Telerehabilitation With Digital Technologies for the Continuum of Care of Stroke Patients: a Multicentre Randomized Controlled Trial on Effectiveness, Acceptability, Usability, and Economic Sustainability
Status: Recruiting
Location: See all (13) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Fondazione Don Carlo Gnocchi, IRCCS Santa Maria Nascente
NOT_YET_RECRUITING
Milan
IRCCS Istituti Clinici Scientifici Maugeri
NOT_YET_RECRUITING
Milan
IRCCS Istituti Clinici Scientifici Maugeri
NOT_YET_RECRUITING
Montescano
IRCCS Fondazione Mondino
NOT_YET_RECRUITING
Pavia
Fondazione Don Carlo Gnocchi, Centro Santa Maria della Provvidenza
RECRUITING
Rome
Fondazione Don Carlo Gnocchi, Centro Santa Maria al Mare
NOT_YET_RECRUITING
Salerno
Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo
NOT_YET_RECRUITING
Sant'angelo Dei Lombardi
IRCCS Istituti Clinici Scientifici Maugeri
NOT_YET_RECRUITING
Telese Terme
Fondazione Don Carlo Gnocchi, Polo specialistico riabilitativo
NOT_YET_RECRUITING
Tricarico
Contact Information
Primary
Irene G Aprile, MD, PhD
iaprile@dongnocchi.it
+390633086553
Backup
Marco Germanotta, PhD
mgermanotta@dongnocchi.it
+390633086553
Time Frame
Start Date:2025-05-20
Estimated Completion Date:2026-07-31
Participants
Target number of participants:160
Treatments
Experimental: Treatment with Digital Tools
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.
Active_comparator: Educational Program
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.
Collaborators: Cure Ortopediche Traumatologiche SpA, IRCCS National Neurological Institute C. Mondino Foundation, Università di Pavia, Ospedale Policlinico San Martino, Scuola Superiore Sant'Anna di Pisa, Campus Bio-Medico University, Istituti Clinici Scientifici Maugeri SpA