Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Bilateral robot-assisted rehabilitation for upper limb recovery in subacute stroke patients

Official title: Effects of Bilateral Upper Limb Robot-assisted Rehabilitation on Motor Recovery in Patients With Subacute Stroke: an Italian Multicenter Randomized Controlled Trial

Run by IRCCS San Raffaele Roma · NCT06906588 · Data updated 2026-11-12

This study tests if using robotic therapy can help people who have had a stroke recover better use of their arms compared to regular rehab methods.

More Stroke trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment70 (estimated)
SponsorIRCCS San Raffaele Roma
Academic / other
Locations3 sites (Cassino, Italy and 2 other locations)
StatusRecruiting
StartedMay 19, 2024
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedOctober 19, 2026
Trial IDNCT06906588 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults over 18 years old with unilateral hemipyramidal syndrome occurring within six months of a stroke.

Probably not a fit

Patients with unstable clinical conditions, severe visual impairment, or other neurological disorders may not benefit from this study.

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

What this trial studies

This clinical trial investigates the effectiveness of Bilateral Robot-Assisted Therapy (BRAT) in improving motor recovery of the upper limbs in individuals with subacute stroke. Participants will be randomly assigned to either the experimental group receiving BRAT or a control group undergoing conventional rehabilitation. The study aims to measure improvements in motor function using the Fugl-Meyer Assessment - Upper Limb (FMA-UL). The trial seeks to determine if robotic rehabilitation can provide better outcomes compared to standard arm re-education methods.

Why it matters

Potential benefit: If successful, this approach could significantly enhance motor recovery and functional independence for stroke survivors.

How similar studies have gone: Previous studies have shown promising results for robotic-assisted therapies in stroke rehabilitation, indicating potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Both sexes;
* Age \>18 years;
* Unilateral hemipyramidal syndrome as demonstrated by a brain CT or MRI;
* Distance from acute event \< 6 months;
* Modified Ashworth Scale (MAS) of shoulder, elbow, and wrist \<3;
* Ability to understand and sign the informed consent for the study;
* Ability to perform the study procedures.

Exclusion Criteria:

* Unstable general clinical conditions;
* Bilateral pyramidal hemisyndrome severe visual impairment;
* Recent injection of Botulinum Toxin to the affected upper limb or planned for the duration of the study;
* Interruption of treatment for 1 week or 5 consecutive sessions;
* Inability to adhere to the exercise program due to poor compliance;
* Presence of neurological pathologies superimposed on the stroke event, psychiatric complications or personality disorders;
* Presence of osteoarticular and neuromuscular pathologies that may compromise the motor skills of the upper limb;
* Participants who have not signed the informed consent to the study.

Where it's running

  • IRCCS San Raffaele Roma
    Rome, Italy, Italy
    Recruiting
  • San Raffaele Cassino
    Cassino, Italy, Italy
    Not yet recruiting
  • San Raffaele Sulmona
    Sulmona, Italy, Italy
    Not yet recruiting

Study contacts

Similar studies

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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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.