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Can a soft robot help damaged brains move again?

NCT ID NCT07750314

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This trial tests a soft, wearable robotic exoskeleton designed to assist arm and hand movements in people with acquired brain injury. Participants, including healthy volunteers, perform a set of arm movements with and without the device's help. The study measures how usable the device feels and whether it changes muscle activity, aiming to see if this gentle robot could support rehabilitation and daily assistance.

What this could mean

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

Active substance
FRONTIER soft exoskeleton, a wearable robotic device that assists upper limb movements
What this could lead to
If it works, this could lead to a comfortable, wearable robot that helps people with brain injuries regain arm movement and independence.
What could go wrong
This is a small early feasibility study, so the device may not prove effective or comfortable for everyone. It only tests short-term use, not long-term benefits.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

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

Accepted

You do not need to have the condition being studied to take part.

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: Healthy volunteers: * Male and female participants * Age ≥ 18 and ≤ 80 years * Absence of neurological, neuromuscular, or orthopedic conditions that may affect upper-limb use * Willingness to comply with study procedures and to sign the informed consent form * Ability to understand and sign the informed consent form Patients: * Male and female participants * Age ≥ 18 and ≤ 80 years * Clinical diagnosis of acquired brain injury (ABI), in the chronic phase (≥ 6 months after the event) * Persistent upper-limb motor impairment * Medically stable condition and ability to sit upright or stand for the duration of the testing session * Willingness to participate in the study intervention * Ability to understand and sign the informed consent form * Preserved cognitive function, assessed by the Mini-Mental State Examination (MMSE ≥ 24/30) Exclusion Criteria: Healthy volunteers: * Age \< 18 or \> 80 years * Women who are pregnant, breastfeeding, or planning to become pregnant during the study period Patients: * Age \< 18 or \> 80 years * Cognitive impairment interfering with the understanding of the tasks or study protocol, assessed by the Mini-Mental State Examination (MMSE \< 24/30) * Women who are pregnant, breastfeeding, or planning to become pregnant during the study period

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • IRCCS Ospedale San Raffaele

    Milan, Milan, 20132, Italy

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