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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIRCCS San Raffaele Roma

About this trial

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.

Eligibility criteria

Qualifiers

Both sexes;

Age >18 years;

Unilateral hemipyramidal syndrome as demonstrated by a brain CT or MRI;

Distance from acute event < 6 months;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Experimental
  • Control

Treatment groups

70 Participants
are divided into 2 treatment groups

Sponsors and collaborators

IRCCS San Raffaele Roma

Lead sponsor

Ministry of Health, Italy

Collaborator