NCT06547827Recruiting
Rehabilitation With and Without Robot and Allied Digital Technologies in Stroke Patients
Rehabilitation With and Without Robot and Allied Digital Technologies (RADTs) in Stroke Patients: a Pragmatic Multicenter Randomised Controlled Trial on the Effectiveness, Acceptability, Usability, and Economic-organizational Sustainability of RADTs From Subacute to Chronic Phase
Source: ClinicalTrials.gov · Last updated 24 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 596 (estimated)
- First submitted
- 29 Jul 2024
- Start date
- 12 Aug 2024
- Primary completion date
- Nov 2026
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Diseases
- Stroke
- NCT number
- NCT06547827
What you commit to
- Study type: Interventional
- Planned participants: 596
- From 12 Aug 2024 to the primary completion date, Nov 2026
- 27 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Serious uncorrectable visual impairments preventing the patient from performing treatment with technological and/or robotic devices;
Other illness
- Behavioral/cognitive disorders preventing adequate patient compliance with both traditional and robotic rehabilitation treatment (severe cognitive deficit, Montreal Cognitive Assessment \<10);
Other
- Clinical instability;
- Rigidity or hypertonia (Modified Ashworth Scale \> 3) in the plegic/paretic limb;
- Pregnant women;
- Refusal to sign the informed consent.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (27)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Don Carlo Gnocchi, Centro Gala Coordinator of this site? Confirm its status | Acerenza | Italy | Recruiting |
| IRCCS Istituti Clinici Scientifici Maugeri Coordinator of this site? Confirm its status | Bari | Italy | Recruiting |
| Azienda Socio Sanitaria Territoriale (ASST) Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco" Coordinator of this site? Confirm its status | Catania | Italy | Recruiting |
| Università degli Studi Magna Graecia di Catanzaro (A.O.U. "Renato Dulbecco" Catanzaro) Coordinator of this site? Confirm its status | Catanzaro | Italy | Recruiting |
| Istituto S. Anna di Ezio Pugliese s.r.l. Coordinator of this site? Confirm its status | Crotone | Italy | Recruiting |
| Università di Foggia (Azienda Ospedaliero-Universitaria "Policlinico Riuniti" - Foggia) Coordinator of this site? Confirm its status | Foggia | Italy | Recruiting |
| IRCCS Ospedale Policlinico San Martino Coordinator of this site? Confirm its status | Genova | Italy | Recruiting |
| IRCCS Centro Neurolesi Bonino Pulejo Coordinator of this site? Confirm its status | Messina | Italy | Recruiting |
| Fondazione Don Carlo Gnocchi, IRCCS Santa Maria Nascente Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| IRCCS Istituti Clinici Scientifici Maugeri Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| IRCCS Istituti Clinici Scientifici Maugeri Coordinator of this site? Confirm its status | Montescano | Italy | Recruiting |
| Università degli Studi di Padova (Azienda Ospedale Università di Padova) Coordinator of this site? Confirm its status | Padova | Italy | Recruiting |
| IRCCS Fondazione Mondino Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
| IRCCS Istituti Clinici Scientifici Maugeri Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
| Università di Pisa (A.O.U. Pisana) Coordinator of this site? Confirm its status | Pisa | Italy | Recruiting |
| IRCCS San Raffaele Roma s.r.l. Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| Fondazione Don Carlo Gnocchi - Centro Santa Maria della Provvidenza Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| Università Humanitas University - Hunimed (IRCCS Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.) Coordinator of this site? Confirm its status | Rozzano | Italy | Recruiting |
| Fondazione Don Carlo Gnocchi, Centro Santa Maria al Mare Coordinator of this site? Confirm its status | Salerno | Italy | Recruiting |
| Università degli Studi di Salerno (Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona) Coordinator of this site? Confirm its status | Salerno | Italy | Recruiting |
| Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo Coordinator of this site? Confirm its status | Sant'Angelo dei Lombardi | Italy | Recruiting |
| Azienda Sanitaria dell'Alto Adige - Ospedale di Vipiteno Coordinator of this site? Confirm its status | Sterzing | Italy | Recruiting |
| IRCCS Istituti Clinici Scientifici Maugeri Coordinator of this site? Confirm its status | Telese Terme | Italy | Recruiting |
| APSS Trento Coordinator of this site? Confirm its status | Trento | Italy | Recruiting |
| Fondazione Don Carlo Gnocchi, Polo specialistico riabilitativo Coordinator of this site? Confirm its status | Tricarico | Italy | Recruiting |
| San Camillo IRCCS s.r.l. Coordinator of this site? Confirm its status | Venezia | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.