Safety and Usability of the ATLAS 2030 Exoskeleton in Pediatric Patients With Spinal Cord Injury

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-14
SponsorMarsiBionics

About this trial

The goal of this clinical trial is to analyze the usability and safety of the robotic gait ATLAS 2030 in a cohort of pediatric patients with Spinal Cord Injury, with the aim of extending its indication for use to pediatric spinal cord injury

Eligibility criteria

Qualifiers

Having a subacute or chronic spinal cord injury (SCI) and being clinically stable with a general condition good enough to participate in the therapeutic program with the ATLAS 2030.

Age between 3 and 14 years.

Medical authorization to perform standing and gait training with weight-bearing.

Consent from the participant or legal guardian to participate in the study.

Disqualifiers

Impossibility for the family to complete treatment schedule planning.

Any contraindication for standing and/or walking.

Spasticity (Modified Ashworth Scale (MAS) = 4 in the lower limbs at the time of device use).

Joint contracture of the hip and/or knee > 20 degrees.

Trial design

Treatments tested in this trial

  • Rehabilitation treatment with ATLAS2030

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators

MarsiBionics

Lead sponsor

Hospital Nacional de Parapléjicos de Toledo

Collaborator

Fundación del Lesionado Medular

Collaborator