Safety and Usability of the ATLAS 2030 Exoskeleton in Pediatric Patients With Spinal Cord Injury
Condition(s) studied
Investigational drug(s) / intervention(s)
Rehabilitation treatment with ATLAS2030: 10 sessions of Rehabilitation Treatment with ATLAS2030 with With an evaluation session before the first session and another one after 10 sessions.
Study summary
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
Primary outcome measure(s)
- Serious Adverse Events — From enrollment to the last assessment session at 8 weeks
occurrence of any serious adverse event to the participant - Falls prevalence — From enrollment to the last assessment session at 8 weeks
Number of falling events occurred from the participant or caregiver - Skin integrity — From enrollment to the last assessment session at 8 weeks
Occurrence of any injury of the skin in the areas of contact and produced by the use of the device - Pain assessment — From enrollment to the last assessment session at 8 weeks
pain measured by the Visual Analogic Scale (VAS) by the participant, scored from 0 to 10, being 0 "no pain" and 10 "unbearable pain" - Heart rate — from the beginning to the end of treatment at 6 weeks
measurement of heart rate - Oxygen saturation — from the beginning to the end of treatment at 6 weeks
measurement of Oxygen saturation when medical prescription - Blood pressure — from the beginning to the end of treatment at 6 weeks
measurement of blood pressure. Systolic and diastolic pressures will be assessed - User and/or caregiver perception of the device — From enrollment to the last assessment session at 8 weeks
Questions that are scored from 0 to 5 on aspects related to comfort, weight, volume, etc - Device usage data — From enrollment to the last assessment session at 8 weeks
Total walking time. Unit of Measure: Minutes. - Number of steps — From enrollment to the last assessment session at 8 weeks
Number of steps with the device - Usage modes — From enrollment to the last assessment session at 8 weeks
two different usage modes (active and automatic). - Speed — From enrollment to the last assessment session at 8 weeks
speed achieved with the device (steps per minute) - Range of motion — From enrollment to the last assessment session at 8 weeks
Passive Degree to which a joint can move (hip, knee, and ankle joints in both legs). From 0º to 180º.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Hospital Nacional Parapléjicos | Toledo | Spain | Recruiting |
More MarsiBionics trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06772077 on ClinicalTrials.gov ↗ ← All trials in Spain