Ireland
--:--IST
Recruiting Not applicable

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

NCT06772077 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2025-02-17
Last updated
2025-08-14

Condition(s) studied

Spinal Cord Injury (SCI)

Investigational drug(s) / intervention(s)

Rehabilitation treatment with ATLAS2030

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

Sex
ALL
Min age
3 Years
Max age
14 Years
Healthy volunteers
No
Inclusion Criteria: * 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. * Adequate level of acceptance and commitment from the family. Inclusion criteria related to device characteristics: * Weight ≤ 35 kg. * Hip width ≤ 34 cm. It is advised that for measurements under 28 cm, verification should be performed to ensure there is no excessive base of support that might induce foot inversion in the standing position. * Femur length (distance from the greater trochanter to the lateral condyle of the femur) between 24 cm and 33 cm. Femur lengths shorter than 24 cm are acceptable as long as the hip motor of the device does not extend above the user's iliac crest, avoiding hypermobility of the lumbar spine. * Tibia length (distance from the lateral condyle to the lateral malleolus of the tibia) between 23 cm and 32 cm. Tibia lengths shorter than 23 cm are acceptable as long as they can be compensated with a lift and the user's ankle joint remains within the area of the ankle motor. * EU shoe size between 27 and 33. Exclusion Criteria: * 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. * Need to walk with more than 9 degrees of hip abduction. * Need to walk with more than 9 degrees of dorsal or plantar ankle flexion, or inability to use an orthosis to achieve 90° at the ankle. * Severe skin lesions in areas of contact with the device. * Planned surgical intervention during the study period or previous orthopedic surgery on the spine and/or lower limbs contraindicating treatment. * Known advanced osteoporosis evidenced by bone densitometry, particularly with a history of prior fractures or fractures without trauma. Traumatic bone fractures in the lower limbs or pelvic girdle within the past 6 months. * Unstable fractures, joint dislocations, or other joint pathologies in the trunk and lower limbs contraindicating the treatment. * Severe rigid orthopedic deformities of the spine that prevent the use of the device. * Presence of frequent seizures, uncontrolled epilepsy, or difficult-to-control behavioral disorders. * Presence of decompensated heart or lung disease, or any other condition causing exercise intolerance. * Allergy to any of the materials used in the ATLAS 2030: cotton, nylon, polyester, polyamide, polyethylene, or polypropylene.

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)

FacilityCityRegionStatus
Hospital Nacional Parapléjicos Toledo Spain Recruiting
Official registry record

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