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ACTIVE NOT RECRUITING
NCT06620198
PHASE4

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

Sponsor: I.R.C.C.S. Fondazione Santa Lucia

View on ClinicalTrials.gov

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.

Official title: Effects of Robot-Assisted Therapy for Upper Limb Functional Recovery in Patients with Guillain-Barré Syndrome: a Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

62

Start Date

2024-10-01

Completion Date

2027-10-01

Last Updated

2025-03-18

Healthy Volunteers

No

Interventions

DEVICE

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.

DEVICE

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.

Locations (1)

IRCCS Santa Lucia Foundation

Rome, Lazio, Italy