Discussion This study’s comparison of the Lokomat intervention with a gait-related PT program is the first randomized trial that we are aware of in paediatric CP that incorporates a broad set of outcomes spanning the body structure/function, activity and participation aspects of the ICF-CY (World Health Organization 2007) as well as health-related quality of life (McDougall et al. 2010). To address co-intervention limitations in previous trials, RAGT is being delivered in isolation of other therapies. Group comparisons will be strengthened by having comparable group size, using a therapy intensity and duration designed to promote functional change with time for learning and transfer into daily life. The inclusion of individualized goals and use of outcomes reflective of real-life activity and participation are unique to this study. The detailed reporting of intervention protocols and individual goals will permit operationalization of therapy, extending potential benefits beyond the study cohort and informing transfer of the intervention approach into clinical practice. The intervention session design is strengthened by the input and experience of participating PTs from the CDP clinical area. The evaluation of an order effect (Lokomat or PT first) may provide important insights into clinical integration of Lokomat therapy with gait-related PT. For example, if overall gross motor outcomes are better when Lokomat therapy is given before a block of PT (e.g., quality gains on the Lokomat can be used to set the stage for functional and participation gains with PT), this may be of value when determining the sequencing of blocks of therapy to achieve gait-related goals.
If efficacious, RAGT holds promise for transforming treatment for children with CP and other neurological disorders by potentially making walking therapy more stimulating and engaging as well as more inclusive of a range of children. We expect our results to inform further research with children with other neurological disorders such as acquired brain injury and spinal cord injury, in addition to a multi-centre factorial design study with children with CP. The findings of the trial will be disseminated through peer-reviewed journals, national and international conferences. Strategies to integrate motor learning principles into practice will be communicated to physiotherapists through in-person workshops, informed by analysis of session content using the MLSRI (Kamath et al. 2012). Upon trial completion, a summary of findings will be communicated to participants and families. Intervention protocols will be reported in detail, with results reported in accordance with CONSORT guidelines.