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

Recruiting now · Not applicable

Conditions studied: Stroke

In brief

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.

Key facts

Study ID

NCT06547827

Run by

Fondazione Don Carlo Gnocchi ETS

People needed

596

Starts

2024-08-12

Expected to finish

2026-11-30

Last updated by the study team

2026-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• First-ever diagnosis of ischemic or haemorrhagic stroke confirmed by Computed Tomography or Magnetic Resonance Imaging;
• Age 18 years and over;
• Time since the event equal to or less than 6 months;
• Mild to severe impairment of the upper limb (motor section of the Fugl-Meyer Assessment of Upper Extremity ≤ 58) and/or mild to severe impairment of the lower limb (score on the Functional Ambulation Categories scale ≤ 4) and/or mild to severe impairment of balance (Berg Balance Scale ≤ 45);
• Clinical stability allowing transfer to the gym and execution of the planned treatments.

You may not qualify if…

• Clinical instability;
• Behavioral/cognitive disorders preventing adequate patient compliance with both traditional and robotic rehabilitation treatment (severe cognitive deficit, Montreal Cognitive Assessment <10);
• Rigidity or hypertonia (Modified Ashworth Scale > 3) in the plegic/paretic limb;
• Serious uncorrectable visual impairments preventing the patient from performing treatment with technological and/or robotic devices;
• Pregnant women;
• Refusal to sign the informed consent.

Where it is running

• Fondazione Don Carlo Gnocchi, Centro Gala — Acerenza, Italy (enrolling)
• IRCCS Istituti Clinici Scientifici Maugeri — Bari, Italy (enrolling)
• Azienda Socio Sanitaria Territoriale (ASST) Papa Giovanni XXIII — Bergamo, Italy (enrolling)
• Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco" — Catania, Italy (enrolling)
• Università degli Studi Magna Graecia di Catanzaro (A.O.U. "Renato Dulbecco" Catanzaro) — Catanzaro, Italy (enrolling)
• Istituto S. Anna di Ezio Pugliese s.r.l. — Crotone, Italy (enrolling)
• Università di Foggia (Azienda Ospedaliero-Universitaria "Policlinico Riuniti" - Foggia) — Foggia, Italy (enrolling)
• IRCCS Ospedale Policlinico San Martino, — Genova, Italy (enrolling)
• IRCCS Centro Neurolesi "Bonino Pulejo" — Messina, Italy (enrolling)
• Fondazione Don Carlo Gnocchi, IRCCS Santa Maria Nascente — Milan, Italy (enrolling)
• IRCCS Istituti Clinici Scientifici Maugeri — Milan, Italy (enrolling)
• IRCCS Istituti Clinici Scientifici Maugeri — Montescano, Italy (enrolling)
• Università degli Studi di Padova (Azienda Ospedale Università di Padova) — Padova, Italy (enrolling)
• IRCCS Fondazione Mondino — Pavia, Italy (enrolling)
• IRCCS Istituti Clinici Scientifici Maugeri — Pavia, Italy (enrolling)
• Università di Pisa (A.O.U. Pisana) — Pisa, Italy (enrolling)
• Fondazione Don Carlo Gnocchi, Centro Santa Maria della Provvidenza — Roma, Italy (enrolling)
• IRCCS San Raffaele Roma s.r.l. — Roma, Italy (enrolling)
• Università Humanitas University - Hunimed (IRCCS Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.) — Rozzano, Italy (enrolling)
• Fondazione Don Carlo Gnocchi, Centro Santa Maria al Mare — Salerno, Italy (enrolling)
• Università degli Studi di Salerno (Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona) — Salerno, Italy (enrolling)
• Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo — Sant'Angelo dei Lombardi, Italy (enrolling)
• Azienda Sanitaria dell'Alto Adige - Ospedale di Vipiteno — Sterzing, Italy (enrolling)
• IRCCS Istituti Clinici Scientifici Maugeri — Telese Terme, Italy (enrolling)
• APSS Trento — Trento, Italy (enrolling)

Full record on ClinicalTrials.gov

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