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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-17
SponsorMarsiBionics

About this trial

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 .

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • CLINICAL EXPLORER

Treatment groups

60 Participants
are divided into 1 treatment group

Sponsors and collaborators

MarsiBionics

Lead sponsor

Hospital Infantil Universitario Niño Jesús, Madrid, Spain

Collaborator

APAC, I.A.P.

Collaborator