Telerehabilitation With Digital Technologies for the Continuum of Care of Stroke Patients (StrokeHomeFit4)

Don Carlo Gnocchi Onlus Foundation

Status: Enrolling

Conditions: Stroke

Treatments: Other: Integrated Treatment with Digital Tools; Other: Home-Based Educational Program

Study type: Interventional

Funder types: Other

Identifiers

NCT06978413

PNC0000007 (Other Grant/Funding Number)

Fit4MedRobStroke@Home

Details and patient eligibility

About

The goal of the pragmatic study is to evaluate the effectiveness of a home-based telerehabilitation protocol for patients with post-stroke disabilities, compared to a home-based educational program.

The main question it aims to answer is:

Is home-based neuromotor and cognitive rehabilitation using digital tools more effective than a traditional educational program for improving static and dynamic balance in patients with subacute and chronic stroke? Researchers will compare the outcome (Berg Balance Scale) measured at baseline with the outcome after treatment to test its effectiveness.

Full description

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of first ischemic or hemorrhagic stroke verified by Computed Axial Tomography or MRI.
• Age greater than 18 years.
• Latency since the event: a) greater than 3 months and less than or equal to 6 months; b) greater than 6 months and less than 24 months.
• Ability to perform the Timed Up and Go Test.

Exclusion criteria

• Unstable clinical conditions.
• Behavioral/cognitive disorders that prevent adequate patient compliance with the study (severe cognitive impairment, Montreal Cognitive Assessment<17.5).
• Severe visual impairment that cannot be corrected by lenses, preventing the patient from performing treatment with digital instruments.
• Refusal to sign informed consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups

Treatment with Digital Tools

Experimental group

Description:

The experimental treatment involves home-based telerehabilitation protocols utilizing digital tools. Patients will perform task-oriented activities aimed at improving balance through standing and/or seated exercises under both static and dynamic conditions. Exercise complexity will be progressively adapted and personalized based on the patient's performance, improvement trajectory, and instrumental feedback from the digital system. All devices must have a CE mark for medical devices and be used according to the manufacturer's specifications.

Treatment:

Other: Integrated Treatment with Digital Tools

Educational Program

Active Comparator group

Description:

Patients in the Control Group will follow a self-guided educational program supported by printed materials outlining daily living activities to be performed at home.

Treatment:

Other: Home-Based Educational Program