An observational study in Cerebral Palsy Infantile, sponsored by FIDMAG Germanes Hospitalàries. Completed at 1 site in Spain. Open to participants aged 2 Years to 14 Years. Per ClinicalTrials.gov, last updated 2025-07-15.
Sponsored by FIDMAG Germanes Hospitalàries · Observational
Title of the Study IMPACT OF THE ATLAS 2030 PEDIATRIC EXOSKELETON ON GAIT FUNCTIONALITY AND QUALITY OF LIFE IN CHILDREN WITH CEREBRAL PALSY OR RELATED CONDITIONS
Justification Cerebral palsy and gait rehabilitation It is estimated that around 93 million children worldwide have some form of moderate or severe disability. Cerebral palsy (CP) is the most common motor disability in children, with a prevalence of 1.8 per 1,000 live births in Europe. CP causes severe motor dysfunction, sometimes resulting in the inability to stand or walk. This is due to damage in areas of the central nervous system (CNS) that control movement and posture. CP causes a series of signs and symptoms such as spasticity, muscle contractures, incoordination, loss of selective motor control, or weakness, which interfere with motor function and daily living activities in these children.
As part of physical therapy, there are different types of pediatric robotic devices that assist with gait. These include: Lokomat, a stationary treadmill-based device; the G-EO System, which is also stationary and has a stair-climbing function; Innowalk, which enables standing; and other similar devices like NX-A3, Robogait, and Walkbot-K. Also notable is Prodrobot, which differs from the above as it performs suspended walking.
Walking has been shown to have physiological and functional benefits, including the prevention of muscle contractures, maintenance of bone density, and improvement of cardiovascular function. Booth et al., in their meta-analysis, suggest that gait therapy produces more beneficial effects in children with CP than conventional therapy. Moreover, effective and functional mobility-whether independent or aided by support systems-enhances children's abilities to interact with and explore their surroundings. In the treatment of neuromuscular diseases (NMDs), low-impact exercise and supported ambulation are highly beneficial.
Robot-assisted gait rehabilitation involves integrating these electromechanical systems into treatment programs. Calderón et al. argue that robotic devices enable early gait retraining and that their benefits lie in increasing training volume while reducing fatigue for both the patient and therapists. This allows for more repetitions, consistency, and quality of treatments in a safe manner.
Medical Device Description The ATLAS 2030 exoskeleton is a robotic active orthosis with 8 degrees of freedom, classified as a THKAFO-type device. It aims to improve the user's motor level, with the goal of not only increasing life expectancy but also reducing or delaying complications associated with disease progression or prolonged sitting.
It is attached to the human body in a non-invasive manner without direct skin contact, using a physical interface based primarily on straps and braces. Its chassis is adjustable in length and width for children between 100 cm and 130 cm in height.
It performs human walking with active mobility in a three-dimensional space, providing controlled movement in the sagittal and frontal planes. In addition to walking forward and backward, it replicates sit-to-stand and stand-to-sit movements.
The ATLAS exoskeleton is optimized for children with neuromuscular diseases (spinal muscular atrophy, muscular dystrophies, myopathies, etc.) and cerebral palsy. The device also self-adjusts to the patient's strength and mobility needs thanks to ARES technology, which absorbs joint disturbances and ensures safe control of the exoskeleton.
ATLAS 2030 evolves intelligently with rehabilitation progress. It is easily adjustable to the child's growth and can be put on in just 5 minutes.
Main Objective
To evaluate improvements in motor functions related to gait with the use of the ATLAS 2030 pediatric exoskeleton. Specifically, the following will be assessed:
Study Design Observational study under routine clinical practice with pre-, post-, and follow-up measurements
Target Disease or Disorder Inability or severe difficulty with independent walking in children aged 2 to 14 years with disabilities due to cerebral palsy or related conditions
Primary Outcome Measures
Study Population and Total Number of Patients 20 children between the ages of 2 and 14, with Gross Motor Function Classification System levels III, IV, or V
Treatment Duration 6 weeks of treatment and an additional 6 weeks of follow-up
1,853 studies on the registry are indexed under Cerebral Palsy; 435 are open to participants now.
This study's enrollment of 13 is below the median of 63 across 455 observational studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →FIDMAG Germanes Hospitalàries is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children with cerebral palsy aged 2-14 years.
Exclusion Criteria:
Children aged 2-14 years with cerebral palsy with Gross Motor Function Classification System (GMFCS) level III, IV or V. They underwent intensive training with 4 weekly sessions during 6 weeks with the ATLAS 2030 exoskeleton, a wearable device that provides gait assistance through eight degrees of freedom, four for each leg, including hip, knee, and ankle rotations. During training sessions, participants were fitted with the exoskeleton and performed 25 minutes of automatic forward walking, 15 minutes of active forward walking, 15 minutes of automatic forward walking, 5 minutes of automatic backward walking, 5 minutes of active backward walking, and exoskeleton removal. During the walk, therapeutic activities based on therapeutic objectives were carried out according to the participants' abilities.
Device: ATLAS 2030 Exoskeleton
They underwent intensive training with 4 weekly sessions during 6 weeks with the ATLAS 2030 exoskeleton, a wearable device that provides gait assistance through eight degrees of freedom, four for each leg, including hip, knee, and ankle rotations. During training sessions, participants were fitted with the exoskeleton and performed 25 minutes of automatic forward walking, 15 minutes of active forward walking, 15 minutes of automatic forward walking, 5 minutes of automatic backward walking, 5 minutes of active backward walking, and exoskeleton removal. During the walk, therapeutic activities based on therapeutic objectives were carried out according to the participants' abilities.
Gross Motor Function Measure scale (GMFMS-88)
The scale contains 88 items on a 4-point scale (0-3) that are divided into five dimensions: A) Lying and Rolling (17 items); B) Sitting (20 items); C) Crawling and Kneeling (14 items); D) Standing (13 items); and E) Walking, Running, and Jumping (24 items). A higher score on the scale indicates better gross motor function and, therefore, greater achievement of motor development milestones.
Time frame: 12 weeks
6-minute walk test
It measures the distance walked in 6 minutes, with the aim of evaluating physical endurance during exercise. In this case, it was performed while using the device in active mode, forward, and threshold 1.
Time frame: 12 weeks
Total steps in active mode forward and backward
Total steps in active mode forward and backward, to measure adaptation to exercise, in this case, walking with the device.
Time frame: 12 weeks
Plan to share: No
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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FIDMAG Germanes Hospitalàries