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

NCT07159360 | Not Yet Recruiting DMC

• 1 other identifier: EXC
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 2

Brief 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. 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 .

Conditions

Neuromuscular Disorders; Neurodevelopmental Disorders

Keywords

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

Outcome Measures

Primary Outcomes (9)

• Serious Adverse Events

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

  through study completion, along 8 weeks

• Falls prevalence

  Number of falling events occurred from the participant or caregiver

  through study completion, along 8 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 8 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 8 weeks

• Heart rate

  measurement of heart rate with a smart band

  through study completion, along 8 weeks

• Oxygen saturation

  measurement of Oxygen saturation with a smart band

  through study completion, along 8 weeks

• Blood pressure

  measurement of blood pressure with a smart band

  through study completion, along 8 weeks

• Donning and doffing time

  Time to don and doff the device to each participant

  through study completion, along 8 weeks

• 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 at 8 weeks

Secondary Outcomes (9)

• Gait analysis

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

• Range of motion

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

• Quality of life (EQ-5D)

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

• Level of fatigue

  through study completion, along 8 weeks

• Level of Spasticity

  Day 1 and through study completion, along 8 weeks

Study Arms (1)

CLINICAL EXPLORER

EXPERIMENTAL

An initial assessment (screening visit), 8 intervention sessions (2 per week) in the rehabilitation center, and a final assessment.

Device: CLINICAL EXPLORER

Interventions

CLINICAL EXPLORER DEVICE

8 sessions of use of the device in the rehabilitation center

CLINICAL EXPLORER

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age between 2 and 17 years.
• Consent from the participant or legal guardian to participate in the study.
• Age between 2 and 17 years.
• Consent from the participant or legal guardian to participate in the study.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• MarsiBionics: lead
• Hospital Infantil Universitario Niño Jesús, Madrid, Spain: collaborator
• APAC, I.A.P.: collaborator

Study Sites (2)

Asociación Pro Personas con Paralisis Cerebral (APAC-IAP)

Mexico City, Mexico City, 06720, Mexico

Location

Hospital Infantil Universitario Niño Jesús-Servicio de Neuro Ortopedia

Madrid, Madrid, 28009, 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

Central Study Contacts

Carlos Cumplido Trasmonte, Clinical Lead

CONTACT

+34918711900; carlos.cumplido@marsibionics.com

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: May 23, 2025
• First Posted: September 8, 2025
• Study Start: September 15, 2025
• Primary Completion: October 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-08

Locations

ES (1); ME (1)