Bilateral robot-assisted rehabilitation for upper limb recovery in subacute stroke patients
Effects of Bilateral Upper Limb Robot-assisted Rehabilitation on Motor Recovery in Patients With Subacute Stroke: an Italian Multicenter Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS San Raffaele Roma Academic / other |
| Locations | 3 sites (Cassino, Italy and 2 other locations) |
| Trial ID | NCT06906588 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with unilateral hemipyramidal syndrome occurring within six months of a stroke.
Not a fit: Patients with unstable clinical conditions, severe visual impairment, or other neurological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance motor recovery and functional independence for stroke survivors.
How similar studies have performed: Previous studies have shown promising results for robotic-assisted therapies in stroke rehabilitation, indicating potential for success in this approach.
Eligibility criteria
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 this trial is running
Cassino, Italy and 2 other locations
- San Raffaele Cassino — Cassino, Italy, Italy (Not_yet_recruiting)
- IRCCS San Raffaele Roma — Rome, Italy, Italy (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.