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Robot suit helps kids with movement disorders take steps at home

NCT ID NCT06765070

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests a wearable robotic exoskeleton called EXPLORER in 15 children with movement problems from conditions like cerebral palsy. The goal is to see if it helps them walk better in their everyday environments, such as home and the community. The study focuses on safety, ease of use, and how much it improves walking and participation in daily activities.

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 15 people

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

Started

Mar 2025

Expected to finish

Dec 2025

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

2 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 any pathology or condition causing neurodevelopmental disorders. * Ability to continuously use the device for two weeks, at least 3 times per week, without causing excessive fatigue that would prevent the participant from carrying out their usual activities. * Availability and commitment from the family to use the device at least 3 times per week during the planned period, in different environments and with various objectives. * Medical authorization for standing, gait training and weight bearing. * Informed consent signed by legal guardians. * Maximum user weight of 60 kg. * Hip width (between greater trochanters) ≤37 cm. * Length of the thigh (distance from the greater trochanter to the lateral condyle of the tibia) from 21cm to 36cm. * Tibia leg length (distance from the lateral condyle of the tibia to the lateral malleolus) from 20cm to 35cm. * Shoe size ≤40 (EU) Exclusion Criteria: * Medical contraindications for standing or walking. * Non-reducible contractures or heterotropic ossifications above the degrees allowed by the device or out of the trajectory imposed by the device * Spasticity equal to 4 on the Modified Ashworth Scale at the time of use of the device. * More than 20º of hip and/or knee non-reducible contractures at the time of using the exoskeleton. * Necessity to walk with more than 5º of hip abduction. * Impossibility to reach 5º of ankle dorsiflexion with ir without orthoses. * Lower length dysmetria that cannot be mitigated with a wedge under the foot. * Skin lesion on parts of the lower extremities that are in contact with the device. * History of fracture without trauma. * Presence of other conditions causing exercise intolerance (such as uncontrolled hypertension, coronary artery disease, arrhythmia, congestive heart failure, severe pulmonary disease). * Conductual disorders that may interfere with the use of the device or their participation in the study, like impulsiveness. * Allergy to any of the EXPLORER materials: cotton, nylon, polyester, PPS, PEEK or ABS.

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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.

Contacts and locations

Locations

  • Hospital Infantil Universitario Niño Jesús - Servicio de Rehabilitación

    Madrid, Madrid, 28009, Spain

  • Hospital Infantil Universitario Niño Jesús-Servicio de Neuro Ortopedia

    Madrid, Madrid, 28009, Spain

  • Hospital Universitario 12 Octubre

    Madrid, Madrid, 28041, Spain

  • Hospital Universitario Gregorio Marañón

    Madrid, Madrid, 28007, Spain

  • Hospital Universitario La Paz

    Madrid, Madrid, 28046, Spain

  • Universidad Rey Juan Carlos

    Alcorcón, Madrid, 28922, Spain

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