RecruitingNot ApplicableNCT06772077

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

Sponsor

MarsiBionics

Enrollment

20 participants

Start Date

Feb 17, 2025

Study Type

INTERVENTIONAL

Conditions

Spinal Cord Injury (SCI)

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

Min Age: 3 YearsMax Age: 14 Years

Inclusion Criteria10

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.
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 Criteria14

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.