Does botulinum neurotoxin A make walking easier in children with cerebral palsy? A randomized clinical trial.

It aimed for 96 participants but randomised 61, so the results are less reliable than intended. Recruitment was affected by the pandemic and by families' fear of missing an established treatment. Most children were at GMFCS level I, so the findings may not apply to children who need more support to walk. GMFCS levels were unevenly distributed between groups, which may have influenced the estimated effect. Participants received only one injection, so repeated injections may have a different effect on walking. The wide age range may have made it harder to detect a true effect, and younger children with dynamic contractures may respond differently. Some participants had previous botulinum toxin treatment and may not have been free of its effects at inclusion. No adjustment was made for many outcome tests, so the calf pain finding could be chance.

The study was funded by the Faculty of Medicine and Health Sciences at the Norwegian University of Science and Technology. It was described as independent of the drug industry, with monitoring independent of the sponsor and no competing interests.

Do not conclude that botulinum toxin makes walking easier because the toxin group had a within-group drop in energy cost at the later visit. The difference between toxin and placebo was not significant, the primary outcome was null, and the study did not reach its planned sample size.