Neuromuscular DisordersNCT06765070
Efficacy and Usability of the EXPLORER Exoskeleton in Children With Neurodevelopmental Disorders in Natural Environments
A study testing EXPLORER in people with Neuromuscular Disorders and Neurodevelopmental Disorders, run by MarsiBionics at 6 sites in Spain.
Trial summary
Neurodevelopmental disorders often lead to abnormal development of the Central Nervous System (CNS), frequently causing motor dysfunctions such as an inability to stand and walk. EXPLORER is a robotic gait exoskeleton designed to rehabilitate children with motor disabilities in home and outdoor environments. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Neuromuscular Disorders, Neurodevelopmental Disorders
- What is being tested?
- EXPLORER
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 6 sitesSpain
- Study dates
- 1 Mar 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
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- 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)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites
Universidad Rey Juan Carlos
Alcorcón, Madrid, 28922
Hospital Universitario Gregorio Marañón
Madrid, Madrid, 28007
Hospital Infantil Universitario Niño Jesús - Servicio de Rehabilitación
Madrid, Madrid, 28009
Hospital Infantil Universitario Niño Jesús-Servicio de Neuro Ortopedia
Madrid, Madrid, 28009
Hospital Universitario 12 Octubre
Madrid, Madrid, 28041
Hospital Universitario La Paz
Madrid, Madrid, 28046
About this study
Official title: Efficacy and Usability of the EXPLORER Exoskeleton in Children With Neurodevelopmental Disorders in Their Natural Environment
Neurodevelopmental disorders often lead to abnormal development of the Central Nervous System (CNS), frequently causing motor dysfunctions such as an inability to stand and walk. EXPLORER is a robotic gait exoskeleton designed to rehabilitate children with motor disabilities in home and outdoor environments.
The aim of this study is to evaluate the efficacy and usability of EXPLORER in children with motor disability within their natural settings, including home and community environments.
Read the detailed description
Neurodevelopmental disorders often lead to abnormal development of the Central Nervous System (CNS), frequently causing motor dysfunctions such as an inability to stand and walk. Robotic devices are a useful tool in the rehabilitation of these children, but most of them are designed to be used in the clinical setting. EXPLORER is a robotic device designed to assist gait in children with motor disability in their homes and the community. The aim of this study is to evaluate the efficacy and usability of EXPLORER in children with motor disability within their natural settings, including home and community environments.
An initial session will be conducted in the participant's natural environment, during which the researchers will instruct the primary caregivers on the use of the device. Subsequently, the device will be left for a two-month period for use in the natural settings deemed appropriate by the family.
- Being tested
- EXPLORER
- Keywords
- Neurodevelopmental disorders, Neuromuscular disorders, cerebral palsy, acquired brain injury, spinal muscular atrophy, robotics, gait, rehabilitation, spinal cord injury
- Medical subject headings
- Neuromuscular Diseases, Neurodevelopmental Disorders, Cerebral Palsy, Brain Injuries, Muscular Atrophy, Spinal, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXPLORERDevice
Two-week period with the robotics gait device for use in the natural settings deemed appropriate by the family.
| Study group | Role | What they receive |
|---|---|---|
| EXPLORER | Experimental | Two-week period with the robotics gait device for use in the natural settings deemed appropriate by the family. Receives: Device: EXPLORER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Adverse Events
occurrence of any serious adverse event to the participant or the caregiver
Measured: through study completion, along 2 weeks
Falls prevalence
Number of falling events occurred from the participant or caregiver
Measured: through study completion, along 2 weeks
Skin integrity
Occurrence of any injury of the skin in the areas of contact and produced by the use of the device
Measured: through study completion, along 2 weeks
Pain (Visual Analogic Scale)
pain measured by the Visual Analogic Scale (VAS) by the participant and the caregiver, scored from 0 to 10, being 0 "no pain" and 10 "unbearable pain"
Measured: through study completion, along 2 weeks
Donning and doffing time
Time to don and doff the device to each participant
Measured: through study completion, along 2 weeks
Device usage time
Time using the device
Measured: through study completion, along 2 weeks
Number of steps
number of steps with the device
Measured: through study completion, along 2 weeks
Usage modes
two different usage modes (active and automatic).
Measured: through study completion, along 2 weeks
Speed
speed achieved with the device (steps per minute)
Measured: through study completion, along 2 weeks
Device accessibility
Environments where the device has been used and level of accessibility in each environment measured with a 5 points Likert scale (0 not accessible - 5 very accessible)
Measured: through study completion, along 2 weeks
Range of motion
Passive Degree to which a joint can move (hip, knee, and ankle joints in both legs). From 0º to 180º.
Measured: Before starting the intervention (S1) and after completing the two weeks of use
Participation
Measured with the Child and Adolescent Scale of Participation. 20 ordinal scaled items across 4 subsections.
Maximum total score is 80 (20 items x 4) and the minimum total score is 20 (20 items x 1)
Measured: Before starting the intervention (S1) and after completing the two weeks of use
Secondary outcomes (1)
QUEST
Using the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) questionnaire administered to the participants' caregivers at the end of the intervention. The QUEST 2.0 scale has 12 items. Each item is rated on a 5-point Likert scale
Measured: at the end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start1 Mar 2025
- Primary completion1 Apr 2025
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MarsiBionics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Infantil Universitario Niño Jesús, Madrid, Spain, Hospital General Universitario Gregorio Marañon, Hospital Universitario La Paz, Hospital Universitario 12 de Octubre, Universidad Rey Juan Carlos
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765070
- Sponsor's protocol ID
- EXP-I-EF
- Status last verified
- Sep 2025
- First submitted
- 20 Dec 2024
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Usability of the EXPLORER Exoskeleton in Children With Neurodevelopmental Disorders in Their Natural Environment
- ClinicalTrials.gov ID
- NCT06765070
- Acronym / sponsor ID
- EXP-I-EF
- Keywords
- Neurodevelopmental disorders, Neuromuscular disorders, cerebral palsy, acquired brain injury, spinal muscular atrophy, robotics, gait, rehabilitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- MarsiBionicsIndustry (pharma, biotech, devices)
- Collaborators
- Hospital Infantil Universitario Niño Jesús, Madrid, Spain, Hospital General Universitario Gregorio Marañon, Hospital Universitario La Paz, Hospital Universitario 12 de Octubre, Universidad Rey Juan Carlos
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neurodevelopmental disorders often lead to abnormal development of the Central Nervous System (CNS), frequently causing motor dysfunctions such as an inability to stand and walk. EXPLORER is a robotic gait exoskeleton designed to rehabilitate children with motor disabilities in home and outdoor environments.
The aim of this study is to evaluate the efficacy and usability of EXPLORER in children with motor disability within their natural settings, including home and community environments.
Detailed description
Neurodevelopmental disorders often lead to abnormal development of the Central Nervous System (CNS), frequently causing motor dysfunctions such as an inability to stand and walk. Robotic devices are a useful tool in the rehabilitation of these children, but most of them are designed to be used in the clinical setting. EXPLORER is a robotic device designed to assist gait in children with motor disability in their homes and the community. The aim of this study is to evaluate the efficacy and usability of EXPLORER in children with motor disability within their natural settings, including home and community environments.
An initial session will be conducted in the participant's natural environment, during which the researchers will instruct the primary caregivers on the use of the device. Subsequently, the device will be left for a two-month period for use in the natural settings deemed appropriate by the family.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EXPLORER | Experimental | Device: EXPLORERTwo-week period with the robotics gait device for use in the natural settings deemed appropriate by the family. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EXPLORERTwo-week period with the robotics gait device for use in the natural settings deemed appropriate by the family. | Device | EXPLORER |
Primary outcome
Serious Adverse Events
Time frame: through study completion, along 2 weeks
occurrence of any serious adverse event to the participant or the caregiver
Falls prevalence
Time frame: through study completion, along 2 weeks
Number of falling events occurred from the participant or caregiver
Skin integrity
Time frame: through study completion, along 2 weeks
Occurrence of any injury of the skin in the areas of contact and produced by the use of the device
Pain (Visual Analogic Scale)
Time frame: through study completion, along 2 weeks
pain measured by the Visual Analogic Scale (VAS) by the participant and the caregiver, scored from 0 to 10, being 0 "no pain" and 10 "unbearable pain"
Donning and doffing time
Time frame: through study completion, along 2 weeks
Time to don and doff the device to each participant
Device usage time
Time frame: through study completion, along 2 weeks
Time using the device
Number of steps
Time frame: through study completion, along 2 weeks
number of steps with the device
Usage modes
Time frame: through study completion, along 2 weeks
two different usage modes (active and automatic).
Speed
Time frame: through study completion, along 2 weeks
speed achieved with the device (steps per minute)
Device accessibility
Time frame: through study completion, along 2 weeks
Environments where the device has been used and level of accessibility in each environment measured with a 5 points Likert scale (0 not accessible - 5 very accessible)
Range of motion
Time frame: Before starting the intervention (S1) and after completing the two weeks of use
Passive Degree to which a joint can move (hip, knee, and ankle joints in both legs). From 0º to 180º.
Participation
Time frame: Before starting the intervention (S1) and after completing the two weeks of use
Measured with the Child and Adolescent Scale of Participation. 20 ordinal scaled items across 4 subsections. Maximum total score is 80 (20 items x 4) and the minimum total score is 20 (20 items x 1)
1 secondary outcome
QUEST
Time frame: at the end of the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EXPLORER in people with Neuromuscular Disorders and Neurodevelopmental Disorders, run by MarsiBionics at 6 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious Adverse Events (time frame: through study completion, along 2 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.