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Neuromuscular DisordersNCT07159360

Safety, Usability, and Effectiveness of a Gait Exoskeleton for Children and Adolescents With Neurodevelopmental Disorders.

A study testing CLINICAL EXPLORER in people with Neuromuscular Disorders and Neurodevelopmental Disorders, run by MarsiBionics at 2 sites in 2 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Neurodevelopmental disorders often result in abnormal development of the Central Nervous System (CNS), frequently causing motor dysfunctions such as the inability to stand and walk. Read more about this study

Who is it for?
Ages 2 to 17 yearsHealthy volunteers can take part
What is being tested?
CLINICAL EXPLORER
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesin 2 countries
Study dates
15 Sep 2025to 1 Jun 2026
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
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Age between 2 and 17 years.
  • Consent from the participant or legal guardian to participate in the study.
  • No diagnosis of neurodevelopmental disorders such as CP, NMD, LM, or MS. Inclusion Criteria for Phase 1
  • Age between 2 and 17 years.
  • Consent from the participant or legal guardian to participate in the study.
  • Diagnosis of neurodevelopmental disorders such as CP, NMD, LM, or MS. Inclusion Criteria Related to the EXPLORER CLINICAL Device Characteristics
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  • Medical authorization to stand upright and perform weight-bearing gait training.
  • Weight less than or equal to 60 kg.
  • Hip width less than or equal to 40 cm.
  • Distance from the hip joint center to the knee joint center: 21 cm - 36 cm.
  • Distance from the knee joint center to the ankle joint center: 20 - 35 cm.
  • EU shoe size less than or equal to 40.

Who cannot join

  • Any medical contraindication for standing or walking.
  • Presence of non-reducible contractures or heterotopic ossification above the degrees allowed by the device and/or outside the trajectory imposed by the device.
  • Spasticity (MAS) = 4 in lower limbs at the time of device use.
  • Structured hip and/or knee contracture greater than 20 degrees.
  • Inability to stand or walk with more than 5 degrees of hip abduction.
  • Inability to achieve 5 degrees of dorsal ankle flexion from the neutral position with or without orthosis.
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  • Tibial leg length discrepancy that cannot be mitigated with the use of a foot wedge.
  • Skin alterations in areas of contact with the device.
  • History of fracture without trauma.
  • Presence of other conditions that cause exercise intolerance (such as uncontrolled hypertension, coronary artery diseases, arrhythmia, congestive heart failure, severe pulmonary disease).
  • Behavioral disorders that interfere with proper use of the device, such as impulsivity.
  • Allergy to any of the materials of the EXPLORER CLÍNICO: cotton, nylon, polyester, PPS, PEEK, or ABS. The materials used in EXPLORER CLÍNICO that were not previously used in ATLAS 2030, a medical device certified by the AEMPS, are PPS, PEEK, and ABS.

Trial locations and contacts

2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Carlos Cumplido Trasmonte, Clinical Lead contact

+34918711900

carlos.cumplido@marsibionics.com

2 sites in 2 countries

Mexico1 site

  • Asociación Pro Personas con Paralisis Cerebral (APAC-IAP)

    Mexico City, Mexico City, 06720

    Mayra Patricia Estrella Piñón

Other trials in Mexico

Spain1 site

  • Hospital Infantil Universitario Niño Jesús-Servicio de Neuro Ortopedia

    Madrid, Madrid, 28009

    Ignacio Martínez Caballero

Other trials in Spain

About this study

Neurodevelopmental disorders often result in abnormal development of the Central Nervous System (CNS), frequently causing motor dysfunctions such as the inability to stand and walk. CLINICAL EXPLORER is a clinical-use robotic device for gait training, representing the evolution of the ATLAS 2030 exoskeleton and the EXPLORER device for home use. The aim of this study is to evaluate the safety and usability of CLINICAL EXPLORER .

Read the detailed description

Neuromuscular and neurological disorders in children cause muscle weakness and spasticity, leading to severe motor dysfunctions such as the inability to maintain posture or walk. Manually assisted gait training can be physically demanding for therapists, which is why robotic devices have been developed to reduce their workload, provide objective assessments through integrated sensors, and improve rehabilitation quality. Beyond mobilizing muscles and joints, these devices enhance brain neuroplasticity and the child's connectivity with their environment, positively impacting self-esteem and social interaction. A clinical-use robotic device for gait training has been developed, representing the evolution of the ATLAS 2030 exoskeleton and the EXPLORER device for home use.

Being tested
CLINICAL EXPLORER
Keywords
Neurodevelopmental disorders, Neuromuscular disorders, cerebral palsy, acquired brain injury, spinal muscular atrophy, robotics, gait, 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.

  • CLINICAL EXPLORERDevice

    8 sessions of use of the device in the rehabilitation center

Study groups in NCT07159360
Study groupRoleWhat they receive
CLINICAL EXPLORERExperimentalAn initial assessment (screening visit), 8 intervention sessions (2 per week) in the rehabilitation center, and a final assessment.
Receives: Device: CLINICAL EXPLORER

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serious Adverse Events

    occurrence of any serious adverse event to the participant or the caregiver

    Measured: through study completion, along 8 weeks

  2. Falls prevalence

    Number of falling events occurred from the participant or caregiver

    Measured: through study completion, along 8 weeks

  3. 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 8 weeks

  4. 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 8 weeks

  5. Heart rate

    measurement of heart rate with a smart band

    Measured: through study completion, along 8 weeks

  6. Oxygen saturation

    measurement of Oxygen saturation with a smart band

    Measured: through study completion, along 8 weeks

  7. Blood pressure

    measurement of blood pressure with a smart band

    Measured: through study completion, along 8 weeks

  8. Donning and doffing time

    Time to don and doff the device to each participant

    Measured: through study completion, along 8 weeks

  9. 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 at 8 weeks

Secondary outcomes (9)

  1. Gait analysis

    Spatiotemporal parameters will be done through photogrammetry.

    Measured: Day 1 and at the end of the intervention at 8 weeks

  2. Range of motion

    Passive Degree to which a joint can move (hip, knee, and ankle joints in both legs). From 0º to 180º.

    Measured: Day 1 and at the end of the intervention at 8 weeks

  3. Quality of life (EQ-5D)

    The EQ-5D is a standardized instrument used to measure and evaluate the quality of life. It assesses five key dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a 3-level or 5-level scale, reflecting the severity of the condition (e.g., no problems, some problems, or extreme problems). The EQ-5D also includes a visual analogue scale (VAS) where individuals rate their overall health on a scale from 0 to 100. The tool is widely used in clinical trials, health surveys, and economic evaluations to assess health-related quality of life and make comparisons across different patient populations or interventions.

    Measured: Day 1 and at the end of the intervention at 8 weeks

  4. Level of fatigue

    Fatigue of both the participant and the therapist, Measured with the Borg scale

    Measured: through study completion, along 8 weeks

  5. Level of Spasticity

    Evaluation of spasticity with Modified Ahsworth Scale

    Measured: Day 1 and through study completion, along 8 weeks

  6. Muscular activity (EMG)

    EMG (Electromyography) is a technique that measures the electrical activity of muscles to assess their function. It helps detect neuromuscular disorders and evaluate muscle activation patterns, using either surface electrodes or needle inserts to record muscle activity. Measured with the system FREEEMG/BTS®.

    Measured: through study completion, along 8 weeks

  7. Cerebral activity (EEG)

    EEG (Electroencephalography) is a method used to record electrical activity in the brain. It involves placing electrodes on the scalp to measure brain wave patterns, helping to diagnose conditions like epilepsy, sleep disorders, and brain injuries. Measured with Enobio® EEG systems.

    Measured: through study completion, along 8 weeks

  8. Acceptability

    Analysis of the drop-out rate during the study period

    Measured: at the end of the intervention, 8th week

  9. Accessibility of the participant

    Rate of the participants suitable to use the device

    Measured: through study completion, along 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2025
  2. Study start15 Sep 2025 (estimated)
  3. Primary completion1 Oct 2025 (estimated)
  4. Study completion1 Jun 2026 (estimated)

Resources

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
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07159360
Sponsor's protocol ID
EXC
Status last verified
Aug 2025
First submitted
23 May 2025
Last updated
8 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing CLINICAL EXPLORER in people with Neuromuscular Disorders and Neurodevelopmental Disorders, run by MarsiBionics at 2 sites in 2 countries.

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 12 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: opening soon, as of the sponsor's last update on 8 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 2 sites in Mexico, 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?

Contact Carlos Cumplido Trasmonte, Clinical Lead (+34918711900, carlos.cumplido@marsibionics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serious Adverse Events (time frame: through study completion, along 8 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07159360.

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 8 Sep 2025.

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