Efficacy and Usability of the EXPLORER Exoskeleton in Children With Neurodevelopmental Disorders in Natural Environments

NCT06765070 | Active Not Recruiting DMC

• 1 other identifier: EXP-I-EF
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 6

Brief 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. 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.

Conditions

Neuromuscular Disorders; Neurodevelopmental Disorders

Keywords

Neurodevelopmental disorders; Neuromuscular disorders; cerebral palsy; acquired brain injury; spinal muscular atrophy; robotics; gait; rehabilitation; spinal cord injury

Outcome Measures

Primary Outcomes (12)

• Serious Adverse Events

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

  through study completion, along 2 weeks

• Falls prevalence

  Number of falling events occurred from the participant or caregiver

  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

  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"

  through study completion, along 2 weeks

• Donning and doffing time

  Time to don and doff the device to each participant

  through study completion, along 2 weeks

• Device usage time

  Time using the device

  through study completion, along 2 weeks

• Number of steps

  number of steps with the device

  through study completion, along 2 weeks

• Usage modes

  two different usage modes (active and automatic).

  through study completion, along 2 weeks

• Speed

  speed achieved with the device (steps per minute)

  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)

  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.

  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)

  Before starting the intervention (S1) and after completing the two weeks of use

Secondary Outcomes (1)

• QUEST

  at the end of the intervention

Study Arms (1)

EXPLORER

EXPERIMENTAL

Two-week period with the robotics gait device for use in the natural settings deemed appropriate by the family.

Device: EXPLORER

Interventions

EXPLORER DEVICE

Two-week period with the robotics gait device for use in the natural settings deemed appropriate by the family.

EXPLORER

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• MarsiBionics: lead
• Hospital Infantil Universitario Niño Jesús, Madrid, Spain: collaborator
• Hospital General Universitario Gregorio Marañon: collaborator
• Hospital Universitario La Paz: collaborator
• Hospital Universitario 12 de Octubre: collaborator
• Universidad Rey Juan Carlos: collaborator

Study Sites (6)

Universidad Rey Juan Carlos

Alcorcón, Madrid, 28922, Spain

Location

Hospital Universitario Gregorio Marañón

Madrid, Madrid, 28007, Spain

Location

Hospital Infantil Universitario Niño Jesús - Servicio de Rehabilitación

Madrid, Madrid, 28009, Spain

Location

Hospital Infantil Universitario Niño Jesús-Servicio de Neuro Ortopedia

Madrid, Madrid, 28009, Spain

Location

Hospital Universitario 12 Octubre

Madrid, Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Neuromuscular Diseases; Neurodevelopmental Disorders; Cerebral Palsy; Brain Injuries; Muscular Atrophy, Spinal; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Nervous System Diseases; Mental Disorders; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Spinal Cord Diseases; Motor Neuron Disease; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: January 9, 2025
• Study Start: March 1, 2025
• Primary Completion: April 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

ES (6)