Evaluating the ATLAS 2030 Exoskeleton for Children with Spinal Cord Injury
Safety and Usability of the ATLAS 2030 Exoskeleton in Pediatric Patients With Spinal Cord Injury
This study is testing a robotic exoskeleton to see if it can help children aged 3 to 14 with spinal cord injuries move better and feel healthier during their rehab sessions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 3 Years to 14 Years |
| Sex | All |
| Sponsor | MarsiBionics Industry-sponsored |
| Locations | 1 site (Toledo) |
| Trial ID | NCT06772077 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety and usability of the ATLAS 2030 robotic gait exoskeleton in pediatric patients suffering from spinal cord injury. The study will involve ten rehabilitation sessions using the exoskeleton, along with two assessment sessions before and after the intervention. The primary focus is to determine how well the device can be integrated into a therapeutic program for improving mobility and overall well-being in children aged 3 to 14 years with spinal cord injuries. Additionally, the study will evaluate the device's impact on factors such as fatigability, mood, health perception, and gait speed.
Who should consider this trial
Good fit: Ideal candidates are children aged 3 to 14 years with subacute or chronic spinal cord injuries who are clinically stable and can participate in weight-bearing activities.
Not a fit: Patients who do not meet the weight and size criteria for the exoskeleton or those with severe medical conditions that prevent participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance rehabilitation outcomes and quality of life for children with spinal cord injuries.
How similar studies have performed: While the ATLAS 2030 has been previously approved for other pediatric conditions, this specific application for spinal cord injury is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Toledo
- Hospital Nacional Parapléjicos — Toledo, Spain (Recruiting)
Study contacts
- Study coordinator: Carlos Cumplido Trasmonte
- Email: carlos.cumplido@marsibionics.com
- Phone: 0034 914900090
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.