Abstract: Four studies, comprising 104 participants, met the inclusion criteria. One study did not report data within the appropriate follow-up timeframe and data from two studies were insufficient for analysis. The single study from which we extracted data had 47 participants and was a randomised, controlled, parallel-group trial conducted in Sweden. It tested the hypothesis that combined treatment with serial casting and botulinum toxin type A (BTX) was more effective than serial casting alone in reducing ITW gait. This study found that more participants treated with BTX improved (defined as toe walking less than 50% of the time, as reported by parents) (risk ratio (RR) 1.21, 95% confidence interval (CI) 0.57 to 2.55; 1 trial, 46 participants; very low-certainty evidence). However, there was little or no difference between groups in passive ankle joint dorsiflexion range of movement on the right with the knee extended (mean difference (MD) -1.48º, 95% CI -4.13 to 1.16; 1 trial, 47 participants), on the right with the knee flexed (MD -0.04º, 95% CI -1.80 to 1.73; 1 trial, 46 participants), on the left with the knee flexed (MD 1.07, 95% CI -1.22 to 3.37), or on the left with the knee extended (MD 0.05, 95% CI -0.91 to 1.91). Nor was there a clear difference between the groups in recurrence of toe-walking gait (assessed via severity of toe walking (graded 1 (mild), 2 (moderate), or 3 (severe)) on gait analysis, analysed as continuous data: MD 0.34 points, 95% CI -0.09 to 0.78; 46 participants). In principle, MDs greater than zero (i.e.) positive values) would favour BTX and casting and negative values would favour casting alone. We have not reported effects as better or worse because all results were from evidence of very low certainty. We downgraded the certainty of evidence because of study limitations (outcome assessment was not blinded) and imprecision. Outcomes of pain and active range of motion were not reported in the included study. In terms of adverse events, calf pain was reported twice in the casting-only group and three times in the BTX group. There were three minor skin problems in each group and one reported case of pain directly after BTX injection. The report did not state if calf pain and skin irritation were from the same or different participants. The study authors reported that adverse events did not alter treatment adherence. The certainty of evidence from one study, which compared serial casting with serial casting with BTX for ITW in children, was too low for conclusions to be drawn. A further three studies reported outcomes relating to BTX, footwear, exercises, and different types of orthoses as interventions, however the outcome data were too limited to assess their effects.

Plain-language summary: Four trials met the inclusion criteria. They included a total of 104 people; however, three trials did not provide results that we could include in the review. (One trial studied different kinds of foot orthoses, which are in-shoe devices that redistribute force and change gait), and two investigated the effects of adding botulinum toxin injections to various treatments such as stretching, exercises, splints, and footwear.) This review therefore only included the results of one trial, in which 47 children (aged between 5 and 14.5 years) received treatment with either plaster casts alone or plaster casts and injections of botulinum toxin A (BTX) into calf muscles. The study reported how much the children toe walked (based on their parents' observation), any change in ankle range of movement, and relapse (whether the children were still toe walking 12 months after treatment). The included study took place in Sweden and was not funded by anyone with a commercial interest in the results of the study. The evidence was too uncertain to determine whether or not there were differences in outcomes (amount of toe walking observed by parents, range of movement at the ankle, or recurrence of toe walking at 12 months) between children who received plaster casts and injections of BTX into calf muscles, compared to those who received plaster casts alone. There were small numbers of adverse events in both groups, including calf pain and minor skin problems during treatment. The available evidence is too uncertain to determine whether treatment with BTX injections and plaster casts are any more effective than just plaster casts in children with toe walking not associated with a medical condition. The limited evidence found in this review indicates a need for future research on treatments for this condition.