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

NCT ID: NCT07159360

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2026-06-01

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 .

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.

Conditions

Neuromuscular Disorders; Neurodevelopmental Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CLINICAL EXPLORER

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

Group Type: EXPERIMENTAL

CLINICAL EXPLORER

Intervention Type: DEVICE

8 sessions of use of the device in the rehabilitation center

Interventions

CLINICAL EXPLORER

8 sessions of use of the device in the rehabilitation center

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital Infantil Universitario Niño Jesús, Madrid, Spain

OTHER

Sponsor Role: collaborator

APAC, I.A.P.

UNKNOWN

Sponsor Role: collaborator

MarsiBionics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Asociación Pro Personas con Paralisis Cerebral (APAC-IAP)

Mexico City, Mexico City, Mexico

Hospital Infantil Universitario Niño Jesús-Servicio de Neuro Ortopedia

Madrid, Madrid, Spain

Countries

Mexico; Spain

Central Contacts

Carlos Cumplido Trasmonte, Clinical Lead

Role: CONTACT

carlos.cumplido@marsibionics.com

+34918711900

Facility Contacts

Mayra Patricia Estrella Piñón

Role: primary

Ignacio Martínez Caballero

Role: primary

Other Identifiers

EXC

Identifier Type: -

Identifier Source: org_study_id