Rehabilitation for stroke patients using robotics and digital technologies

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

This study is testing if using robots and digital tools for rehabilitation can help stroke patients recover better than traditional methods.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 596 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fondazione Don Carlo Gnocchi Onlus (Academic / other)
• Locations: 13 sites (Acerenza and 12 other locations)
• Trial ID: NCT06547827 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and over who have experienced their first stroke within the last six months and have varying degrees of upper and/or lower limb impairment.

Not a fit: Patients with clinical instability or severe cognitive deficits that hinder compliance with rehabilitation protocols may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance rehabilitation outcomes for stroke patients, leading to improved daily functioning and quality of life.

How similar studies have performed: While there is ongoing debate regarding the effectiveness of robotic rehabilitation, this study aims to provide clearer evidence through a large-scale, pragmatic approach.

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.

Where this trial is running

Acerenza and 12 other locations

• Fondazione Don Carlo Gnocchi, Centro Gala — Acerenza, Italy (Recruiting)
• IRCCS Istituti Clinici Scientifici Maugeri — Bari, Italy (Not_yet_recruiting)
• IRCCS Ospedale Policlinico San Martino, — Genova, Italy (Recruiting)
• Fondazione Don Carlo Gnocchi, IRCCS Santa Maria Nascente — Milan, Italy (Not_yet_recruiting)
• IRCCS Istituti Clinici Scientifici Maugeri — Milan, Italy (Not_yet_recruiting)
• IRCCS Istituti Clinici Scientifici Maugeri — Montescano, Italy (Recruiting)
• IRCCS Fondazione Mondino — Pavia, Italy (Recruiting)
• IRCCS Istituti Clinici Scientifici Maugeri — Pavia, Italy (Recruiting)
• Fondazione Don Carlo Gnocchi, Centro Santa Maria della Provvidenza — Roma, Italy (Recruiting)
• Fondazione Don Carlo Gnocchi, Centro Santa Maria al Mare — Salerno, Italy (Not_yet_recruiting)
• Fondazione Don Carlo Gnocchi, Polo Specialistico Riabilitativo — Sant'Angelo dei Lombardi, Italy (Recruiting)
• IRCCS Istituti Clinici Scientifici Maugeri — Telese Terme, Italy (Not_yet_recruiting)
• Fondazione Don Carlo Gnocchi, Polo specialistico riabilitativo — Tricarico, Italy (Recruiting)

Study contacts

• Principal investigator: Irene G Aprile — IRCCS Fondazione Don Carlo Gnocchi
• Study coordinator: Irene G Aprile, MD, PhD

Conditions Stroke; rehabilitation; robotics