Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06906588

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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