Can a soft robot help damaged brains move again?
NCT ID NCT07750314
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 Hide 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Acquired brain injury are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Could music be medicine for the injured brain?
- Exercise as medicine: could a simple movement program help adults recover after brain injury?
- Can a balance-training program help brain injury survivors walk safer and live better?
- Can talk therapy tame brain Injury's emotional storm?
- New french scale to measure sensation in brain injury patients
- Could a magnetic headset boost brain power after injury or illness?