Summary of findings 9. BoNT‐A compared to serial casting in the treatment of lower limb spasticity in children with cerebral palsy: long‐term results.
BoNT‐A compared to serial casting in the treatment of lower limb spasticity in children with cerebral palsy: long‐term results | ||||||
Patient or population: children with CP Setting: long‐term follow‐up (> 24 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 6 to 24 months |
The mean peak ankle dorsiflexion in stance in the control group was 5.20. | The mean peak ankle dorsiflexion in stance in the intervention group was 2.00 lower (8.50 lower to 4.50 higher). | ‐ | 26 (1 RCT) | ⊕⊕⊕⊝ Moderatea | No difference between groups |
Observational gait analysis Assessed with: PRS Follow‐up: range 6 to 24 months | The mean gait score in the control group was 2.67. | The mean gait score in the intervention group was 0.46 higher (1.33 lower to 2.25 higher). | ‐ | 18 (1 RCT) | ⊕⊕⊕⊝ Moderatea | No difference between groups |
Function Assessed with: GMFM (goal scores) Follow‐up: range 6 to 24 months | The mean function score in the control group was 64.57. | The mean function score in the intervention group was 2.02 lower (26.85 lower to 22.81 higher). | ‐ | 18 (1 RCT) | ⊕⊕⊕⊝ Moderatea | No difference between groups |
Range of motion (passive ankle dorsiflexion) Assessed with: goniometry (degrees) Follow‐up: range 6 to 24 months | The mean passive ankle dorsiflexion in the control groups ranged from 14.00 to 14.87. | The mean passive ankle dorsiflexion in the intervention groups was 1.02 lower (5.63 lower to 3.58 higher). | ‐ | 44 (2 RCTs**) | ⊕⊕⊝⊝ Lowb | **2 studies reported on this outcome per lower limb. No difference between groups |
Satisfaction (not measured) | ‐ | ‐ | ‐ | ‐ | ‐ | Not measured in any trial |
Spasticity (ankle plantarflexors) Assessed with: MAS Follow‐up: range 6 to 24 months | The mean ankle plantarflexors score in the control groups ranged from 1.87 to 2.30. | The mean ankle plantarflexors score in the intervention groups was 0.17 higher (0.34 lower to 0.67 higher). | ‐ | 44 (2 RCTs***) | ⊕⊕⊝⊝ Lowb | ***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, as this outcome was reported by a single study with a small sample size. bDowngraded two levels for imprecision due to the small sample size and because two studies evaluated each limb as an independent unit of analysis.