Upper Limb Robot-Assisted Therapy in Patients with Guillain-Barré Syndrome (RAUL-Project)

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

Status and phase: Active, not recruiting; Phase 4

Conditions: Guillain Barré Syndrome

Treatments: Device: Armeo® Power 2 Exoskeleton - Passive Mobilization without Feedback; Device: Armeo® Power 2 Exoskeleton - Active Rehabilitation with Feedback and Exercise Gaming

Study type: Interventional

Funder types: Other

Identifiers

NCT06620198

110SL24

Details and patient eligibility

About

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.

Full description

Guillain-Barré Syndrome is a leading cause of acute flaccid paralysis, presenting with limb weakness and hyporeflexia or areflexia. Guillain-Barré Syndrome is an immune-mediated polyradiculoneuropathy, with around 100,000 new cases reported worldwide annually. This study aims to assess the effectiveness of a robot-assisted rehabilitation treatment for upper limb motor recovery in patients with Guillain-Barré Syndrome. A double-blind randomized trial will be conducted, where the experimental group will undergo actual robotic rehabilitation sessions, while the control group will perform sessions in which the robot will carry out simple mobilization, comparable to traditional interventions. This approach will help maintain participant blinding. Patients will be evaluated before and after treatment, and with two follow-up assessments 60 and 90 days after therapy initiation. Evaluations will include muscle recruitment and autonomy in daily living activities.

Enrollment: 62 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of Guillan-Barré Syndrome;
2. UL motor impairment (0-4 in the Medical Research Council scale);
3. sub-acute phase (until 180 days);
4. Patients able to maintain the sitting position.

Exclusion criteria

1. Concomitant neurological, orthopedic, metabolic, and oncological diseases;
2. Cognitive impairment assessed with the Mini Mental State Examination (score under 24 points);
3. Visual deficit;
4. Hearing disorders.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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62 participants in 2 patient groups

Active-assisted therapy with an upper limb robotic exoskeleton

Experimental group

Description:

Patients will receive upper limb neurorehabilitation training using a robotic exoskeleton administered by the therapist. 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. The computer-robot interface is designed to offer various exergames that require specific upper limb movements. All movements performed by the patient using the exoskeleton will provide immediate audiovisual feedback on the computer screen. The training will consist of 20 sessions, with five 45-minute sessions per week.

Treatment:

Device: Armeo® Power 2 Exoskeleton - Active Rehabilitation with Feedback and Exercise Gaming

Passive mobilization with an upper limb robotic exoskeleton

Active Comparator group

Description:

Patients will undergo a neurorehabilitation intervention with a SHAM treatment under the guidance of the experimental therapist.

Treatment:

Device: Armeo® Power 2 Exoskeleton - Passive Mobilization without Feedback