Evaluating the rehabilitative and assistive impact of the Agilik exoskeleton: a pre-post single-group study in children with cerebral palsy.

INTRODUCTION: Cerebral palsy (CP) is a common childhood-onset neurological condition often associated with crouch gait, a pathological walking pattern impairing mobility. Wearable robotic devices are emerging as promising tools for paediatric gait rehabilitation, but evidence on their rehabilitative and assistive effects remains limited. This exploratory study evaluated the rehabilitative and assistive effects of a 10-session training programme using Agilik, a paediatric knee exoskeleton, in children with CP and crouch gait, during level-ground, uphill, and downhill walking. METHODS: Eight children with CP completed the intervention. Assessments were performed at baseline (T0) and post-intervention (T1), including walking endurance, speed, balance, spasticity, and clinical joint and muscle length assessments. Three-dimensional gait analysis (GRAIL system) quantified sagittal-plane hip, knee, and ankle range of motion during level-ground, uphill, and downhill walking. At T1, joint range of motion was analysed with and without Agilik to assess its assistive effect. User satisfaction was evaluated using the child-adapted QUEST 2.1 questionnaire. RESULTS: Given the exploratory nature of this study, results were interpreted primarily at the individual level using predefined minimal clinically important difference (MCID) thresholds. When clinically relevant changes occurred, improvements were more frequently observed than deteriorations in walking endurance (MCID > 15 m), speed (MCID > 0.1 m/s), muscle lengths (>5°), and joint range of motion (>5°). No significant group-level rehabilitative changes were observed (all p > 0.05). In contrast, the assistive evaluation showed statistically significant increases in knee and hip range of motion across all walking conditions (p < 0.05), with all participants improving at the knee in every condition. Satisfaction scores (7-point scale) were high for size, appearance, usability, and set-up time (median ≥ 4/7), while weight, reliability, and timely performance received lower ratings (median 3.5/7). CONCLUSIONS: This exploratory study demonstrates a clear assistive biomechanical benefit of Agilik, particularly at the knee and hip. Individual-level analyses suggest that some participants may experience clinically meaningful improvements following training; however, these observations are hypothesis-generating and cannot be interpreted as evidence of a rehabilitative effect. Larger randomised controlled studies are needed to determine whether repeated exposure to assisted gait translates into sustained functional gains.