Koman 1994.
Methods |
Method of randomisation: not described Blinding: double‐blind study Intention‐to‐treat analysis: no Loss of follow‐up: no losses to follow‐up Unit of analysis: lower limb for local measures and child for global measures |
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Participants |
Place: 1 centre in the USA Period of study: not described Number assigned: 12 Number assessed: 12
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 outcomes:
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Notes |
Comments:
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) | Unclear risk | Comment: not described |
Allocation concealment (selection bias) | Unclear risk | Comment: not described |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Comment: double‐blind study |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: outcome assessors were blind to group allocation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: no missing outcome data |
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 |