The aim of the study is to evaluate the effectiveness of a home-based treatment based on rehabilitation technologies by comparing it with a traditional educational program at home.
Primary objective: Demonstration of the superiority of a home-based rehabilitation program with digital tools (home-based technological telerehabilitation) over a home-based educational program (home-based usual care) in patients with stroke outcomes in improving static and dynamic balance.
Secondary objectives:
- Evaluation of the impact of the frequency of the intervention on recovery;
- Evaluation of the acceptability of the intervention with digital tools for the patient, the caregiver, and the health care provider;
- Evaluation of the usability of the intervention with digital tools for the patient and the caregiver;
- Evaluation of the economic sustainability of the integrated rehabilitation intervention with digital tools for the patient, the payer, and society through the creation of a cost-effectiveness, cost-utility, and, for the health system, budget impact analysis model evaluation and prediction, and related sensitivity analyses.
The study is designed as a multicenter, multimodal, randomized, controlled, parallel group (1:1), blinded interventional trial. It will be conducted at multiple clinical centers participating in a national research initiative. Randomization will be centralized and stratified by clinical center, time since stroke, and age.
The sample size was determined using a 2-tailed, 2-sample t-test, assuming a power of 80%, a type I error t of 0.05, a mean difference of 2.7 units on the primary outcome (specifically, the change in the Berg Balance Scale, corresponding to the minimum detectable change in chronic stroke patients) and a common standard deviation of 5.37 points. With these assumptions, a sample size of 128 cases was estimated. Further, considering a dropout rate of 20%, the final estimated sample size required is 160 cases. The calculation was performed using G*Power software.
All participating centers will follow a standardized operating procedure regarding treatment and outcome assessment to ensure consistency across all sites. Data will be systematically collected using the REDCap (Research Electronic Data Capture) platform.