Mall 2006.
Methods |
Method of randomisation: randomisation done using a predetermined list Blinding: both participants and assessors blinded to the intervention Intention‐to‐treat analysis: yes Loss of follow‐up: 4 children lost to follow‐up BoNT‐A group:
Placebo group:
Unit of analysis: not described |
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Participants |
Place: 9 centres in Germany and 1 centre in Austria Period of study: not described Number assigned: 61 Number assessed: 57
Inclusion criteria:
Exclusion criteria:
Age:
Gender:
Motor distribution:
GMFCS:
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Interventions |
BoNT‐A group:
Placebo group:
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Outcomes |
Length of follow‐up:
Primary outcome:
Secondary outcomes:
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Notes |
Comments: none Source of funding: not reported Conflicts of interest: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Comment: randomisation was done using a predetermined list |
Allocation concealment (selection bias) | Low risk | Quote: "The master list was kept confidential by the drug supplier" |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Comment: both participants and personnel were blinded to the intervention |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: outcome assessors were blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: all predetermined outcomes were described in the results, but no means, SD, or P values were given for most of the non‐significant results. This was likely due to space restrictions in the journal. |
Selective reporting (reporting bias) | Unclear risk | Comment: study protocol not available. It appears that the relevant outcomes were addressed. |
Other bias | Low risk | Comment: no other sources of bias identified |