Summary of findings 2. BoNT‐A compared to usual care or physiotherapy in the treatment of lower limb spasticity in children with cerebral palsy: medium‐term results.

BoNT‐A compared to usual care or physiotherapy 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 lower limb muscles Comparison: usual care or physiotherapy
Outcomes	Anticipated absolute effects* (95% CI)		Relative effect (95% CI)	Number of participants (studies)	Quality of the evidence (GRADE)	Comments
	Risk with usual care or physiotherapy	Risk with BoNT‐A
Instrumented gait analysis (kinematics) (not measured)	‐	‐	‐	‐	‐	Not measured in any trial
Observational gait analysis Assessed with: PRS Follow‐up: range 12 to 16 weeks	The mean gait score in the control group was 8.93.	The mean gait score in the intervention group was 2.80 higher (1.55 higher to 4.05 higher).	‐	40 (1 RCT)	⊕⊝⊝⊝ Very lowa	Favours BoNT‐A group (higher gait scores in BoNT‐A group)
Function Assessed with: various scales (GMFM total scores,GMFM goal scores, and GAS) Follow‐up: range 12 to 16 weeks	‐	The SMD in the intervention group was 1.04SD higher (0.16 higher to 1.91 higher).	‐	191 (4 RCTs)	⊕⊝⊝⊝ Very lowb	Favours BoNT‐A group (higher function scores in BoNT‐A group). High statistical heterogeneity. Rule of thumb to interpret the magnitude of effect for the SMD: 0.2 represents a small effect, 0.5 a moderate effect, and 0.8 a large effect (Cohen 1988).
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 3.10 to 26.1 degrees.	The mean passive ankle dorsiflexion in the intervention groups was 6.36 degrees higher (4.03 higher to 8.69 higher).	‐	272 (5 RCTs**)	⊕⊝⊝⊝ Very lowc	**1 study reported on this outcome per lower limb. Favours BoNT‐A group (higher passive ankle dorsiflexion in BoNT‐A group). Note: 2 studies reported this outcome as changes from baseline.
Satisfaction (not measured)	‐	‐	‐	‐	‐	Not measured in any trial
Spasticity (ankle plantarflexors) Assessed with: various scales Follow‐up: range 12 to 16 weeks	‐	The SMD in the intervention group was 1.66 SD lower (2.88 lower to 0.43 lower).	‐	226 (3 RCTs***)	⊕⊝⊝⊝ Very lowc	***1 study reported on this outcome per lower limb. Favours BoNT‐A group (lower ankle plantarflexors spasticity in BoNT‐A group). High statistical heterogeneity. Rule of thumb to interpret the magnitude of effect for the SMD: 0.2 represents a small effect, 0.5 a moderate effect, and 0.8 a large effect (Cohen 1988).
Adverse events	‐	‐	‐	‐	‐	See Table 1
*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; GAS: Goal Attainement Scale;GMFM: Gross Motor Function Measure; PRS: Physician Rating Scale; RCT: randomised controlled trial; SD: standard deviation; SMD: standardised mean difference.
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 two levels for several potential sources of bias and one level for imprecision, since this outcome was reported by a single study with a relatively small sample size.
 ^bDowngraded two levels for several potential sources of bias and one level due to high statistical heterogeneity.
 ^cDowngraded two levels for several potential sources of bias and one level for imprecision, as the unit of analysis in one study was each lower limb.