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

Phase 4

Active, not recruiting

• Conditions: Guillain Barré Syndrome
• Interventions: Device: Armeo® Power 2 Exoskeleton - Active Rehabilitation with Feedback and Exercise Gaming; Device: Armeo® Power 2 Exoskeleton - Passive Mobilization without Feedback

• Registration Number: NCT06620198
• Lead Sponsor: I.R.C.C.S. Fondazione Santa Lucia

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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-26
• Study First Submitted QC: 2024-09-30
• Study Start: 2024-10-01
• Study First Posted: 2024-10-01
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-18
• Primary Completion: 2026-10-01
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 62

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active-assisted therapy with an upper limb robotic exoskeleton	Armeo® Power 2 Exoskeleton - Active Rehabilitation with Feedback and Exercise Gaming	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.
Passive mobilization with an upper limb robotic exoskeleton	Armeo® Power 2 Exoskeleton - Passive Mobilization without Feedback	Patients will undergo a neurorehabilitation intervention with a SHAM treatment under the guidance of the experimental therapist.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
The 36-Item Short-Form Health Survey (SF-36)	Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).	The SF-36 will be used to assess the change in health-related quality of life. The SF-36 is organized into 8 different domains that are divided into physical components (Physical functioning, limitations due to physical problems, bodily pain and general perceptions of health status) and mental components (Social functioning, general mental health, limitations due to emotional problems and vitality). Each of the 8 domain scores, added together, is linearly transformed on a scale from 0 to 100, where 0 equals negative health and 100 equals positive health.
modified Barthel Index (mBI)	Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).	The mBI will be used to assess the change in the autonomy of patients during their activities of daily living. This scale has a score ranging from 0 to 100 points, a higher score corresponds to a better performance in the activities of daily living.
ABILHAND	Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).	The ABILHAND will be used to assess manual dexterity. The ABILHAND is a questionnaire-based assessment tool that measures the difficulty a patient perceives in using their hands to perform manual operations and activities in daily living. It assesses upper limb functionality. It has nonlinear logit values ranging from 1.72 to -2.18.
The Medical Research Council scale (MRC)	Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).	The MRC will be used to assess muscle strength. The score ranges from 0 to 5 where 0 equals no muscle recruitment and 5 normal muscle force.
The nine hole peg test (NHPG).	Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).	The NHPG will be used to assess fine manual dexterity. The NHPT consists of a square board with 9 pegs. At one end of the board are holes to insert the pegs, and at the other end is a shallow round plate to store the extracted pegs. The NHPT is administered by asking the patient to take the pegs from a container, one by one, and insert them into the holes on the board, as quickly as possible.
Grip strength	Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).	Grip strength will be assessed using a manual digital dynamometer. The maximum strength of the whole hand will be recorded for three times without feedback (with the patient sitting with his back to the monitor).

Trial Locations

Locations (1)

IRCCS Santa Lucia Foundation; 🇮🇹 Rome, Lazio, Italy