Summary of findings 7. BoNT‐A compared to serial casting in the treatment of lower limb spasticity in children with cerebral palsy: short‐term results.
| BoNT‐A compared to serial casting in the treatment of lower limb spasticity in children with cerebral palsy: short‐term results | ||||||
| Patient or population: children with CP Setting: short‐term follow‐up (2 to 8 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) (degrees) Follow‐up: range 2 to 8 weeks | The mean peak ankle dorsiflexion in stance in the control group was 8.70. | The mean peak ankle dorsiflexion in stance in the intervention group was 0.60 lower (5.78 lower to 4.58 higher). | ‐ | 21 (1 RCT) | ⊕⊕⊝⊝ Lowa | No difference between groups |
| Observational gait analysis Assessed with: PRS Follow‐up: range 2 to 8 weeks | The mean gait score in the control group was 2.87. | The mean gait score in the intervention group was 0 higher (1.66 lower to 1.66 higher). | ‐ | 18 (1 RCT) | ⊕⊕⊕⊝ Moderateb | No difference between groups |
| Function Assessed with: GMFM (goal scores) Follow‐up: range 2 to 8 weeks | The mean function score in the control group was 60.15. | The mean function score in the intervention group was 2.01 higher (23.31 lower to 27.33 higher). | ‐ | 18 (1 RCT) | ⊕⊕⊕⊝ Moderateb | No difference between groups |
| Range of motion (ankle dorsiflexion) Assessed with: goniometry (degrees) Follow‐up: range 2 to 8 weeks | The mean passive ankle dorsiflexion in the control group was 13.70. | The mean passive ankle dorsiflexion in the intervention group was 1.77 higher (4.25 lower to 7.79 higher). | ‐ | 18 (1 RCT**) | ⊕⊕⊝⊝ Lowc | No difference between groups. **1 study reported on this outcome per lower limb. |
| Satisfaction (not measured) | ‐ | ‐ | ‐ | ‐ | ‐ | Not measured in any trial |
| Spasticity (ankle plantarflexors) Assessed with: MAS Follow‐up: range 2 to 8 weeks | The mean ankle plantarflexors score in the control group was 1.60. | The mean ankle plantarflexors score in the intervention group was 0.20 lower (0.81 lower to 0.41 higher). | ‐ | 18 (1 RCT***) | ⊕⊕⊝⊝ Lowc | No difference between groups. ***1 study reported on this outcome per lower limb. |
| Adverse events | Study population | RR 0.59 (0.03 to 11.03) | 64 (3 RCTs) | ⊕⊕⊝⊝ Lowd | No difference between groups. Adverse events for all studies (multiple follow‐up times). High statistical heterogeneity | |
| 667 per 1000 | 393 per 1000 (20 to 1000) | |||||
| *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; RR: risk ratio. | ||||||
| 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 imprecision, as this outcome was reported by a single study with a small sample size and was available only for some of the participants. bDowngraded one level for imprecision, as this outcome was reported by a single study with a small sample size. cDowngraded two levels for imprecision, as this outcome was reported by a single study with a small sample size, and the study reported each lower limb as the unit of analysis for this outcome. dDowngraded one level for high statistical heterogeneity amongst studies and one level for imprecision due to a relatively small sample size and small number of events.