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 |
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Interventions | Group A: botulinum toxin A (6 U/kg for muscle) bilaterally in gastrocnemius + AFO + exercise Group B: botulinum toxin A |
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Outcomes |
Primary outcome Improvement in toe walking (defined as greater than 50% of time spent heel‐toe walking)
Secondary outcomes Passive ankle dorsiflexion
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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. |