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

Recruiting now · Not applicable

Conditions studied: Stroke, Sabacute Stroke

In brief

The goal of this clinical trial is to study the clinical effects of a robotic rehabilitation treatment through a bilateral exoskeleton (Bilateral Robot-Assisted Therapy-BRAT) during standard rehabilitation, on motor recovery, compared to conventional arm re-education in people suffering from stroke in the subacute phase. The main question it aims to answer is what the effectiveness of Bilateral Robot-Assisted Therapy (BRAT) is in rehabilitating the upper limb in individuals with subacute stroke compared to conventional rehabilitation treatment in terms of motor function improvement as measured by the Fugl-Meyer Assessment - Upper Limb (FMA-UL), motor domain. Researchers will compare two groups (Experimental Group - EG and Control Group - CG) to see if the BRAT is more effective than conventional rehabilitation treatment in terms of motor recovery. Participants will be randomly assigned to one of the two treatment groups (EG or CG) and will be clinically and instrumentally evaluated at baseline (T0) and at the end of treatment (T1). EG, in addition to the standard rehabilitation treatment, will perform a 45-minute session of BRAT per day through the Arm Light Exoskeleton Hybrid (Alex RS - Wearable Robotics) robotic system. The CG, in addition to the standard routine rehabilitation treatment, will follow a conventional rehabilitation of the upper limbs without the use of technological devices. Finally, a telephone follow-up is scheduled three months after the end of the treatment.

Key facts

Study ID

NCT06906588

Run by

IRCCS San Raffaele Roma

People needed

70

Starts

2024-05-19

Expected to finish

2026-12-31

Last updated by the study team

2025-04-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• IRCCS San Raffaele Roma — Rome, Italy, Italy (enrolling)
• San Raffaele Cassino — Cassino, Italy, Italy
• San Raffaele Sulmona — Sulmona, Italy, Italy

Full record on ClinicalTrials.gov

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