Bjornson 2007.

Methods	Method of randomisation: block randomisation stratified by age and the use of oral baclofen. Sequence generation method not described Blinding: the investigators, study co‐ordinators, physical therapists, and participants were blinded to the intervention Intention‐to‐treat analysis: no Loss of follow‐up: no Unit of analysis: child
Participants	Place: 1 centre in the USA Period of study: October 1997 to September 2001 Number assigned: 33 Number assessed: 33 17 BoNT‐A group 16 placebo group Inclusion criteria: Spastic diplegic CP Aged 3 to 12 years Community or indoor ambulators No fixed musculoskeletal deformities Stable social environment Ongoing physical therapy Clinical indication for gastrocnemius block Exclusion criteria: See above Age: BoNT‐A group (mean (SD)): 5.38 (2.06) Placebo group (mean (SD)): 5.55 (2.52) Gender: BoNT‐A group: 70% males; 30% females Placebo group: 37% males; 63% females Motor distribution: Only spastic diplegia GMFCS: BoNT‐A group: 47% level I; 41% level II; 12% level III Placebo group: 25% level I; 50% level II; 25% level III
Interventions	BoNT‐A group: Single BoNT‐A injection (onabotulinumtoxinA) into the medial and lateral heads of gastrocnemius (12 U/kg) Orthotic type, PT regimen, and the need for serial casting were not controlled Placebo group: Sham injection of normal saline into the gastrocnemius Orthotic type, PT regimen, and the need for serial casting were not controlled
Outcomes	Length of follow‐up: Follow‐up of 24 weeks Assessments at baseline, 3, 8, 12, and 24 weeks Primary outcomes: Total and elastic path length (spasticity measurement system) GMFM‐66 and GMFM‐88 Secondary outcomes: Quantitative electromyographic kinesiology Ashworth Deep tendon reflexes Clonus Ankle passive range of motion Maximum voluntary torque Energy cost index Canadian Occupational Performance Measure Goal Attainment Scaling
Notes	Comments: Low enrolment rate (55%) Source of funding: National Center for Medical Rehabilitation Research and National Institutes of Health (RO1 HD35750). BoNT‐A was provided without charge by Allergan. Conflicts of interest: not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Comment: sequence generation not described
Allocation concealment (selection bias)	Unclear risk	Comment: allocation method not clearly described
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Comment: the investigators, study co‐ordinators, physical therapists, and participants were blinded to the intervention
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Comment: the outcome assessors were blinded to the intervention
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: no incomplete outcome data
Selective reporting (reporting bias)	Unclear risk	Comment: study protocol not available. Most of the relevant outcomes were reported.
Other bias	Unclear risk	Comment: the study authors describe an inclusion rate of 55% of all eligible patients