Ackman 2005.

Methods	Method of randomisation: a block design randomisation sequence was used, in a way that each child enrolled in any centre was randomly assigned to 1 of the 3 groups. Randomisation stratified by topographic pattern of CP. Blinding: the evaluating clinician, parents, and children were blinded. The physician or site co‐ordinator was aware of the group to which the child had been randomised. Intention‐to‐treat analysis: yes Loss of follow‐up: 5 children 3 BoNT‐A only group 1 placebo/cast group 1 BoNT‐A/cast group Unit of analysis: child
Participants	Place: 5 centres in the USA Period of study: not described Number assigned: 39 Number assessed: 34 9 BoNT‐A only group 13 placebo/cast group 12 BoNT‐A/cast group Inclusion criteria: Spastic hemiplegic or diplegic CP Aged 3 to 10 years Independent ambulators without assistive devices Functional equinus Neutral ankle position with full knee extension Exclusion criteria: Previous surgery to tendo‐achilles or subtalar joint No BoNT‐A injections in previous 6 months Hip or knee flexion contractures > 10° Age: BoNT‐A‐only group (mean (range)): 69 (40 to 105) months Placebo/cast group (mean (range)): 68 (36 to 108) months BoNT‐A/cast group (mean (range)): 72 (41 to 99) months Gender: BoNT‐A‐only group: 6 males; 6 females Placebo/cast group: 6 males; 8 females BoNT‐A/cast group: 6 males; 7 females Motor distribution: BoNT‐A‐only group: 4 diplegia; 8 hemiplegia Placebo/cast group: 4 diplegia; 10 hemiplegia BoNT‐A/cast group: 5 diplegia; 8 hemiplegia GMFCS: BoNT‐A‐only group: 11 level I; 1 level II Placebo/cast group: 14 level I; 0 level II BoNT‐A/cast group: 12 level I; 1 level II
Interventions	All children received a total of 3 treatments, at baseline and 3 and 6 months. BoNT‐A‐only group: 3 BoNT‐A (brand not described) injections into medial and lateral heads of gastrocnemius (dose 4 U/kg to each muscle) Day and night AFOs were recommended Placebo/cast group: 3 placebo injections Cast(s) applied at each clinical visit, remained on for 3 weeks After cast removal, day and night AFOs were recommended BoNT‐A/cast group: 3 BoNT‐A injections (brand not described) into medial and lateral heads of gastrocnemius (dose 4 U/kg to each muscle) Cast(s) applied at each clinical visit, remained on for 3 weeks After cast removal, day and night AFOs were recommended
Outcomes	Length of follow‐up: Follow‐up of 12 months Assessments at baseline, 3, 6, 7.5, and 12 months Primary outcomes: Velocity and stride length Ankle kinematics Ankle dorsiflexion at initial contact Peak dorsiflexion in stance Peak dorsiflexion in swing Secondary outcomes: Spasticity (Modified Ashworth Scale and Tardieu) Passive and active ankle dorsiflexion Ankle dorsiflexion and plantarflexion strength Ankle power generation
Notes	Comments: The initial power calculations determined the need for 25 children in each group. However, even though 90 children met the inclusion criteria, the authors reported a refusal rate higher than 50%. For the purposes of this review, we decided to include only the isolated BoNT‐A and placebo/cast groups. This was done in order to comply with our protocol, which established that studies where both intervention groups received BoNT‐A injections would be excluded. The authors kindly provided raw data tables from the study upon our request. Source of funding: funded by an unrestricted educational grant by Allergan Inc. Conflicts of interest: not reported, but the grant mentioned above could be considered as a possible conflict of interest.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Comment: not described clearly, but the block sequence is likely to have been computer generated
Allocation concealment (selection bias)	Unclear risk	Comment: not described clearly, but the study authors state that the randomisation list was provided only to the individual responsible for co‐ordinating the injection procedure
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Comment: evaluating clinicians and parents were not aware whether children received BoNT‐A or placebo injections. The study authors state that parents of children in the BoNT‐A‐only group were instructed not to discuss the treatment with the assessing clinician.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Comment: individuals responsible for data analysis were blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: no missing outcome data
Selective reporting (reporting bias)	Unclear risk	Comment: the study protocol was not available. The relevant outcomes seem to have been reported.
Other bias	Unclear risk	Comment: the initial power calculations determined the need for 25 children in each group. However, even though 90 children met the inclusion criteria, the authors reported a refusal rate higher than 50%.