Actively Recruiting
Safety and Usability of the ATLAS 2030 Exoskeleton in Pediatric Patients With Spinal Cord Injury
Led by MarsiBionics · Updated on 2025-08-14
20
Participants Needed
1
Research Sites
49 weeks
Total Duration
On this page
Sponsors
M
MarsiBionics
Lead Sponsor
H
Hospital Nacional de Parapléjicos de Toledo
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Safety and Usability of the ATLAS 2030 Exoskeleton in Pediatric Patients With Spinal Cord Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged between 3 and 14 years
- Diagnosed with subacute or chronic spinal cord injury and clinically stable
- Medically authorized to perform standing and gait training with weight-bearing
- Consent given by participant or legal guardian
- Family shows adequate acceptance and commitment to the study
- Weight of 35 kg or less
- Hip width of 34 cm or less (with verification if under 28 cm to avoid foot inversion)
- Femur length between 24 cm and 33 cm (shorter lengths allowed if device fits safely)
- Tibia length between 23 cm and 32 cm (shorter lengths allowed with compensation)
- EU shoe size between 27 and 33
You will not qualify if you...
- Family unable to complete treatment schedule
- Any contraindication for standing or walking
- Severe spasticity (Modified Ashworth Scale = 4) in lower limbs during device use
- Joint contracture of hip or knee over 20 degrees
- Need to walk with more than 9 degrees of hip abduction
- Need to walk with more than 9 degrees of ankle flexion or inability to use orthosis for 90° ankle
- Severe skin lesions where device contacts skin
- Planned surgery during study or previous orthopedic surgery contraindicating treatment
- Advanced osteoporosis or recent fractures in lower limbs or pelvic area
- Unstable fractures, joint dislocations, or joint problems in trunk or lower limbs
- Severe rigid orthopedic spine deformities preventing device use
- Frequent seizures, uncontrolled epilepsy, or difficult behavioral disorders
- Decompensated heart or lung disease or other exercise intolerance conditions
- Allergy to any materials in the ATLAS 2030 device (cotton, nylon, polyester, polyamide, polyethylene, polypropylene)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital Nacional Parapléjicos
Toledo, Spain, 45004
Actively Recruiting
Research Team
C
Carlos Cumplido Trasmonte
CONTACT
E
Elisa López-Dolado
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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