Telerehabilitation With Digital Technologies for the Continuum of Care of Stroke Patients
Telerehabilitation With Digital Technologies for the Continuum of Care of Stroke Patients: a Multicentre Randomized Controlled Trial on Effectiveness, Acceptability, Usability, and Economic Sustainability
Fondazione Don Carlo Gnocchi Onlus
160 participants
May 20, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria4
- 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.
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Interventions
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.
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.
Locations(13)
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NCT06978413