Actively Recruiting
Bilateral Robot-assisted Upper Extremity Rehabilitation on Motor Recovery in People With Subacute Stroke
Led by IRCCS San Raffaele Roma · Updated on 2025-04-04
70
Participants Needed
3
Research Sites
136 weeks
Total Duration
On this page
Sponsors
I
IRCCS San Raffaele Roma
Lead Sponsor
M
Ministry of Health, Italy
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Bilateral Robot-assisted Upper Extremity Rehabilitation on Motor Recovery in People With Subacute Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Both sexes
- Age greater than 18 years
- Unilateral hemipyramidal syndrome confirmed by brain CT or MRI
- Stroke occurred within the last 6 months
- Modified Ashworth Scale (MAS) for shoulder, elbow, and wrist less than 3
- Ability to understand and sign the informed consent
- Ability to perform study procedures
You will not qualify if you...
- Unstable general clinical conditions
- Severe bilateral pyramidal syndrome or severe visual impairment
- Recent or planned Botulinum Toxin injection to the affected upper limb during study
- Treatment interruption for 1 week or 5 consecutive sessions
- Inability to follow the exercise program due to poor compliance
- Neurological disorders beyond stroke, psychiatric complications, or personality disorders
- Osteoarticular or neuromuscular conditions affecting upper limb motor skills
- Not having signed informed consent to participate
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
San Raffaele Cassino
Cassino, Italy, Italy, 03043
Not Yet Recruiting
2
IRCCS San Raffaele Roma
Rome, Italy, Italy, 00166
Actively Recruiting
3
San Raffaele Sulmona
Sulmona, Italy, Italy, 67039
Not Yet Recruiting
Research Team
D
Dr. Sanaz Pournajaf, DPT
CONTACT
D
Dr. Elena Sofia Cocco, Bioengineer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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