Summary of findings 8. BoNT‐A compared to serial casting in the treatment of lower limb spasticity in children with cerebral palsy: medium‐term results.

BoNT‐A compared to serial casting in the treatment of lower limb spasticity in children with cerebral palsy: medium‐term results
Patient or population: children with CP Setting: medium‐term follow‐up (12 to 16 weeks) Intervention: BoNT‐A injections into the ankle plantarflexors Comparison: short‐leg serial casting for ankle equinus deformity
Outcomes	Anticipated absolute effects* (95% CI)		Relative effect (95% CI)	Number of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with casts	Risk with BoNT‐A
Instrumented gait analysis (peak ankle dorsiflexion in stance) Assessed with: (degrees) Follow‐up: range 12 to 16 weeks	The mean peak ankle dorsiflexion in stance in the control groups ranged from 6.30 to 6.90 in 2 studies.	The mean peak ankle dorsiflexion in stance in the intervention groups was 3.03 higher (3.56 lower to 9.62 higher).	‐	61 (3 RCTs**)	⊕⊕⊝⊝ Lowa	**2 studies reported on this outcome per lower limb. No difference between groups. Note: 1 study reported on this outcome as changes from baseline. High statistical heterogeneity
Observational gait analysis Assessed with: PRS Follow‐up: range 12 to 16 weeks	The mean gait score in the control group was 2.73.	The mean gait score in the intervention group was 0.65 higher (1.21 lower to 2.51 higher).	‐	18 (1 RCT)	⊕⊕⊕⊝ Moderateb	No difference between groups
Function Assessed with: GMFM (goal scores) Follow‐up: range 12 to 16 weeks	The mean function score in the control group was 61.41 in 1 study.	The mean function score in the intervention group was 3.64 higher (1.55 lower to 8.82 higher).	‐	41 (2 RCTs)	⊕⊕⊕⊝ Moderatec	No difference between groups. Note: 1 study reported on this outcome as changes from baseline.
Range of motion (passive ankle dorsiflexion) Assessed with: goniometry (degrees) Follow‐up: range 12 to 16 weeks	The mean passive ankle dorsiflexion in the control groups ranged from 14.62 to 18.00 in 2 studies.	The mean passive ankle dorsiflexion in the intervention groups was 1.82 higher (2.26 lower to 5.91 higher).	‐	67 (3 RCTs***)	⊕⊕⊝⊝ Lowd	***2 studies reported on this outcome per lower limb. No difference between groups. Note: 1 study reported on this outcome as changes from baseline.
Satisfaction (not measured)	‐	‐	‐	‐	‐	Not measured in any trial
Spasticity (ankle plantarflexors) Assessed with: MAS Follow‐up: range 12 to 16 weeks	The mean ankle plantarflexors score in the control groups ranged from 1.78 to 2.1.	The mean ankle plantarflexors score in the intervention groups was 0.13 higher (0.25 lower to 0.52 higher).	‐	67 (3 RCTs****)	⊕⊕⊝⊝ Lowd	****2 studies reported on this outcome per lower limb. No difference between groups
Adverse events	‐	‐	‐	‐	‐	See Table 7
*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). BoNT‐A: botulinum toxin type A; CI: confidence interval; CP: cerebral palsy; GMFM: Gross Motor Function Measure; MAS: Modified Ashworth Scale; PRS: Physician Rating Scale; RCT: randomised controlled trial.
GRADE Working Group grades of evidence High quality: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate quality: we are moderately confident in the effect estimate; the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low quality: our confidence in the effect estimate is limited; the true effect may be substantially different from the estimate of the effect. Very low quality: we have very little confidence in the effect estimate; the true effect is likely to be substantially different from the estimate of effect.

^aDowngraded one level for imprecision and one level due to statistical heterogeneity amongst studies.
 ^bDowngraded one level for imprecision, as this outcome was reported by a single study with a small sample size.
 ^cDowngraded one level for imprecision due to the small sample size.
 ^dDowngraded two levels for imprecision due to the small sample size and because two studies evaluated each limb as an independent unit of analysis.