RecruitingNot ApplicableNCT06547827

Rehabilitation With and Without Robot and Allied Digital Technologies in Stroke Patients

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


Sponsor

Fondazione Don Carlo Gnocchi ETS

Enrollment

596 participants

Start Date

Aug 12, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying robotic rehabilitation and traditional rehabilitation for people with stroke. The study is currently recruiting participants at 13 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERrobotic 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.

OTHERtraditional 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(27)

Fondazione Don Carlo Gnocchi, Centro Gala

Acerenza, Italy

IRCCS Istituti Clinici Scientifici Maugeri

Bari, Italy

Azienda Socio Sanitaria Territoriale (ASST) Papa Giovanni XXIII

Bergamo, Italy

Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco"

Catania, Italy

Università degli Studi Magna Graecia di Catanzaro (A.O.U. "Renato Dulbecco" Catanzaro)

Catanzaro, Italy

Istituto S. Anna di Ezio Pugliese s.r.l.

Crotone, Italy

Università di Foggia (Azienda Ospedaliero-Universitaria "Policlinico Riuniti" - Foggia)

Foggia, Italy

IRCCS Ospedale Policlinico San Martino,

Genova, Italy

IRCCS Centro Neurolesi "Bonino Pulejo"

Messina, 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

Università degli Studi di Padova (Azienda Ospedale Università di Padova)

Padova, Italy

IRCCS Fondazione Mondino

Pavia, Italy

IRCCS Istituti Clinici Scientifici Maugeri

Pavia, Italy

Università di Pisa (A.O.U. Pisana)

Pisa, Italy

Fondazione Don Carlo Gnocchi, Centro Santa Maria della Provvidenza

Roma, Italy

IRCCS San Raffaele Roma s.r.l.

Roma, Italy

Università Humanitas University - Hunimed (IRCCS Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.)

Rozzano, Italy

Fondazione Don Carlo Gnocchi, Centro Santa Maria al Mare

Salerno, Italy

Università degli Studi di Salerno (Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona)

Salerno, Italy

Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo

Sant'Angelo dei Lombardi, Italy

Azienda Sanitaria dell'Alto Adige - Ospedale di Vipiteno

Sterzing, Italy

IRCCS Istituti Clinici Scientifici Maugeri

Telese Terme, Italy

APSS Trento

Trento, Italy

Fondazione Don Carlo Gnocchi, Polo specialistico riabilitativo

Tricarico, Italy

San Camillo IRCCS s.r.l.

Venezia, Italy

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NCT06547827


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