TABLET TOSCANA to Develop Innovative Organizational Models for Tele-Rehabilitation in Subjects with Congenital and Acquired Developmental Disabilities: A Wait-List Control Group Trial Protocol

Abstract

Background/Objectives: In recent years, the advent of new technologies has fostered their application in neuro-psychomotor and language rehabilitation, particularly since the COVID-19 pandemic. Tele-rehabilitation has emerged as an innovative and timely solution, enabling personalized interventions monitored by clinicians. TABLET TOSCANA project aims to develop innovative tele-rehabilitation organizational models in children, adolescents and young adults with congenital and acquired developmental disabilities, using the Virtual Reality Rehabilitation System (VRRS) Home Kit and the MedicoAmico APP. Methods: The trial is designed according to the CONSORT statement guidelines. The project encompasses three phases: adapting the technologies for pediatric use, validating them through a wait-list study, and analyzing feasibility and effectiveness data to define new organizational models. A randomized wait-list-control study with 100 subjects aged 6 to 30 years will compare tele-rehabilitation versus prosecution of standard care. Discussion: Although literature highlights tele-rehabilitation benefits such as improved access, cost savings, and enhanced treatment adherence, practical implementation remains limited (i.e., the definition of standardized procedures). TABLET TOSCANA project seeks to address these gaps by focusing on multi-domain treatments for neurodevelopmental disabilities and emphasizing the integration of tele-rehabilitation into local health services. Conclusion: The project aims to improve the continuity and intensity of care through innovative models that integrate tele-rehabilitation into local health services. The results could inform healthcare policies and promote the development of innovative and collaborative models of care, paving the way for more effective and widespread tele-rehabilitation solutions and fostering collaborative networks among professionals.

Keywords: COVID-19; Information and Communication Technologies; feasibility; neurodevelopmental disorders; organizational models; pediatric neurological rehabilitation; tele-rehabilitation.

Figure 1

Three main phases of TABLE TOSCANA study. A synthetic overview of the three project phases detailed in the text: implementation of technological devices, hypothesizing in the meanwhile new organizational models integrating tele-rehabilitation within conventional care pathways; systems validation through a two parallel arm, wait-list study, recruiting participants with congenital and acquired neurodevelopmental disabilities; data analysis, both considering organizational dimensions, feasibility, and efficacy results.

Figure 2

New organizational models’ hypothesis. (a) depicts the decision-making procedure with different steps for assigning patients to one of the study arms, according to the interdisciplinary clinical assessment (using standardized tests and technological devices) and the identified treatment goals. If the designed objectives could be achievable through technology and patients meet the inclusion criteria for the Tablet Toscana project, tele-rehabilitation pathways will be initiated. (b) illustrates the tele-rehabilitation pathway, involving an initial familiarization phase for patients and families with the system, followed by a 3-month treatment with mixed online and offline sessions. Thus, post-treatment evaluations will be conducted to gather efficacy and feasibility data.

Figure 3

Flowchart of TABLET-TOSCANA study according to CONSORT guidelines. Graphical representation of the two parallel arms wait-list study, illustrating the pathway from the identification of the eligible patients, according to the inclusion and exclusion criteria, proceeding through a baseline assessment of cognitive, motor and speech-communication functions. Thus, a stratification process will be foreseen, considering different demographic, clinical and technological parameters, in order to foster the random assignment to one of the two experimental groups or to the control one. After a 3-month tele-rehabilitation program, with mixed online and offline sessions, post-treatment evaluations will be conducted.

Figure 4

Spirit Figure. Schedule of study enrolment, interventions and assessments.

Figure 5

Technological devices for tele-rehabilitation purposes. (a) VRRS Home Kit Tablet: A case provided to patients and their families, equipped with a tablet and a set of integrated motion sensors, allowing to delivery of home tele-rehabilitation pathways. (b) MedicoAmico APP: A medical device directly downloadable to patients’ and families’ devices (computer, phone, tablet) to perform cognitive, speech-language, and motor interventions. Remotely monitored by the clinician.

Figure 6

MedicoAmico APP exercises’ library. (a) Examples of motor activities implemented and now available on MedicoAmico APP. (b) Examples of cognitive and speech-communication exercises available within the wide library of the medical device. Parameters, including repetition, time and difficulty levels, are displayed in the upper section.