Bambini Kids Robot-Assisted Gait Training Safety and Effectiveness Trial in Children With Cerebral Palsy
Summary
NIH has registered a clinical trial evaluating the safety and effectiveness of the Bambini Kids pediatric robotic exoskeleton in children with cerebral palsy (CP). The single-arm study will assess robot-assisted gait training (RAGT) as an intervention for gait impairment and motor performance limitations in the pediatric CP population. The trial is registered as NCT07539389 with an estimated completion date of April 20, 2026.
“The Bambini Kids exoskeleton is a pediatric robotic device designed to assist lower-limb movements, including hip, knee, and ankle joints, to facilitate more natural gait patterns.”
What changed
NIH registered a new clinical trial (NCT07539389) for the Bambini Kids pediatric robotic exoskeleton device in children with cerebral palsy. The study will evaluate safety and clinical performance of robot-assisted gait training as an intervention for pediatric gait impairment. No compliance obligations are created by this registry entry.
Compliance officers and clinical operations teams monitoring rehabilitation technology trials should note this pediatric device study. Medical device manufacturers developing or marketing similar pediatric exoskeleton or gait-training devices may wish to track this trial for emerging clinical evidence supporting real-world rehabilitation use.
Archived snapshot
Apr 21, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Safety and Effectiveness of Bambini Kids Robot-Assisted Gait Training (RAGT) in Children With Cerebral Palsy
N/A NCT07539389 Kind: NA Apr 20, 2026
Abstract
Cerebral palsy (CP) is a common cause of gait impairment in children, leading to limitations in mobility and daily activities. Although conventional physical therapy is widely used, it has limitations in delivering consistent and intensive training. Robot-assisted gait training (RAGT) has emerged as a promising approach to provide repetitive, high-intensity, and task-specific training, with potential benefits in gait function and motor performance.
The Bambini Kids exoskeleton is a pediatric robotic device designed to assist lower-limb movements, including hip, knee, and ankle joints, to facilitate more natural gait patterns.
This study aims to evaluate the safety and clinical performance of Bambini Kids in children with cerebral palsy and to generate clinical evidence to support its use in real-world rehabilitation settings.
Conditions: Cerebral Palsy (CP)
Interventions: Exoskeleton, Rehabilitation physical therapy
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