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. 2019 Oct 6;2019(10):CD012363. doi: 10.1002/14651858.CD012363.pub2

D'Apote 2012.

Methods Randomised, controlled, cross‐over trial
Participants Number of participants: planned enrolment of 15 in each group. At the time of reporting, 9 children (sex unknown) were included in the intervention group.
Baseline characteristics
Average age: 7.6 years
Participant inclusion criteria: not stated
Participant exclusion criteria: not stated
Interventions Group A: botulinum toxin A (6 U/kg for muscle) bilaterally in gastrocnemius + AFO + exercise
Group B: botulinum toxin A
Outcomes Primary outcome
Improvement in toe walking (defined as greater than 50% of time spent heel‐toe walking)
  • Technique: kinematics and kinetics associated with EMG and Vicon, scale not reported

  • Time frame: measures were taken at baseline, 1, 3, and 6 months.

  • Outcome type: interval


Secondary outcomes
Passive ankle dorsiflexion
  • Technique: not reported

  • Time frame: measures were taken at baseline, 1, 3, and 6 months after injection.

  • Outcome type: interval

Conflicts of interest Not reported
Funding Not reported
Notes Location: Italy (assumed)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk The article states it is a cross‐over RCT however there is nothing that states how the participants are randomised or how treatments were allocated.
Allocation concealment (selection bias) Unclear risk The article does not state the method of allocation concealment, therefore we cannot place a judgement on this.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk The article does not state if any blinding was applied to either participants or personnel.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk The article does not state if any blinding was applied.
Incomplete outcome data (attrition bias) 
 All outcomes High risk The article reports data for all participants enrolled in the study at the time of publication with reference to further participants being recruited.
Selective reporting (reporting bias) High risk No data were available for extraction.
Other bias Unclear risk The article reported interim outcome data from an incomplete study.