Rehabilitation for stroke patients using robotics and digital technologies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicentre randomized controlled pragmatic trial aims to evaluate the effectiveness of rehabilitation using Robot and Allied Digital Technologies (RADTs) compared to traditional rehabilitation methods in stroke patients. The study will involve a large sample of patients who have experienced a stroke within the last six months, assessing their recovery in activities of daily living. The primary objective is to demonstrate that rehabilitation with RADTs is not inferior to traditional methods, while secondary objectives include comparing improvements in various physical and cognitive domains. The trial will also analyze neurophysiological factors related to recovery and quality of life outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fondazione Don Carlo Gnocchi, Centro Gala
  Acerenza, Italy Recruiting
• IRCCS Istituti Clinici Scientifici Maugeri
  Bari, Italy Recruiting
• Azienda Socio Sanitaria Territoriale (ASST) Papa Giovanni XXIII
  Bergamo, Italy Recruiting
• Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco"
  Catania, Italy Recruiting
• Università degli Studi Magna Graecia di Catanzaro (A.O.U. "Renato Dulbecco" Catanzaro)
  Catanzaro, Italy Recruiting
• Istituto S. Anna di Ezio Pugliese s.r.l.
  Crotone, Italy Recruiting

Study contacts

• Principal investigator: Irene G Aprile — IRCCS Fondazione Don Carlo Gnocchi
• Study coordinator: Irene G Aprile, MD, PhD
• Email: iaprile@dongnocchi.it
• Phone: +390633086553

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Deep phenotyping to explore recovery in young adults after stroke

  This project will test whether a detailed health and sample-collection approach (deep phenotyping) is practical and acceptable for people aged 18–55 who have had a stroke.

  Recruiting The Florey Institute of Neuroscience and Mental Health · Heidelberg, Victoria and 1 other locations · NCT07019493

• Stem cell therapy for chronic stroke recovery

  This study is testing whether using a patient's own stem cells can help people with long-term stroke recovery feel better and improve their daily functioning.

  Recruiting Phase 2 Hokkaido University Hospital · Sapporo, Hokkaido · NCT06752720

• AI-based tools to help diagnose, treat and predict stroke outcomes across multiple hospitals

  This study tests AI-powered tools on real-world stroke patients to see if they can improve pre-hospital triage, diagnosis, and outcome prediction while data stay securely within each hospital.

  Recruiting at 2 sites Hospital Universitari Vall d'Hebron Research Institute · Leuven and 6 other locations · NCT07924371

• Web-based therapy using action observation and mirror therapy for arm weakness after stroke

  This trial tests whether a mobile telerehabilitation app delivering action observation therapy (AOT) alone or combined AOT with mirror therapy (AOT-MT) can improve upper limb function in people with subacute stroke.

  Recruiting Chang Gung Memorial Hospital · Taoyuan · NCT07921108

• Remote Ischaemic Conditioning for Fatigue After Stroke 2

  Aat least 12 weeks after stroke, adults with post-stroke fatigue will try a simple hand-arm cuff treatment at home to see if it helps reduce fatigue.

  Recruiting Phase 2 Sheffield Teaching Hospitals NHS Foundation Trust · Sheffield, South Yorkshire · NCT07914647

• Dual-task balance training plus computer-based cognitive training after stroke

  In adults who recently had a stroke, the study tests whether adding computerized cognitive exercises to balance training improves balance and other recovery outcomes.

  Recruiting Matia Foundation · San Sebastián, GUIPUZCOA · NCT07913620

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.