Telerehabilitation With Digital Technologies for the Continuum of Care of Stroke Patients

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.

Conditions

• Stroke

Interventions

OTHER

Integrated Treatment with Digital Tools

Patients will undergo a 6-week remote telerehabilitation program. The recommended frequency of treatment is a minimum of 3 sessions per week, but patients may adjust the schedule in agreement with their assigned therapist. If a patient is unable to complete at least 18 sessions due to clinical reasons, they will be considered as a dropout. Moreover, one session per week will be conducted synchronously, with the therapist remotely supervising the patient's activities in real time, while the remaining sessions will be asynchronous, allowing the patient to complete the exercises independently.

OTHER

Home-Based Educational Program

Patients will be monitored over a six-week period through weekly phone calls to assess their progress and overall condition. Additionally, participants are required to maintain an activity diary to document their engagement with the prescribed activities.

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA

  collaborator OTHER

• IRCCS National Neurological Institute "C. Mondino" Foundation

  collaborator OTHER

• Ospedale Policlinico San Martino

  collaborator OTHER

• Cure Ortopediche Traumatologiche SpA

  collaborator UNKNOWN

• Università di Pavia

  collaborator UNKNOWN

• Scuola Superiore Sant'Anna di Pisa

  collaborator OTHER

• Campus Bio-Medico University

  collaborator OTHER

• Fondazione Don Carlo Gnocchi Onlus

  lead OTHER

Principal Investigators

• Irene G Aprile, MD, PhD · IRCCS Fondazione Don Carlo Gnocchi

• Christian Lunetta · IRCCS Istituti Clinici Scientifici Maugeri

• Roberto De Icco · IRCCS Fondazione Mondino

• Carlo Trompetto · IRCCS Ospedale Policlinico San Martino

• Ennio Ferlazzo · COT Istituto Clinico Polispecialistico

• Silvana Quaglini · Università di Pavia

• Giuseppe Turchetti · Università Sant'Anna di Pisa

• Leandro Pecchia · Campus Bio-Medico University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-20

Primary Completion

2026-05-01

Completion

2026-07-31

Countries

• Italy

Study Locations