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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | IRCCS San Raffaele Roma Academic / other |
| Locations | 3 sites (Cassino, Italy and 2 other locations) |
| Status | Recruiting |
| Started | May 19, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | October 19, 2026 |
| Trial ID | NCT06906588 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
- Principal investigator: Dr. Sanaz Pournajaf, DPT — IRCCS San Raffaele Roma
- Study coordinator: Dr. Sanaz Pournajaf, DPT
- Email: sanaz.pournajaf@sanraffaele.it
- Phone: +39-06-52252405
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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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.
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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.
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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.
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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.
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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.
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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.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.