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Robotic leg brace could help kids with CP walk better at home

NCT ID NCT06622655

Symptom relief Sponsor: IRCCS Eugenio Medea Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a powered leg brace called Agilik can help children with cerebral palsy who walk with bent knees (crouch gait). Forty children will either use the device at home for 2 months or receive standard therapy. Researchers will measure changes in walking endurance and knee extension, and check for any medical problems.

What this could mean

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

Active substance
Agilik powered orthosis (a wearable robotic device that helps with knee extension during walking)
What this could lead to
If it works, this could offer a new home-based therapy to improve walking endurance and knee control for children with cerebral palsy.
What could go wrong
This is a small early-stage trial with only 40 participants, so results may not apply to all. The device may not provide lasting improvement or could cause discomfort or safety issues.

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 40 people

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

Started

Oct 2024

Expected to finish

Nov 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

5 to 17 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: * Diagnosis of CP and a crouch gait * Provision of signed and dated informed consent form. * Stated willingness to comply with all study procedures and availability for the duration of the study, or alternatively, ability to do so based on parent report and physician observation during history and physical examination. * Body weight between 20 and 125 Kg * Knee flexion retraction assessed in supine position by less than 10°. Hamstring contracture as assessed by straight leg raising test does not limit ability to participate in the study. * Subjects must not have had a tibio-tarsal arthrodesis. In addition, they must have at least 5° of passive dorsi-flexion of the ankle. * Able to walk at least 3 m without stopping, with or without a walking aid. * Able to understand and follow simple directions based on parent report and physician observation during historical and physical examination. * GMFCS level I, II and III * MAS score ≤ 2 Exclusion Criteria: * Any severe neurological, musculoskeletal and/or cardiorespiratory involvement preventing the ability to walk; * A history of uncontrolled seizure in the past year * Severe spasticity * Hip and/or knee flexion contracture of more than 20°

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Conditions

The condition(s) this trial relates to.

cerebral palsy

As listed by the trial registrant

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

Cerebral palsy (CP)

How to take part

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

  1. The places running it

    6 sites. 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

  • Fondazione Don Carlo Gnocchi Onlus

    RECRUITING

    Roma, 00194, Italy

  • Fondazione Don Carlo Gnocchi Onlus - Centro S. Maria al Mare

    RECRUITING

    Salerno, 84131, Italy

  • Fondazione Don Carlo Gnocchi Onlus - IRCCS S. Maria Nascente

    RECRUITING

    Milan, 20148, Italy

  • Fondazione Mondino

    NOT_YET_RECRUITING

    Pavia, 27100, Italy

  • IRCCS E. MEDEA - Associazione "La Nostra Famiglia"

    RECRUITING

    Bosisio Parini, Lecco, 23842, Italy

  • IRCCS Fondazione Stella Maris

    NOT_YET_RECRUITING

    Calambrone, Pisa, 56128, Italy

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