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Can a robotic exoskeleton rebuild arm strength after Guillain-Barré?

NCT ID NCT06620198

Symptom relief Sponsor: I.R.C.C.S. Fondazione Santa Lucia Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Guillain-Barré syndrome can leave people with weak arms and hands, making daily tasks hard. This trial tests whether adding robot-assisted arm training to usual therapy helps adults in the sub-acute phase of recovery. Participants use the Armeo Power 2 exoskeleton for 20 sessions of 45 minutes, playing exercise games that adjust to their strength. Researchers compare this with a sham control to see if it improves arm function and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Robot-assisted arm rehabilitation using the Armeo Power 2 exoskeleton with exercise gaming
What this could lead to
If it works, robot-assisted training could become a standard add-on to conventional therapy for people recovering arm function after Guillain-Barré syndrome.
What could go wrong
The trial is small, with 62 participants, and robot-assisted therapy may not outperform sham training. Results may not apply to people with severe weakness or other neurological conditions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 62 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

chronic inflammatory demyelinating polyradiculoneuropathy Guillain-Barre syndrome polyradiculoneuropathy polyradiculopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Guillain Barré syndrome

Contacts and locations

Locations

  • IRCCS Santa Lucia Foundation

    Rome, Lazio, 00179, Italy

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