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

Launched by FONDAZIONE DON CARLO GNOCCHI ONLUS · Aug 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of rehabilitation for stroke patients using advanced technologies, like robots, compared to traditional rehabilitation methods. The goal is to see if these robotic and digital tools can help patients recover better and faster after a stroke. Researchers want to understand how well these methods work and if they are a cost-effective option for rehabilitation.

To participate in the trial, individuals must be at least 18 years old and have had their first stroke within the last six months. They should have some difficulty moving their arms, legs, or balancing, but they must be stable enough to participate in therapy sessions. Participants will engage in rehabilitation sessions, which may involve both traditional therapies and the use of robotic technologies. This trial is currently recruiting participants and aims to provide important insights into how these innovative approaches can improve recovery for stroke patients.

Gender

ALL

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 from performing treatment with technological and/or robotic devices;
• • Pregnant women;
• • Refusal to sign the informed consent.