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

ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione Don Carlo Gnocchi ETS

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

596 Participants
are divided into 2 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