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

NCT06620198 | Active Not Recruiting Phase 4

• 1 other identifier: 110SL24
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Guillain Barré Syndrome

Keywords

Polyradiculopathy; Chronic Inflammatory Demyelinating Polyradiculoneuropathy; Polyradiculoneuropathy; Exoskeleton device; Robotic Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment scale for Upper Extremity (FMAUE)

  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.

  Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).

Secondary Outcomes (6)

• The 36-Item Short-Form Health Survey (SF-36)

  Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).

• modified Barthel Index (mBI)

  Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).

• ABILHAND

  Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).

• The Medical Research Council scale (MRC)

  Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).

• The nine hole peg test (NHPG).

  Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).

Other Outcomes (1)

• Mini-Mental State Examination (MMSE)

  T0 (Baseline)

Study Arms (2)

Active-assisted therapy with an upper limb robotic exoskeleton

EXPERIMENTAL

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.

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

Passive mobilization with an upper limb robotic exoskeleton

ACTIVE COMPARATOR

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

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

Interventions

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

Active-assisted therapy with an upper limb robotic exoskeleton

Armeo® Power 2 Exoskeleton - Passive Mobilization without Feedback 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.

Passive mobilization with an upper limb robotic exoskeleton

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• I.R.C.C.S. Fondazione Santa Lucia: lead

Study Sites (1)

IRCCS Santa Lucia Foundation

Rome, Lazio, 00179, Italy

Location

MeSH Terms

Conditions

Guillain-Barre Syndrome; Polyradiculopathy; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; Polyradiculoneuropathy

Condition Hierarchy (Ancestors)

Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alex Martino Cinnera, PhD

  IRCCS Santa Lucia Foundation

  STUDY CHAIR

• Diego Piatti, BSc

  IRCCS Santa Lucia Foundation

  STUDY CHAIR

• Laura Casagrande Conti, MSc

  IRCCS Santa Lucia Foundation

  STUDY DIRECTOR

• Martina D Arienzo, BSc

  IRCCS Santa Lucia Foundation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Assessors, Patients and their caregivers will be blinded for the entire duration of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Clinical Trial

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 1, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 18, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 2024/10/01
• Access Criteria: on resonable request to the study\' PI

Locations

IT (1)