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Rehabilitation With and Without Robot and Allied Digital Technologies in Stroke Patients
Sponsor: Fondazione Don Carlo Gnocchi Onlus
Summary
Rehabilitation after stroke often employs Robot and Allied Digital Technologies (RADTs), yet evidence on their effectiveness remains inconclusive due to study heterogeneity and limited sample sizes. This multicentre randomized controlled pragmatic trial aims at comprehensively and accurately assessing the effectiveness of rehabilitation mediated by RADTs after a stroke, compared to traditional rehabilitation, also considering economic sustainability.
Official title: Rehabilitation With and Without Robot and Allied Digital Technologies (RADTs) in Stroke Patients: a Pragmatic Multicenter Randomised Controlled Trial on the Effectiveness, Acceptability, Usability, and Economic-organizational Sustainability of RADTs From Subacute to Chronic Phase
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
596
Start Date
2024-08-12
Completion Date
2026-07-31
Last Updated
2025-02-12
Healthy Volunteers
No
Conditions
Interventions
robotic rehabilitation
Treatment will occur in a gym equipped with devices for all the domains, with two physiotherapists supervising groups of 4 to 6 patients, depending on their clinical severity. Patients will undergo a total of 25 sessions, each lasting 45 minutes, with the following frequency: * 5 times a week for 5 weeks, for inpatients; * 3 times a week for 8.3 weeks, for outpatients.
traditional rehabilitation
A physiotherapist-to-patient ratio of 1:1 is provided for the treatment in all participating centres. Patients will undergo a total of 25 sessions, each lasting 45 minutes, with the following frequency: * 5 times a week for 5 weeks, for inpatients; * 3 times a week for 8.3 weeks, for outpatients.
Locations (13)
Fondazione Don Carlo Gnocchi, Centro Gala
Acerenza, Italy
IRCCS Istituti Clinici Scientifici Maugeri
Bari, Italy
IRCCS Ospedale Policlinico San Martino,
Genova, Italy
Fondazione Don Carlo Gnocchi, IRCCS Santa Maria Nascente
Milan, Italy
IRCCS Istituti Clinici Scientifici Maugeri
Milan, Italy
IRCCS Istituti Clinici Scientifici Maugeri
Montescano, Italy
IRCCS Fondazione Mondino
Pavia, Italy
IRCCS Istituti Clinici Scientifici Maugeri
Pavia, Italy
Fondazione Don Carlo Gnocchi, Centro Santa Maria della Provvidenza
Roma, Italy
Fondazione Don Carlo Gnocchi, Centro Santa Maria al Mare
Salerno, Italy
Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo
Sant'Angelo dei Lombardi, Italy
IRCCS Istituti Clinici Scientifici Maugeri
Telese Terme, Italy
Fondazione Don Carlo Gnocchi, Polo specialistico riabilitativo
Tricarico, Italy