Timely and Personalized Interventions and Vigilant Care in Neurodegenerative Conditions: The FIT4TeleNEURO Pragmatic Trial

Abstract

Parkinson's disease (PD) and multiple sclerosis (MS) are two chronic neurological diseases (CNDs) that have a high demand for early and continuous rehabilitation. However, accessing professional care remains a challenge, making it a key priority to identify sustainable solutions for ensuring early rehabilitation availability. Objective: The FIT4TeleNEURO pragmatic trial proposes to investigate, in real-life care settings, the superiority in terms of the effectiveness of early rehabilitation intervention with harmonized, mix-model telerehabilitation (TR) protocols (TR single approach, task-oriented-TRsA; TR combined approach, task-oriented and impairment-oriented-TRcA) compared to conventional management (control treatment, CeT) in people with PD and MS. Design, and Methods: This multicenter, randomized, three-treatment arm pragmatic trial will involve 300 patients with CNDs (PD, N = 150; MS, N = 150). Each participant will be randomized (1:1:1) to the experimental groups (20 sessions of TRsA or TRcA according to a mix-model-3 asynchronous + 1 synchronous session/week) or the control group (20 sessions of CeT). Primary and secondary outcome measures will be obtained at the baseline (T0), post-intervention (T1, 5 weeks after baseline), and follow-up (T2, 3 months after the end of the treatment). A multidimensional evaluation (cognitive, motor, and quality of life domains) will be conducted at each time point of assessment (T0; T1; T2). The primary outcome measures will be the assessment of change (T0 vs. T1 vs. T2) in static and dynamic balance, measured using the Mini-Balance Evaluation Systems Test. Usability and acceptability assessment will be also investigated. Expected Results: Implementing TR protocols will enable a more targeted and efficient response to the growing demand for rehabilitation in the early stages of CNDs. Both the TRsA and TRcA approaches are expected to be more effective than CeT, with the combined approach likely providing greater benefits in secondary outcome measures. Finally, the acceptability of the asynchronous modality could open the door to scalable solutions, such as digital therapeutics.

Keywords: Parkinson’s disease; chronic neurological diseases; digital medicine; multiple sclerosis; rehabilitation; telemedicine; telerehabilitation.

Figure 1

SPIRIT figure for the schedule of enrollment, interventions, and assessments in the pragmatic trial. T0 = baseline (pre-intervention phase); T1 = post-treatment assessment (5 weeks after baseline); T2 = follow-up assessment (12 weeks after the end of the treatment). MDS-UPDRS: Movement Disorder Society—Unified Parkinson’s Disease Rating Scale; EDSS: Expanded Disability Status Scale; BI: Barthel Index; SUS: System Usability Scale; TAM: Technology Acceptance Model.

Figure 2

The trial work plan.

Figure 3

Representative figure of the clinical trials.

Figure 4

Trunk medio-lateral and antero-posterior sway, expressed as the root mean square of the acceleration detected by the IMU on lower back, in a representative healthy participant (left panel) and in a representative person with mild MS (right panel), during standing on foam with eyes close. Note the larger oscillations in the participant with MS, meaning unstable static balance.