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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Neurodevelopmental Disorders; Neuromuscular Disorders
• Intervention / Treatment: Device: EXPLORER

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 Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Alcorcón, Madrid, Spain, 28922
      • Universidad Rey Juan Carlos
    • Madrid, Madrid, Spain, 28046
      • Hospital Universitario La Paz
    • Madrid, Madrid, Spain, 28009
      • Hospital Infantil Universitario Niño Jesús-Servicio de Neuro Ortopedia
    • Madrid, Madrid, Spain, 28007
      • Hospital Universitario Gregorio Maranon
    • Madrid, Madrid, Spain, 28009
      • Hospital Infantil Universitario Niño Jesús - Servicio de Rehabilitación
    • Madrid, Madrid, Spain, 28041
      • Hospital Universitario 12 Octubre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EXPLORER; Two-week period with the robotics gait device for use in the natural settings deemed appropriate by the family.	Device: EXPLORER; Two-week period with the robotics gait device for use in the natural settings deemed appropriate by the family.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at the end of the intervention

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Actual): April 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 20, 2024
• First Submitted That Met QC Criteria: January 2, 2025
• First Posted (Actual): January 9, 2025

Study Record Updates

• Last Update Posted (Estimated): September 25, 2025
• Last Update Submitted That Met QC Criteria: September 22, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: gait; rehabilitation; spinal muscular atrophy; spinal cord injury; cerebral palsy; robotics; acquired brain injury; Neurodevelopmental disorders; Neuromuscular disorders
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Wounds and Injuries; Neurodegenerative Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Damage, Chronic; Spinal Cord Diseases; Motor Neuron Disease; Neurodevelopmental Disorders; Brain Injuries; Cerebral Palsy; Spinal Cord Injuries; Muscular Atrophy, Spinal; Neuromuscular Diseases
• Other Study ID Numbers: EXP-I-EF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No