About this trial
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 criteria
Qualifiers
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);
Disqualifiers
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;
Trial design
Treatments tested in this trial
- robotic rehabilitation
- traditional rehabilitation
Treatment groups
Sponsors and collaborators
Fondazione Don Carlo Gnocchi ETS
Lead sponsor
Istituti Clinici Scientifici Maugeri SpA
Collaborator
IRCCS National Neurological Institute "C. Mondino" Foundation
Collaborator
Ospedale Policlinico San Martino
Collaborator
Università di Pavia
Collaborator
Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
Collaborator