Telerehabilitation With Digital Technologies for the Continuum of Care of Stroke Patients
ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione Don Carlo Gnocchi Onlus
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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
Treatments tested in this trial
- Integrated Treatment with Digital Tools
- Home-Based Educational Program
Treatment groups
160 Participants
are divided into 2 treatment groupsSponsors and collaborators
Fondazione Don Carlo Gnocchi Onlus
Lead sponsor
Istituti Clinici Scientifici Maugeri SpA
Collaborator
IRCCS National Neurological Institute "C. Mondino" Foundation
Collaborator
Ospedale Policlinico San Martino
Collaborator
C.O.T. Cure Ortopediche Traumatologiche S.p.A.
Collaborator
Università di Pavia
Collaborator
Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
Collaborator
Campus Bio-Medico University
Collaborator
Source ClinicalTrials.gov