Robot-assisted gait training in cerebral palsy: a GRADE-assessed systematic review and meta-analysis with trial sequential analysis.

BACKGROUND: Cerebral palsy (CP) causes gait impairments, limiting functional independence. Robot-assisted gait training (RAGT) may improve walking, but its effectiveness is unclear. METHODS: A systematic review and meta-analysis of RCTs comparing RAGT with conventional therapy (CT) in children was conducted. Primary outcomes were gait, balance, and gross motor function. Study quality was assessed using the ROB 2 and GRADE frameworks. Meta-analyses were performed in R using fixed- or random-effects models, with effects expressed as mean differences or, where trials reported an outcome on different scales, as standardised mean differences, together with sensitivity analyses, publication bias assessment, and Trial Sequential Analysis (TSA). RESULTS: Fifteen RCTs, including 542 patients, met the inclusion criteria, and fourteen contributed to the meta-analyses. No significant differences were observed for hip flexion/extension, GMFM-66, total GMFM, GMFM-88 Dimension D, stride length, walking speed, step width, or balance (all p > 0.05). RAGT showed modest benefits over conventional physiotherapy in the 6MWT (MD 17.52 m, 95% CI 7.70 to 27.34), the 10MWT (MD 0.11 m/s, 95% CI 0.05 to 0.17) and GMFM-88 Dimension E (SMD 0.30, 95% CI 0.05 to 0.54). TSA confirmed robust evidence for the 6MWT and for Dimension E; Dimension D remained inconclusive, the required information size not having been reached. CONCLUSION: RAGT yields similar improvements to CT in most motor, gait, and balance outcomes in children with CP, whereas RAGT offers modest additional benefit in walking endurance, walking speed, and the walking/running/jumping dimension of the GMFM-88.