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

RecruitingNAAges 18 Years - anyAllFondazione Don Carlo Gnocchi ETS
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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What it tests

  • robotic rehabilitation
  • traditional rehabilitation
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Where

27 sites
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

…and 19 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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