Safety and Effectiveness of Bambini Kids Robot-Assisted Gait Training in Children With Cerebral Palsy: A Randomized Clinical Trial

Cerebral palsy (CP) is one of the most common causes of gait impairment in children, and it's a non-progressive neurodevelopmental disorder that results in permanent impairments in motor function and postural control. The prevalence of cerebral palsy in Korea has been reported to be approximately 2.6 per 1,000 individuals. Patients with CP experience limitations in gait and activities of daily living due to muscle spasticity, muscle weakness, and impairments in balance and coordination, which consequently lead to reduced independence and decreased quality of life.

Physical activity is essential for promoting overall health in children with cerebral palsy, and has been shown to improve stability, balance, overall motor function, and aerobic capacity, while reducing the risk of depression and enhancing key functional domains such as social participation and quality of life. To achieve these benefits, conventional physical therapy approaches, including partial body weight-supported gait training, task-oriented training, and treadmill-based training, have been widely used; however, these approaches are associated with substantial physical burden on therapists and limitations in consistently providing repetitive and high-intensity training.

To address these limitations, robot-assisted gait training (RAGT) is getting attention in the field of rehabilitation. RAGT enables the consistent delivery of high-intensity and high-frequency repetitive training in accordance with physiological gait patterns and allows automatic recording of training parameters for objective analysis and comparison. In addition, some wearable exoskeleton can be applied in non-clinical settings, thereby expanding their potential use beyond hospital environments.

The therapeutic effects of robot-assisted gait training (RAGT) have been demonstrated in adult patients with spinal cord injury (SCI) and stroke through multiple randomized controlled trials and systematic reviews, showing positive impacts on gait ability, muscle strength, balance, and recovery of activities of daily living. Studies in children with cerebral palsy have also reported that RAGT has a beneficial effect on activity-related outcomes such as standing ability, gait speed, and walking distance. Early application of rehabilitation in children during developmental stages is of particular clinical importance, as it may promote neuroplasticity during periods when gait patterns and motor function remain modifiable, thereby potentially preventing long-term progression of disability. In a recent multicenter clinical study, significant improvements in gross motor function, balance control, and gait patterns were observed after 6 weeks of robot-assisted gait training, and these effects were maintained at follow-up. Borggraefe et al. reported that patients with milder impairment (GMFCS Levels I-II) showed significantly greater improvements in Gross Motor Function Measure(GMFM-88) dimensions D and E compared to those with moderate to severe impairment (GMFCS Levels III-IV). However, some studies have suggested that the relatively short duration of interventions may have led to an overestimation of treatment effects, indicating the need for further validation.

Recently, in addition to robot-assisted training in medical institutions, studies have actively investigated the feasibility and effectiveness of using exoskeleton robots in home and community settings for children with cerebral palsy. This approach has gained attention as a novel strategy to improve access to therapy and to support continuous rehabilitation in daily life.