Bilateral Robot-assisted Upper Extremity Rehabilitation on Motor Recovery in People With Subacute Stroke

Launched by IRCCS SAN RAFFAELE ROMA · Mar 26, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a new robotic rehabilitation treatment called Bilateral Robot-Assisted Therapy (BRAT) for people recovering from a stroke. The goal is to see if using this robotic device, along with standard rehabilitation, can help improve arm movement better than traditional therapy alone. Participants will be divided into two groups: one will use the robotic device along with their usual therapy, while the other will receive only the standard treatment. Researchers will evaluate how well each group improves over the course of the trial.

To participate in this study, individuals must be over 18 years old and have had a stroke within the last six months that affects one side of their body. They should also be able to understand and agree to participate in the study. Participants can expect to engage in daily rehabilitation sessions, including 45 minutes with the robotic device if they’re in the experimental group. After completing the treatment, there will be a follow-up call three months later to check on their progress. This trial is currently looking for volunteers, and it’s a great opportunity for those who meet the criteria to explore new ways to enhance their recovery.

Gender

ALL

Eligibility 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.