Guillain Barré SyndromePhase 4RAUL-ProjectNCT06620198

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

A Phase 4 study testing Armeo® Power 2 Exoskeleton - Active Rehabilitation with Feedback and Exercise Gaming and Armeo® Power 2 Exoskeleton - Passive Mobilization without Feedback in people with Guillain Barré Syndrome, run by I.R.C.C.S. Fondazione Santa Lucia at 1 site in Italy.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Guillain Barré Syndrome
What is being tested?: Armeo® Power 2 Exoskeleton - Active Rehabilitation with Feedback and Exercise Gaming and Armeo® Power 2 Exoskeleton - Passive Mobilization without Feedback
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 62 participants
Where: 1 siteItaly
Study dates: 1 Oct 2024to 1 Oct 2027
Phase: Phase 4
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site

IRCCS Santa Lucia Foundation
Rome, Lazio, 00179

Other trials in Italy

About this study

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

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.

Read the 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
Being tested: Armeo® Power 2 Exoskeleton - Active Rehabilitation with Feedback and Exercise Gaming, Armeo® Power 2 Exoskeleton - Passive Mobilization without Feedback
Keywords: Polyradiculopathy, Chronic Inflammatory Demyelinating Polyradiculoneuropathy, Polyradiculoneuropathy, Exoskeleton device, Robotic Rehabilitation
Medical subject headings: Guillain-Barre Syndrome, Polyradiculopathy, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, Polyradiculoneuropathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Armeo® Power 2 Exoskeleton - Active Rehabilitation with Feedback and Exercise GamingDevice
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.
Armeo® Power 2 Exoskeleton - Passive Mobilization without FeedbackDevice
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.

Study groups in NCT06620198
Study group	Role	What they receive
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. Receives: 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. Receives: Device: Armeo® Power 2 Exoskeleton - Passive Mobilization without Feedback

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (6)

The 36-Item Short-Form Health Survey (SF-36)
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.
Measured: Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).
modified Barthel Index (mBI)
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.
Measured: Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).
ABILHAND
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.
Measured: Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).
The Medical Research Council scale (MRC)
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.
Measured: Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).
The nine hole peg test (NHPG).
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.
Measured: Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).
Grip strength
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).
Measured: Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20241 Oct 2027

First posted1 Oct 2024
Study start1 Oct 2024
Primary completion1 Oct 2026 (estimated)
Study completion1 Oct 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Guillain Barré SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized Clinical Trial
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 62 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06620198
Sponsor's protocol ID: 110SL24
Acronym: RAUL-Project
Status last verified: Sep 2026
First submitted: 26 Sep 2024
Last updated: 18 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
High-Tech Rehabilitation Pathway for Acute Adult Neuromuscular Diseases - Fit4MedRob-Acute MND Project
Critical Illness Myopathy, Guillain Barré Syndrome
Not yet recruitingPhase 2
A Study of Empasiprubart as Add-On Therapy to IVIg in Adult Participants With Guillain-Barré Syndrome
Guillain-Barré Syndrome (GBS)
RecruitingPhase 3
An Open Label Clinical Study to Evaluate Tanruprubart (Also Commonly Known as ANX005) in Participants With Guillain-Barré Syndrome (FORWARD Study)
Guillain-Barre Syndrome
Not yet recruitingObservational study
Peripheral Nerve Ultrasound in Children With Guillain-Barré Syndrome
Guillain-Barre Syndrome
Not yet recruitingObservational study
Myocardial Changes in Pediatric Guillain-Barré Syndrome
Myocardial Dysfunction, Guillain-Barre Syndrome

All Guillain Barré Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Robot-Assisted Therapy for Upper Limb Functional Recovery in Patients With Guillain-Barré Syndrome: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT06620198
Acronym / sponsor ID: RAUL-Project / 110SL24
Conditions: Guillain Barré Syndrome
Keywords: Polyradiculopathy, Chronic Inflammatory Demyelinating Polyradiculoneuropathy, Polyradiculoneuropathy, Exoskeleton device, Robotic Rehabilitation
Phase: Phase 4
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 62 participants (estimated)
Lead sponsor: I.R.C.C.S. Fondazione Santa LuciaUniversity, hospital or other
Study start: 1 Oct 2024 (actual)
Primary completion: 1 Oct 2026 (estimated)
Study completion: 1 Oct 2027 (estimated)
First posted: 1 Oct 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Guillain-Barré Syndrome is an immune-mediated polyradiculoneuropathy, with around 100,000 new cases reported worldwide annually.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: Randomized Clinical Trial

Arm	Type	Receives
Active-assisted therapy with an upper limb robotic exoskeleton	Experimental	Device: Armeo® Power 2 Exoskeleton - Active Rehabilitation with Feedback and Exercise GamingPatients 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	Active comparator	Device: Armeo® Power 2 Exoskeleton - Passive Mobilization without FeedbackPatients will undergo a neurorehabilitation intervention with a SHAM treatment under the guidance of the experimental therapist.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Armeo® Power 2 Exoskeleton - Active Rehabilitation with Feedback and Exercise GamingPatients 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	Active-assisted therapy with an upper limb robotic exoskeleton
Armeo® Power 2 Exoskeleton - Passive Mobilization without FeedbackPatients 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.	Device	Passive mobilization with an upper limb robotic exoskeleton

Primary outcome

Fugl-Meyer Assessment scale for Upper Extremity (FMAUE)
Time frame: 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.

6 secondary outcomes

The 36-Item Short-Form Health Survey (SF-36)
Time frame: Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).
modified Barthel Index (mBI)
Time frame: Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).
ABILHAND
Time frame: Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).
The Medical Research Council scale (MRC)
Time frame: Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).
The nine hole peg test (NHPG).
Time frame: Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).
Grip strength
Time frame: Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
Individual participant dataSharing planned: Yes

Related trials for Guillain Barré Syndrome

Recruiting
High-Tech Rehabilitation Pathway for Acute Adult Neuromuscular Diseases - Fit4MedRob-Acute MND Project
Critical Illness Myopathy, Guillain Barré Syndrome
Not yet recruitingPhase 2
A Study of Empasiprubart as Add-On Therapy to IVIg in Adult Participants With Guillain-Barré Syndrome
Guillain-Barré Syndrome (GBS)
RecruitingPhase 3
An Open Label Clinical Study to Evaluate Tanruprubart (Also Commonly Known as ANX005) in Participants With Guillain-Barré Syndrome (FORWARD Study)
Guillain-Barre Syndrome
Not yet recruitingObservational study
Peripheral Nerve Ultrasound in Children With Guillain-Barré Syndrome
Guillain-Barre Syndrome
Not yet recruitingObservational study
Myocardial Changes in Pediatric Guillain-Barré Syndrome
Myocardial Dysfunction, Guillain-Barre Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alex Martino Cinnera, PhD study chair

IRCCS Santa Lucia Foundation

Diego Piatti, BSc study chair

IRCCS Santa Lucia Foundation

Laura Casagrande Conti, MSc study director

IRCCS Santa Lucia Foundation

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fugl-Meyer Assessment scale for Upper Extremity (FMAUE) (time frame: Baseline (t0); 30 days (t1); 60 days (t2); 90 days (t3).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06620198.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.