Lessons learned from conducting a pragmatic, randomized, crossover trial on robot -assisted gait training in children with cerebral palsy (PeLoGAIT)

PURPOSE: To investigate the effectiveness of outpatient robot -assisted gait training (RAGT) in ambulatory children with spastic cerebral palsy.

METHODS: Children were randomized to two different intervention sequences within a pragmatic crossover design. They performed five weeks of RAGT (3 sessions per week) and five weeks of usual care (UC). Dimension E of the Gross Motor Function Measure -88 (GMFM E) as the primary outcome as well as Dimension D (GMFM D), and timed walking tests were assessed before and after each treatment sequence and after a 5 -week follow-up.

RESULTS: The trial was stopped early because of recruitment problems. We included 16 children with a mean age of 11.3 years (6.0-15.3 years). GMFM E median (IQR) change scores were - 0.7 (- 2.8 to 3.5) after RAGT and 0 (- 2.4 to 2.4) after UC. Neither GMFM E nor any secondary outcome measure changed significantly after RAGT or UC, nor were any period, follow-up, or carry-over effects observable.

CONCLUSIONS: RAGT as a single intervention was not effective in improving walking abilities in the included children. It should be embedded in a holistic treatment approach, as it cannot cover all aspects relevant to gait. Furthermore, children?s personalized rehabilitation goals should be carefully monitored with individualized measurement instruments.