Upper Limb Robot-Assisted Therapy in Patients With Guillain-Barré Syndrome

Condition(s) studied

Investigational drug(s) / intervention(s)

Armeo® Power 2 Exoskeleton - Active Rehabilitation with Feedback and Exercise Gaming: Patients will undergo 20 session of 45 minutes each with an exoskeleton for upper limb rehabilitation. The assistance provided by the device is adjusted based on the maximum force (as a percentage of the upper limb's weight) the robot needs to exert to assist the patient's movements. Each session will include exercises designed to improve the range of motion (ROM) of the shoulder, elbow, wrist, and enhance hand coordination. The training parameters, such as difficulty level, duration, and visual stimuli, will be adjusted based on the patient's residual abilities. The selected exercises may involve movements of a single joint along one axis, combined movements of a single joint around 2 or 3 axes, selective exercises for the opening and closing hand, or multi-joint exercises. All exercises will be realized with audiovisual feedback.

Armeo® Power 2 Exoskeleton - Passive Mobilization without Feedback: Patients will undergo 20 session of 45 minute of a neurorehabilitation intervention with a SHAM treatment under the guidance of the experimental therapist. This will involve passive mobilization using the exoskeleton for the upper limb, without any audiovisual feedback. They will not realize any active movement during the training.

Study summary

Guillain-Barré Syndrome is an immune-mediated polyradiculoneuropathy, with around 100,000 new cases reported worldwide annually.

The aim of this double-blind randomized controlled trial with a SHAM control group is to evaluate the effects of robot-assisted therapy, integrated with conventional therapy, on upper limb motor recovery in patients with GBS.

Eligibility

Primary outcome measure(s)

• Fugl-Meyer Assessment scale for Upper Extremity (FMAUE) — Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).
  THE FMAUE will be used to assess the change in the motor and sensory functions of the upper limb. The FMAUE included five domains: motor functioning, sensitivity, coordination, range of motion and pain. The score ranging from 0 to 66 points, a higher score corresponds to a better function of the upper limb.

Trial sites (1)

More I.R.C.C.S. Fondazione Santa Lucia trials in Italy

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