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โ† Trials
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Bilateral Robot-assisted Upper Extremity Rehabilitation on Motor Recovery in People With Subacute Stroke

RecruitingNAAges 18 Years - anyAllIRCCS San Raffaele Roma
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In plain words

What the trial is, and whether it could suit you

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 t

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Experimental
  • Control
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Where

3 sites
San Raffaele Cassino
Cassino, Italy
IRCCS San Raffaele Roma
Rome, Italy
San Raffaele Sulmona
Sulmona, Italy
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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