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

NCT ID: NCT06620198

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2027-10-01

Brief 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.

Detailed 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.

Conditions

Guillain Barré Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active-assisted therapy with an upper limb robotic exoskeleton

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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.

Passive mobilization with an upper limb robotic exoskeleton

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

Group Type: ACTIVE_COMPARATOR

Armeo® Power 2 Exoskeleton - Passive Mobilization without Feedback

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alex Martino Cinnera, PhD

Role: STUDY_CHAIR

IRCCS Santa Lucia Foundation

Diego Piatti, BSc

Role: STUDY_CHAIR

IRCCS Santa Lucia Foundation

Laura Casagrande Conti, MSc

Role: STUDY_DIRECTOR

IRCCS Santa Lucia Foundation

Martina D Arienzo, BSc

Role: STUDY_DIRECTOR

IRCCS Santa Lucia Foundation

Locations

IRCCS Santa Lucia Foundation

Rome, Lazio, Italy

Countries

Italy

Other Identifiers

110SL24

Identifier Type: -

Identifier Source: org_study_id