will adhere to the obligations imposed by EU Regulation 2017/745 (Article 80) and the MDCG Guideline 2020-10/1 ("Safety reporting in clinical investigations of medical devices under Regulation (EU) 2017/745").

A specific insurance policy will be established, which will be activated immediately before the start of the clinical trial. Insurance quotes have been requested and are currently under evaluation. The policy will comply with the provisions of the Ministerial Decree of July 14, 2009, which guarantees specific coverage for damages caused to subjects by the trial activities throughout its duration, covering the civil liability of the investigator and the sponsor, without excluding damages unintentionally caused as a result of an accidental event and/or attributable to negligence, imprudence, or incompetence.

•The collected data will be presented using descriptive statistics, such as mean and standard deviation for numerical variables, and percentages for categorical variables.

The population will be defined to include patients in the multidomain treatment group or the control group (monodomain). The analyzable population will be defined by excluding patients who are not eligible for entry and those who do not receive the full treatment (due to treatment interruption for any reason). The primary endpoint at the end of treatment will be compared between the two treatment groups.

For the primary outcome, a planned subgroup analysis will be conducted to assess the presence of treatment effect modifiers. Continuous secondary outcomes will be analyzed in the population. All tests will be two-tailed with a significance level of 5%, and effect estimates will include a 95% confidence interval (CI).

Categorical outcomes will be reported as proportions with 95% CIs and compared using appropriate statistical tests. Similar analysis will be conducted to demonstrate any improvement in parameters measured during the follow-up (T2). This analysis will include subjects who completed the treatment, representing the population to be studied in the months following the completion of the treatment.