NCT06547827 Rehabilitation With and Without Robot and Allied Digital Technologies in Stroke Patients

Trial Parameters

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Brief 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 Criteria

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 fro

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