Status:
RECRUITING
Rehabilitation With and Without Robot and Allied Digital Technologies in Stroke Patients
Lead Sponsor:
Fondazione Don Carlo Gnocchi Onlus
Collaborating Sponsors:
Istituti Clinici Scientifici Maugeri SpA
IRCCS National Neurological Institute "C. Mondino" Foundation
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
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. ...
Detailed Description
The aim of this study is to evaluate, in a pragmatic trial on a large sample of patients who have experienced a stroke within the six months prior to enrollment, the effectiveness of a multimodal trea...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
596 Patients enrolled
Trial Details
Trial ID
NCT06547827
Start Date
August 12 2024
End Date
July 31 2026
Last Update
February 12 2025
Active Locations (13)
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1
Fondazione Don Carlo Gnocchi, Centro Gala
Acerenza, Italy
2
IRCCS Istituti Clinici Scientifici Maugeri
Bari, Italy
3
IRCCS Ospedale Policlinico San Martino,
Genova, Italy
4
Fondazione Don Carlo Gnocchi, IRCCS Santa Maria Nascente
Milan, Italy